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The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the AT TX 3.0 S, BH 3.0 S, SSO 3.5 L, and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase, inCoris mesostructure and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two- piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems follows in the document)

The Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification is a modification to the Sirona Dental CAD/CAM System as previously cleared under K181520. The modified Sirona Dental CAD/CAM System with CEREC Chairside Software that is the subject of this premarket notification includes a line extension to the existing offerings. These additional TiBase variants facilitate compatibility with currently marketed dental implant systems.

The modified Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification consists of:

• CEREC SW "chairside" CAD/CAM software
• CEREC AC digital acquisition unit
• CEREC AC Connect digital acquisition unit
• CEREC Omnicam 3D digital intraoral scanner
• CEREC MCXL product family of CAM milling units
• Additional Sirona TiBase titanium base components (line extension subject to this submission) compatible with Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 implants.
• inCoris ZI zirconium mesostructure blocks

As subject to this premarket notification, the Sirona Dental CAD/CAM System with CEREC Chairside Software is utilized to digitally acquire and record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of prefabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system.

As subject to this premarket notification, the subject Sirona Dental CAD/CAM System with CEREC Chairside Software is modified to include a line extension to the existing TiBase offerings by introducing TiBases which are compatible with the Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 dental implants.

The CEREC SW CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL milling equipment and the defined zirconium/zirconia block materials.

The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for the design and fabrication of two-piece, CAD/CAM dental abutments.

Here's a breakdown of the acceptance criteria and the study information for the Sirona Dental CAD/CAM System with CEREC Chairside Software, based on the provided text:

Preamble: This 510(k) submission, K193408, is for a modification to an existing device (Sirona Dental CAD/CAM System, K181520), specifically a line extension for additional TiBase variants to facilitate compatibility with more dental implant systems. Therefore, the "study" described is primarily focused on demonstrating that the new variants perform comparably to the previously cleared predicate, rather than a de novo clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in terms of a specific number for each test. The dynamic fatigue testing mentions "test sample constructs," implying multiple items were tested, but a precise number is not provided.
• Data Provenance: This is non-clinical performance data. The location of the testing is not specified, but it would have been generated by Dentsply Sirona or a contracted testing lab. It is inherently prospective data, generated specifically for this submission to demonstrate the performance of the new TiBase variants.

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

• Not Applicable. This submission is for a medical device (dental CAD/CAM system components), not an AI/imaging diagnostic device that requires expert review for ground truth establishment. The "ground truth" here is based on engineering specifications, material properties, and standardized performance tests (e.g., ISO 14801).

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical performance testing of physical components and software functionality, there is no expert adjudication process involved in the same way as for diagnostic AI outcomes. The performance is assessed against established engineering standards and design specifications.

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

• No. An MRMC comparative effectiveness study was not performed. This device is a CAD/CAM system for fabricating dental abutments, not an AI diagnostic tool used by human readers to interpret medical images.

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

• Yes, indirectly. The performance tests described (geometric compatibility, dynamic fatigue, biocompatibility, sterilization validation, software integration) evaluate the device's performance in a standalone manner, separate from its use by a human operator in a clinical setting for diagnosis. The software component, specifically, underwent system integration testing to validate its requirements and functionality for designing the mesostructure, which is a standalone algorithm function.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Results:
  • Geometric compatibility: Original manufacturer's implant geometry specifications.
  • Dynamic fatigue: Adherence to ISO 14801 standards for dental implants.
  • Biocompatibility: Previous clearance (K181520) and established material properties.
  • Sterilization: Adherence to ISO 17665-1 and ANSI/AAMI ST79 standards.
  • Software integration: System requirements and design controls.

8. The Sample Size for the Training Set

• Not Applicable (or not provided in the document). This device is a CAD/CAM system modification, not an AI model that requires a training set in the typical machine learning sense. The software component is likely developed using traditional software engineering principles and validated through integration testing.

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

• Not Applicable. See point #8.

