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JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

.DentalCare Dental Implant System is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare Dental Implant System is intended for immediate function on single tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. When a one-stage surgical approach is applied, the immediately loaded when good primary stability is achieved and the functional load is appropriate.

Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

JDental Care implant system JDIcon 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single stage or two stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations

JDentalCare S.r.l. manufactures Dental Implant Systems made by Endosseous Dental Implants, Abutment and related accessories, in order to support dentist in performing Dental Implant Surgery.

In order to grant Dentists with a wide range of prosthesis solution, the JDentalCare® Dental Implant System are proposed with different trade name within families lines JDEvolution® plus, JDIcon®, JDIcon® plus, characterized mainly by same mechanical and surface treatment solution and different measure of the hexagon in the connection system. All families have the internal hexagon connection.

JDentalCare® Dental Implant System is a two-piece implant made of commercially pure titanium. The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis.

The connection is done through an internal hexagon: abutment and other accessories are exclusively designed for JDentalCare® Dental Implant System.

The provided text is a 510(k) Premarket Notification for a dental implant system. It details the device's description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about an AI/ML-enabled medical device.

Therefore, I cannot extract information related to acceptance criteria and the study proving the device meets those criteria for an AI/ML device, as the document describes a physical dental implant system and not an AI/ML product.

The sections regarding acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training sets are all relevant to the evaluation of AI/ML models. Since this document is about a physical medical device (dental implants), these concepts are not applicable in this context.

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For Standard Length IBR36d Implant Range:

Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

When using Southern Implants' Standard Length IBR36D Implants with angulation of 36° a minimum of 4 implants must be used and splinted

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

For Extra Length IBR36d Implant Range:

Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

Extra Length IBR36d Implants can be placed bicortically in cases of reduced bone density. Extra Length IBR36d Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Extra Length IBR36d Implants are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

For Extra Length IBR24d Implant Range:

Southern Implants' External Hex Implants are intended for surgical placement in the upper jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

Southern Implants' Extra Length IBR24d Implant Range when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

External Hex implants are fully-threaded, tapered, root-form dental implants with an external hexagonal abutment interface, and are threaded internally for attachment of mating multiple-unit abutments, cover screws, or healing abutments. The External Hex implants have a Co-Axis design with the prosthetic platform angled at 36° and 24° (inclined) from orthogonal to the long axis of the implant.

Additionally, the External Hex implants are provided in two configurations, regular surface and MSC surface implants. The regular surface implants are fully roughened excluding a machined collar at the coronal aspect of the implant. The MSC surface implants have an extended length of machined area at the coronal aspect of the implant, with the remaining implant length being roughened.

The implants subject to this submission are the External Hex IBR36d and IBR24d implant range. The reduced platform MSC-IBR24d implants are only provided as Co-Axis implants, in both the regular surface and MSC surface configuration. The reduced platform IBR36d implants are only provided as Co-Axis implants, in regular surface configuration. The IBR36d implants are available in two body configurations depending on the implant length.

The IBR36d implants of overall lengths 8.5 mm to 18 mm have a major body diameter of 4.20 mm tapering to 2.60 mm. The IBR36d implants of overall lengths 20 mm to 24 mm have a major body diameter of 4.20 mm tapering to 2.00 mm. Both the IBR24d and MSC-IBR24d implants of overall lengths 20 mm have a major body diameter 4.07 mm tapering to 2.60 mm. All of the subject device implants utilize the same prosthetic connection, previously cleared in K163634.

All External Hex implants are manufactured from unalloyed titanium (cold-worked, grade 4, UTS ≥ 900 MPa). The MSC-IBR24d implants have a smooth machined surface of length 3 mm extending parallel from the implant prosthetic platform for all implant lengths. The remainder of the implant is grit-blasted with aluminum oxide particles to provide a surface roughness of 1-2 um. The subject device implant material and surface are identical to those of the implants cleared in K163634.

The IBR36d and IBR24d External Hex implants are provided with a dedicated pre-mounted fixture mount of 36° and 24 respectively, similar to that provided with the other Co-Axis External Hex implants cleared in K163634.

All of the subject device implants utilize the same prosthetic connection, previously cleared in K163634 for the External Hex IBR24d and MSC-IBR24d implants. The External Hex implants are used in conjunction with the same abutments cleared for use with the External Hex IBR24d implants (implants cleared in K163634). These abutments are cleared in K053478, K070841, K093562, and K163634. The components that are compatible with the External Hex implants include Cover Screw, Healing Abutment, and Compact Conical Abutments. The Compact Conical Abutments are compatible with Temporary Titanium Abutment Cylinders, Gold Abutment Cylinders, and Passive Abutments.

The subject device Co-Axis implants are indicated for use with straight multiple-unit abutments with a 0° allowable restoration angle, only. This includes restricting straight abutments, that can be restored on a multi-unit abutment, that have an allowable restoration angle of up to 20° associated with them, so that they may only have a restoration angle of 0°. Thus, all the possible compatible abutments will have a 0° allowable restoration angle.

All External Hex implants are provided sterile to the end-user in a single-unit package, and are for single-patient, single-use only.

