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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 implants are 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 24mm may be tilted up to 30º. When used in the mandible or maxilla with implants with lengths of 18, 20, 22 or 24 mm at an angulation of 30º, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22 or 24 mm at angulations between 0º and less than 30º, the S.I.N. Dental Implant System implants are only indicated for multiple unit restoration in splinted applications that utilize at least two implants.

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes various endosseous implants with 16° Morse tapers interface connection. This submission adds to the S.I.N. Dental Implants System, the Versalis S implants line.

The Versalis S implant line has the Versalis S and Versalis S Plus implants, and both have a Morse taper connection with an internal 16° cone taper. The Versalis S implants have implant body lengths from 8.5 to 24mm and body diameter Ø from 3.5 to 7.0mm., they are manufactured from unalloyed titanium conforming to ASTM F67, with a double acid-etched surface treatment. The Versalis S Plus implants have implant body lengths from 8.5 to 24mm and body diameter Ø from 3.5 to 7.0mm., they are manufactured from unalloyed titanium conforming to ASTM F67, with a double acid-etched surface treatment plus hydroxyapatite surface coating.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), Grade 4. The material used to manufacture the dental implants in this submission (conforming to ASTM F67) is identical to the material used to manufacture the device implants cleared in primary predicate K170392 and in additional predicate K222231.

The provided text is a 510(k) clearance letter for a dental implant system. It does not contain any information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria. The "Performance Data" section discusses non-clinical testing for the dental implant itself, such as sterilization validation, shelf-life testing, and biocompatibility, as well as fatigue testing and MRI environment compatibility. This is for a physical medical device, not a software device that relies on AI/ML.

Therefore, I cannot provide the requested information as it is not present in the given document.

To reiterate, the document is about a physical dental implant system and the performance data pertains to its physical properties, sterility, and biocompatibility, not to the performance of an AI/ML algorithm.

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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.

Unitite Slim, Unitite, Unitite Compact, Strong SW CM S.I.N Dental Implant System implants with lengths less than 7 mm are intended for delayed loading only.

Epikut CM, Epikut Plus CM, Epikut S, Epikut S Plus S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

Epikut CM, Epikut Plus CM, Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.

The purpose of this submission is to add labeling claims for a surface treatment designated HA™®, which is applied to implants of the S.I.N. Dental Implant System, as previously cleared in K170392. K193096. K200992, K211921, K221453, and K222231. The new labeling claims and the information supporting the claims are shown below in Performance Data.

The following information is a summary of the designs of the subject device implants, as they have been previously cleared with the HA"" surface treatment. Note that there are no changes to any aspect of the design, nor to the HA" surface treatment, as described in the respective 510(k) Premarket Notifications referenced above.

The previously cleared implants that are the subject of this submission includes eleven (11) product lines from six (6) 510(k)s. Implant body diameters, platform diameters and lengths for each product line are shown below in Table 10.1 Summary of Subject Device Designs and Sizes.

K170392: Unitite Slim, Unitite, Unitite Compact K193096: Strong SW CM Plus, Strong SW HE Plus, Strong SW HI Plus K200992: Strong SW Plus K211921: Epikut Plus CM, Epikut Plus HE K221453: Epikut Plus CM (additional lengths) K22231: Epikut S Plus

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The HA1000 surface treatment is identical to that cleared in K211921.

The provided text is a 510(k) Premarket Notification from the U.S. FDA for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices by comparing their indications for use, designs, materials, and manufacturing processes, with an emphasis on adding new labeling claims related to a surface treatment.

Crucially, this document states: "No clinical data were included in this submission." This means that the device's performance was not proven through a study involving human subjects or artificial intelligence (AI). The document relies on non-clinical data such as in vitro testing, animal testing referenced from published literature, sterilization, endotoxin, shelf-life, biological evaluation, MR compatibility, and fatigue testing to support the claims and substantial equivalence.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and specific performance metrics for an AI/device study cannot be extracted from this document.

However, I can extract the information related to the non-clinical performance data presented to meet the criteria for substantial equivalence to predicates.

Here's a breakdown of what can be extracted and an explanation of why other requested information is not present:

Information that CANNOT be extracted from this document (and why):

• A table of acceptance criteria and the reported device performance (for clinical/AI studies): Not applicable as no clinical or AI study was performed. The acceptance criteria relate to demonstrating substantial equivalence through non-clinical data, not specific performance metrics against a ground truth for a diagnostic claim.
• Sample sizes used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI device).
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for test set: Not applicable as no clinical study or diagnostic AI was evaluated.
• The sample size for the training set: Not applicable (not an AI device).
• How the ground truth for the training set was established: Not applicable (not an AI device).

