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For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications.

The Flexi-Seal® SIGNAL™ Fecal Management System is comprised of a soft catheter tube assembly, a Luer-lock syringe, a collection bag with cap and a cinch clamp to pinch off flow in the catheter when required for medication retention or to stop waste flow. The components are contained in a rigid thermoformed plastic clamshell. The catheter main drain tube is fabricated from collapsible silicone rubber with the addition of an odor adsorber, which is added in order to help contain the fecal odor which often permeates through the wall of the catheter. The drain tube has a low-pressure silicone retention balloon at the distal end and a connector for attaching a collection bag (provided with the device and also available separately) at the proximal end. There is a recess (pocket) under the balloon for the clinician's finger, which allows the device to be positioned digitally. Two ports are attached to the side of the catheter. One port is used to inflate the retention balloon with water or saline after the device has been inserted into the patient's rectum. This port also provides a visual and tactile signal of when the low pressure retention balloon is filled to its optimal volume. The other port is used to flush the device if needed and administer medication if prescribed. An additional sampling port is located on the side of the catheter, which allows access to clinicians for stool sample collection. A syringe (provided with the device) is used to fill and evacuate the retention balloon for insertion and removal. The device, collection bag and syringe are intended for single us, are provided non-sterile and contain no components made with animal products, natural rubber latex or DEHP.

The provided document is a 510(k) premarket notification for a medical device called the Flexi-Seal® Signal™ Fecal Management System. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and a study to prove they are met in the manner one might find for a novel device or AI/software.

However, I can extract and infer information relevant to your request based on the content available.

Here's an analysis of the acceptance criteria and the study as described in the document, framed around your specific questions:

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

The document does not explicitly present "acceptance criteria" in a quantitative, pass/fail table format with specific thresholds and reported performance against those thresholds like one might see for a diagnostic device's sensitivity/specificity. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to a predicate device (Flexi-Seal® SIGNAL™ Fecal Management System, K112342). The performance is reported as being "substantially equivalent" in various parameters.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical bench testing rather than human clinical studies with a test set of patients. Therefore, specific sample sizes for a "test set" in the context of patient data are not applicable. The testing was conducted by ConvaTec Ltd. which is based in the UK. The document does not specify if the testing was done at their UK facility or elsewhere, nor does it refer to "retrospective" or "prospective" as these terms typically apply to clinical studies using patient data.

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 question is not applicable. The device is a physical medical device, not a diagnostic algorithm requiring expert "ground truth" for interpretation. The evaluation involved bench testing of physical properties and biocompatibility.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when interpreting ambiguous results, often involving multiple readers. This premarket notification describes bench testing for substantial equivalence, not such a clinical study.

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

This question is not applicable. The device is a physical fecal management system, not an AI or software device that would involve human readers or AI assistance.

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

This question is not applicable. The device is a physical medical device, not an algorithm.

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

For the physical and functional parameters, the "ground truth" is established by bench testing against engineering specifications and performance standards. For biocompatibility, the "ground truth" is established by adherence to ISO-10993 standards. These are objective, measurable physical properties, not subjective interpretations or clinical outcomes in the typical sense of "ground truth".

8. The sample size for the training set

This question is not applicable. This is a physical device clearance, not an AI/ML submission that would involve a "training set."

9. How the ground truth for the training set was established

This question is not applicable, as there is no "training set" for this type of device submission.

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For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications.

The Flexi-Seal® SIGNAL™ Fecal Management System is comprised of a soft catheter tube assembly, a Luer Syringe, a collection bag with filter and a cinch clamp to pinch off flow in the catheter when required for medication retention. The components are contained in a snap closed tray.

The catheter main drain tube is fabricated from collapsible silicone rubber. The drain tube has a low-pressure polyurethane or silicone retention balloon at the distal end and a connector for attaching a collection bag (provided with the device and separately) at the proximal end. There is a recess under the balloon for the clinician's finger allowing the device to be positioned digitally.

Two ports are attached to the side of the catheter. One port is used to inflate the retention balloon with water or saline after the device has been inserted into the patient's rectum. This port also provides a visual and tactile signal of when the low pressure retention balloon is filled to its optimal volume. The other port is used to flush the device if needed and administer medication, if prescribed.

A syringe (provided with the device) is used to fill and evacuate the retention balloon for insertion and removal.

The device, collection bay and syringe are intended for single us, are provided nonsterile, and have no components made with animal products, natural rubber latex or DEHP.

This 510(k) concerns modifications to the indications for use, materials and design featured with the predecessor device, the ConvaTec Fecal Management System (ref. K032734).

The provided text outlines the performance summary of the Flexi-Seal® SIGNAL™ Fecal Management System. However, it does not include detailed acceptance criteria or a study design with specific metrics, sample sizes, expert qualifications, or ground truth establishment as would be typically found for AI/ML device evaluations.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. This means the device is compared against existing, legally marketed devices to show it performs similarly and is equally safe and effective.

Here's an analysis based on the provided text, addressing your questions where possible:

Acceptance Criteria and Device Performance

The document describes non-clinical testing performed to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance thresholds (e.g., "must collect X mL of stool per hour") or quantitative performance metrics (e.g., "collected Y mL of stool per hour"). The criteria are implicitly met by demonstrating "substantial equivalence" to predicate devices through non-clinical testing.

2. Sample size used for the test set and the data provenance
The document refers to "non-clinical testing" and states that "the device's performance has been found to be substantially equivalent." This implies laboratory or bench testing rather than clinical data from a "test set" of patient cases. Therefore, the concepts of data provenance (e.g., country of origin, retrospective/prospective) and a "test set" in the context of clinical data are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of a "test set" requiring expert ground truth, as the evaluation was based on non-clinical, functional, and structural testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or human review for this type of non-clinical evaluation.

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
Not applicable. This device is a fecal management system, not an AI/ML diagnostic or prognostic tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is based on engineering and materials standards, functional performance specifications, and biocompatibility standards applied to the device and its predicate devices. For instance, material strength would be validated against established material properties, and biocompatibility against ISO 10993 standards.

8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical functional, structural, and biocompatibility testing. It is not an AI/ML device, and therefore, many of the typical questions related to AI/ML device evaluation (such as test set sample sizes, expert review, training data, MRMC studies) are not applicable to this submission. The "study" proving the device meets acceptance criteria is the aggregate of the described non-clinical tests that showed comparable performance to the legally marketed predicate devices.

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