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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.

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:

2. Sample size used for the test set and the data provenance: Not applicable (no AI/ML test set mentioned). The document refers to non-clinical testing of physical device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (no AI/ML ground truth mentioned).

4. Adjudication method for the test set: Not applicable (no AI/ML test set 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 (no AI/ML or human reader study mentioned).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (no AI/ML algorithm mentioned).

7. The type of ground truth used: Not applicable (no AI/ML ground truth mentioned). The "ground truth" for this submission are the established performance characteristics and safety profiles of the predicate devices and general standards for dental implants.

8. The sample size for the training set: Not applicable (no AI/ML training set mentioned).

9. How the ground truth for the training set was established: Not applicable (no AI/ML training set mentioned).

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S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Epikut Long Surgical Kit and the associated instruments is 422 grams.

The weight of the empty Epikut Long Surgical Kit is 310 grams.

The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). The subject device tray is to be used to organize and protect the instruments that are sterilized by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior components during sterilization. The tray is perforated to allow for penetration of the sterilant, is to be used with moist heat (steam), and requires the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone (PSU), and holders of various geometries to position instruments in the kits are manufactured from silicone.

The subject device is provided in one (1) size and one (1) configuration; the primary predicate device K201688 is provided in 5 sizes and 14 configurations. The subject device and the predicate device have similar overall dimensions, enclose similar volumes, and have similar vent to volume ratios. Differences in the dimensions and vent to volume ratios between the subject device and the predicate device are mitigated by the sterilization validation performed.

The provided document details the nonclinical testing performed for the S.I.N. Instrument Kits to demonstrate that they meet the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test. However, it indicates that the tests were nonclinical, implying that the data provenance is likely from laboratory testing rather than human subjects or a specific country of origin for patient data. The tests are described as validations, which typically involve testing multiple units of the device under specified conditions. The provenance for the referenced standards (K201688 and K212404 for predicate devices) would apply to the methodologies but not necessarily the data for the subject device.

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

Not applicable. The tests performed are nonclinical and involve validation against established industry standards and regulatory guidance, not expert interpretation of medical images or patient data. The "ground truth" for these tests is defined by the acceptance criteria set forth in the referenced standards and FDA guidance.

4. Adjudication method for the test set:

Not applicable. As the tests are nonclinical validations against predefined criteria, there is no need for expert adjudication. The results are determined by whether the device's performance meets the quantitative or qualitative requirements of the standard/guidance.

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 S.I.N. Instrument Kits are sterilization trays, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm or AI system, so standalone algorithm performance is irrelevant. The tests performed are for the physical sterilization kit itself.

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

The "ground truth" for these nonclinical tests is established by industry standards (e.g., ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, USP <85>, ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12) and FDA guidance documents (e.g., "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"). These standards and guidance define the acceptable performance parameters and methodologies for ensuring the safety and effectiveness of medical devices like sterilization kits. For example, for bacterial endotoxin testing, the ground truth for "Pass" is a level ≤ 20 EU/device.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or AI, and therefore does not have a training set.

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

Not applicable. As there is no training set for this device.

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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. Implants with lengths less than 7 mm are intended for delayed loading only.

The subject device consists of four Morse taper connection product lines: Unitite, Unitite Compact, and Strong SW CM. All implants are threaded cylindrical root-form designs. The Unitite provided with an acid-etched and HA surface, the Strong SW CM is provided with an acid-etched surface, Each product line has abutments available in multiple designs (temporary, cementable, angled, UCLA, ball, multi-unit). Subject device abutments are straight only.

Unitite implants are available in six implant body diameters (2.9. 3.5. 4.0. 4.3. 5.0 and 6.0 mm) and eight lengths (5, 6, 7, 8.5, 10, 11.5, 13, and 15 mm). Strong SW CM implants are available in four implant diameters (3.5, 3.8, 4.5.5.0 mm) and five lengths (8.5. 10. 11.5. 13. and 15 mm). Unitite abutments are available in five prosthetic platform diameters (3.3, 3.5, 4.0, 4.5, and 4.8 mm). Strong SW CM abutments are available in four prosthetic platform diameters (3.3, 3.5, 4.5 and 4.8 mm). Subject Device components are made of commercially pure titanium, titanium alloy, cobalt-chromium, or polycarbonate.

The provided text is a 510(k) Summary for the S.I.N. Dental Implant System (K170392). It details the device, its intended use, and a comparison to predicate devices, but does not contain any information about clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies related to device performance.

The document states: "No clinical data were included in this submission."

