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

The purpose of this submission is to add components to the S.I.N. Dental Implant System. This submission includes zygomatic dental implants and mating abutments for screw-retained, multi-unit prostheses.

The subject device Zygomatic Plus Morse Taper implants have a body diameter of 4.0 mm that tapers to approximately 2.3 mm at the apex. The implants have a Morse taper ("CM") abutment interface connection, with an internal 16° cone taper. The abutment platform is 4.0 mm. All implants are threaded starting at the apex and extending approximately 17 mm in the coronal direction, with a major thread diameter of 4 mm; the thread tapers over the final 6 mm of the implant to the apex. The implants are provided with overall lengths of 30, 32.5. 35. 37.5. 40. 42.5.45. 47.5. 50. 52.5.57.5. and 60 mm. The surface of all subject device implants is acid-etched from the implant platform to the apex, followed by application of a hydroxyapatite coating (HA nano).

The subject device abutments are multi-unit, indexed abutments for use only with the subject device Zygomatic Plus Morse Taper implants for maxillary full-arch restorations. The subject device abutments have a prosthetic platform diameter of 4.8 mm, and gingival heights of 1.5, 2.0, and 2.5 mm. The prosthetic post is angled 52° or 60° to the long axis of the implant. These components are used with previously cleared abutment screws.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. All implants have an acid-etched HA100 surface treatment, identical to that cleared in K231127. All subject device abutments are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. All subject device implants and abutments are provided sterile to the end user.

The provided text is a 510(k) Summary for a dental implant system. It explicitly states that no clinical data were included in this submission to support substantial equivalence (see "No clinical data were included in this submission." on page 6 of 9).

Therefore, it is not possible to provide specific details about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies, as这些 types of studies were not conducted or reported in this 510(k) submission.

The "Performance Data" section (pages 6-7 of 9) refers to non-clinical data only:

• mechanical testing
• gamma irradiation sterilization
• bacterial endotoxin testing
• MR environment evaluation
• sterile barrier shelf life data
• biocompatibility data

These tests are typically conducted to assess the physical and biological characteristics of the device, not its clinical performance in patients as would be measured in an AI/MRMC study.

In summary, based on the provided document, no study was conducted to prove the device meets acceptance criteria related to AI/MRMC performance as outlined in your request. The submission relies on substantial equivalence to predicate devices, supported by non-clinical performance data.

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

The purpose of this submission is to add components to the S.I.N. Dental Implant System. This submission includes zygomatic dental implants, mating abutments for screw-retained, multi-unit prostheses, and the corresponding abutment screws.

The subject device Zygomatic Plus Morse Taper implants have a body diameter of 4.0 mm that tapers to 1.65 mm at the apex. The implants have a Morse taper ("CM") abutment interface connection, with an internal 16° cone taper. The abutment platform is 4.0 mm. All implants are threaded starting at the apex and extending approximately 17 mm in the coronal direction, with a major thread diameter of 4 mm; the thread tapers over the final 6 mm of the implant to the apex. The implants are provided with overall lengths of 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 57.5, and 60 mm. The surface of all subject device implants is acid-etched from the implant platform to the apex, followed by application of a hydroxyapatite coating (HA nano).

The subject device abutments are multi-unit, indexed abutments for use only with the subject device Zygomatic Plus Morse Taper implants for maxillary full-arch restorations. The subject device abutments have a prosthetic platform diameter of 4.8 mm, and gingival heights of 2 mm and 3 mm. The prosthetic post is angled 45° to the long axis of the implant. These components are used with subject device abutment and prosthetic screws, or previously cleared screws.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. All implants have an acid-etched HA1200 surface treatment, identical to that cleared in K200992. All subject device abutments are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. All subject device implants, abutments, and abutment screws are provided sterile to the end user.

I am sorry, but based on the provided text, I cannot provide a comprehensive description of the acceptance criteria and the study that proves the device meets them, as requested. The document is an FDA 510(k) summary for a dental implant system. While it mentions performance data, it primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a full study report of the subject device's performance against those criteria.

Here's why I cannot fulfill each requested point:

1. A table of acceptance criteria and the reported device performance: The document does not explicitly state acceptance criteria for the new device in a quantifiable way beyond citing compliance with standards like ISO 11137-1, ISO 11137-2, ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119, ASTM F67, and ASTM F136. It mentions mechanical testing was done "to demonstrate that the subject device abutments... have sufficient strength for the intended use," but it doesn't provide specific numerical acceptance limits or the reported performance values against them.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text states "Non-clinical data provided in this submission...mechanical testing conducted using a method modified from ISO 14801 and engineering analysis," but it does not specify the sample size used for this mechanical testing. There is no information about data provenance (country of origin, retrospective/prospective). No clinical data was included in this 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): This information is not relevant to the type of non-clinical, mechanical, and sterilization testing described in the document. No expert review of a "test set" in the context of clinical interpretation or diagnosis is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no expert "test set" for clinical evaluation is mentioned.

