(246 days)
Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100NX Flex Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.
Summit Medical Inc. Instru-Safe Instrument Protection System are cassettes / trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes / trays by themselves do not maintain sterility. The cassettes / trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes / trays have perforations to allow sterilant penetration. The cassettes / trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassette / tray.
The provided document is a 510(k) premarket notification for a medical device (Instru-Safe® Instrument Protection System) and describes the device's intended use and performance testing related to sterilization. It is not an AI/ML device, and therefore, many of the requested categories for AI/ML studies are not applicable.
Here's a breakdown based on the provided text, while noting the irrelevance of AI-specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Performance Data Section) | Reported Device Performance (from "Performance Data" and "Performance" sections) |
|---|---|
| Sterilization compatibility (allowing sterilization of enclosed medical devices during a Sterrad 100NX Flex Sterilization Cycle with legally marketed wrap or Aesculap rigid container) | Sterilization validation testing was performed to demonstrate Instru-Safe Instrument Protection System compatibility when used in a Sterrad 100NX Flex Sterilization Cycle with a legally marketed wrap or Aesculap rigid container. This new sterilization cycle does not affect safety and effectiveness of the Instru-Safe Instrument Protection System. The device's "Performance" section explicitly states "Sterrad 100NX Flex Sterilization Cycle" under "Sterilant Penetration." |
| Material Biocompatibility (cytotoxicity) | MEM Elution Cytotoxicity (ISO 10993-5) test samples met USP and ISO 10993-5 requirements, passed, and are considered non-toxic. |
| Shelf Life (reusability) | Reusable (5-year accelerated shelf life study). "No Change" (from predicate device's shelf life). |
2. Sample size used for the test set and the data provenance
The document does not specify a numerical sample size for the sterilization validation testing. It mentions "Sterilization validation testing was performed" for compatibility with the Sterrad 100NX Flex Sterilization Cycle. The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given the nature of validation for a physical medical device, it would most likely be prospective testing conducted in a laboratory or clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device involves demonstrating the physical property of sterilization compatibility and material biocompatibility, which are typically assessed through standardized laboratory tests, not expert interpretation of diagnostic data.
4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation of data requiring adjudication.
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. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth used would be based on the validated efficacy of the Sterrad 100NX Flex Sterilization Cycle to sterilize medical devices and the results of ISO 10993-5 cytotoxicity testing. This is objective, measurable data from physical and biological tests, not expert consensus, pathology, or outcomes data in a diagnostic sense.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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).