Therefore, based on the provided text, I cannot complete the requested information. However, I can extract the information provided about performance data (non-clinical) and the device's characteristics.

Here's what I can provide based on the given text:

1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the traditional sense of performance metrics for a clinical study with a device output. Instead, it describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance
Not applicable. No clinical test set. Non-clinical tests were conducted; however, specific sample sizes for these tests are not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set or ground truth established by experts is mentioned.

4. Adjudication method for the test set
Not applicable. No clinical test set or adjudication process 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
No MRMC study was done. 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 physical dental implant system, not an algorithm or AI.

7. The type of ground truth used
Not applicable. No clinical ground truth is mentioned.

8. The sample size for the training set
Not applicable. No training set is mentioned as this device is not an AI/ML algorithm.

9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for it is mentioned.

Summary of what the document implies about meeting acceptance criteria:

The document demonstrates that the "S.I.N. Dental Implant System" meets the requirements for substantial equivalence to its predicate devices through a series of non-clinical tests. These tests cover aspects like sterilization, shelf-life, biocompatibility, and physical performance (e.g., insertion). The "acceptance criteria" here implicitly refer to the successful completion of these standard tests demonstrating that the device is as safe and effective as the legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The absence of clinical data in the submission indicates that the FDA deemed the non-clinical evidence sufficient for a finding of substantial equivalence.

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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. Revolution Compact with a 6 mm length is intended for delayed loading only.

The subject device includes six product lines (Revolution Compact, Micro-Mini Revolution, Strong SW HE, TryOn, Strong SW HI). Five of the product lines have an external hex implant/abutment connection (HE) and one has an internal hex implant/abutment connection (HI). Each product line includes implants with an acid-etched surface and abutments in multiple designs (healing, provisional, cemented, UCLA, overdenture, conical and mini).

Revolution implants (Revolution Compact, Micro-Mini Revolution) are cylindrical implants with apical cutting flutes and are placed with the Revolution Assembler mount. Strong SW HI are cvlindrical implants with apical cutting flutes and micro-threads on the collar. Strong SW HE has and external connection and Strong SW HI has an internal connection. TryOn implants with apical cutting flutes and a machined collar. Subject Device components are made of commercially pure titanium, titanium alloy or cobalt-chromium alloy. All subject device abutments have 0° angulation.

This document is a 510(k) summary for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technological characteristics, rather than presenting a performance study with acceptance criteria in the typical sense for a medical device with an AI/ML component.

Therefore, many of the requested details about acceptance criteria, study design, and AI performance metrics are not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria for a performance study in the way a clinical trial or AI validation study would. Instead, it demonstrates "substantial equivalence" of the S.I.N. Dental Implant System to existing predicate devices based on:

• Indications for Use: The subject device's indications align with those of multiple predicate devices.
• Technological Characteristics: Comparison of design (prosthesis attachment, restoration, implant/abutment interface, dimensions) and material composition (implant, surface, abutment, abutment screw) to predicate devices.
• Non-clinical Testing Data: This includes validation of sterilization, biocompatibility, endotoxin testing, and shelf-life testing. These are regulatory compliance criteria, not performance metrics related to diagnostic or predictive accuracy.

Reported Device Performance (in terms of substantial equivalence):

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not applicable. This document does not describe a performance study involving a "test set" of patient data for evaluating diagnostic or predictive accuracy. The testing mentioned is for non-clinical aspects (sterilization, biocompatibility, etc.), which would involve material samples or batches.
• Data Provenance: Not applicable in the context of patient data. The "data" refers to non-clinical testing results.

3. Number of Experts for Ground Truth and Their Qualifications

• Not applicable. This document pertains to the substantial equivalence of a physical dental implant system and does not involve AI/ML or a ground truth established by experts for diagnostic performance.

4. Adjudication Method

• Not applicable. There is no "adjudication method" described as it relates to expert consensus for a test set.

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

• No. This document explicitly states: "No clinical data were included in this submission." An MRMC study would fall under clinical effectiveness.

6. Standalone (Algorithm Only) Performance Study

• No. The device is a physical dental implant system, not a software algorithm.

7. Type of Ground Truth Used

• Not applicable. Not relevant for this type of device submission. The "truth" here relates to the physical and material properties meeting regulatory standards and being substantially equivalent to legally marketed devices, verified through laboratory testing and predicate comparisons.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this device is not an AI/ML product.

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

• Not applicable. There is no "ground truth for a training set" as this device is not an AI/ML product.

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