What CAN be extracted/inferred regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission:

The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to existing legally marketed devices (predicates). The "study that proves the device meets the acceptance criteria" in this case refers to the non-clinical tests and comparisons performed to show this equivalence and support the new labeling claims.

1. A table of acceptance criteria and the reported "device performance" (in terms of non-clinical criteria):

The acceptance criteria for this 510(k) submission are implicitly met by demonstrating that the subject device is as safe and effective as the predicate devices and that the new labeling claims are supported by scientific evidence. The "performance" here refers to meeting specific engineering, biological, and material standards, not diagnostic accuracy.

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J & P Click Attachments are designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. They are used in fixed hybrid restorations that can be attached with a click in system. Click attachments are indicated for use with vertical implant placements. They are indicated for the following implant systems: Biohorizons Tapered Tissue Level implants in diameters 3.8, 4.2, 4.6, 5.2 mm Nobel Biocare NobelActive including 3.5. 4.3, 5.0 mm diameter NobelActive, 3.75, 4.3, 5.0mm diameter NobelParallel and 3.5. 4.3. 5.0mm diameter NobelReplace Conical Connection Implants Implant Direct Legacy 3 for 3.7, 4.2, 4.7, 5.2mm diameter implants Surgikor Versatile for 3.5, 3.75, 4.2, 4.5, 5.0, 6.0mm diameter implants Surgikor Fixation for 3.5. 3.9. 4.3. 5.0mm diameter implants Surgikor Solution for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0mm diameter implants Neodent Grand Morse for 3.5, 3.75, 4.0, 4.3 and 5.0 mm diameter implants MIS Seven for implant diameters 3.75, 4.2, 5, and 6mm Zimmer for Tapered Screw-Vent in 3.7, 4.1 and 4.7mm implant diameter Hiossen ETIII for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, and 7.0mm implant diameters SIN Cone Morse 11.5° and 16° implant lines 11.5° Strong SW/SW Plus implant diameters 3.5. 3.8.4.5. 5.0mm Unitite implant diameters 3.5. 4.0.4.3. 5.0. 6.0 Tryon CM Conical implant diameters 3.5, 4.5, 5.0 Tryon CM Cylindrical implant diameters 3.5, 3.75, 4.0. 5.0 Epikut CM/CM Plus implant diameters 3.5, 3.8, 4.0. 4.5, 5.0 16 ° Strong SW CM Plus implant diameters 3.5, 3.8, 4.5 and 5.0mm Epikut S/S Plus implant diameters 3.5, 3.8. 4.0. 4.5. 5.0mm

J & P Click Attachments provide a rigid connection of fixed, partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. They consist of abutments, attachment housings, and inserts. The abutments are provided in various OEM implant and abutment connections. The abutments are made from Ti-6AL-4V ELI which meets ASTM F136. All varieties of click attachments come in collar heights of 1, 2, 3, 4, 5 and 6mm. Abutment platform diameters include: Biohorizons 3.5, and 4.5mm Nobel Biocare Nobel Active 3.5 and 3.9mm (NobelParallel and NobelReplace Conical Connection are the same) Implant Direct Legacy 3.5 and 4.5mm Surgikor Versatile 3.5 and 4.5mm Surgikor Fixation and Solution 3.5 and 3.9mm Neodent Grand Morse 3.0mm MIS Seven 3.5 and 4.5mm Zimmer for Tapered ScrewVent 3.5 and 4.5mm Hiossen ETIII 3.35mm SIN 2.5mm for 11.5° cone morse and 2.72 mm for 16° cone morse

The document describes the J & P Click Attachments, which are dental implant abutments. The submission aims to demonstrate substantial equivalence to a predicate device, the Zest High Retention Attachment System (K220252), and several reference predicates.

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

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note that the provided text is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a new clinical study. Therefore, the "acceptance criteria" here are based on comparative attributes for demonstrating substantial equivalence, and "reported device performance" refers to the characteristics of the J & P Click Attachments as compared to the predicate.

Study Proving Device Meets Acceptance Criteria:

The document describes a series of non-clinical tests and a comparison to predicate devices, rather than a single "study that proves the device meets acceptance criteria" in the sense of a clinical trial with predefined statistical endpoints. The primary method for demonstrating substantial equivalence is through comparative analysis with predicate devices and non-clinical testing.

