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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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CompactCath is 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 Intermittent Urinary Catheter is a sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.

The provided text is a 510(k) summary for the CompactCath Intermittent Urinary Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria and a study proving a device meets them in the context of an Artificial Intelligence (AI) device.

However, based on the information provided, here's what can be extracted and what cannot be answered concerning acceptance criteria and a study:

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

The document states: "Product testing was completed and met the acceptance criteria. Testing included flow measurements, bond strength, deployment, and insertion force using anatomical models to simulate clinical use for both the CompactCath device and the predicate device. Test results show the products are equivalent."

While acceptance criteria were met, the specific numerical criteria and the reported performance values are not provided in this summary. The word "equivalent" is used to describe the results compared to the predicate device, but no quantitative data for either the criteria or the performance is given.

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 document. The testing involved "anatomical models to simulate clinical use," but the number of models/tests, their origin, or whether the study was retrospective or prospective (which isn't directly applicable as it's not a clinical study on human subjects) is not detailed.

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 information is not applicable/provided. The testing described involves physical measurements on a medical device (flow, bond strength, deployment, insertion force) using anatomical models. Establishing "ground truth" through expert consensus is typically relevant for diagnostic imaging or AI devices that interpret data, where human experts label or interpret cases. Here, the "ground truth" would be the direct physical measurements themselves (e.g., actual flow rates, actual insertion force).

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

This information is not applicable/provided. Adjudication methods like "2+1" or "3+1" are used in studies where multiple human readers or AI systems interpret data, and discrepancies need to be resolved to establish a consensus ground truth. This is not relevant to the type of physical performance testing described for a urinary catheter.

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 information is not applicable. The device described is a physical medical device (an intermittent urinary catheter), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable. As stated above, this is a physical medical device, not an AI algorithm.

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

For the performance testing, the "ground truth" would be the physical measurements themselves (e.g., direct measurements of flow rates, bond strength, deployment characteristics, and insertion force). These are objective measurements rather than interpretations requiring expert consensus or pathology.

8. The sample size for the training set

This information is not applicable/provided. As this is not an AI device, there is no "training set."

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

This information is not applicable/provided.

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CompactCath Intermittent Urinary Catheter is indicated for use in male, female, and pediatric patients (adolescent and transitional adolescent) 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 Intermittent Urinary Catheter is a sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.

The provided document describes the CompactCath Intermittent Urinary Catheter and its substantial equivalence to a predicate device, K100878 Self Cath Catheter Coloplast A/S. The information about the acceptance criteria and the study that proves the device meets them is limited, as the document focuses on demonstrating substantial equivalence rather than presenting a detailed clinical study report with, for example, a standalone algorithm performance, or an MRMC study.

However, based on the Testing section and the Performance specifications & testing summary (avg.) table, we can extract the following information:

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

Note on Acceptance Criteria: The document states "Product testing was completed and met the acceptance criteria." The table above extrapolates the "acceptance criteria" from the reported performance of the predicate device (Coloplast) as the basis for comparison to demonstrate substantial equivalence. The CompactCath performance is then compared directly against these values. For some criteria, the CompactCath matches or is within an acceptable range, while for others (like shelf life), the difference is acknowledged and deemed equivalent in the context of substantial equivalence, not necessarily identical.

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

• Sample Size for Test Set: The document does not explicitly state the sample sizes used for the various tests (flow measurements, bond strength, deployment, insertion force, biocompatibility, sterilization validation, expiry dating). It only mentions that testing was completed.
• Data Provenance: Not specified. The studies appear to be in-house laboratory testing of the devices, not human clinical trials or data from specific countries of origin. They are therefore prospective in nature, as they involve testing the manufactured devices.

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. The tests performed are engineering and laboratory tests (e.g., flow rate, force measurement, biocompatibility, sterilization validation), not subjective assessments requiring expert consensus on a "ground truth" in the way a medical image or diagnostic test would.

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

Not applicable, for the same reasons as point 3.

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

No. This type of study (MRMC for AI assistance) is not relevant to this medical device, which is a physical intermittent urinary catheter, not an AI-powered diagnostic or therapeutic system.

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

Not applicable, as it's a physical medical device, not an algorithm.

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

The "ground truth" for the performance tests appears to be the measured performance data of the legally marketed predicate device (Coloplast Self Cath Catheter). For other tests like biocompatibility, the ground truth is adherence to recognized standards (ISO10993). For sterilization, the ground truth is validated sterilization cycles achieving a specific SAL (10^-6).

8. The 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, as explained in point 8.

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