Search Results

Manufacturer

Date Cleared

2024-07-12

(58 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K212404,K201688

Intended Use

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterlized 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 PTG Surgical Kit and associated instruments is 632 grams.

The weight of the empty Epikut PTG Surgical Kit is 353 grams.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device (S.I.N. Instrument Kits, an instrument sterilization tray). This document describes the nonclinical testing and acceptance criteria for mechanical and sterilization performance of the device itself, rather than the performance of an AI/ML algorithm.

Therefore, the specific information requested in your prompt regarding acceptance criteria and study design for an AI/ML device (e.g., sample sizes, expert ground truth, MRMC studies, standalone algorithm performance, training set details) cannot be extracted from this document. This document describes a traditional medical device, not an AI/ML enabled one.

However, I can extract the acceptance criteria and performance data for the device itself based on the provided "Summary of Nonclinical Testing" table.

Acceptance Criteria and Device Performance (Non-AI/ML)

The S.I.N. Instrument Kits are sterilization trays. The studies performed are to ensure the trays can be properly cleaned, sterilized, and maintain their integrity over a specified lifespan.

1. Table of acceptance criteria and the reported device performance:

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Manual Cleaning Validation	To validate that the cleaning instructions appropriately clean the tray, and to ensure the sterilization cycle will be effective.	Protein assay: No color change = absence of protein residue (Sensitivity = 1 µg protein residue)
Total organic carbon assay: results **	To validate that the cleaning instructions appropriately clean the tray, and to ensure the BET level meets FDA expectation (≤ 20 EU/device).	Endotoxin results: ≤ 20 EU/device	Pass
Sterilization Validation (including sterilant penetration and dry time validation)	To validate that the sterilization instructions appropriately sterilize the tray and contents.	3 consecutive half-cycles performed for each of 3 sizes of trays demonstrate complete inactivation of all biologic indicators.
A minimum SAL (Sterility Assurance Level) of 10^-6 is achieved if the Instructions for Use are followed.	Pass
Dry Time	To validate that the sterilization instructions appropriately dry the wrapped tray for storage.	Using pre-cycle and post-cycle weights, the weight gain after drying will be ≤ 3%.	Pass
Life Cycle / Simulated Use-life Validation	To validate the service life of the trays as stated in the Instructions for Use.	Visual inspection, component dimensional fit verification, functional closure/latch verification for 250 use cycles.	Pass
Biocompatibility of Subject Device (Cytotoxicity testing)	To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay.	Non-cytotoxic if: ≤ 50% of L-929 cells exposed to extract of device show rounding and lysis.	Pass

Since this document does not pertain to an AI/ML device, the following points typical for AI/ML device evaluations are not applicable and thus, no information can be extracted for them:

2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable (for AI/ML, but for a physical device, the "ground truth" is established through standardized testing procedures and specified acceptance criteria, as shown in the table).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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K Number

K232821

Device Name

Manufacturer

Date Cleared

2024-05-31

(261 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K193096,K200992,K211921,K221453,K222231,K170392

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criterion (Implicitly required for 510(k) & specific claims)	Reported Device "Performance" (Evidence provided)
Equivalence in Intended Use	Subject device's Indications for Use (IFUS) are identical or substantially similar to those of predicate and reference devices (K170392, K193096, K200992, K211921, K221453, K222231). This includes general placement, loading conditions, specific length limitations for delayed loading, and angulation requirements for longer implants.
Equivalence in Design/Physical Characteristics	The design (body/platform diameters, lengths, implant/abutment interface) of the subject device implants (including the new HA™® surface) is identical to those previously cleared in predicate/reference 510(k)s (K170392, K193096, K200992, K211921, K221453, K222231).
Equivalence in Materials	Subject device is manufactured from unalloyed titanium conforming to ASTM F67, identical to predicate devices. The HA™® surface treatment is identical to that cleared in K211921.
Sterilization Efficacy	Demonstrated by gamma irradiation sterilization to a sterility assurance level of 10^-6 by VDmax25 method, according to ISO 11137-1 and ISO 11137-2 (referenced from K211921).
Absence of Pyrogens/Endotoxins	Bacterial endotoxin testing (LAL test) according to ANSI/AAMI ST72 on manufacturing water (weekly) and sterilized product (quarterly) demonstrated all sterile product meets a limit of

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K Number

K231127

Device Name

Manufacturer

Date Cleared

2023-12-07

(231 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K161598,K222497,K190718,K200992,K203725

Intended Use

Device Description

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.

