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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.

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 <85>, 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 <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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