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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.

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 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:

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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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 , 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.

Ask a specific question about this device

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 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.

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

Study Details

1. 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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).

7. 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.

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

   • This question is not applicable as there is no training set.

Ask a specific question about this device

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 subject device includes a total of 4 instrument trays. The subject device trays are reusable rigid containers, comprising a base (bottom), one or more removable inner travs, 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 instrument in the kits are manufactured from silicone. The subject device includes a total of 3 sizes (same lid, base, and enclosed volume), and a total of 4 tray configurations.

The document provides information on the nonclinical testing performed for the S.I.N. Instrument Kits to demonstrate they meet acceptance criteria.

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

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

• Sterilization Validation: 3 consecutive half-cycles were performed for each of the 3 sizes of trays. This indicates a sample size of at least 9 sterilization cycles in total (3 sizes * 3 half-cycles).
• Other tests: The exact sample sizes for Manual Cleaning Validation, Bacterial Endotoxin Testing, Dry Time, Life Cycle / Simulated Use Life Validation, and Biocompatibility are not explicitly stated by number, but the results indicate that sufficient samples were tested to meet the acceptance criteria.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that the manufacturer is S.I.N. - Sistema de Implante Nacional S.A. from Brazil, it is likely the testing was conducted in Brazil or at an international testing facility. The nature of the tests (laboratory testing of medical devices) implies a prospective test setup.

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

This section is not applicable. The tests performed are laboratory-based performances of a medical device (instrument kits for sterilization) against established regulatory standards and guidance, not diagnostic evaluations requiring expert consensus on "ground truth."

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

This section is not applicable for this type of nonclinical, laboratory-based device performance testing. Ground truth is established by the predefined acceptance criteria of the test methodologies.

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 type of study is not applicable as the device is a medical instrument kit for sterilization, not an AI-based diagnostic tool.

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

No. This concept is not applicable as the device is a physical medical instrument kit.

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

The "ground truth" for this device's performance is based on established scientific and regulatory standards and methods for medical device sterilization, cleaning, biocompatibility, and durability. These include:

• Predefined acceptance criteria based on standard test methods (e.g., absence of protein residue, endotoxin levels, sterility assurance level (SAL), weight gain after drying, visual inspection for integrity, cytotoxicity).
• Compliance with recognized standards such as USP , ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 10993-5, and ANSI/AAMI/ISO 10993-12.
• FDA Guidance documents (e.g., "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling").

8. The sample size for the training set

This section is not applicable as the device is a physical medical instrument kit, not an AI/machine learning model that requires training data.

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

This section is not applicable as the device is a physical medical instrument kit and does not involve a training set or AI model.

Ask a specific question about this device

S.I.N. Instrument Kits are intended 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 vycles, 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 subject device includes a total of 14 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 instrument in the kits are manufactured from silicone. The subject device includes a total of 5 sizes (same lid, base, and enclosed volume), and a total of 14 tray configurations.

The provided text describes the acceptance criteria and a non-clinical study to prove that the S.I.N. Instrument Kits meet these criteria for their intended use as sterilization wraps/containers.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set:
  • For Sterilization Validation, the test set involved "3 sizes of trays". The document lists 5 overall tray dimensions and 14 configurations, suggesting that not all configurations were tested for sterilization, but rather representative sizes.
  • For Life Cycle / Simulated Use Life Validation, the testing involved simulating 250 use cycles.
  • Specific quantities for other tests (Manual Cleaning, Bacterial Endotoxin, Biocompatibility) are not explicitly stated, but the "Pass" results imply adequate testing was performed.
• Data Provenance: The document states the manufacturer is S.I.N. - Sistema de Implante Nacional S.A. based in São Paulo, Brazil. The testing described is non-clinical, implying laboratory-based studies rather than patient data. The document does not specify if the testing was performed retrospectively or prospectively, but standard validation studies like these are typically conducted prospectively.

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

This information is not applicable to this study. The study involves non-clinical performance testing of a medical device (sterilization instrument kits), not an AI algorithm or diagnostic device that requires human expert review to establish ground truth from patient data. The "ground truth" here is based on objective, quantifiable measures against established industry standards for sterility, cleanliness, and material properties.

4. Adjudication Method for the Test Set:

This information is not applicable as the study involves objective, non-clinical laboratory testing, not subjective human-in-the-loop performance evaluation that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices (especially AI-assisted models) where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. This submission describes the non-clinical performance of a sterilization instrument kit, which does not involve human interpretation in the same way. The document explicitly states: "No clinical data were included in this submission."

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

This question is not applicable as the device is a physical instrument kit for sterilization, not an AI algorithm or software. The testing performed is to validate the physical and functional aspects of the kit itself.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on objective, quantifiable measurements and adherence to established industry standards for medical device reprocessing and biocompatibility. Specifically:

• Sterility: Sterility Assurance Level (SAL) of 10^-6, complete inactivation of all biologic indicators.
• Cleanliness: Absence of protein residue (no color change in protein assay), Total Organic Carbon (TOC) assay results below limit of quantification.
• Endotoxin Levels: Endotoxin results ≤ 20 EU/device.
• Dryness: Weight gain after drying ≤ 3%.
• Physical integrity and functionality: Visual inspection, component dimensional fit verification, and functional closure/latch verification after simulated use cycles.
• Biocompatibility: Non-cytotoxic according to L-929 cell exposure.

These are not "expert consensus", "pathology", or "outcomes data" in the typical sense applied to diagnostic AI models.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical medical device, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no AI model or training set involved.

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