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DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted or non-splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth, and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate.

DESS® NEO GM Dental Implants are compatible with DESS® Dental Smart Solutions abutments having the identical NEO GM connection manufactured by Terrats Medical SL.

DESS® NEO GM Dental Implants with a diameter of 3.5 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.5 mm implants is intended only for rehabilitation of the anterior region of the mouth.

DESS® Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

This submission includes dental implants that are compatible with DESS® Dental Smart Solutions abutments having the identical NEO GM connection manufactured by the sponsor of this submission, Terrats Medical SL, and cleared under K212628, K222288, K233316, K240208, and K242340. No claims of compatibility between the subject device implants and abutments from any OEM other than DESS® Dental Smart Solutions will be made. This submission also includes DESSLoc abutments that are compatible with eight (8) dental implant lines from five (5) OEM manufacturers. Also included in this submission is one (1) Pre-Milled Blank abutment that is compatible with three (3) implant lines manufactured by Alpha Dent Implants GmbH.

This submission includes one implant line, the Dental Implant NEO GM, a series of self-tapping, threaded, root-form dental implants to be placed at bone level. The subject device implants are provided in body diameters of 3.55 mm, 3.75 mm, 4.0 mm, 4.3 mm, 5.0 mm, 6.0 mm, and 7.0 mm. The subject device implant body diameters will be labeled as 3.5 mm, 3.75 mm, 4.0 mm, 4.3 mm, 5.0 mm, 6.0 mm, and 7.0 mm. Implant with body diameters ranging from 3.55 mm to 5.0 mm are provided in overall lengths of 7.9 mm, 9.9 mm, 11.4 mm, 12.9 mm, 15.9 mm, and 17.9 mm. Implants with body diameters 6.0 mm and 7.0 mm are provided in overall lengths of 7.9 mm, 9.9 mm, and 11.4 mm. The subject device implant lengths will be labeled as 8 mm, 10 mm, 11.5 mm, 13 mm, 16 mm, and 18 mm. All subject device implants, regardless of body diameter, have an internal Morse taper connection with a 16° included angle and 2.99 mm diameter opening at the top of the implant. This NEO GM connection is identical to the connection for abutments cleared previously in K242340.

All subject device implants are made of unalloyed titanium conforming ASTM F67 and ISO 5832-2. The entire endosseous surface, except for a small coronal bevel, features a grit blasted and double acid etched (SLA) surface, which is identical to the surface treatment for DESS® implants that were cleared in K212538.

This submission also includes DESSLoc Abutments designed for overdenture retention. The subject device DESSLoc Abutments are straight, non-engaging abutments that attach directly to the implant and are compatible with eight (8) dental implant lines from five (5) OEM manufacturers.

The subject device DESSLoc Abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The subject device DESSLoc abutments have a zirconium nitride (ZrN) coating produced by a physical vapor deposition (PVD) process. The ZrN coating is applied to increase the surface hardness and reduce wear of the abutment surface. The ZrN coating for the subject device DESSLoc Abutments is identical to the ZrN coating applied to DESSLoc Abutments cleared in K242340, K240208, K222288, K191986, and K170588.

This submission also includes one (1) Pre-Milled Blank Abutment that is compatible with three (3) implant lines manufactured by Alpha Dent Implants GmbH, including Implant Active Konus, Implant Classic Konus, and Implant Active Bio, cleared in cleared in K210499. Reverse engineering compatibility analysis of the Alpha Dent implants, abutments, and abutment screws and Terrats Medical SL abutments and abutment screws was provided in the prior Terrats Medical SL submission K243212.

The Pre-Milled Blank Abutment has a maximum (before milling) diameter of 10 mm and a solid cylindrical design and an engaging implant connection. The Pre-Milled Blank Abutment is manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. All patient-specific custom abutment fabrication for the Pre-Milled Blank Abutment is by prescription on the order of the clinician and will be done at a Terrats Medical validated milling center under FDA quality system regulations. The design parameters for the CAD-CAM fabrication of a custom abutment from the Pre-Milled Blank Abutment are:

• Minimum wall thickness – 0.45 mm
• Minimum post height for single-unit restoration – 4.0 mm (post height measured above the gingival height of the final patient-matched design)
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 6.0 mm
• Pre-Milled Blanks are for straight abutments only

The abutment screw for use with the Pre-Milled Blank Abutment and the Alpha Dent implants was cleared previously in K243212.