The provided text describes the 510(k) summary for the "External Hex Implant System" and references performance data to support its substantial equivalence to legally marketed predicate devices. However, it does not contain explicit "acceptance criteria" for the device, nor a study design with specific performance metrics against those criteria in the way typically seen for AI/ML device evaluations.

Instead, the document focuses on demonstrating substantial equivalence based on non-clinical performance data (mechanical testing and biocompatibility) and clinical literature review. The clinical literature review is used to show that similar devices with comparable characteristics (e.g., angulation, length) have proven safe and effective.

Therefore, I cannot directly provide a table of acceptance criteria and reported device performance with specific metrics like sensitivity, specificity, or AUC, as these are not defined or reported in the provided text. The "performance" discussed relates to the device's mechanical strength and the success rates of similar implants documented in clinical literature, not an AI algorithm's diagnostic performance.

However, I can extract the relevant information regarding the studies referenced to support the device's safety and effectiveness, interpreting "acceptance criteria" as the demonstration of substantial equivalence through various assessments:

Interpretation of "Acceptance Criteria" for this device:

For this device, "acceptance criteria" are not quantitative performance metrics in the traditional sense for diagnostic AI. Instead, they are met by demonstrating the device's substantial equivalence to legally marketed predicate devices through:

• Biocompatibility: Conformance to ISO 10993-1.
• Mechanical Performance: Conformance to ISO 14801 (static and dynamic compression-bending fatigue test), with results showing sufficient strength for intended use.
• Sterilization: Conformance to ISO 11137-1, ISO 11137-2, and USP 39-NF 34 for bacterial endotoxin.
• Dimensional Analysis: Verification of critical dimensions.
• Clinical Safety and Performance (via Literature Review): Demonstrated favorable survival rates and clinical indices for comparable implants under similar conditions and specifications (length, angulation, loading protocols). This implicitly acts as an "acceptance criterion" for clinical effectiveness by showing established safety and effectiveness of similar devices.
• MR Safety: Conformance to FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (ASTM F2503, ASTM F2013, ASTM F2182, ASTM F2119).

Summary of Information from the Provided Text:

1. Table of "Acceptance Criteria" (interpreted as equivalence demonstration points) and "Reported Device Performance":

| Area of "Acceptance Criteria" (Demonstration of Equivalence) | Reported Device Performance / Evidence |
| Biocompatibility | Evaluated according to ISO 10993-1 (referenced from K163634). |
| Mechanical Performance (Static & Dynamic Compression-Bending) | Testing to ISO 14801 was performed on representative worst-case constructs for angulation and abutment/screw materials. Twelve (12) samples for each subject device group were subjected to fatigue testing. The fatigue limit was determined to be where a total of three (3) samples endured 5 x 10^6 cycles with no failures. Results confirmed that the strength of the subject device is sufficient for its intended use. |
| Sterilization & Shelf Life | Sterilization according to ISO 11137-1, ISO 11137-2. Bacterial endotoxin according to USP 39-NF 34. Sterile barrier shelf life (referenced from K222457). |
| Dimensional Analysis | Performed. (No specific values reported in this section, but implied to meet design specifications). |
| Clinical Safety & Performance (Standard Length IBR36d) | Retrospective analysis of real-world clinical data (literature review). The literature review demonstrated that implants with lengths of 7-18mm and angulation range of 20-50° as part of a splinted approach showed similar success rates to standard implants. Survival rates and clinical indices were favorable in both maxillary and mandibular applications, with immediate and delayed loading protocols. The subject device (8.5-18mm lengths, 36° angle) falls within this "window of successful implants." |
| Clinical Safety & Performance (Extra Length IBR36d) | Retrospective analysis of real-world clinical data (literature review). The literature review supported the use of long implants (10-25mm) placed at angles of 15-90° in the pterygoid region, showing similar success rates to standard implants. The subject device (20-24mm lengths, 36° angle) falls within this "window of successful implants." |
| MR (Magnetic Resonance) Safety | MR safety testing (ASTM F2503, F2013, F2182, F2119) was performed on previously cleared devices (referenced from K222457). The subject devices are considered equally MR Safe as the predicate devices because they are not worst-case components in terms of material, size, or shape. |

2. Sample Size and Data Provenance for Test Set (Clinical Literature Review):

• Standard Length IBR36d: A retrospective analysis of real-world clinical data was conducted by reviewing 14 clinical literature articles.