AI/ML Overview

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:

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.
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.
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.
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.
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.
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.
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.
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.
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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K Number

K230069

Device Name

S.I.N. Sistema de Implante Nacional S.A.

Manufacturer

Date Cleared

2023-04-06

(86 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K221453,K222231,K211921,K200992,K170392,K193096

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance/Evidence from Document
Intended Use Equivalence	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.

Acceptance Criteria (Demonstration of Substantial Equivalence)

Reported Device Performance/Evidence from Document

Intended Use Equivalence

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.

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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K Number

K221453

Device Name

S.I.N. Sistema de Implante Nacional S.A.

Manufacturer

Date Cleared

2022-12-15

(210 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K211921,K193096,K170392,K200992,K222231

Intended Use

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.

Device Description

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.

AI/ML Overview

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:

Acceptance Criterion (Implicitly based on standards)	Reported Device Performance (as summarized)
Sterility Assurance Level (SAL) of 10⁻⁶ (ISO 11137-1 & 11137-2 for gamma; ANSI/AAMI/ISO 17665-1 & TIR 17665-2 for moist heat)	Demonstrated by selecting/substantiating a 25 kGy dose (gamma) and by overkill method (moist heat), referenced from predicate devices.
**Bacterial Endotoxin Limit

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K Number

K222231

Device Name

Manufacturer

Date Cleared

2022-10-27

(94 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K200992,K211921,K203725,K050406,K170392

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Demonstrated Equivalence to Predicate Devices)	Reported Device Performance (as demonstrated by non-clinical studies/analysis)
Intended Use (Functional and esthetic rehabilitation of edentulous mandible or maxilla)	Equivalent to K211921, K203725, K170392, and K050406. The subject device's Indications for Use statement is largely identical or similar to the predicate devices, with specific language related to tilting angles and required number of implants/splinting justified by K050406 and K203725.
Material Composition (Unalloyed titanium, ASTM F67)	Equivalent to K211921, K203725, K170392. All subject device implants are manufactured from the same material.
Endosseous Surface Treatment (Acid-etched; HA™ for Epikut S Plus)	Equivalent to K211921 and K170392 for acid-etching. The HA™ treatment is identical to that cleared in K211921. Characterization (SEM, XPS, TEM, XRD, adherence) from K211921 leveraged.
Sterilization Method & Sterility Assurance Level (SAL) (Gamma irradiation to 10⁻⁶ SAL at 25 kGy)	Equivalent to K211921 and K203725. Sterilization method selected and substantiated according to ISO 11137-1 and ISO 11137-2.
Bacterial Endotoxin Limit (

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K Number

K222514

Device Name

S.I.N. Sistema de Implante Nacional S.A.

Manufacturer

Date Cleared

2022-10-27

(69 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K212404,K201688

Intended Use

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.

Device Description

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.