Non-Clinical Testing Performed:

• Abutment Steam Sterilization: Done according to ISO 17665-1.
• Cytotoxicity Testing: Conducted according to ISO 10993-5.
• Reverse Engineering Tolerance Analyses: Conducted for all OEM implant systems in the indications for use. These analyses covered OEM implant body models, OEM abutment models, and OEM abutment screw models to ensure compatibility.
• MR Environment Condition (MRI Review): Non-clinical worst-case MRI review was performed using scientific rationale and published literature (e.g., Woods, Terry O., et al., 2019) to evaluate magnetic compatibility, specifically for magnetically induced displacement force and torque, based on the entire system and material composition (Ti-6AL-4V ELI).

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

• The document does not describe a clinical "test set" with human or animal subjects in the traditional sense of a clinical study.
• The "test set" for the reverse engineering tolerance analyses would be the designs and physical specifications of the OEM implant systems. The number of samples for these analyses is not specified beyond "all OEM implant systems in the indications for use."
• Data provenance: Not explicitly stated, but the submission is for an FDA 510(k), implying compliance with US regulatory standards. Non-clinical tests like cytotoxicity (ISO 10993-5) and sterilization (ISO 17665-1) are international standards.

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 provided in the document. The substantial equivalence determination is based on comparative attributes and non-clinical engineering and biological testing, not on expert-adjudicated ground truth from a clinical data set.

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

• This information is not applicable as there is no mention of a human-reviewed "test set" requiring adjudication in the context of this 510(k) submission.

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 provided and is not applicable to this type of medical device (dental implant attachments). MRMC studies are typically used for imaging diagnostics involving human readers and AI. This device is a mechanical component, not an AI software.

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

• This information is not provided and is not applicable. This device is a physical dental component and does not involve an algorithm or AI.

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

• For the non-clinical tests:
  • Sterilization: Ground truth is defined by the requirements of ISO 17665-1.
  • Cytotoxicity: Ground truth is defined by the requirements and endpoints of ISO 10993-5.
  • Reverse Engineering Tolerance Analyses: Ground truth is the design specifications and tolerances of the referenced OEM implant systems.
  • MRI Environment Review: Ground truth is established by scientific rationale and published literature referenced (e.g., relating to magnetic properties of materials).
• For substantial equivalence: The "ground truth" is the established characteristics and performance of the legally marketed predicate devices, as documented in their 510(k) clearances and product specifications.

8. The sample size for the training set

• This information is not provided and is not applicable. The device is a physical medical device, not an AI or software device that undergoes a training phase.

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

• This information is not provided and is not applicable (see point 8).

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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.

All digitally-designed custom abutments for use with Pre-Milled CAD-CAM Abutments are to be sent to a S.I.N.-validated milling center for manufacture.

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components cleared previously in K221453, K222231, K211921, K193096, and K170392.

This submission adds Pre-Milled CAD-CAM Abutments to the S.I.N. Dental Implant System. The subject device abutments are provided with 11.5° CM and 16° CM connections compatible with the above S.I.N. dental implants.

The design parameters for the CAD-CAM fabrication of patient-specific abutments from Pre-Milled CAD-CAM Abutments are the same for the 11.5° CM implant connection and the 16° CM implant connection. The design limit parameters are:

Minimum wall thickness - 0.55 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height - 0.55 mm Maximum gingival height - 3.5 mm Minimum prosthetic platform diameter - 3.5 mm Maximum prosthetic post height - 6 mm Maximum angulation - 30°

The subject device abutments are compatible with previously cleared S.I.N. Dental Implant bodies summarized in the following table.

All subject device abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136, and are to be used with compatible abutment screws previously cleared in K170392. All subject device abutments are provided non-sterile and are to be moist heat sterilized by the end user.

This document describes the regulatory clearance for the S.I.N. Dental Implant System, specifically focusing on the addition of Pre-Milled CAD-CAM Abutments. This is a 510(k) submission, which means the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

Therefore, the information you're requesting regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, sample sizes for test sets, ground truth establishment by experts, MRMC studies, and training sets, is not applicable to this type of regulatory submission.

Here's why and what information is provided in the document related to "acceptance criteria" from a substantial equivalence perspective:

In a 510(k) submission for a device like this, "acceptance criteria" are primarily met through non-clinical performance data demonstrating that the new device (the subject device with the added components) is as safe and effective as the predicate device(s). The "study" proving this typically involves engineering analyses and bench testing, comparing the subject device to the predicate device(s) or established standards.

