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The Bard® DigniShield® Stool Management System with odor barrier properties is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients and to provide access for the administration of medications. Adult use only.

The Bard® DigniShield® Stool Management System is sold as a tray (kit) including a catheter, collection bag and stand alone components. The catheter consists of a retention cuff, transsphincteric zone, drainage tubing, inflation arm, irrigation arm, flush arm and piston valve connector. The retention cuff and trans-sphincteric zone are constructed from silicone and the drainage tubing is constructed from a Thermoplastic Elastomer (TPE) material. The system includes a collection bag which is manufactured from the same TPE material as the drainage tubing. The collection bag interfaces with the catheter and allows for the collection of fecal matter. Additionally, the kit includes a syringe, lubricating jelly and odor eliminator. The tube clamp is used to retain medication during administration and the syringe is used to facilitate inflation of the catheter cuff.

The provided text describes the Bard® DigniShield® Stool Management System. This is a medical device, and the submission is a Traditional 510(k) for premarket notification, indicating it is a Class II device. The document focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving a novel performance claim through a clinical study. Therefore, the information requested for acceptance criteria, device performance, and study details like sample size, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not directly applicable or provided in this type of submission.

The section titled "Summary of Performance (Nonclinical)" states that "The subject device as substantially equivalent to the predicate device for all functions and relevant testing for performance testing and biocompatibility has been performed." This implies that the device was evaluated against established standards or predicate device performance, but specific quantitative acceptance criteria and detailed study results are not elaborated in the summary.

Here's a breakdown of the available information in relation to your request:

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

   • Acceptance Criteria: Not explicitly stated as quantitative metrics in this summary. The submission aims to demonstrate substantial equivalence to predicate devices, meaning it must meet the same safety and effectiveness profiles. This would typically involve non-clinical performance testing (e.g., fluid dynamics, strength, material compatibility) and biocompatibility, but specific numerical targets are not provided here.
   • Reported Device Performance: The summary states that "The subject device as substantially equivalent to the predicate device for all functions and relevant testing for performance testing and biocompatibility has been performed." This indicates successful performance against relevant benchmarks, but specific data points or results are not included in this document.

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

   • Not applicable/Not provided. This 510(k) summary does not describe a clinical study with a test set of patient data. The evaluation would have been based on non-clinical (benchtop) testing.

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)

   • Not applicable/Not provided, as there is no clinical test set requiring expert ground truth establishment.

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

   • Not applicable/Not provided.

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/Not provided. This device is a stool management system, not an AI-assisted diagnostic tool.

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

   • Not applicable/Not provided.

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

   • Not applicable/Not provided. The "ground truth" for this device would relate to engineering specifications, material properties, and functionality standards, not clinical outcomes in the context of expert diagnosis or pathology.

8. The sample size for the training set

   • Not applicable/Not provided, as this is not an AI/machine learning device.

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

   • Not applicable/Not provided.

In summary, this 510(k) submission is for a physical medical device (stool management system) and relies on demonstrating substantial equivalence through non-clinical performance and biocompatibility testing, rather than clinical studies requiring patient data, expert review, or AI model training/testing. Therefore, most of the detailed information requested regarding clinical study design and performance metrics is not found in this type of regulatory document.

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The BARD® DigniShield™ Stool Management System is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients.

The BARD® DigniShield™ Stool Management System is sold as a tray (kit). The catheter portion of the system consists of a retention cuff, a trans-sphincteric zone and a drainage tube which are constructed from a Styrenic-based Thermoplastic Elastomer (TPE) material. The system includes a collection bag which is also manufactured from the same TPE material. Additionally, the tray (kit) contains stand alone finished components, a syringe, lubricating jelly, and an odor eliminator. The collection bag interfaces with the catheter and allows for the collection of the fecal matter. The syringe is used to facilitate the inflation of the retention cuff portion of the catheter. The lubricating jelly is provided to minimize patient discomfort and irritation of the rectum while the device is being inserted into the rectal vault. The catheter is connected to a collection bag. When the catheter is disconnected from the collection bag, the self-sealing mechanisms of both the catheter and collection bag are engaged. This minimizes the leakage of fecal matter from either the catheter or the collection bag. The device is single-use, non-sterile, and has no components made of natural rubber latex.

Here's an analysis of the provided text regarding the BARD® DigniShield™ Stool Management System, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria (e.g., a certain percentage of successful insertions, a specific rate of leakage reduction) are not explicitly stated. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through functional and structural integrity testing.

Summary of Study Information:

The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical trial with specific performance endpoints. Therefore, many of the requested details about a clinical study are not present in this submission.

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

The document only states that "Functional and structural integrity testing... has been performed." It does not specify:

• The sample size of devices used for this testing.
• The data provenance (e.g., country of origin, retrospective or prospective). This testing appears to be bench testing or in-vitro performance evaluation, not human clinical data.

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

Not applicable. The study described is functional and structural integrity testing (bench testing, biocompatibility), not a clinical study requiring expert assessment of patient data.

4. Adjudication Method for the Test Set

Not applicable. There's no indication of a clinical test set or subjective assessments that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document makes no mention of a multi-reader multi-case comparative effectiveness study or human readers improving with or without AI assistance. This device is a physical medical device, not an AI software.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical device, not an algorithm.

7. Type of Ground Truth Used

For the functional and structural integrity testing, the "ground truth" would be established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and performance benchmarks derived from the predicate devices. For biocompatibility, the ground truth is defined by the ISO 10993 standards for biological evaluation of medical devices.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set.

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