(221 days)
The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in the STERRAD 100NX sterilization system using the Express cycle and in the STERRAD 100S sterilization system using the standard cycle. The sterilization cycle parameters of the sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per tray is 1 da Vinci Xi Endoscope. The max weight of tray and endoscope is 7.7 lbs.
The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.
The Endoscope Sterilization Tray is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100NX and 100S sterilization systems.
This document is a 510(k) Summary for the Intuitive Surgical Endoscope Sterilization Tray (K133942), which is a Class II device. It primarily details a comparison to a predicate device to demonstrate substantial equivalence, rather than providing a detailed study of its own performance against pre-defined acceptance criteria for an AI/CADe device.
Therefore, many of the requested sections for AI/CADe device studies, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies, are not applicable to this document. This document describes a medical device used for sterilization, not an algorithm or AI system.
However, I can extract the general "performance data" claims from the document as it relates to demonstrating substantial equivalence.
Here's an attempt to answer based solely on the provided text, acknowledging that it does not contain the specific details typically found in AI/CADe performance studies.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format for performance beyond "dimensional measurements" and "functional verification." It concludes that the device "meets the design input requirements."
| Acceptance Criteria (Implied) | Reported Device Performance (Claimed) |
|---|---|
| Dimensional measurements met | "dimensional measurements... demonstrate that the subject device is substantially equivalent" |
| Functional verification met | "functional verification... demonstrate that the subject device is substantially equivalent" |
| Cleaning test requirements met | "cleaning... tests demonstrate that the subject device is substantially equivalent" |
| Sterilization test requirements met | "sterilization tests demonstrate that the subject device is substantially equivalent" |
| Substantial Equivalence to Predicate Device (K103213) | "The Intuitive Surgical Endoscope Sterilization Tray is substantially equivalent to the Entellus Medical FinESS Endoscope Sterilization Tray (K103213)." |
| Compatible with da Vinci Xi 8 mm endoscopes | "Compatible with da Vinci Xi 8 mm endoscopes" |
| Compatible with STERRAD 100NX and 100S sterilizers | "STERRAD 100NX and 100S" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Performance test data (bench, cleaning, and sterilization tests)" but does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as this is not an AI/CADe device and no "ground truth" in the context of expert review for medical image analysis is described. The device's performance is assessed through physical, chemical, and biological tests related to cleaning and sterilization.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this is not an AI/CADe device and no adjudication method for expert review of a test set is described.
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
This information is not applicable. An MRMC study is relevant for AI/CADe devices to assess the impact on human reader performance. This document concerns a physical medical device (sterilization tray).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant for a sterilization tray.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable in the context of AI/CADe devices. For this device, the "truth" or "success" of performance would be determined by objective measurements and standardized test methods for cleaning and sterilization effectiveness (e.g., microbial kill, absence of residues, structural integrity).
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/CADe device.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" or corresponding "ground truth" for this type of medical 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).