All subject device implants are provided sterile, and all subject device abutments are provided non-sterile. The Pre-Milled Blank Abutment is supplied with the previously-cleared non-sterile abutment screw for attachment to the corresponding compatible implant. All subject device components are provided in single-unit packages for single-patient, single-use only.

The provided FDA 510(k) Clearance Letter for DESS® Dental Implants (K251280) does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of AI/ML device performance.

The document is a clearance letter for a dental implant system, which is a physical medical device, not an AI/ML-driven diagnostic or treatment planning software. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth) are not applicable to the content provided.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use and Indications for Use
• Technological Characteristics (design, materials, surface treatment, sterilization methods, dimensions)
• Performance Data (non-clinical data such as MRI review, sterilization validation, bacterial endotoxin testing, shelf life, biocompatibility, and mechanical testing according to ISO 14801).

Since the request specifically asks for AI/ML-related performance evaluation, and the provided document is not for an AI/ML device, I cannot fulfill the request as stated with the given input.

However, I can extract the non-clinical performance data and the comparison to predicate devices, which serve as the "study" and "acceptance criteria" for this type of physical medical device in the context of a 510(k) submission.

Non-Clinical Performance Data (Serving as "Study" for Substantial Equivalence):

1. Worst-Case MRI Review:

   • Method: Scientific rationale and published literature (T.O. Woods, J.G. Delfino, and S. Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation Volume 49, No. 2 (March/April 2021): 783–795).
   • Scope: Evaluated all compatible implant bodies, abutments, and fixation screws and their material composition.
   • Parameters: Magnetically induced displacement force and torque, per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
   • Outcome: Rationale addressed parameters; device components found suitable for the MR environment.

2. Gamma Irradiation Sterilization Validation (for implants):

   • Method: Selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2.
   • Acceptance Criteria: Sterility Assurance Level (SAL) of $10^{-6}$.
   • Outcome: Analysis showed the subject device implants met the SAL and did not create a new worst case compared to predicate device K212538.

3. Bacterial Endotoxin Testing:

   • Method: Limulus amebocyte lysate (LAL) testing according to ANSI/AAMI ST72.
   • Acceptance Criteria: Limit of

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BruxZir® NOW SRC is a pre-manufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. BruxZir® NOW SRC consists of two major parts. Specifically, the precemented titanium abutment and zirconia superstructure components make up a two-piece abutment. All digitally designed CAD/CAM customizations for BruxZZir® NOW SRC are only intended to be designed and manufactured according to digital dentistry workflow, which incorporates of the digital dentistry workflow including scan files from Intra-Oral Scanners, CAD software, milling machine and associated tooling and accessories.

BruxZir® NOW SRC is a pre-manufactured two-piece hybrid abutment crown composed of a fully sintered zirconia superstructure and a pre-installed Ti-base (titanium base) that is used with the glidewell.io™ In-Office Solution. The zirconia and Ti-base components make up a two-piece abutment, which is used in conjunction with endosseous dental implants to restore chewing function. The CAD/CAM software is intended to design the final abutment shape including anatomic features and facilitate in-office milling.

The Ti-base of BruxZir® NOW SRC is pre-cemented to a post-sintered zirconia superstructure, which is to be designed and fabricated to support screw-retained prosthetic restorations. After machining in the fastmill.io"M In-Office Mill, this two-piece abutment is mounted onto the implant and fixed with a screw. BruxZir® NOW SRC can be milled in-office by a dental professional and dental laboratories.