  • Sample Size (Patients/Implants, per article):
    • Article 1: Not specified, but follow-up up to 17 years.
    • Article 2: Not specified (100% survival rate), follow-up 3 years (42 months).
    • Article 3: Not specified (98.7% survival rate), follow-up 3 years.
    • Article 4: Not specified (96.1% and 95.7% survival rates), follow-up 5 years.
    • Article 5: "High level of implant failures (10%), however; the same number of tilted implants and straight implants failed." Follow-up 1 year.
    • Article 6: Not specified (96.6% survival rate), follow-up 5 years.
    • Article 7: Not specified (94.5% survival rate), follow-up 7 years.
    • Article 8: Not specified (94.8% survival rate), follow-up 10 years.
    • Article 9: Not specified (98.1% for tilted implants), follow-up 3 years.
    • Article 10: Not specified (93.9% cumulative survival rate), follow-up 5-13 years.
    • Article 11: Not specified (93% survival rate), follow-up 18 years.
    • Article 12: Not specified (100% survival rate for tilted implants), follow-up 13 months.
    • Article 13: Not specified, follow-up 3 years (42 months).
    • Article 14: Not specified (100% survival rate), follow-up 3 years (42 months).
    • Note: Specific sample sizes (number of patients or implants) for each referenced article are generally not provided in the summary, which is common for literature reviews used in 510(k) submissions to support equivalence.
  • Data Provenance: Retrospective analysis of real-world clinical data (published literature). The country of origin of the data is not specified for individual studies but can be inferred from the journal names and author affiliations in the references (e.g., Clinical Oral Implants Research, Odontology, Journal of Oral Implantology, Clin Implant Dent Rel Res, European Journal of Oral Implantology, The Journal of the American Dental Association, Dentistry Journal).

• Extra Length IBR36d: A retrospective analysis of real-world clinical data was conducted by reviewing 5 clinical literature articles.

  • Sample Size (Patients/Implants, per article):
    • Article 1: "Many authors have reported success rates of pterygoid implants ranging from 90% to 100% after follow-up period ranging from 1 to 12 years."
    • Article 2: "Thirteen articles were included, reporting a total of 1053 pterygoid implants in 676 patients."
    • Article 3: "121/125 of the implants were considered successful" after 2 years.
    • Article 4: "A total of 634 patients received 1,893 pterygoid implants."
    • Article 5: Not specified (93.9% survival rate), follow-up 3 years.
  • Data Provenance: Retrospective analysis of real-world clinical data (published literature). The country of origin of the data is not specified for individual studies but can be inferred from the journal names and author affiliations in the references (e.g., International Journal of Contemporary Dental and Medical Reviews, Journal of Oral Implantology, Dent Adv Res, Journal of Craniomaxillofacial Surgery, International Journal of Oral Maxillofacial Implants).

3. Number of Experts and Qualifications for Ground Truth: No direct "ground truth" establishment by experts for specific cases in the context of an AI algorithm is mentioned in this document. The clinical studies cited in the literature review represent real-world clinical outcomes and expert clinical practice by the authors of those papers. Their original reports would have involved clinical expertise to determine success/failure, bone loss, etc.

4. Adjudication Method: Not applicable. This document relies on published clinical literature, not an internal test set requiring adjudication for ground truth. The adjudication method, if any, would have been part of each individual study in the literature review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This document does not pertain to an AI algorithm or human-in-the-loop performance. It describes a physical dental implant device.

6. Standalone (Algorithm Only) Performance Study: No. This document describes a physical dental implant device, not an algorithm.

7. Type of Ground Truth Used (for Clinical Performance): The "ground truth" for the clinical performance claims is derived from real-world clinical outcomes data reported in the referenced scientific literature. This includes:
* Implant survival rates
* Marginal bone loss (MBL)
* Clinical indices (e.g., pain, prosthetic mobility, bleeding, discomfort)
* Success rates of implants under various loading protocols (immediate/delayed) and angulations.

8. Sample Size for the Training Set: Not applicable. This document describes a physical dental implant system, not a machine learning model that requires a training set. The "training" for the device's design would be engineering principles, material science, and clinical experience/literature.

9. How the Ground Truth for the Training Set was Established: Not applicable, as it's not an AI/ML device.

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Blue Sky Bio Multi One Implant System is intended for surgical placement in the bone of the upper or lower jaw to provide support for prosthetic devices to restore chewing function. Implants may be used with single-stage or two-stage procedures. They can be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Multi One Implants are indicated for multiunit restorations in splinted applications. Blue Sky Bio Multi One Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.

Blue Sky Bio Long Implant System is intended for surgical placement in the bone of the upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. Implants may be used with single-stage or two-stage procedures, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Long implants can be placed bicortically in cases of reduced bone density. Blue Sky Bio Long implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Blue Sky Bio Long Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.

Blue Sky Bio PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

Blue Sky Bio BIO|MAX MULTI ONE Implants include a one-piece implant/abutment construct provided with body diameters of 3.0 mm to 4.3 mm. in multiple lengths from 10 mm to 20 mm. They are provided with a head angulation of 17°, 30°, or 45°. Multi One Implants with body diameters of 3.5 mm and 4.3 mm, in lengths ranging from 10 mm to 20 mm with a 45° angulation are indicated for the pterygoid region only. Implant body diameters of 3.0 mm and 3.25 mm are only intended for the alveolar ridge and not intended for placement in the pterygoid region.

Blue Sky Bio BIO|LONG implants and BIO|MAX MULTI ONE LONG implants include implant lengths designed for placement into the posterior maxillary region. including the pterygoid plate. The implants have one of three connections, an internal hexagon interface (3.5 mm platform), a tapered internal hexagon interface (NP platform) or a Multi One one-piece design. The implants are provided with a body diameter of 3.7 mm to 5.0 mm in implantable lengths ranging from 20 mm to 25 mm. BIO|MAX MULTI ONE LONG implants are provided with a head angulation of 17°, 30°, or 45°. Blue Sky Bio BIO/LONG implants and BIQIMAX MULTI ONE LONG implants are intended to be used with the TILT procedure in the maxilla as shown in the clinical literature. Implants with 45° angulation are indicated for the pterygoid region only. BIOJINTERNAL HEX LONG implants (3.5 mm Platform) are for use with abutments of up to 30° only.