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ATLANTIS™ ISUS Implant Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

ATLANTIS™ ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:

Implants:
Biomet 3i Certain 3.25, 4/3 - Prevail 3/4/3, 4/3
Biomet 3i Certain 4.0, 5/4 – Prevail 4/5/4. 5/4
Biomet 3i Certain 5.0, XP 4/5 - Prevail 5/6/5, 6/5
Biomet 3i Certain 6.0, XP 5/6
BioHorizons Internal/Tapered 3.5, 4.5, 5.7
Camlog Screw-line Implant 3.3
Camlog Screw-line / Root-line Implant 3.8, 4.3, 5.0, 6.0
DENTSPLY Implants XiVE S 3.0, S 3.4, S 3.8, S 4.5, S 5.5
DENTSPLY Implants OsseoSpeed™ TX 3.0, 3.5/4.0, 4.5/5.0
DENTSPLY Implants Osseospeed™ Profile TX 4.5/5.0
DENTSPLY Implants Osseospeed™ EV 3.0, 3.6, 4.2, 4.8, 5.4
DENTSPLY Implants Osseospeed™ Profile EV 4.2, 4.8
Keystone Dental PrimaConnex SD 3.3/3.5
Keystone Dental PrimaConnex RD 4.0/4.1
Keystone Dental PrimaConnex WD 5.0
Keystone Dental Genesis 3.8, 4.5, 5.5/6.5
Nobel Biocare NobelActive NP 3.5 - RP 4.3, 5.0
Nobel Biocare NobelReplace NP-3.5 - RP 4.3 - WP 5.0 – 6.0
Straumann Bone Level 3.3 NC - 4.1, 4.8 NC
Straumann Standard Plus 3.5 NN
Straumann Standard / Standard Plus 4.8 RN – 4.8 WN
Zimmer Dental Tapered Screw Vent S-V 3.5/S-V 3.3, 3.7 / S-V 4.5/ S-V 4.5
Zimmer Dental Tapered Screw Vent 5.7

Abutments:
Biomet 3i Low Profile Abutment
DENTSPLY Implants ATIS Uni Abutment EV
DENTSPLY Implants ATIS UniAbutment 20°, ATIS UniAbutment 45°
DENTSPLY Implants ATIS Angled Abutment EV
DENTSPLY Implants ATIS Angled Abutment 20°
DENTSPLY Implants ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5
DENTSPLY Implants XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5
DENTSPLY Implants XiVE TG 3.4, TG 3.8, TG 4.5
Nobel Biocare Multi-Unit Abutment RP
Straumann Bone Level Multi-Base Angled Abutment
Straumann Bone Level Multi-Base Abutment D3.5, D4.5
Straumann RN Abutment Level, WN Abutment Level
Straumann Screw-Retained Abutment 3.5, 4.6
Zimmer Dental Tapered Abutment

The ATLANTIS™ ISUS Implant Suprastructures include new implant and abutment interfaces of the predicate ISUS Implant Suprastructures, cleared in K122424.

The ATLANTIS™ ISUS Implant Suprastructures are patient-specific restorative devices that are intended to be attached to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTIS™ ISUS suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device.

The subject ATLANTIS™ ISUS Implant Suprastructures are available in the same design types as cleared for the predicate ISUS Implant Suprastructures in K122424:

1. Bar Intended as a fixed supporting structure for a removable dental prosthesis.
2. Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
3. Hybrid Intended as a fixed denture framework.

Screws are available for all compatible implant and abutments systems to screw the ATLANTIS™ ISUS Implant Suprastructures into the implant or onto the abutment.

In addition to the introduction of the new interfaces of the ATLANTIS™ ISUS Implant Suprastructures, the product reference names of the compatible interfaces are adjusted in the indications for use for the currently marketed ATLANTIS™ ISUS Implant Suprastructures to better reflect the original manufacturer's product description.

The provided document describes a 510(k) premarket notification for a medical device, specifically the ATLANTIS™ ISUS Implant Suprastructures. This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information provided focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices, rather than a clinical study establishing acceptance criteria in the traditional sense of AI performance metrics like sensitivity, specificity, or AUC.

Based on the document, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for a dental implant component, the "acceptance criteria" are related to mechanical and material equivalence to predicate devices, and "device performance" refers to its ability to meet these engineering standards. There are no performance metrics like sensitivity or specificity.