Detailed breakdown based on the provided document:

1. Table of Acceptance Criteria (from a Substantial Equivalence Perspective) and Reported Device Performance:

The "acceptance criteria" for a 510(k) are essentially demonstrating that the new device has the same intended use and similar technological characteristics as the predicates and that any differences do not raise new questions of safety or effectiveness. The reported performance is shown through the non-clinical tests.

This statement is identical to the primary predicate device (K193096) for the core indications, and similar to reference devices with minor differences that are addressed (e.g., specific implant lengths not relevant to the subject device, or predicate not explicitly mentioning CAD-CAM abutments which is addressed by K193096). |
| Technological Characteristics Equivalence | Abutment Design Parameters: The design parameters for the CAD-CAM fabrication of patient-specific abutments from Pre-Milled CAD-CAM Abutments are provided (Minimum wall thickness - 0.55 mm, Minimum post height for single-unit restoration - 4.0 mm, Minimum gingival height - 0.55 mm, Maximum gingival height - 3.5 mm, Minimum prosthetic platform diameter - 3.5 mm, Maximum prosthetic post height - 6 mm, Maximum angulation - 30°). These parameters are compared to those of predicate abutments (e.g., Abutment Cemented Angled Indexed SIT with CM 11.5° interface and Abutment Cemented Morse Angled with CM 16° interface).

Material: Titanium alloy (Ti-6Al-4V) conforming to ASTM F136, same as predicate devices.

Sterilization Method: Non-sterile, to be moist heat sterilized by end-user. Validation performed to a sterility assurance level of 10^-5 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2. Similar to some predicate devices.

Biocompatibility: Referenced from K170398 for abutment material ASTM F136 (ISO 10993-5 cytotoxicity).

MR Safety: Referenced from K221453 (ASTM F2052, F2213, F2182, F2119, and FDA guidance).

Mechanical Performance: Engineering analysis provided to demonstrate that the subject device abutments, in combination with compatible previously cleared dental implants, do not create a new worst-case construct in terms of mechanical testing according to ISO 14801. Mechanical testing data were referenced from K200992 conducted according to ISO 14801. |
| Safety and Effectiveness Equivalence (absence of new risks)| An engineering rationale was provided to demonstrate that the use of the subject device abutments in combination with the compatible implants raise no new risks and that mechanical testing data provided in a prior submission (K200992) are applicable to the subject abutments. The non-clinical performance data (sterilization, biocompatibility, MR safety, mechanical) supports this. |

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

• Sample Size for Test Set: Not applicable in the context of clinical performance evaluation for this 510(k). The "test set" here refers to the samples of the device and implant components used for bench testing (e.g., mechanical testing, sterility validation). The document indicates mechanical testing was done per ISO 14801, which would have defined the number of samples required for that specific test, but the exact number isn't provided in this summary.
• Data Provenance: The manufacturing entity, S.I.N. - Sistema de Implante Nacional S.A., is based in São Paulo, Brazil. The testing would typically be performed either in-house by the manufacturer or by contract research organizations (CROs) in a relevant country. The document does not specify the country where the non-clinical tests (e.g., mechanical, sterilization validation) were explicitly conducted. These non-clinical tests are prospective, meaning they are performed specifically to support the submission.

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):

• Not Applicable. This device clearance is based on non-clinical performance data (bench testing, engineering analysis) and substantial equivalence to predicate devices, not on human interpretation or diagnosis. Therefore, there is no "ground truth" established by medical experts in the way it would be for an AI diagnostic device.

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

• Not Applicable. As no expert review or clinical trial data requiring adjudication was performed, this concept is irrelevant to this 510(k) submission.

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. This is not an AI/software as a medical device (SaMD) and no MRMC study was conducted or is required for this type of implant device.

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

• Not Applicable. This is a physical dental implant system, not a software algorithm.

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

• For this 510(k) submission, the "ground truth" for demonstrating device performance is typically established by:
  • International Standards: e.g., ISO 14801 for mechanical testing of dental implants, ISO 10993 for biocompatibility, ISO 17665 for sterilization. These standards provide accepted methodologies and performance requirements.
  • Engineering Principles and Analyses: Demonstrating that the new components, when combined with existing cleared components, do not introduce new failure modes or decrease mechanical integrity compared to the predicate.
  • Comparison to Predicate Devices: Showing that the subject device's characteristics (design, material, intended use) are sufficiently similar to legally marketed devices.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning/AI device, so there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) clearance letter for a dental implant system, a physical medical device. The "acceptance criteria" and "proof" are demonstrated through extensive non-clinical (bench) testing and engineering analyses to show substantial equivalence to predicate devices and adherence to relevant industry standards, rather than clinical trials involving human subjects or AI algorithm performance metrics.

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