Details of specific implant diameters and lengths are outlined in the table below. Abutment screws compatible with the BIOJLONG Implants were cleared in K060957. K102034 and K190491.

Blue Sky Bio PEEK abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation. Subject device PEEK abutments are provided with two implant/abutment connections, BIO|INTERNAL HEX (3.5 mm Platform) and BIO|MAX (NP).

The subject device implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Previously cleared abutments and abutment screws are made of material conforming to ASTM F136. Temporary PEEK abutments are made from TECAPEEK conforming to ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.

The Blue Sky Bio Implant System (K212785) is a dental implant system. The document does not explicitly state acceptance criteria or a formal study that proves the device meets specific acceptance criteria in the typical sense of a clinical trial with predefined endpoints and statistical analysis. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance testing and a review of existing clinical literature.

Here's a breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria with corresponding reported device performance in terms of clinical outcomes (e.g., success rates, marginal bone loss) derived from a dedicated study of the subject device. Instead, it relies on:

• Non-clinical performance test data demonstrating compliance with ISO standards and FDA guidance for dental implants.
• Clinical literature review to support the safety and effectiveness of similar implant dimensions and placement techniques, concluding that the subject device's dimensions and indications do not raise new questions of safety and effectiveness.

Here's a summary of the non-clinical performance and the basis of equivalence:

2. Sample Size Used for the Test Set and the Data Provenance

• Non-clinical tests: The document does not specify sample sizes for the non-clinical tests. For leveraged data (packaging, sterilization, material biocompatibility), the sample sizes would refer to those used for the predicate devices, which are not detailed here. For fatigue, the ISO standard typically specifies a minimum number of samples (e.g., 11 per group for staircase method).
• Clinical Literature Review (not a "test set" in the traditional sense): This is a review of retrospective and prospective studies already published in scientific literature. The data provenance is global, as scientific literature authors are not limited by country. The "test set" here refers to the patient cohorts described in the reviewed articles, which would vary significantly. For example, one article mentions "1053 pterygoid implants in 676 patients" (Article 7).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable as there was no dedicated clinical "test set" with a pre-established ground truth. The submission relies on scientific literature published by various researchers and clinicians, implicitly accepted by the regulatory body as supporting evidence.

4. Adjudication Method for the Test Set

Not applicable, as there was no dedicated clinical "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a dental implant system, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a physical medical device (dental implant).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the safety and effectiveness claims related to clinical use (e.g., implant success rates, complications, bone loss), the "ground truth" is derived from the clinical outcomes data reported in the published scientific literature that was reviewed. This literature typically involves various forms of clinical follow-up, radiographic assessment, and professional judgment by the treating clinicians/researchers in those studies.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with < 7 mm length are for delayed loading only when appropriate stability has been achieved. MUA Xeal: The MUA Xeal is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. On1 Base Xeal: The On1 Base Xeal device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base Xeal, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAM software, ceramic material, milling machine and associated tooling and accessories.

Onl Universal Abutment (previously cleared by K181869) The Onl 11M device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The Onl Universal Abutunent consist of three major parts. Specifically, the Onl Base, the Onl Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material , milling machine and associated tooling and accessories.

TREFOIL System (previously cleared per K172352) The TREFOIL System is used to restore chewing function in fully edentulous mandibles. The three implants of the Trefoil Implants are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol. The following prerequisites must be fulfilled: -Adequate quantity of bone (minimum height of 13 mm implant and 14.5 mm for 13.0implant and minimum width of 6-7 mm). -Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. -Implant-supported prosthetics seated directly on dedicated implants

Healing Cap Multi-Unit Titanium (previously cleared per K171142) The Healing Cap Multi-unit Titanium is a premanufactured prosthetic component to be directly connected to the dental abutment during soft tissue healing to protect the internal connection of the abutments and prepare the soft tissue for the prosthetic procedure. Maximum intra-oral use is 180-days.

TREFOIL System (previously cleared per K170135) The Trefoil system is used to restore chewing function in fully edentulous mandibles. The three implants of the Trefoil system are placed between the mental foramina in fully edentitious mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol. The following prerequisities must be fulfilled: - Adequate quantity of bone (minimum width of 7 mm; and minimum heights of 13 mm implant and 14.5 mm for 13.0 mm implant) -Adequate mouth opening (minimum 40 mm) to accomodate the guided surgery intruments. -Implant-supported prosthetics seated directly on dedicated implants

Onl Concept (previously cleared per K161655) The On 17M device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

NobelZygoma 0° (previously cleared per K 161598) Nobel Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Temporary Snap Abutment (previously cleared per K161435) The Temporary Snap Abutment is intended to be used to fabricate and support provisional restorations that and in creating an esthetic emergence through the gingiva during period and prior to final restoration. The Temporary SnapAbutment can be used for cement retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Temporary Snap Abutiment is not to exceed one hundred and eighty(180) days.

