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The Qora® Stool Management Kit is indicated for fecal management by diverting liquid or semi-formed stool to minimize skin contact with bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use of this device, including replacement with other same devices, should not exceed 29 days.

Similar to the predicate device, the modified device is a non-sterile, single-use device intended to use for the management of fecal incontinence in bedridden patients. The device consists of an indwelling diverter, an external transit sheath, and an external collection bag. The kit also includes a collection bag hanger and a transit sheath clamp. The self-conforming indwelling fecal diverter, which is provided pre-loaded into a hygienic applicator used to deploy inside the rectum, remains in place by apposition to the rectal wall when deployed. The transit sheath acts as a conduit to facilitate the transfer of fecal matter from the indwelling diverter to the collection bag. The device includes three ports attached to the transit sheath, to facilitate irrigating of the indwelling divery, sample collection, and to allow withdrawal in a trauma-free manner.

The provided text describes a 510(k) premarket notification for the Qora® Stool Management Kit, assessing its substantial equivalence to a predicate device, the Qora AIM™ Stool Management Kit. This submission focuses on a modification to the device, specifically a change in the stainless-steel wire within the indwelling diverter, and a name change for marketing purposes.

This document does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria. Instead, it is a declaration of substantial equivalence based on the similarity of the modified device to a previously cleared predicate device and non-clinical testing to ensure the modification does not negatively impact safety or effectiveness.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not present in the provided document.

The document highlights the following:

• Device Name: Qora® Stool Management Kit
• Predicate Device: Qora AIM™ Stool Management Kit (K153506)
• Reason for Submission: Modification to the stainless-steel wire in the indwelling diverter and a name change for marketing.
• Conclusion: The modified device is substantially equivalent to the predicate device, and the changes do not raise new issues of safety or effectiveness.

The "Summary of Non-clinical Testing" section states:

• "Validation and verification testing, primarily dimensional force testing, identical to that performed on the original device, were performed on the modified device/components to ensure that the performance of the modified device is equivalent to the performance of the predicate device met all previous device specifications for the predicate device."
• "MR testing of the modified device was performed by the same independent laboratory, following the same applicable ASTM standards and US FDA guidance document... The test results of the modified device were found to be within the same acceptable range for Conditional usage as those cleared for Qora AIM™ SMK under K153506."

This indicates that the acceptance criterion was that the performance of the modified device should be equivalent to the performance of the predicate device and meet "all previous device specifications" for the predicate device. The study to prove this involved "validation and verification testing, primarily dimensional force testing," and MR testing. However, no specific numerical or statistical acceptance criteria, performance metrics, or study results are provided beyond the statement of equivalence and meeting previous specifications.

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