AI/ML Overview

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:

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Manual Cleaning Validation (FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 2015), Referenced from K201688)	To validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the sterilization cycle will be effective.	Not explicitly stated in the document, but implied successful cleaning for effective sterilization.	Pass
Bacterial Endotoxin Testing (USP , Referenced from K201688)	To validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the BET level meets FDA expectation.	≤ 20 EU/device	Pass
Sterilization Validation (including sterilant penetration and dry time validation ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, Referenced from K201688)	To validate that the sterilization instructions listed in the Instructions for Use appropriately sterilize the tray and contents.	Not explicitly stated in the document, but implied successful sterilization.	Pass
Dry time (Referenced from K201688)	To validate that the sterilization instructions listed in the Instructions for Use appropriately dry the wrapped tray for storage.	Not explicitly stated in the document, but implied successful drying.	Pass
Life Cycle / Simulated Use-life Validation (FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 2015), Referenced from K201688)	To validate the service life of the trays as stated in the Instructions for Use.	Not explicitly stated in the document, but implied successful validation of service life.	Pass
Biocompatibility of Subject Device - Cytotoxicity testing (ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12, Referenced from K201688 and K212404)	To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay.	Not explicitly stated in the document, but implied absence of significant cytotoxicity.	Pass

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 , 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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K Number

K222005

Device Name

S.I.N. - Sistema De Implante Nacional S.A.

Manufacturer

Date Cleared

2022-09-29

(84 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K212404,K201688

Intended Use

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.

Device Description

The subject device includes a total of three (3) instrument trays. The subject device trays are reusable rigid containers, comprising a base (bottom), one or more removable inner trays, and a lid (cover). The subject device trays are 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 trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require 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 includes two (2) sizes (lid, base, and enclosed volume), and a total of three (3) tray configurations.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the S.I.N. Instrument Kits.

Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Performance
Manual Cleaning Validation (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling)	Validate cleaning instructions and ensure sterilization cycle effectiveness.	Protein assay: No color change = absence of protein residue (Sensitivity = 1 µg protein residue). Total organic carbon assay: Results )	Validate cleaning instructions and ensure BET level meets FDA expectation (≤ 20 EU/device).
Sterilization Validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2)	Validate sterilization instructions and ensure appropriate sterilization of tray and contents.	3 consecutive half-cycles performed for each of 3 sizes of trays demonstrate complete inactivation of all biologic indicators; A minimum SAL of 10^-6 is achieved if the Instructions for Use are followed.	Pass
Dry Time (Referenced from K201688)	Validate that sterilization instructions appropriately dry the wrapped tray for storage.	Using pre-cycle and post-cycle weights, the weight gain after drying will be ≤ 3%.	Pass
Life Cycle / Simulated Use Life Validation (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling)	Validate the service life of the trays as stated in the Instructions for Use.	Visual inspection, component dimensional fit verification, functional closure/latch verification for 250 use cycles.	Pass
Biocompatibility of Subject Device (Cytotoxicity testing - ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12)	Evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay.	Non-cytotoxic if ≤ 50% of L-929 cells exposed to extract of device show rounding and lysis.	Pass

Study Details

Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "3 consecutive half-cycles performed for each of 3 sizes of trays" for Sterilization Validation. For Biocompatibility, it states "L-929 cells exposed to extract of device." The exact number of units or iterations per test beyond what is explicitly stated (e.g., how many trays were tested for cleaning, how many units for biocompatibility extract) is not explicitly detailed in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only lists the standards followed (e.g., FDA Guidance, USP, ANSI/AAMI/ISO).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The tests performed are laboratory-based and follow established standards, implying no human expert consensus was required to establish ground truth for these specific performance criteria.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable as the tests are non-clinical, objective validations against predetermined criteria, not assessments requiring expert adjudication of subjective findings.
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 comparative effectiveness study was done. This device (S.I.N. Instrument Kits, which are instrument sterilization trays) is a physical medical device, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone (algorithm-only) performance study was done. As mentioned above, this is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for these non-clinical tests is based on objective measurements and adherence to established regulatory standards and protocols (e.g., protein residue levels, endotoxin levels, sterility assurance level (SAL), weight change, visual inspection, dimensional verification, cell viability).
The sample size for the training set:
- There is no training set as this is a physical medical device validation, not a machine learning model.
How the ground truth for the training set was established:
- This question is not applicable as there is no training set.

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K Number

K212404

Device Name

Manufacturer