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CompactCath TM Lubricated Intermittent Urinary Catheter and OneCath TM Intermittent Urinary Catheter are indicated for use in male, female, and pediatric patients (adolescents and transitional adolescents) with chronic urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The CompactCath™ and OneCath™ Intermittent Urinary Catheter are sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.

Both catheters will be offered in multiple French sizes (8 – 18 Fr.), lengths (10" and 16"), two tip designs (straight and coudé).

This document is a 510(k) summary for the CompactCath™ Lubricated Intermittent Urinary Catheter and OneCath™ Intermittent Urinary Catheter. It outlines the device's information, predicate devices, indications for use, device description, and comparison.

Here's an analysis of the provided text to extract information about acceptance criteria and study proving device performance, specifically for a medical device, not an AI algorithm:

Acceptance Criteria and Device Performance

The provided document describes the performance testing conducted for the CompactCath™ Lubricated Intermittent Urinary Catheter and OneCath™ Intermittent Urinary Catheter. This is a medical device, not an AI algorithm, and therefore the criteria and study methodology are focused on physical and material properties, sterilization, and biological safety, rather than AI performance metrics like sensitivity, specificity, or AUC.

The document states:
"The following performance tests were completed and the result met the acceptance criteria."

This implicitly indicates that for each test, there was a predefined acceptance criterion (e.g., "must meet the standards outlined in BS EN 1616: 1997 + A1:1999"). The document confirms that these criteria were met by stating "the result met the acceptance criteria."

Since this is a physical medical device, not an AI, many of the typical AI study questions (like sample size for test/training sets, expert adjudication, MRMC studies, effect size of human readers, ground truth for AI, etc.) are not applicable.

Here's the information extracted and framed in the context of a medical device submission:

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

The document lists the standards and regulations the device was tested against. The "reported device performance" is a blanket statement that the device met the acceptance criteria for all listed tests. Specific numerical results or detailed pass/fail thresholds for each individual test within these standards are not provided in this summary.

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

This information is not provided in the 510(k) summary. For device performance testing, samples are drawn from production lots, but specific numbers for each test are typically detailed in the full test reports, not the summary. Data provenance is generally not a concept applied in the same way to functional device testing as it is to clinical or imaging data sets.

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 is not applicable as this is a physical medical device. Ground truth, in this context, relates to compliance with engineering standards and biological safety, not expert consensus on medical images or diagnoses.

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

This is not applicable as this is a physical medical device. Adjudication refers to resolving disagreements in expert interpretations, which is not relevant to validating device specifications against engineering standards.

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 is not applicable as this is a physical medical device. MRMC studies are used for evaluating diagnostic imaging systems or AI algorithms, not for physical devices like catheters.

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

This is not applicable as this is a physical medical device. "Standalone" performance refers to an AI algorithm's performance without human interaction.

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

The "ground truth" for this medical device's performance testing is defined by the validated and recognized international and national standards (BS EN, ASTM, ISO) and FDA guidance documents. These standards specify the test methodologies, acceptable ranges, and limits for various physical, chemical, and biological properties of the device.

8. The sample size for the training set

This is not applicable as this is a physical medical device. There is no "training set" in the context of functional and biocompatibility testing for a physical device.

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

This is not applicable as this is a physical medical device.

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