The digital workflow requires the use of the following equipment:

• Scanner: Intra-oral scanner
• Design Software: CloudPoint FastDesign Chairside (K231529)
• Restorative Material: Fully sintered zirconia; BruxZir® NOW(K220816)
• Milling Unit: fastmill.io™ In-Office Mill

The BruxZir® NOW SRC is designed and fabricated to be compatible with the Hahn™ Tapered Implant System (K143353) and the Inclusive® Tapered Implant System (K121406, K153099). BruxZir® NOW SRC is provided non-sterile and intended for single use and prescription use.

The provided text describes the BruxZir® NOW SRC, a dental implant abutment, and its substantial equivalence to a predicate device. It primarily focuses on mechanical, sterilization, biocompatibility, shelf-life, and packaging data to support its claims. There is no information provided in the document about acceptance criteria, device performance, AI/algorithm studies, ground truth establishment, or expert involvement. The document primarily reports on non-clinical testing.

Here's a breakdown of what CANNOT be answered based on the provided text:

• Acceptance criteria and reported device performance (in the context of clinical or AI performance): The document doesn't define specific acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, as it's not evaluating an AI/diagnostic device. It broadly states the device has "sufficient strength" and provides a "maximum angulation correction of 20 degrees" based on mechanical testing.
• Sample size for test set and data provenance (for AI): Not applicable as there is no AI or clinical test set described.
• Number of experts used to establish ground truth and qualifications: Not applicable.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used (for AI/clinical performance): Not applicable.
• Sample size for the training set (for AI): Not applicable.
• How the ground truth for the training set was established (for AI): Not applicable.

However, I can extract information about the non-clinical studies performed and their general conclusions:

Non-Clinical Studies and Findings:

Sample Sizes and Data Provenance for Non-Clinical Tests:

• Mechanical Testing: The document refers to "worst-case scenario" testing but does not specify the number of samples or the origin of the data. It's implicitly laboratory-based data for device components.
• Sterilization Validation: Refers to "testing sample used in the previous steam sterilization validation testing for the reference device (K160979)" which "represented the worst-case scenario." No specific number is given for the subject device itself.
• Biocompatibility Evaluation: This is a biological evaluation following ISO 10993-1. Sample size not specified.
• Shelf Life: Based on material science principles; no direct sample size for testing is implied.
• Packaging Validation: "Previous packaging validation" for a reference device was used. No specific sample size for the subject device's packaging.
• MR Environment: Based on scientific rationale and published literature; not a direct experimental study with a sample size for this submission.

Further Notes:

• The document states "No clinical data was included in this submission." This explicitly confirms that the information requested about clinical performance, expert ground truth, and reader studies is not present in this document.
• The device is a "pre-manufactured prosthetic component" for dental implants, not an AI or diagnostic software. Therefore, the questions related to AI-specific performance metrics, training/test sets, and ground truth are not applicable to the scope of this FDA submission.

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SDS 1.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. SDS1.2_33xx implants are recommended as single-tooth implant for upper lateral and lower incisors for fixed prosthetic restorations only.

SDS 1.2 healing caps-disc, SDS .2 temporary caps and SDS 1.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS1.2 dental implant and enable the production/ fixation of long-term temporary restorations or protect the implant during healing phase for up to 180 days.

SDS1.2 dental implants are a one-piece implant system to fit a synthetic root replacement into the human jaw. The implants are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. The SDS1.2 dental implants are used to fix the prosthetic restoration and are suitable for patients with an intolerance to metal. The implants have a self-tapping Dynamic Thread® in the implant for good primary stability. Its bone-condensing section has a 2.5x thread depth. The upper section of the implant has a micro-thread. The outer surface of the SDS1.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined. SDS1.2 implants are provided in different length/ diameter combinations and with 2 different shoulder designs. The implants are provided sterile in sterile packaging and are intended for single use. SDS1.2 dental implants must not be re-sterilized or disinfected either. When delivered, all SDS1.2 dental implants are mounted with the disposable SDS1.2 insertion tool.

Temporary restorations can be produced either individually or by using the prefabricated SDS1.2 Temporary cap as basis. The SDS1.2 Temporary caps are made of PEEK (polyether ether ketone). The SDS1.2 Temporary cap may only be used for screw-retaining temporary restorations with SDS1.2 standard screw (SDS1.2_SS-T) and must not be cemented. The SDS1.2 Temporary caps are provided non-sterile and must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for use" document. They are intended for single-use and can stay for a maximum period of 180 days in situ.

