(111 days)
Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during Amsco V-PRO Low Temperature Sterilization Cycles. 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), which focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study. The document primarily details the device's intended use and compares its characteristics and performance to a previously cleared predicate device.
Therefore, many of the requested elements for describing an acceptance criteria study, such as sample size for test sets, ground truth establishment for test and training sets, the number and qualifications of experts, adjudication methods, or MRMC studies, are not explicitly mentioned or applicable in this type of regulatory submission.
However, based on the information provided, here's an attempt to address the request as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the intended use and the predicate device's performance. The "Performance Data" section in the summary directly addresses this.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Sterilant Penetration in Amsco V-PRO Low Temperature Sterilization Systems (Standard, Lumen, Non Lumen Cycles) | Sterilization validation testing was performed to demonstrate Instru-Safe Instrument Protection System compatibility when used in an Amsco V-PRO Low Temperature Sterilization Systems with a legally marketed wrap or Aesculap rigid container. |
| Material Compatibility | No changes from predicate device (K133015). |
| Toxicological Properties (Biocompatibility/Cytotoxicity) | MEM Elution Cytotoxicity (ISO 10993-5): Test samples met USP and ISO 10993-5 requirements; considered non-cytotoxic under test conditions. |
| Shelf Life | No Change (Reusable, 5-year accelerated shelf life study for predicate device). |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of an AI/algorithm study. For the sterilization validation, the specific number of units tested (cassettes/trays, instruments, sterilization cycles) is not provided. The data provenance would be from internal testing conducted by Summit Medical Inc. as part of their regulatory submission. The study is prospective in nature for a new device attempting to be cleared for the specified sterilization cycles.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document does not describe the establishment of ground truth by experts for a test set in the context of an AI/algorithm. The "ground truth" for sterilization effectiveness would be determined by standard microbiological and physical indicator tests, which do not typically involve human expert interpretation in the same way as, for example, image analysis.
4. Adjudication method for the test set
Not applicable. There is no mention of adjudication for a test set as this is not an AI/algorithm performance study.
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-assisted device, and no MRMC study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical instrument protection system, not a software algorithm.
7. The type of ground truth used
For the sterilization validation, the ground truth would be established through sterilization effectiveness testing using biological and chemical indicators, which are standard methods to confirm the complete inactivation of microorganisms. For the biocompatibility claim, the ground truth was established by laboratory testing against ISO 10993-5 requirements.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm, 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 mentioned.
§ 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).