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 device is a dental implant system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a dental implant system, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here would be the physical properties and performance characteristics determined by established engineering and sterilization standards (e.g., sterility assurance level, mechanical strength, biocompatibility, MR compatibility). These are not expert consensus in a clinical sense, pathology, or outcomes data.

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established: Not applicable, for the same reason as point 8.

The document focuses on demonstrating that the S.I.N. Dental Implant System (specifically the new zygomatic implants and abutments) is substantially equivalent to legally marketed predicate devices through non-clinical data, including:

• Gamma irradiation sterilization validation.
• Mechanical testing (modified from ISO 14801).
• MR compatibility testing (referenced from K222231 and standards ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119).
• Sterile barrier shelf life data (referenced from K203725).
• Biocompatibility data (referenced from K200992 and standards ASTM F67, ASTM F136).

The substantial equivalence argument highlights similarities in indications for use, design principles, materials, manufacturing, sterilization, and shelf life to various predicate and reference devices. However, it does not provide detailed acceptance criteria and specific performance results for the subject device beyond qualitative statements like "sufficient strength."

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

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

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 components to the S.I.N. Dental Implant System, which includes components cleared previously in K211921, K203725, K200992, K193096, K170398, and K051859.

This submission includes dental implants Epikut CM with a Morse taper (CM) abutment interface and an acid-etched endosseous surface, and Epikut Plus CM implants with an endosseous surface produced by acid-etching followed by application of a hydroxyapatite coating (HA ""0"). The implant design and endosseous surfaces are identical to those cleared in K211921, with the exception of the additional body/platform diameter (4.0 mm) and the longer lengths (18, 20, 22, and 24 mm).

This submission includes Multifunctional Abutments with Morse taper connections (16°, 11.5°, and 4°), and protectors and temporary cylinders for these abutments; the subject device Multifunctional Abutments are compatible with subject device implants (CM 11.5°) and previously-cleared implants (CM 16° and 4°). This submission also includes Multifunctional Abutment components (cylinders) manufactured from Co-Cr-Mo alloy compatible with the subject Multifunctional Abutments and with abutments cleared in K170392; CAD-CAM abutment components (called "Interface") manufactured from Ti-6A1-4V alloy and Co-Cr-Mo alloy, compatible with the subject Multifunctional Abutments and with abutments cleared in K170392; and screws compatible with subject device components and previously cleared components with the 11.5° Morse taper connection. All subject device abutments are straight, with no angulation allowed.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The acid etching procedure is applied to all subject device dental implants. The acid etching process in this submission is identical to the process used to manufacture the dental implants cleared in K211921, and the HAM00 surface treatment is identical to that cleared in K211921.

The subject device implants are compatible with abutments and prosthetic components in this submission and components cleared previously in K200992, K193096, K170392, and K051859.

The subject device abutments and prosthetic components are compatible with implants and components in this submission and components cleared previously in K211921. K200992. K193096, and K170392.

This document is a 510(k) Premarket Notification for the S.I.N. Dental Implant System. It does not describe an acceptance criteria or a study proving device performance against an acceptance criteria in the way typically found for AI/ML-driven medical devices. Instead, it demonstrates substantial equivalence to previously cleared predicate devices through non-clinical performance data and detailed comparisons of technological characteristics.

Therefore, the requested information elements related to acceptance criteria, specific study designs (test sets, training sets, expert review, MRMC studies, standalone performance), and ground truth establishment are not applicable to this type of submission.

The document focuses on showing that the new components (implants and abutments) of the S.I.N. Dental Implant System are as safe and effective as existing legally marketed predicate devices. This involves demonstrating equivalency in:

• Intended Use: The indications for use are substantially equivalent to the predicate devices.
• Technological Characteristics: Materials, manufacturing processes, design principles, sterilization methods, and performance data (non-clinical) are comparable or identical.

Here's a breakdown of the requested information based on the provided document, highlighting why most are not directly present:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table, with specific numerical acceptance criteria and a corresponding performance metric for an AI device, is not present because this is a 510(k) for a physical medical device (dental implants and components) and not an AI/ML software. The "performance data" provided are non-clinical tests demonstrating material properties, sterilization efficacy, biocompatibility, and mechanical integrity, which are described qualitatively or by reference to established standards (e.g., ISO, ASTM).

Here's an illustrative table based on the provided "PERFORMANCE DATA" section, but it does not represent AI/ML acceptance criteria:

Ask a specific question about this device

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

S.I.N. Dental Implants with lengths of 18, 20, 22, or 24 mm 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.

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components cleared previously in K211921, K200992, and K170392.

This submission includes dental implants Epikut S with a Morse taper (CM) abutment interface and an acid-etched endosseous surface, and Epikut S Plus implants with an endosseous surface produced by acidetching followed by application of a hydroxyapatite coating (HA™M). The implant design and endosseous surfaces are nearly identical to the Epikut Plus CM implants cleared in K211921, with the exception of the implant-abutment connection (subject device 16° Morse taper, K211921 11.5° Morse taper), the additional body/platform diameter (4.0 mm), and the longer lengths (18, 20, 22, and 24 mm).

