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For urological use only. Intended for use by patients for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.

The Hydrophilic Intermittent Urinary Catheter is made from silicone elastomer with a hydrophilic coating. The device is for urological use only. It is intended for use by patients for bladder management including urine drainage, collection, and measurement. The device consists of an all silicone elastomer single lumen catheter and includes a silicone handle. The catheter has drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The outer surface of the all silicone catheter has a hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. The handle provides the patient-user an ergonomically designed area for a secure grip and notouch area when inserting the catheter.

The provided text describes a 510(k) premarket notification for a Urological Catheter, focusing on its substantial equivalence to predicate devices. The information primarily covers device description, intended use, technological characteristics, and non-clinical performance data. It does not contain the specific details required to complete your request for acceptance criteria and the study that proves the device meets those criteria, particularly regarding AI/algorithm performance, human readers, or detailed test set characteristics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to an AI/algorithm-based device, as this documentation pertains to a physical medical device.

The document discusses non-clinical performance data which includes:

• Design Qualification:
  • Included dimensional analysis, appearance, and functional testing according to EN 1616.
  • Lubricity testing according to modified ASTM D1894.
• Long Term Stability/Shelf Life:
  • Included dimensional analysis, appearance, and functional testing according to EN 1616.
• Biocompatibility:
  • ISO 10993-5, Cytotoxicity
  • ISO 10993-10, Sensitization GPMT (Klingman), 2 extracts
  • ISO 10993-10, Vaginal Irritation w/Histopathology, 2 extracts

However, these are performance metrics for a physical device, not an AI or algorithm.

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The device is intended for use for urethral or intermittent catheterization. Device sizes are supplied for pediatric and adult male and female applications

The catheter consists of a single lumen catheter with two or four drainage eyes on the proximal tip. The catheter is available in a combination of French sizes and lengths to accommodate pediatric and adult male and female applications. Available catheter lengths range from 6.4 to 15.65 inches and French sizes from 6 to 26 French.

The provided text is a 510(k) summary for a medical device (Rochester Medical Corporation Personal Catheter™). It describes the device, its intended use, and comparisons to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML powered device.

The "Testing and Test Results" section refers to:

• Flow rates meeting ASTM 623-89 Standard for Foley Catheters.
• Biocompatibility testing (Cytotoxicity, Sensitization, Reactivity, Genotoxicity, Systemic Toxicity, Muscle Implant, and Bladder Irritation).

These are standard performance and safety tests for a physical medical catheter, not an AI/ML algorithm.

Therefore, I cannot provide the requested information as it is not present in the given input.

To answer your request, the input document would need to describe a study evaluating an AI/ML device, including details such as:

1. Acceptance Criteria: Specific quantitative thresholds for metrics like accuracy, sensitivity, specificity, AUC, F1-score, etc.
2. Reported Device Performance: The actual measured values of these metrics.
3. Sample Size & Data Provenance: Details about the datasets used for testing and training.
4. Ground Truth Establishment: How the true labels (e.g., presence/absence of disease) were determined.
5. Adjudication Method: If human experts were used for ground truth, how disagreements were resolved.
6. MRMC Study: If the AI was evaluated in a human-in-the-loop setting.
7. Standalone Performance: If the AI's performance without human intervention was measured.
8. Training Set Details: Information about the data used to train the AI model.

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