Multi-Unit Abutment Plus (previously cleared per K161416) The Multi-unit Abutment Plus is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

NobelProcera HT ML FCZ Implant Bridge and Framework (previously cleared per K160158) The NobelProcera HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

NobelSpeedy Groovy (previously cleared per K160119) NobelSpeedy® Groovy implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelSpeedy® Groovy implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants allow also for bicortical anchorage in cases of reduced bone density. NobelSpeedy® Groovy implants 20, 22, 25 mm when placed in the maxilla are only indicated for multiple unit restoration in splinted applications that utilize at least two implants.

TREFOIL System (previously cleared per K152836) The TREFOIL System is used to restore chewing function in fully edentulous mandibles. The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is acheved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol. The following prerequisites must be fulfilled: -Adequate quantity of bone (minimum height of 13 mm and minimum width of 6-7 mm). -Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. -Implant-supported prosthetics seated directly on dedicated implants

NobelZygoma 45° (previously cleared per K152093) Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthelies and chewing finction. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied.

NobelActive Wide Platform (WP) ( previously cleared per K133731) Nobel Biocare's NobelActive implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient estherics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

NobelProcera Overdenture Bar (previously cleared per K132749) The NobelProcera Overdenture Bar is indicated for use as an overdenture bar that attaches to implants in the treatment of partially or totally edentulous jaws for the purpose of restoring function.

NobelProcera Angulated Screw Channel Abuttment Conical Connection (previously cleared per K 132746) The NobelProcera Angulated Screw Channel Conical Connection are premanufactured prostheire components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare PEEK Abutments (previously cleared per K120954) The Nobel Biocare PEEK Abuments are premanufactured prosthetic components directly connected to the endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

NobelActive 3.0 (previously cleared per K111581) The Nobel Active 3.0 implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate finction provided that stability requirements detailed in the manual are satisfied.

NobelActive 3.0mm (previously cleared per K102436) The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

NobelProcera Implant Bridge Zirconia (previously cleared per K091907) The NobelProcera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

NobelProcera Zi Abutments (previously cleared per K091904) The NobelProcera Zi Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

NobelProcera Ti Abutment (previously cleared per K091756) The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

NobelActive 8.5 mm & 18.0 mm (previously cleared per K083205) Nobel Biocare's Nobel Active implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's Nobel ective implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelReplace Hexagonal Implants (previously cleared per K073142) Nobel Biocare's NobelReplace Hexagonal Implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelActive Multi Unit Abutment (previously cleared per K072570) NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

NobelActive Internal Connection Implant (previously cleared per K071370) Nobel Biocare's Nobel Active implant are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive mplants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Adapter PS (previously cleared per K063592) Nobel Biocare's Adapter PS is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Zygoma Angled Abutments (previously cleared per K052885) The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic component directly connected to the implant and is intended for use as an aid in prosthetic rehabilitation.

Zygoma TiUnite (previously cleared per K050641) Nobel Biocare's zygoma TiUnite is a tianium, endosseous implant with components intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function, Nobel Biocare's Zygoma TiUnite inclueds endosseous implants, a cover screw, healing abutments, and multi unit abutments.

Nobelspeedy Implants (previously cleared per K050406) NOBELSPEEDY TM Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NOBELS PEEDY TM Implants are indicated for single or multiple unt restorations in splinted or non-splications. Nobel Biocare NOBELSPEEDY TM Implants may be placed immediately to put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied. NOBELSPEEDY TM Implants are indicated for use in soft bone or whenever immediate or early loading is applied. The NOBELSPEEDY TM Implants incorporate a groove on the implant thread and are preferred over models without the groove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants. In addition, the NOBELSPEEDY TM Implants are preferred in these soft bone indications because bone formation on the Til nore rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates. NOBELSPEEDY TM Implants may be tilted up to 450. When used with angulations between 300 and 450 a minimum of four implants must be used and splinted.

Groovy Implants (previously cleared per K050258) Nobel Biocare's Groovy Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Groovy Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare Groovy Implants may be placed immediately to put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied. Groovy implants are indicated for use in soft bone in posterior regions or whenever immediate or early loading is applied. The Groovy implants incorporate a groove on the implant thread and are preferred over models without the grove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants.

Procera Implant Bridge, models 15-1001, 15-1002, 15-1052 (previouly cleared per K041236) The Procera Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Procera Implant Bridge can be used at the implant or abutment level of the following implant systems: Nobel Biocare Branemark System Nobel Biocare Replace SelectThe Procera Implant Bridge can be used at the implant level of the following implant systems: Nobel Biocare Replace Nobel Biocare Steri-Oss HL Nobel Biocare Novum Straumann Dental Implant System Regular neck 4.8 Straumann Dental Implant System Wide neck 6.5 The Procera Implant Bridge can be used at abutment level of the following implant systems: Nobel Biocare ARK abutment for Teeth-in-Hour concept.