SDS1.2 Healing caps-disc may be used to protect the dental implant. The Healing caps-disc are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. They can be fixed by screw-retaining with SDS1.2 standard titanium screws. The SDS1.2 Healing caps-disc are provided non-sterile and must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for use" document. They are intended for single-use and can stay for a maximum period of 180 days in situ.

The SDS1.2 dental implant system's acceptance criteria and the study proving it meets them are described below based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SDS1.2 dental implant system are primarily based on demonstrating substantial equivalence to predicate devices through various tests and compliance with established standards. The reported device performance indicates that these criteria have been met.

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

The document indicates that non-clinical testing was performed, including biocompatibility, performance testing (e.g., fatigue testing), sterilization validation, and packaging validation. However, specific sample sizes for these tests are not explicitly stated. The document only mentions that "the testing results were analyzed and evaluated" and that testing was "planned and performed."

The document also explicitly states:

• "No animal testing"
• "No clinical testing"

Therefore, there is no information on sample sizes from human, animal, or clinical trials. The provenance of the data is implicitly from laboratory testing conducted as part of the regulatory submission process, likely by the manufacturer or accredited testing facilities. The specific country of origin for the non-clinical test data is not provided, though the manufacturer is based in Switzerland.

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

Not applicable. This device is not an AI/ML device that requires human expert adjudication for ground truth establishment. The ground truth for performance evaluation is established through objective physical and chemical test methods and compliance with established industry standards.

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

Not applicable, as this is not an AI/ML device requiring human adjudication or ground truth establishment based on expert consensus for a test set.

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. The SDS1.2 dental implant system is a physical medical device, not an AI/ML diagnostic or assistive tool. No MRMC study was conducted.

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

Not applicable. The SDS1.2 dental implant system is a physical medical device, not an algorithm.

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

The "ground truth" for the device's performance is established through adherence to recognized international standards and validated laboratory test methods. This includes:

• Biocompatibility testing (ISO 10993 series)
• Mechanical performance testing (e.g., fatigue testing per ISO 14801)
• Material standards compliance (e.g., ISO 13356 for Y-TZP)
• Sterilization and packaging validation standards (ISO 11137, ISO 11607)
• Comparison to technological characteristics of predicate devices that have already demonstrated safety and effectiveness.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of AI/ML or statistical model development. The design and manufacturing processes are validated, and the device's performance is confirmed through non-clinical testing.

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

Not applicable. There is no training set for this physical medical device.

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TAV Medical Dental 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 and in order to restore the patient chewing function. The Implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

TAV Medical Dental Implant System is a two piece dental implant system for one stage or two stage surgical implantation of dental implant provided with cover screw and supported by a compatible abutment systems and surgical instruments. The implant is fabricated from a medical grade titanium alloy 6Al 4V ELI, according to ASTM F136. TAV Medical implant includes a body portion and a collar. The body portion is configured to extend into and Osseo integrate with the alveolar bone. The top surface of the collar lies flush with the crest of the jawbone bone. TAV Medical abutment lies on the top surface and extends through the soft tissue, which lies above the alveolar bone. The abutment supports the final prostheses. TAV Medical implants include the following brands: Silhouette, Sirius, and iCone. TAV Medical Abutments are intended for used as an adapter between the implant and the crown. The abutments are characterized by four distinct geometrically features: Height/length, angle, diameter and internal/external hex lock or conical connection. Anodized Color coding is used for categorical consideration only. TAV Medical abutments, as other available in the market of dental prosthetics are dental components composed either of titanium (Ti 6AL 4V ELI), PEEK and Yttrium Stabilized Zirconia (ZrO2). All the abutments fixation screws are composed of Ti 6AL 4V ELI. The abutments are supplied non-sterile to be sterilized by the physician before use according to the accompanied instruction for use. Abutment device refers to the fixture that is assembled on the implant. The crown is then built on the abutment. The prosthetic parts are divided into 3 main categories: Cemented retained restorations, Screw retained restorations, and Overdenture retained. Various abutment types are available: Titanium Abutments, Temporary Esthetic PEEK Abutments, Ball attachment, Locker overdenture, and Healing caps.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TAV Medical Dental Implant System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in the format typically used for AI/ML device performance. Instead, it details that the device underwent various non-clinical tests to demonstrate equivalence to predicate devices and adherence to established standards. The acceptance criteria for each test (e.g., biocompatibility according to ISO 10993-1, SAL of 10^-6 for sterilization, satisfactory results for mechanical and biological tests where material differences exist) are implicitly linked to the relevant standards or the statement of "satisfactory results" or "meets design specifications."

