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To collect urine to provide assistance for male urinary incontinence. This device is intended for non-prescription use and it is re-usable after cleaning and washing. It is intended for non probanpuen ass annected to an indwelling catheter. This device is not designed for pediatric use.

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The provided document describes a 510(k) submission for a medical device: "Bouser's Urinal". This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It also includes the intended use statement for the device.

Therefore, I cannot provide the requested information based on this document.

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The purpose of this 510(k) Premarket Notification is to request clearance to market ProSys™ SAMECTM LA under the ConvaTec ProSys™ product line of incontinence products.

ProSys™ SAMEC™ LA is intended for use in the management of male urinary incontinence.

ProSys™ SAMEC™ LA is a one-piece self-adhering male external catheter.

This document is a 510(k) Premarket Notification for the ProSys™ SAMEC™ LA, a male external catheter. The document asserts substantial equivalence to a predicate device, the Mentor Urology, Inc.'s Freedom Cath® Self-Adhering Male External Catheter, based on indications, contraindications, and biocompatibility testing.

However, the provided text does not contain any information about acceptance criteria for a device's performance that would typically be evaluated in a study with a test set, ground truth, experts, or sample sizes related to clinical efficacy or diagnostic accuracy.

The information present focuses solely on the biocompatibility of the adhesive material and the latex rubber. It states:

• Adhesive material: Non-toxic, non-sensitizing, Primary Irritation Index of 0.25 (acceptable range: 0-2 for mildly irritating).
• Latex rubber: Non-toxic, non-irritating, non-sensitizing. Initially failed Cytotoxicity testing, but passed after a 1:32 dilution in the MEM Elution test.

**Therefore, I cannot provide the requested table and study details because the provided text does not describe a study involving:

• Acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy).
• A test set of data (e.g., patient samples, images).
• Ground truth established by experts.
• Sample sizes for test or training sets for an AI/algorithm.
• MRMC studies for human reader improvement.**

The "study" referenced is exclusively about biocompatibility testing, which has different types of acceptance criteria (e.g., irritation indices, passage of cytotoxicity tests at certain dilutions) than those for clinical performance of a diagnostic or therapeutic device that would involve AI.

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The Hollister Self Retaining Male External Catheter is a urosheath type incontinence device intended to be used as an external catheter to collect urine from urinary incontinent males.

The Hollister Self Retaining Male External Urinary Catheter is a condom-like device made from Natural Rubber Latex. The device features a unique inner flap that aids in the protection of the penile skin from irritation due to backwash of urine and helps to maximize wear time. The external catheter is presented on a plastic collar to enable easy application and maintain the catheter shape integrity during shipping.

Here's an analysis of the provided 510(k) summary regarding the Hollister Self Retaining Male External Urinary Catheter, focusing on the requested acceptance criteria and study details.

Based on the provided text, there is no specific acceptance criteria table or a detailed study description with performance metrics that would typically be found for AI/ML-driven devices. The document is for a physical medical device (urinary catheter) and focuses on substantial equivalence, biocompatibility, and intended use rather than algorithmic performance.

Therefore, for many of your specific questions related to AI/ML studies, the answer will be that the information is not applicable or not provided in this document.

Here's an attempt to answer your questions based on the available information, noting where details are missing or irrelevant to an AI/ML context:

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

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

• Not provided. This type of detail is not typically included in 510(k) summaries for non-AI/ML devices. The "tests" mentioned are primarily biocompatibility assessments, not clinical performance studies with specific patient sample sizes in the context of device performance metrics.

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. The "ground truth" for this device is based on material science (biocompatibility) and functional design principles. Expert consensus in the sense of clinicians interpreting data for AI models is not relevant here. The biocompatibility assessments were based on established guidelines (EN 30993, G95-1, USP) which likely involve material scientists and toxicologists, but specific numbers and qualifications are not listed.

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

• Not applicable / Not provided. Adjudication methods are typically for resolving discrepancies in expert interpretations of data, as in clinical trials or AI model evaluations. This is not relevant for the type of assessments described.

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 study is for a physical male external urinary catheter, not an AI/ML diagnostic or assistive device. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant.

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

• Not applicable. This device does not involve an algorithm.

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

• The ground truth for biocompatibility was based on established regulatory standards and guidelines from agencies like the European Commission (EN 30993), United States FDA (G95-1), and United States Pharmacopeia (USP).
• The ground truth for functionality (e.g., retention, protection, ease of application) is based on engineering design principles and presumably internal testing/validation that ensures the device operates as intended.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

• Not applicable. This device does not involve a "training set" or AI/ML-related ground truth.

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