Various Branemark System Implants-Immediate Function Indication previously cleared per K022562 The Branemark System implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Branemark System implants are intended for immediate placement and function on -single tooth and/or multiple tooth applications recognizing stability (type I or n bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

BRANEMARK NOVUM previously cleared per K000018 The "Immediate Loading Treatment Protocol" is intended for use with selected Brânemark System Implants, I hese implants, when placed using the Immediate Loading Treatment Protocol, are indicated for use only in the anterior mandible between the mental foramina.

Amorphous Diamond Coated Screw (previously cleared per K992538) The Amorphous Diamond Coated Screw is used to retain prosthetic components to dental implants or to other proshetic components. The amorphous diamond coating will add a greater pre-load to the screw, which in turn help prevent the screw and prosthetic components from loosening.

Procera® Preparable Abutment System (previously cleared per K974150) Nobel Biocare's Procera® Preparable Abutment System is a set of screw retained preparable abutments that are secured to an endosseous implant and are intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.

AurAdapt Abutment System (previously cleared per K972475) Nobel Biocare's AurAdapt Abutment System is a set of screw retained modifiable gold alloy abutnents which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.

Branemark System - Zygomaticus Fixture System (previously cleared per K970499) The Nobel Biocare Brallemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.

Bio-Esthetic Indirect Abutment (previously cleared per K970073) The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous and partially edentulous patient) can be attached, yet remain retrievable.

Steri-Oss' Tiodized' screws (previously cleared per K964739) The intended use for Steri-Oss' Tiodized screws is the screw retained attachment of prosthetic components to one another and to dental implants.

Replace Titanium Implant System (previously per K964220) The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.

STERI-OSS GOLD ATTACHMENT SYSTEM (previously cleared per K963945) Steri-Oss Gold Attachment System, the intended use of this device is for the screw retained attachment of prosthesis to abutments is for the screw and/or abutments to retained implants.

17° Angulated Abutment (previously cleared per K961736) The Nobelpharma 17° Angulated Abutment is intended to be used in edentulous patients as an anchor to support a prosthesis

MirusCone Abutment System (previously cleared per K961728) The Nobelpharma MirusCone Abutment System is intended to be used in edentulous patients as an anchor to support a prosthesis.

Branemark System- Healing Abutment (previously cleared per K925779) The Nobelpharma Branemark System- Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

Branemark System Estheticone Abutment complete (previously cleared per K925777) The Nobelpharma Branemark System - EsthetiCone Abutment Complete is intended to be used as a component to an endosseous implant.

Branemark Systems - Titanium CoverScrew (previously cleared per K925771) The Nobelpharma Branemark Systems - Titanium CoverScrew is intended to an endosseous implantprior to the first healing period to protect the innerthread of the fixture and prevent bone overgrowth.

Branemark System Abutment Complete (previously cleared per K925769) The Nobelpharma Branemark System Abutment Complete is intended to be used as a component to an endosseous implant to support a prosthetic device.

Branemark System Temporary Solutions (previously cleared per K925766) The Nobelpharma Branemark System Temporary Solutions are intended to be used in the same manner asthe permanent counterpart except that the former are usedto support transitional reconstructions.

Branemark System Standard 3.75 mm Fixture (previously cleared per K925765) All Nobelpharma fixtures for implant are indicated for use in the anterior and posterior regions of the maxilla and mandible. The fixtures are designed to support full arch reconstructions (fixed bridges and overdentures), partial arch reconstructions (fixed bridges) and single tooth replacement.

Brânemark System Self-Tapping Fixture (previously cleared per K925762) The "Immediate Loading Treatment Protocol" is intended for use with selected Branemark System Implants. These implants, when placed using the Immediate Loading Treatment Protocol, are indicated for use only in the anterior mandible between the mental foramina.

Titanium Plasma Spray Cylindrical Implant (previously cleared per K911592) The Steri-Oss Titanium plasma sprayed cylindrical dental implant device are indicated for use in the mandible and maxilla for denture retention in the edentulous and partially edentulous patient.

Angulated Abutment, Complete, Titanium SCDA102 (previously cleared per K905434) Devices are used as connection with osseointegration fixtures.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
2. Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.

In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.

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For Strong SW HE Implants

S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

For Zygomatic Implants and Abutments

S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add components to the S.I.N. Dental Implant System cleared in K170398, including a line of zygomatic dental implants and abutments.

The subject device Strong SW HE dental implants are nearly identical to the Strong SW HE dental implants cleared in K170398, with a cylindrical design that tapers slightly to the apex, a body/endosseous thread diameter of 3.75 mm, and a platform diameter of 4.1 mm. This submission adds overall lengths of 18, 20, 22, and 24 mm. The endosseous threads have a uniform trapezoidal design and have an acidetched surface. The implants have an external hexagon ("HE") abutment interface connection, internal threads, and an internal hexolobular feature for instrument attachment.

The subject device Zygomatic dental implants have a body diameter of 4.5 mm at the coronal end and a body diameter of 3.85 mm at the apical end with additional tapering to the apex. The abutment platform is 4.1 mm and is angled 45° to the long axis of the implant. The coronal end of the Zygomatic implants have a micro-channel surface feature starting at approximately the angled abutment platform extending over a length of approximately 2.9 mm; the micro-channel blends to a micro-thread and extends apically over a length of 2.15 mm. The micro-thread major diameter is 4.5 mm. All Zygomatic implants also are threaded over a length of 10.7 mm at the apical end with a major thread diameter of 3.85 mm. The endosseous threads at the apical aspect of the Zygomatic implants have the same uniform trapezoidal design and acid-etched surface as the Strong SW HE implants are provided in a range of lengths from 34 mm to 59 mm increments. The implant length is measured from the start of the micro-threads to the apex.

