(58 days)
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:
| 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.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).