Here's a summary of the non-clinical testing performed and the reported performance, as extracted from the text:

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or imaging data, as this is a medical device (dental implant system) and not an AI/ML diagnostic software. The "test set" refers to the physical devices and materials undergoing various engineering, biological, and material tests. The specific number of implants, abutments, or material samples used for each test is not detailed.
• Data Provenance: Not applicable in the context of clinical/imaging data provenance, as no such data was used. All testing appears to be non-clinical (bench testing, biocompatibility, sterilization validation).

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

Not applicable. Ground truth in this context refers to the defined parameters and expected outcomes of the physical and chemical tests performed on the dental implants. This is established by engineering standards, material specifications, and regulatory guidelines, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiological reads). Here, the performance is measured against objective, measurable criteria from established scientific and engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers with vs. without AI Assistance

Not applicable. This is not an AI/ML medical device, so no MRMC studies involving human readers or AI assistance were performed or are relevant.

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

Not applicable. This is not an AI/ML medical device.

7. The Type of Ground Truth Used

The "ground truth" for the TAV Medical Dental Implant System is based on:

• Mechanical and Material Standards: Compliance with ISO (e.g., ISO 14801 for fatigue testing, ISO 13356 for Zirconia materials) and ASTM (e.g., ASTM F746 for corrosion) standards.
• Biocompatibility Standards: Conformance to ISO 10993 series and FDA guidance on biocompatibility.
• Sterilization and Packaging Standards: Compliance with ANSI/AAMI/ISO 11137 and ISO 11607-2.
• Design Specifications: The device met its own established design specifications, which are implicitly derived from the intended use and comparison to predicate devices.
• Predicate Device Equivalence: The performance results were considered "satisfactory" if they demonstrated equivalence to the safely and effectively marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML medical device.

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

Not applicable. This is not an AI/ML medical device.

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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.

All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant System: MegaGen AnyRidge® Implant System Implant Diameter (mm) 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 Platform Diameter (mm) 3.5 and 5.0

Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge Implant System are made of titanium alloy and have a prefabricated, precision interface (implant/ abutment connection) and are to be used for fabrication of patient-specific custom abutments using CAD/CAM technology. Each patient-specific abutment is individually prescribed by the clinician and manufactured by a Prismatik Dentalcraft authorized milling center. The proposed device is compatible with the MegaGen AnyRidge Implant System (K140091); 3.5, 4.0. 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4mm implant diameter. Abutments are made from alloyed titanium Ti-6Al-4V ELI which meets ASTM standard F-136.

The Titanium Abutment Blanks are used for fabrication of all-titanium patient-specific abutments. These abutments include Multi-unit, Esthetic, and Straight Abutments. The Straight Abutments come in both Engaging and Non-Engaging connections. The Straight abutments 4.5 mm and 6.0 mm are used for support of CAD/CAM fabricated crowns / bridges or CAD/CAM fabricated zirconia copings. A patient-specific finished device for the 4.5 mm and 6.0 mm straight abutments will consist of both the titanium base and zirconia coping and will contain no angle correction.

The provided text describes the submission of Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System for FDA 510(k) clearance, asserting substantial equivalence to predicate devices. The study conducted is primarily non-clinical performance testing.