This submission includes an implant cover for the subject Zygomatic implants, with a coronal diameter of 4.1 mm that matches the implant platform, and is threaded to match the internal thread of the Zygomatic implants. This submission also includes Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical; these abutments are straight, multi-unit, non-indexed abutments for the external hex connection of the Zygomatic implants. Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical are straight, multi-unit, non-indexed abutments for the external hex connection of the Zygomatic implants. Mini Abutment Zygomatic Standard are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.5 mm), and in gingival heights of 3 mm, and 5.5 mm. Mini Abutment Zygomatic Conical are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.8 mm), and in gingival heights of 2 mm, 3 mm, and 4 mm. Each abutment requires a corresponding subject device abutment screw to match the gingival height of the abutment. The Mini Abutment Standard and Mini Abutment Conical are the only abutments that are compatible with the subject device Zygomatic implants. For the Mini Abutment Zygomatic Standard, this submission also includes an Abutment Protector and a castable Co-Cr Base. For the Mini Abutment Zygomatic Conical, this submission also includes an Abutment Protector, Temporary Titanium Cylinder, and a castable Co-Cr Base. A Coping Screw is also included for use with all zygomatic abutments.

The provided document is a 510(k) summary for a medical device (S.I.N. Dental Implant System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set size, ground truth for training set) is not typically included in such a submission.

However, the document does contain information about performance data used to support the substantial equivalence claim.

Here's a breakdown of the available information relevant to your request:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit "acceptance criteria" are stated in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI device. Instead, the performance data provided relates to the safety and mechanical integrity of the dental implants. The device performance is demonstrated through conformance to relevant standards and established methods for dental implants.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical performance. The "testing" refers to non-clinical tests (e.g., mechanical, sterilization).
  • For bacterial endotoxin testing: "samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis."
  • For shelf life testing: "samples after 4 years of real time aging."
  • For mechanical strength: "worst-case constructs comprising the subject device Zygomatic implants and compatible subject device Mini Abutment Zygomatic Standard."
• Data Provenance: The data is primarily non-clinical and internal to the manufacturer, leveraging past submissions (K170398) and conducted according to international standards (ISO, ASTM, ANSI/AAMI). No country of origin for the "test set" is applicable in the human data sense. It is all retrospective in the sense that previous testing for predicate devices and ongoing quality control testing is referenced.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this submission, as no human-expert-validated "ground truth" test set (clinical data) was used. The performance data is based on non-clinical engineering and biological safety tests.

4. Adjudication Method for the Test Set

This information is not applicable since no human expert review or adjudication of a clinical test set was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable, as the device is a physical dental implant system, not an AI-assisted diagnostic or therapeutic device. No AI component is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable, as the device is a physical dental implant system and does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by engineering standards and biological safety standards. For example:

• Sterility: Defined by a Sterility Assurance Level (SAL) of 10⁻⁶.
• Bacterial Endotoxin: Defined by a quantifiable limit (< 20 EU/device) per standard.
• Mechanical Strength: Defined by performance criteria within the ISO 14801 standard.
• Biocompatibility: Defined by compliance with ISO 10993 standards (leveraged from predicate).

8. The Sample Size for the Training Set

This information is not applicable, as there is no mention of a "training set" for an algorithm. The device design and materials are based on established engineering principles and prior validated devices.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" and associated ground truth for an algorithm.

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The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

The Panthera Dental Milled Bars are indicated for compatibility with:

• · NobelActive: NP Ø3.5; RP Ø4.3 / Ø5.0; WP Ø5.5
• NobelParallel CC: NP Ø3.75: RP Ø4.3 / Ø5.0: WP Ø5.5
• NobelReplace: NP Ø3.5; RP Ø4.0 / Ø4.3 / Ø5.0; WP Ø5.0; 6 Ø6.0
• NobelSpeedy: RP Ø4.0 / Ø5.0; WP Ø5.0 / Ø6.0
• Brånemark: NP Ø3.3; RP Ø3.75 / Ø4.0; WP Ø5.0

The Panthera Dental Milled Bar is a metallic dental restorative device that is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.

The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.

The Type I bars are specific for removable overdenture and include:

• . Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar.

The Type II bars are specific for fixed prostheses and include:

• Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar.

The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.

The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement. The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.