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

This information is not applicable or not provided in the context of an AI device. This document is for a physical medical device (dental suprastructures). The testing performed is non-clinical, involving mechanical and dimensional analysis of device components themselves, rather than testing on a "test set" of patient data.

3. 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)

This information is not applicable or not provided. "Ground truth" in the context of an AI device, established by experts, is not relevant here as this is a physical medical device. The "ground truth" for this device's performance would be the universally accepted engineering standards for dental prosthetics and the demonstrable properties of the materials and design.

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

This information is not applicable or not provided. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI studies. The testing described is non-clinical performance data (mechanical design analysis, dimensional analysis, static and dynamic compression-bending testing).

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 or not provided. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable or not provided. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here is the established engineering standards for dental prosthetics. This includes:

• Mechanical standards: ISO 14801 Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants.
• Material standards: Properties of CPTi, CoCr, Ti-6Al-4V ELI, Ti-6Al-7Nb (as listed for abutment and screw materials).
• Biocompatibility: Demonstrated equivalence to the predicate device (K122424) which had prior biocompatibility testing.
• Design principles: Comparison to existing, legally marketed predicate devices to establish substantial equivalence in intended use and fundamental technology.

8. The sample size for the training set

This information is not applicable or not provided. As this is a physical device submission, there is no "training set" in the context of machine learning. The device's design is "derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription," and then fabricated using computer-assisted manufacturing (CAM).

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

This information is not applicable or not provided. There is no machine learning training set for this device. The "ground truth" for the CAD/CAM design process would be the clinician's prescription and the patient's dental models, which guide the creation of the patient-specific device.

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The Implanova® Bone Level implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® Bone Level system, including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implanova® Bone Level implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Implanova® All-in-One3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central incisor and maxillary lateral incisor regions of partially edentulous jaws. The Implanova® All-in-One 3.0mm implant must be splinted if two or more are used adjacent to each other. Implanova® All-in-One 3.0mm implant are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutments, straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed 11 TX 3.5S and OsseoSpeed "M TX 4.0S implant fixtures.

All bone fixtures within Inplanova® system are endosseous dental implants and are available in Bone Level and All-In-One implants types. Fixtures are available in the following sizes.

· IMPLANOVA® BONE LEVEL IMPLANTS Narrow Medium: 3.5mm Diameter x 10mm Length Narrow Long: 3.5mm Diameter x 12mm Length Narrow XLong (Extra Long): 3.5mm Diameter x 14mm Length

Standard Short: 4.5mm Diameter x 8mm Length Standard Medium: 4.5mm Diameter x 10mm Length Standard Long: 4.5mm Diameter x 12mm Length Standard XLong: 4.5mm Diameter x 14mm Length

Wide Short: 5.5mm Diameter x 8mm Length Wide Medium: 5.5mm Diameter x 10mm Length Wide Long: 5.5mm Diameter x 12mm Length

· IMPLANOVA® ALL-IN-ONE IMPLANTS Slender Medium: 3.0mm Diameter x 10mm Length Slender Long: 3.0mm Diameter x 12mm Length Slender XLong (Extra Long): 3.0mm Diameter x 14mm Length

The material constituents of the all implant fixtures within the Implanova® system is Grade 23 Titanium Alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vnadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). In order to promote osseointegration, a variable portion of the implant surface, depending on the implant's overall length, is surface treated and passivated per ASTM F86 standard.

Abutments for bone level implants are utilized for cement retained restoration. Bone level abutments are available in straight and angled types as well as platform sizes ranging from 4.2mm to 6.5mm. All bone level angled abutments will utilize their respective abutment screw for installation. The material constituents of all Implanova® abutments is grade 23titanium alloy per ASTM F136 Standard Specification for Wrought Titanium 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

Implanova® Bone Level Abutments offer the following models.

