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For the fecal management of patients with little or no bowel control and for patients whose stool is semi-liquid or liquid

ConvaTec Fecal Management System

The provided text is a 510(k) Premarket Notification for the ConvaTec Fecal Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device and biocompatibility testing. The document does not contain information about acceptance criteria or a study proving performance against such criteria. Therefore, I cannot extract the requested information from the provided text.

Here's a breakdown of what is and is not in the document:

What is present:

• Device Name: ConvaTec Fecal Management System
• Applicant: ConvaTec
• Intended Use/Indications: Fecal management for patients with little or no bowel control and for patients whose stool is semi-liquid or liquid.
• Predicate Device: Indwelling Fecal Management System (K012113)
• Classification: Gastrointestinal tube and accessories, 21 CFR 876.5980, Class II
• Biocompatibility Testing: States that testing was done according to ISO 10993 Part I (FDA modified matrix) and concluded the device is non-sensitizing, non-cytotoxic, and non-irritating.
• Regulatory Outcome: 510(k) clearance (substantial equivalence determination).

What is not present (and is required for your request):

• Specific acceptance criteria for device performance.
• Any study results (clinical or performance bench testing beyond biocompatibility) demonstrating the device meets performance criteria.
• Sample sizes for test sets, data provenance, ground truth establishment for a performance study.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Standalone algorithm performance or training set details.

A 510(k) submission, especially for a device demonstrating substantial equivalence, often does not include detailed performance studies with acceptance criteria in the same way a de novo or PMA submission might. The "performance" in this context is often inferred from the predicate device and relevant bench testing (like biocompatibility and basic functional tests not detailed here).

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