Here's a breakdown of the acceptance criteria and the study information for the Panthera Dental Milled Bars, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present acceptance criteria in a tabular format with specific numerical targets. Instead, it describes performance through compliance with recognized standards and successful testing outcomes. The "performance" is primarily demonstrated through meeting mechanical strength requirements and biocompatibility standards, and by showing substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample size for each test (e.g., how many bars were subjected to fatigue testing). It refers to "the bar itself" and "the bar cylinders" for fatigue testing. For reverse engineering, it mentions "each interface connection" and "each components per size and type" which implies multiple samples were analyzed to determine critical parameters and tolerance limits.
• Data Provenance: The document does not specify country of origin for data. The non-clinical testing was conducted by Panthera Dental Inc., a Canadian company. The tests are framed within the context of a 510(k) submission to the U.S. FDA. The testing conducted was for the primary predicate device (K173466) and determined to be applicable to the proposed device due to identical materials and manufacturing processes. The tests were retrospective in the sense that they were done on manufactured devices/components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: This information is not explicitly stated. The document refers to compliance with ISO and FDA guidance documents for testing, which implies a standard methodology rather than expert consensus on a subjective test set.
• Qualifications of Experts: Not specified. Testing was performed by Panthera Dental Inc. or their designated testing facilities to meet recognized standards.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned (fatigue, biocompatibility, sterilization, reverse engineering, process capability) are objective physical, chemical, and mechanical tests, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Panthera Dental Milled Bars are a physical dental device, not an AI or imaging diagnostic tool that would typically involve a reader study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm or software. The mention of CAD/CAM refers to the design and manufacturing process, not an independent algorithm performance.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

• Compliance with recognized standards: ISO 14801 for fatigue testing, ISO 10993 series and USP <85> for biocompatibility, and ANSI/AAMI-ST8 for sterilization.
• Measurement and verification: Reverse engineering to ensure precise fit with implant systems.
• Predicate device equivalence: Performance data for the predicate device (K173466) is directly applied due to identical materials, design principles, and manufacturing processes.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are established based on engineering principles and validated through testing.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of this device. The design specifications and manufacturing parameters are established through engineering design, material science, and testing against industry standards, not via a machine learning training process.

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NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.

NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Implants with <7mm length are for delayed loading only when appropriate stability has been achieved.

NobelParallel™ Conical Connection (herein referred to as NobelParallel™ CC) implants are threaded, root-form, endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore a patient's chewing function.

The sterile, single-use only implants, made of commercially pure titanium (ASTM F67-13), range in length from 6.5 – 17.5 mm (physical implant length) and are provided in four (4) diameters (Ø 3.75 mm, 4.3 mm, 5.0 mm, and 5.5 mm). The implants feature a conical connection which is compatible with Nobel Biocare's narrow platform (NP), regular platform (RP), and wide platform (WP) abutments. The conical connections are color coded to identify the compatible abutment platform(s).

Each implant is individually packaged and provided with its corresponding titanium alloy cover screw (Ti-6Al-4V, per ASTM F136-13 and ISO 5832-3).

The provided text is a 510(k) Summary for a medical device called NobelParallel™ Conical Connection implants. It describes the device, its intended use, comparison to predicate devices, and performance data provided for substantial equivalence determination.

Here's a breakdown of the requested information based on the provided text. Please note that the document is a summary and therefore may not contain all the granular details of a full study report.

Acceptance Criteria and Device Performance

This document does not explicitly state acceptance criteria in a quantitative table format with corresponding device performance values. Instead, it describes differences and similarities to predicate devices and lists the types of studies performed to support substantial equivalence. The implication is that the device's performance, as demonstrated by these studies, met the FDA's criteria for substantial equivalence to existing legally marketed devices.

However, based on the performance data listed, we can infer the types of performance evaluated:

Detailed Study Information (Based on available text):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Clinical Study: "retrospective multi-center single cohort clinical study on NobelParallel Conical Connection short implant (<7mm)."
     • Sample Size: Not specified in the summary.
     • Provenance: "multi-center" implies multiple locations, but specific countries are not mentioned. "retrospective" indicates data was collected on events that occurred in the past.
   • Non-clinical tests: For fatigue, surface area, sterilization, packaging, shelf-life, and endotoxin, sample sizes are not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • The document describes a clinical study and non-clinical tests for a dental implant. Establishing "ground truth" in the typical sense (like for AI image analysis) doesn't directly apply here. The clinical study would involve patient outcomes assessed by clinicians. For non-clinical tests, "ground truth" is typically established by recognized standards (e.g., ISO, ASTM, USP) and laboratory protocols, not by expert consensus in the same way an AI model's output would be adjudicated. No specific number or qualifications of experts for establishing "ground truth" are mentioned.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable in the context of this 510(k) summary for a dental implant's performance assessment. Adjudication methods like 2+1 are typically for establishing ground truth for diagnostic AI algorithms, not for evaluating physical device performance or clinical outcomes in general.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable. This is a 510(k) summary for a physical medical device (dental implant), not a diagnostic AI device requiring MRMC studies.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable, as this is not an algorithm or AI device.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Clinical Study: The clinical study would rely on "outcomes data" related to the performance of the short implants. This could include implant survival rates, bone integration, complications, etc., as assessed by treating clinicians.
   • Non-clinical tests: The "ground truth" for non-clinical tests is based on established regulatory standards (ISO, ASTM, USP) and laboratory measurements of physical and material properties.

7. The sample size for the training set

   • Not applicable. This is a 510(k) summary for a physical medical device, not an AI/ML algorithm that requires a training set.

8. How the ground truth for the training set was established

   • Not applicable, as there is no training set for a physical medical device.

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