· IMPLANOVA® BONE LEVEL ABUTMENTS

Narrow Platform - Straight: 4.2 mm Platform Diameter x 5.7 mm Post Height Narrow Platform – 15 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height Narrow Platform – 20 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height

Standard Platform - Straight: 4.8 mm Platform Diameter x 5.7 mm Post Height StandardPlatform – 15 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height StandardPlatform – 20 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height

Wide Platform - Straight: 6.5 mm Platform Diameter x 5.7 mm Post Height WidePlatform - 15 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height WidePlatform - 20 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height

The system also offers Healing Caps and Cover Screws.

This document is a 510(k) Pre-market Notification for the Implanova® Dental Implant System. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria or a study proving the device meets specific performance criteria with numerical results for the device itself (Implanova®). Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, intended use, and non-clinical testing for safety and appropriate material and manufacturing characteristics.

Here’s a breakdown of the information that is available within the provided text, and what is not present based on your request:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the format requested. The document asserts that "the fatiguetest result of the subject device supports that the subject device is substantially equivalent to the predicate devices" (Pages 11 and 12), and that non-clinical testing "supported that the subject device is substantially equivalent to the predicate devices and it is in conformance with the FDA guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (Page 17). However, the specific acceptance criteria for these tests (e.g., minimum fatigue strength in MPa or N) and the numerical results achieved by the Implanova® device are not listed. The document focuses on similarity to predicate devices rather than meeting discrete performance metrics presented in a table.

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

This information is not provided. The document lists types of non-clinical tests but does not specify the sample sizes used for these tests, nor the data provenance. These are typically details found in the full test reports, which are not included here.

3. 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):

This information is not applicable/provided. The document describes non-clinical, laboratory-based testing (e.g., fatigue, sterilization, cytotoxicity, SEM/EDS) rather than clinical studies requiring expert review of data for ground truth establishment.

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

This information is not applicable/provided. As above, this pertains to clinical study design and human interpretation of results, which is not described here.

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/provided. This document describes an endosseous dental implant system, which is a physical medical device, not an AI-assisted diagnostic or decision support system that would involve human readers or AI improvement metrics.

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

This information is not applicable/provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable/provided in the context of clinical "ground truth." The ground truth for the non-clinical tests would be the established scientific methods and standards (e.g., ISO 14801 for fatigue testing, ISO 11137-1 for sterilization).

8. The sample size for the training set:

This information is not applicable/provided. As this is a physical medical device, there is no "training set" in the context of machine learning or AI models.

9. How the ground truth for the training set was established:

This information is not applicable/provided. As above, there is no "training set."

Summary of available information related to performance and predicate devices:

The document primarily demonstrates substantial equivalence by comparing the Implanova® device to several predicate devices.

Key similarities highlighted for Implanova® Bone Level Implants (compared to BioHorizons Tapered Internal Plus, BioHorizons Internal Implants, U fit Dental Implant System):

• Intended Use: Same intended use (endosseous implantation in mandible and maxilla for artificial root structure, single/multiple missing teeth, support prosthesis, immediate loading when primary stability achieved).
• Operating Principle: Same.
• Basic Design: Incorporates same basic design (self-tapping, bone-level type implant, micro-threaded implant collar, tapered implant body).
• Material: Titanium Alloy grade 23 (Ti6Al4V ELI).
• Surface Treatment: Resorbable Blast Texture Media (calcium phosphate), partial surface treatment.
• Sterile: Yes.
• Sterilization Method: Gamma Radiation.
• Size Range: Similar (e.g., Diameter: 3.5mm, 4.5mm, 5.5mm; Length: 8mm, 10mm, 12mm, 14mm).

Key differences and justification for substantial equivalence despite differences:

• Micro-machined grooves vs. Micro threads: Laser-Lok® micro-machined grooves on predicates vs. micro threads on Implanova®. Justification: "functionally identical" as osteocytes cannot differentiate microscopic differences for osseointegration.
• Flute Lengths: Implanova® has longer flute lengths. Justification: "more tapping edges simply ease the tapping processes but functions the same."
• Twist Direction of Vertical Flutes: Implanova® has a minor left-hand twist (18mm pitch) vs. straight or slight right-hand twist on predicates. Justification: "only slightly increases the sharpness of the edges... and passively guides the swarf materials to consolidate... should not render the device NSE."
• Partial Surface Treatment: Implanova® has partial surface treatment (apical 5mm untreated) vs. modified throughout the implant body on predicates. Justification: Untreated apical area maintains sharpness for cutting bone; surface treatment is not a requirement for osseointegration.
• Fatigue Test Result: The document states that "the fatiguetest result of the subject device supports that the subject device is substantially equivalent to the predicate devices." (No numerical results are provided in the excerpt).