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The acid etching procedure is applied to all subject device dental implants. The acid etching process in this submission is identical to the process used to manufacture the dental implants cleared in K211921, and the HA100 surface treatment is identical to that cleared in K211921.

This FDA 510(k) summary (K222231) describes a dental implant system and focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than on presenting a study with specific acceptance criteria, test sets, or performance metrics in the way these terms are typically used for AI/ML-based diagnostic devices.

The document is a regulatory submission for a medical device (S.I.N. Dental Implant System), not a study evaluating algorithm performance. Therefore, it does not contain information about:

• A table of acceptance criteria and reported device performance in the context of an algorithm's diagnostic accuracy.
• Sample sizes, data provenance, number of experts, adjudication methods for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Sample size for training sets or how ground truth for training sets was established.

Instead, the document focuses on non-clinical performance data to show that the new components of the S.I.N. Dental Implant System (subject device) are as safe and effective as existing legally marketed devices.

Here's an breakdown of the acceptance criteria (or rather, the demonstration of equivalence) and the studies (non-clinical tests and analyses) that prove the device meets these criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating that the subject device's design, materials, manufacturing, sterilization, and performance characteristics are substantially equivalent to predicate devices already cleared by the FDA. The performance data presented are non-clinical and relate to the physical and biological properties of the implant.

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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.

The purpose of this submission is to add components to the S.I.N. Dental Implant System components cleared in K200992, K193096, and K170398.

This submission includes dental implants Epikut CM with a Morse taper (CM) abutment interface and a double acid-etched endosseous surface, and Epikut Plus CM implants with an endosseous surface produced by double acid-etching followed by application of a hydroxyapatite coating (HA™Y). These implant endosseous surfaces are identical to those cleared in K200992.

This submission also includes dental implants Epikut HE with an external hexagon (HE) abutment interface and a double acid-etched endosseous surface, and Epikut Plus HE implants with an endosseous surface produced by double acid-etching followed by application of a hydroxyapatite coating (HA1000). These implant endosseous surfaces also are identical to those cleared in K200992.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The acid etching procedure is applied to all subject device dental implants. The acid etching process in this submission is identical to the process used to manufacture the dental implants cleared in K200992. K193096, and K170398. The Epikut Plus CM and Epikut Plus HE implants have the identical HA™ surface treatment cleared in K200992 and K193096.

The subject device dental implants are compatible with abutments and prosthetic components cleared previously in K200992. K193096. K170398. and K051859. Epikut HE and Epikut Plus HE dental implants are not for use with angled abutments.

The provided document (K211921 510(k) Summary for S.I.N. Dental Implant System) is a 510(k) premarket notification summary submitted to the FDA. It does not describe an AI medical device or a clinical study intended to prove its performance against acceptance criteria for such a device.

Instead, this document describes a dental implant system and its substantial equivalence to previously cleared predicate devices. The performance data presented are non-clinical bench tests (sterilization, bacterial endotoxin, shelf-life, biocompatibility, and coating characterization) to demonstrate the device's physical and biological properties.

Therefore, I cannot directly answer your prompt using the provided text, as the information regarding acceptance criteria, AI device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to the content of this document.

The document explicitly states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence through non-clinical data and comparisons to predicate devices.

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For Strong SW HE Implants

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

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

For Zygomatic Implants and Abutments

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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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.

The purpose of this submission is to add to the S.I.N. Dental Implant System components cleared in K170392 and K170398. This submission adds the following components to the S.I.N. Dental Implant System:

Tryon CM Conical implants, Tryon CM Cylindrical implants, Tryon CM Cylindrical Body and Conical Apex implants, and Strong SW implants, each with a Morse taper connection and the identical acidetched endosseous surface cleared in in K170392;

Strong SW Plus implants with a Morse taper connection and an endosseous surface produced by acidetching followed by application of a hydroxyapatite coating (HA™M) identical to the coating cleared in K170392:

conventional angled abutments and healing caps with a Morse taper connection that are compatible with the Strong SW CM implant line cleared in K170392;

conventional angled abutments and healing caps with a Morse taper connection that are compatible with the subject device Tryon CM implant lines, the subject device Strong SW/Plus implant lines, and the Unitite implant line cleared in K17039;

healing caps with a Morse taper connection that are compatible with the Unitite Compact implant line and the Unitite Slim implant line cleared in K170392;

healing caps with an external hex (HE) or internal hex (HI) connection that are compatible with the Strong SW HE, the Tryon HE implant lines, and the Strong SW HI implant lines, cleared in K170398;

abutment screws for use with the angled abutments or healing caps.

This document is a 510(k) summary for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a standalone study with defined performance metrics.

However, the document does contain information about performance data used to support the substantial equivalence claim. Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a structured table with corresponding device performance metrics. Instead, it lists various non-clinical tests conducted and states that these tests demonstrate substantial equivalence to predicate devices, implying these tests met the necessary standards for such a claim.

Based on the "Performance Data" section (Page 6), the following can be inferred as the type of performance evaluation conducted:

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