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As a disposable, single use Female External Urinary Collection Pouch, it is intended to collect urine and assist in directing it away from the body.

Mediquest, Inc.'s Female External Urinary Collection Pouch

This set of documents describes an FDA clearance for a "Female External Urinary Collection Pouch" manufactured by Mediquest, Inc. The documents are from 1997. Due to the age of the document and the nature of the device (a simple collection pouch), the level of detail regarding device performance studies is very limited and does not align with the typical requirements for describing AI-powered medical devices as outlined in your prompt.

Based on the provided text, I can extract the following:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific performance metrics. The FDA clearance is based on a determination of "substantial equivalence" to a predicate device. This implies that the device meets the same performance and safety standards as the predicate, but those specific standards are not detailed here.

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. For a device like a urinary collection pouch from 1997, a formal "test set" in the context of an AI study would not have been conducted. The substantial equivalence determination likely relied on existing data for the predicate device and potentially limited in-house testing by the manufacturer.

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. Ground truth establishment for a simple, non-AI device is not relevant in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as it's not applicable to this type of device and submission.

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

No such study was conducted or mentioned. This device is not AI-powered.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable, as the device is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This is not applicable. The device is a physical product, and its effectiveness is determined by its ability to collect urine, likely evaluated through basic functional testing or comparison to similar existing products.

8. The sample size for the training set

This information is not provided and is not applicable, as this is not an AI 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 device.

In summary: The provided documents pertain to a pre-AI era medical device (a female external urinary collection pouch) that received FDA clearance based on "substantial equivalence" to a predicate device. Therefore, the detailed requirements for AI device studies (acceptance criteria, test sets, ground truth, expert involvement, etc.) are entirely absent from these brief regulatory letters.

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The Hollister Urine Collection Pouch is intended to collect urine from incontinent men by encompassing the penis

The Hollister Urine Collection Pouch is a one-piece disposable system which collects urine by encompassing the penis. The pouch is made from odor-barrier film and features a synthetic skin barrier adhesive which aids in the protection of the skin. If required the precut opening in the barrier may be enlarged to accommodate the anatomy of the user. Strips of adhesive microporous tape may be used for additional security.

The provided document is a 510(k) summary for the Hollister Urine Collection Pouch. It describes a medical device and compares it to a predicate device for regulatory approval. This document does not contain any information about a study with acceptance criteria, reported device performance, sample sizes, expert ground truth, or adjudication methods in the context of an AI/ML device.

The document discusses:

• Device Description: A one-piece disposable system to collect urine from incontinent men.
• Predicate Device: Hollister Female Urine Collection Pouch, K862934.
• Technological Characteristics Comparison: A table comparing characteristics like intended use, barrier adhesive, barrier backing, barrier thickness, pouch film, drain valve, and drain valve tubing between the proposed and predicate devices.
• Biocompatibility: Assessment based on ISO 10993, FDA guidelines (G95-1), and USP. Materials were found biocompatible.
• Conclusion: The device is safe, effective, and substantially equivalent to the predicate device.

Therefore, I cannot fulfill your request as the information you are asking for (acceptance criteria and study details for an AI/ML device) is not present in the provided text. This document is from 1997 and pertains to a physical medical device, not an AI/ML system.

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The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag.

BioDerm® EID® MALE EXTERNAL INCONTINENCE DEVICE

This document, K963950, is a 510(k) summary for the BioDerm® EID® Male External Incontinence Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and biocompatibility.

It does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document states:

• Indications for Use: The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag.
• Biocompatibility: The results of the biocompatibility tests show the device to be safe for its intended purpose.
• Substantial Equivalence: The BioDerm® EID® male external catheter is substantially equivalent to the Hollister PolyTech™, non-latex, self-adhesive urinary external catheter predicate device.

Therefore, I cannot provide the requested information in the format of acceptance criteria and performance study details because this 510(k) summary does not contain that level of detail regarding performance criteria or studies beyond basic biocompatibility and general safety for its intended purpose through substantial equivalence.

The questions you've asked (about sample size, ground truth, expert qualifications, etc.) are typically associated with studies evaluating the diagnostic or predictive performance of a device (e.g., an AI-powered image analysis tool). This device, an external catheter, is a physical medical device, and its "performance" is assessed differently, primarily through its physical properties, biocompatibility, and functional outcome (facilitating urine drainage), often compared to existing devices.

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