Here's the breakdown of the requested information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format alongside specific reported device performance values. Instead, it states that "The technological characteristics of the subject device have been verified to be essentially the same as the predicate device based on assessments of material composition, dimensional features, and mechanical properties." and that "Comparative testing was performed to show equivalence to the predicate device. This testing was performed according to ISO 14801:2007." This implies that the acceptance criteria are met if the device's performance is comparable to, or within the established range of, the predicate devices under the specified ISO standard for dental implants.

The reported device performance is that it met the requirements of ISO 14801:2007 through Reliability Calculation, Fatigue Testing, and Static Load Failure Testing.

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

The document does not specify the exact sample sizes used for the non-clinical tests (Reliability Calculation, Fatigue Testing, Static Load Failure Testing).

The data provenance is retrospective, as it relies on established standards and comparative testing against predicate devices. The document does not mention the country of origin of the data, but the testing was conducted to meet FDA guidance and ISO standards.

3. Number of Experts and their Qualifications for Ground Truth

This question is not applicable to this submission. The ground truth for this type of device (dental abutments) is established through objective, standardized mechanical and material testing as per ISO and FDA guidance, rather than expert consensus on interpretive data (e.g., medical images).

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data, typically in diagnostic studies. For mechanical performance testing, the results are objectively measured against established standards.

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

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient cases, often with and without AI assistance, to measure improvements in diagnostic accuracy or efficiency. The device in question is a dental abutment, and its effectiveness is determined by mechanical and material properties, not human interpretation of cases.

6. Standalone Performance Study (Algorithm Only)

No. A standalone algorithm performance study was not done. This device is a physical medical device (dental abutment), not an AI algorithm. Its performance is assessed through laboratory testing, not algorithmic output without human involvement.

7. Type of Ground Truth Used

The ground truth used for this device is based on established engineering standards and regulatory guidance. Specifically:

• ISO 14801:2007: Standard for fatigue testing of endosseous dental implants.
• FDA Guidance: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
• Material Standards: ASTM standard F-136 for Ti-6Al-4V ELI.
• Biocompatibility Testing: Applicable prior biocompatibility testing for reference devices K121406 and K143353 (Sensitization, Cytotoxicity, and Systemic Toxicity).

These standards define the acceptable mechanical properties, material composition, and biological safety for such devices.

8. Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This question is not applicable, as there is no training set for a physical dental abutment.

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Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.

Chaorum Implant System are devices made of titanium intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices such as artificial teeth, and to restore the patients chewing function. Chaorum Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantially equivalent to the predicate devices. It offers three different implants in RBM treatment and SLA treatment.

The provided text describes a 510(k) submission for the "Chaorum Implant System," which is an endosseous dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/ML algorithm.

Therefore, many of the requested categories about acceptance criteria, study design for AI/ML performance, sample sizes for AI/ML test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to this document. This submission pertains to a physical medical device (dental implants), not a software or AI/ML-driven device.

However, I can extract information regarding the non-clinical testing performed to validate the safety and substantial equivalence of the physical device.

Here's the relevant information that can be extracted, acknowledging that it does not fit the typical format for AI/ML algorithm evaluation:

1. A table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test, nor does it report specific performance values against those criteria. Instead, it lists the types of non-clinical tests conducted to validate the device's safety and substantial equivalence. The conclusion states that "Based on the similarities and the test results of the validation activities, we conclude that the Chaorum Dental Implant System is substantially equivalent to the predicate device." This implies that the device met the unstated acceptance criteria for each test to support the substantial equivalence claim.

Therefore, for AI/ML-specific criteria, this section is N/A as this is not an AI/ML device.

For the physical device, a table summarizing the types of non-clinical tests performed is provided in the document:

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

N/A. This does not refer to an AI/ML algorithm's test set. The non-clinical tests described involve physical devices and material samples. The document does not specify the number of units or samples used for each physical or biocompatibility test, nor the provenance in the context of "data" (e.g., country of origin, retrospective/prospective). These are laboratory tests on manufactured articles.

