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The C3® External Male Bladder Control Device is intended to be used for the management of urinary incontinence in males.

The C3® External Male Bladder Control Device is a disposable, externally applied occlusive device intended to manage urinary incontinence in males. The male urethra is occluded by applying an external force on the base of the dorsal side of the penile shaft by means of a clamp.

The provided text describes a 510(k) premarket notification for a medical device, the C3® External Male Bladder Control Device. However, it explicitly states that no functional or safety testing was repeated for this device because it is identical to a previously marketed prescription device (K885323). The submission relies on the substantial equivalence of the new Over-The-Counter (OTC) device to this predicate and to other unclassified OTC penile constriction rings.

Therefore, the input text does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria for the K974040 submission. It merely asserts that the device is identical to a previously cleared device, with the only difference being the labeling for OTC use.

Based on the provided text, here's what can be stated about the acceptance criteria and the study that "proves" the device meets acceptance criteria (which, in this case, is a claim of substantial equivalence without new testing for this specific submission):

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated or defined within the provided text for the K974040 submission. The core "acceptance criterion" for this 510(k) is substantial equivalence to existing predicate devices, implying that the safety and efficacy demonstrated by those predicates are met.
• Reported Device Performance: No new performance data is reported as no functional or safety testing was repeated for this 510(k) submission. The device performance is presumed to be identical to the predicate device K885323.

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

• Sample Size: Not applicable, as no new test set or functional/safety testing was conducted for this 510(k) submission (K974040).
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable, as no new test set requiring expert ground truth was established for this 510(k) submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable, as no new test set requiring adjudication was conducted for this 510(k) submission (K974040).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done for this 510(k) submission. The device is a physical bladder control device, not an AI-assisted diagnostic or imaging system where MRMC studies are typically performed.
• Effect Size of Human Readers with/without AI: Not applicable.

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

• Standalone Performance Study: No, a standalone performance study was not done for this 510(k) submission. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not applicable for the K974040 submission, as no new performance data or ground truth establishment was described. The submission relies on the established safety and efficacy of the predicate devices.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. This device is a physical medical device, not an AI/ML algorithm.

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The UroMed ABC device is intended to prevent or reduce episodes of male urinary incontinence.
The UroMed ABC device is indicated to prevent or reduce episodes of male urinary incontinence.

The UroMed ABC device is a urological clamp designed to significantly reduce the leakage of urine by occluding the urethra. The ABC device is clamped on the glans of the penis to provide less compression, yet the same continence as those urological clamps that are placed on the shaft of the penis.

This K971992 document describes the UroMed Alternative Bladder Control Continence Device (ABC), a Class I urological clamp. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined endpoints.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The 510(k) submission for the UroMed ABC device does not articulate specific acceptance criteria for performance metrics (such as efficacy in preventing urine leakage or comfort levels) nor does it report device performance against such criteria. The submission primarily relies on demonstrating substantial equivalence to existing predicate devices.

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

This information is not provided for efficacy or clinical performance. The document only mentions "Bench tests were conducted to evaluate the tack force and the peel force of the ABC device adhesive." It does not specify the sample size for these bench tests, nor does it provide details on data provenance beyond stating "on human skin" for the peel force. There is no information about a test set for clinical performance.

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

This information is not applicable/not provided. There is no mention of a clinical test set requiring expert-established ground truth for the UroMed ABC device. The submission relies on bench testing and substantial equivalence to market approval.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. No clinical test set requiring adjudication is described in the document.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as described in the provided document. The submission focuses on substantial equivalence based on device design and intended use, not on comparing human reader performance with and without AI assistance. The device is a physical medical device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable/not provided. The UroMed ABC is a physical medical device and does not involve an algorithm or AI. Therefore, a standalone performance study in the context of AI algorithms is not relevant.

7. Type of Ground Truth Used

For the bench tests on adhesive performance, the "ground truth" would be the direct measurements of tack force and peel force. However, for the overall effectiveness of the device in preventing urinary incontinence, the document does not refer to any specific ground truth method applied to a clinical study. Instead, it relies on the established safety and effectiveness of its predicate devices through the substantial equivalence pathway.

8. Sample Size for the Training Set

This information is not applicable/not provided. The UroMed ABC device is not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

This information is not applicable/not provided. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment process.

In Summary:

The K971992 submission for the UroMed ABC device is a Class I 510(k) submission, which typically relies on demonstrating substantial equivalence to legally marketed predicate devices. This type of submission generally does not require extensive clinical trials with detailed performance acceptance criteria, test sets, or ground truth establishment in the same manner as novel, higher-risk devices or AI/ML-driven diagnostics. The provided document details the device's design, intended use, and a summary of bench tests for adhesive properties, with the primary argument being substantial equivalence to existing penile clamps.

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The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is indicated for any male, who has urinary incontinence, either on a temporary or long term basis. It is also indicated for those patients who have an adverse reaction to natural latex rubber.

The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is a two piece compression device for males with urinary incontinence. The device consists of a silicone gel filled penile compression wrap for occlusion of the urethra and a silicone ring. It is intended for users who would prefer a reusable soft sided device instead of a rigid clamping device. The device is intended for users with moderate to heavy urinary incontinence to provide a temporary means of urinary continence.

This document is a 510(k) summary for a medical device called the "MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE." It describes the device, its intended use, and some basic safety and testing information.

However, this document does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving the device meets those criteria, or details typically associated with an AI/machine learning device's performance evaluation.

The prompt asks for details like:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, and ground truth establishment (including expert details, adjudication, and pathology).
• Information on Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
• Training set details.

The provided text only refers to:

• Biological Safety Testing: Stating it meets or exceeds Tripartite and ISO 10993 standards and all tests were satisfactory. This refers to material biocompatibility, not device functional performance with respect to incontinence management.
• Physical Testing, Design Verification: Stating various physical tests were performed to show the device and design are "adequate for the use intended." This is very general and does not provide specific acceptance criteria or performance metrics related to its efficacy in treating incontinence.

Therefore, based solely on the provided text ({0} and {1}), I cannot answer the questions regarding acceptance criteria, specific performance studies, or AI/ML-related evaluation details. The document is for a physical medical device (a urological clamp), not an AI algorithm.

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The NEBL CAP-AID (Improved) is designed to effectively occlude the male meatus thereby preventing urinary leakage.
The product prevents urinary leakage in men with urinary incontinence.

The CAP-AID (Improved) is exactly similar in indications, design and features to the original CAP-AID device. Only the materials are different. The material changes requested in the "Improved" version allow additional comfort and ease of use for the patient.

This looks like a 510(k) submission for a penile clamp device, not an AI/ML powered device. As such, the typical acceptance criteria and study design elements requested in your prompt (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through material changes for improved comfort and ease of use, rather than a performance study as would be seen for an AI algorithm.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, data provenance, ground truth establishment, or expert involvement.
• Information on MRMC studies or standalone algorithm performance.

The provided text simply states that "The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical."

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