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Flexi-Seal AIR™ (with ENFit™ Connector) is an indwelling fecal management catheter intended to manage fecal incontinence through the collection of liquid stool and to provide access to administer medications. The device is intended for use in adult patients.

The Flexi-Seal Air™ (supplied non-sterile) is comprised of a low pressure foam-filled 100% silicone rectal retention balloon fixed to the distal end of a soft collapsible silicone catheter tube with a labelled white inflation port and an auto Inflate valve, Luer lock inflation syringe, an ENFit connector for irrigation/medication port with an ENFit compatible syringe, cinch clamp, date formatted labels, a sub-assembled self-closing quick connector to the catheter end, a matching collection bag, and "Diamonds" gelling and odor control sachets (4 sachets per kit). The components are contained in a rigid thermoformed plastic clamshell.

I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for the Flexi-Seal AIR (with ENFit Connector). While it details the device, its intended use, technological comparisons, and the rationale for substantial equivalence to a predicate device, it does not contain information about specific "acceptance criteria" for a study that proves the device meets these criteria in the way you've outlined.

Specifically, the document states:

• "Performance testing for Flexi-Seal Air™ was conducted for functional and structural parameters. In this testing, the device's performance has been found to be substantially equivalent to the predicate device both functionally and structurally (balloon, auto inflate valve, joint strength, mechanical properties, odor barrier, etc)."
• "The device has also been evaluated for biocompatibility in accordance with the US Food and Drug Administration's guidance entitled Use of International Standard ISO 10993-1:2018, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process’, issued September 8, 2023, and has been found safe in such respect for its intended use."

This indicates that various performance tests (functional, structural, biocompatibility) were done to demonstrate substantial equivalence to a predicate device, which is the primary requirement for 510(k) clearance. However, it does not specify:

• A table of explicit "acceptance criteria" and "reported device performance" in a quantitative manner as you've requested.
• Sample sizes for a test set proving a specific performance goal.
• Data provenance, number of experts, adjudication methods, or ground truth establishment as would be present in a clinical performance study for an AI/ML device or a device requiring specific clinical performance metrics to be proven.
• MRMC studies or standalone algorithm performance.

The document is a regulatory submission for a medical device that appears to be a physical product (fecal management catheter), not an AI/ML software device. Thus, the questions regarding "AI vs. without AI assistance," "standalone (algorithm only) performance," and ground truth establishment for a training set are not applicable here.

Therefore, I cannot extract the information you've requested as it is not present in the provided text.

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