Key similarities highlighted for Implanova® All-in-One 3.0mm Implants (compared to Zimmer One-Piece Implant System, NobelDirect 3.0):

• Intended Use: Similar indications for support and retention of fixed single tooth and fixed partial dentures in specific mandibular/maxillary incisor regions, with immediate loading when good primary stability is achieved and appropriate occlusal loading.
• Design & Size: 3.0mm diameter.
• Connection Type: N/A (one-piece design).
• Basic Design: Self-tapping, tissue-level type implant, micro-threaded implant collar, tapered implant body.
• Material: Titanium Alloy grade 23 (Ti6Al4V ELI) (NobelDirect uses CP Titanium grade 4).
• Surface Treatment: Resorbable Blast Texture Media (calcium phosphate), partial surface treatment (Zimmer uses Hydroxyapatite blast media, NobelDirect uses TiUnite).
• Sterile: Yes.
• Sterilization Method: Gamma Radiation.

Key differences and justification for substantial equivalence despite differences:

• Microthreads: Implanova® has microthreads vs. lack of microthreads on predicates. Justification: "only slightly increase the surface area... insignificant deviation... does not render the subject device NSE."
• Flute Lengths, Twist Direction, Partial Surface Treatment: Similar justifications to the bone-level implants regarding these differences.
• Surface Treatment Material: Implanova® uses calcium phosphate blast media; predicates use Hydroxyapatite or TiUnite. Justification: "chemical analysis data... supports that the blast media used for the subject device does not alter surface chemical compositions."

Non-Clinical Testing Performed (Page 17):

• Fatigue Testing (ISO 14801)
• 3rd Party Compatibility
• Sterilization Validation (ISO 11137-1, ISO 11137-2, ISO11737-1, ISO11737-2, ISO 17665-1 and ISO 17665-2)
• Shelf-life Validation (ASTM F1980, ISO 11607-1, ISO 11607-2, ASTM F88, and ASTM F 1929)
• Cytotoxicity Testing (ISO 10993-5)
• SEM/EDS Chemical Surface Analysis

These tests are stated to have "supported that the subject device is substantially equivalent to the predicate devices and it is in conformance with the FDA guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."

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The BHdental Implant system is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient chewing function. The BHdental Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The BHdental Implant System consists of one and two stage endosseous form dental implant, internal and external hexagonal; internal octagonal; cover screws and healing caps; abutment systems, superstructures and surgical instruments.

The provided text describes the BHdental Implant System, which is a dental implant device. For medical devices like this, "acceptance criteria" and "device performance" are typically demonstrated through compliance with recognized standards and specific performance testing, rather than through studies involving human test sets, expert ground truth, or AI comparative effectiveness as would be common for diagnostic AI software.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable in the context of this device and the provided documentation. The performance testing described is primarily mechanical, material, and biocompatibility testing, not clinical studies with human "test sets" in the diagnostic AI sense.
• Data Provenance: Not applicable. The data comes from laboratory and material testing, not human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for dental implant material and mechanical properties is established by the specifications in the standards (e.g., ISO, ASTM) and the results of laboratory tests performed by qualified technicians/engineers.

4. Adjudication method for the test set:

• Not applicable. The "test set" consists of physical devices or materials undergoing engineered tests, not clinical cases requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging interpretation or other scenarios where human readers interact with AI, which is not the case for this dental implant device.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device is based on established engineering standards and material specifications (e.g., the strength required by ISO 14801 for fatigue, the chemical composition specified in ASTM F136, the biological response deemed safe by ISO 10993). Test results are compared against these predetermined specifications.

8. The sample size for the training set:

• Not applicable. This device is not an AI model, so there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable. There is no AI training set.

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