(199 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 any of the following sterilization machines/cycles:
- · STERRAD 100NX sterilization system using the Express cycle
- · STERRAD 100S sterilization system using the Standard cycle
- · Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- · Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
- · Steris V-PRO 1 using the V-PRO/Lumen cycle
The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 8.9 lbs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.
The Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi Endoscopes during the sterilization process. It is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and the lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope.
This document is a 510(k) premarket notification for an "Endoscope Sterilization Tray" (K170640) and does not contain detailed information about acceptance criteria and the comprehensive study that proves the device meets them in the context of the requested questions. This type of FDA filing primarily establishes substantial equivalence to a predicate device, rather than providing granular performance data or detailed study methodology as would be included in a clinical trial report.
However, based on the provided text, I can extract the following information relevant to device performance and testing:
1. A table of acceptance criteria and the reported device performance
The document mentions that "Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements."
The testing mentioned is:
- Cleaning Validation
- Human Factors Validation
No specific quantitative acceptance criteria or reported device performance metrics are provided in this document. The overall "performance" is stated as being "substantially equivalent" to the predicate.
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.
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 provided in the document. The device is a sterilization tray, not a diagnostic or AI device that would typically involve expert ground truth generation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. As addressed above, this type of adjudication is typically for diagnostic interpretation, not for validating a sterilization tray.
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 type of study is not applicable and was not performed for this device. This device is an Endoscope Sterilization Tray, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and was not performed for this device. This device is an Endoscope Sterilization Tray, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For "Cleaning Validation," the ground truth would likely be established through standardized laboratory testing methods to detect residual soil or microbial load, adhering to relevant industry standards (e.g., AAMI, ISO).
For "Human Factors Validation," the ground truth would typically be observations of user interactions and assessment against usability criteria, often involving user tasks and satisfaction surveys.
Specific details are not provided in the document.
8. The sample size for the training set
This information is not provided and is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as this is not an AI/ML device.
In summary: The provided FDA 510(k) document focuses on establishing substantial equivalence for a physical medical device (sterilization tray) and, as such, does not contain the detailed performance study information typically requested for AI/ML or diagnostic devices. The performance data mentioned relates to cleaning and human factors validation, but specific results, sample sizes, and detailed methodologies are not included in this summary.
§ 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).