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

N/A. This is not an AI/ML device that requires human experts to establish ground truth for image interpretation or diagnosis. The "ground truth" for the non-clinical tests would be the accepted standards and specifications for material science, mechanical engineering, and biocompatibility, as evaluated by engineers and scientists in accredited labs.

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

N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in a diagnostic or interpretive task (often in AI/ML performance evaluation). This is not relevant to the non-clinical physical and biological testing of a dental implant.

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:

N/A. MRMC studies are used to evaluate diagnostic systems, often with AI components assisting human readers. This document describes a physical medical device, not a diagnostic system with an AI component.

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

N/A. This is not an AI/ML algorithm; it is a physical dental implant system.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by:

• Engineering specifications and design requirements: For dimensional accuracy, mechanical properties, and compatibility.
• Material standards: ASTM F136, ASTM F67 for titanium alloys.
• International standards: ISO10993 series for biocompatibility.
• Sterilization validation protocols: For sterility and shelf-life.

There is no "expert consensus" or "pathology" in the sense of clinical diagnostic ground truth for these types of tests, other than expert evaluation within the relevant engineering and scientific fields to ensure compliance with standards.

8. The sample size for the training set:

N/A. This is not an AI/ML algorithm. There is no concept of a "training set" for the physical device.

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

N/A. As above, no training set is involved.

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Inclusive® Tapered Implant System is indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

The proposed device, Inclusive® Tapered Implant System, is manufactured from biocompatible Titanium alloy. The implant is designed with an internal hex connection with a diameter of implant with a 6-point flower (drawings are provided in the table below). Equipped with a tapered body and used to replace one or more missing teeth. The surface is blasted with Hydroxyl Apatite and acid etched. The dental implant (proposed device) will be provided sterile using gamma sterilization. The Inclusive Tapered Implant System, includes abutments in the form of healing abutments, engaging and non-engaging temporary abutments, straight and angled titanium abutments, titanium abutment fixation screws and straight multi-unit abutments.

The provided text is a 510(k) summary for the Inclusive® Tapered Implant System. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the document, here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI/algorithm-driven medical device. This is because the device in question is an endosseous dental implant, a physical medical device, not a diagnostic algorithm.

Instead, the "acceptance criteria" are implied by adherence to recognized standards and successful completion of non-clinical performance tests for mechanical integrity and biocompatibility. The "reported device performance" is the conclusion that the device meets these standards and functions equivalently to predicate devices.

Here's a table summarizing the performance evaluation strategy:

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 applicable in the context of this 510(k) submission for a physical dental implant. The "test set" here refers to the physical samples of the device and its components used for non-clinical (laboratory) testing, not a dataset for an algorithm.

• Sample Size: The document does not specify the exact number of implants or abutments tested in the fatigue and static load failure tests. It refers to "finished assembled implant/abutment systems" being tested.
• Data Provenance: The data is generated from laboratory testing of the manufactured devices, not from patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies do not apply in this context.

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 is not applicable. "Ground truth" in the context of this device refers to the physical properties and performance characteristics of the implant, which are established through standardized engineering and material science tests, not through expert human interpretation or consensus. The tests themselves (e.g., fatigue testing, material composition analysis) provide objective data.

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

This is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human interpretations of data (e.g., medical images) need to be reconciled to establish a ground truth. For mechanical and material testing of a physical device, the results are derived from standardized test procedures and measurements, not human consensus on interpretation.

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 is not applicable. The device is a physical dental implant, not an AI or algorithm. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

This is not applicable, as the device is a physical dental implant, not an algorithm.

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

For this physical device, the "ground truth" for demonstrating performance and safety is established through:

• Adherence to recognized standards: E.g., ISO 10993-1 (biocompatibility), ASTM F136 (material properties), ISO 14801 (dynamic fatigue).
• Non-clinical (laboratory) performance testing: Mechanical strength (fatigue and static load failure testing).
• Material verification: Titanium Grade 23 (Ti-6AL-4V ELI) meeting ASTM F-136.
• Sterilization validation: Conformance to ISO and AAMI standards.

These are objective, measurable criteria verified through specific test protocols, rather than subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable, as there is no "training set."

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