Search Results

The Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector) is an indwelling fecal management catheter intended for use 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 subject device, Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector), has the same intended use as the predicate device (K162906). Both devices include a low-profile retention balloon, a finger pocket to allow for easy balloon insertion, a green dome to indicate the optimal fill status of the retention balloon, a red dome to indicate the over inflation status, and the ability to administer medication through the use of a cinch clamp. In addition, the subject device incorporates new features, including: add a self-closing ENFit port for irrigation/medication and provide an ENFit (1) syringe in the kit, (2) add a sub-assembled self-closing quick connector to the catheter end, and add a matching bag connector in the collection bag with an option of (3) incorporating Diamonds™ gelling and odor control sachet (4 sachets per kit) to solidify and deodorize the fecal contents in the collection bag.

Here's an analysis of the provided text, focusing on the acceptance criteria and study proving device performance, as requested.

Important Note: The provided document is an FDA 510(k) Summary for a medical device (Flexi-Seal™ PROTECT PLUS Fecal Management System). This type of submission relies heavily on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, many of the typical "acceptance criteria" and "study" details associated with AI/software devices (like sample sizes for test sets, expert adjudication, MRMC studies, and ground truth establishment methods for AI algorithms) are not applicable here.

The "studies" conducted for this device are primarily benchtop performance tests to ensure the new features do not negatively impact the device's function or safety.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

Given this is a 510(k) submission for a physical medical device with modifications, the "acceptance criteria" are implied to be that the modified device performs similarly to or better than the predicate device and that the new features do not introduce new safety or efficacy concerns. The "study" involves non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device and the "acceptance criteria" are not explicitly listed as quantitative metrics in the document but rather as functional equivalence, I will infer them from the performance tests conducted and the claim of substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size for Test Set: Not explicitly stated in terms of number of devices tested for each bench test, but the document confirms these tests were "performed" and "results are detailed in Section 18 of this Submission" (which is not included in the provided excerpt). For a physical device's bench testing, this typically involves a defined number of units to ensure statistical confidence, often guided by internal quality procedures or relevant standards.
• Data Provenance: The tests were non-clinical benchtop performance tests conducted to support the 510(k) submission. The location of testing is not specified, but the applicant (ConvaTec Limited) is based in the United Kingdom. The data is prospective in the sense that it was generated specifically for this premarket submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• N/A. This information is relevant for AI/software devices where human expert consensus establishes ground truth. For this physical device, ground truth is established through objective physical measurements and observations during bench testing (e.g., measuring joint strength, observing leakage). No "experts" in the sense of clinicians or radiologists are involved in establishing ground truth for these types of engineering/material tests.

4. Adjudication Method for the Test Set:

• N/A. Adjudication (e.g., 2+1, 3+1) is a process used when multiple human readers interpret data to resolve disagreements and establish a consensus "ground truth," typically for complex medical images or diagnoses. This process is not applicable to the objective physical bench testing performed for this device.

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. An MRMC study is specific to evaluating the impact of AI algorithms on human reader performance. This device is a physical fecal management system, not an AI or software product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No. This question applies to AI/software. There is no standalone algorithm for this physical device. Section 6 explicitly states "Software Verification and Validation Testing: Not Applicable."

7. The Type of Ground Truth Used:

• Objective Physical Measurements and Engineering Standards: The "ground truth" for the performance tests (joint strength, leakage, drug efficacy) are the results of controlled laboratory experiments and measurements against predefined engineering specifications (e.g., minimum strength thresholds, zero leakage, successful drug delivery simulation). These are objective, measurable outcomes, not subjective interpretations.

8. The Sample Size for the Training Set:

• N/A. This device is not an AI/machine learning model, so there is no training set in the context of data used to train an algorithm.

9. How the Ground Truth for the Training Set Was Established:

• N/A. As there is no AI training set, this question is not applicable.

Ask a specific question about this device