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The ComfortGlide™ Intermittent Catheter is intended for use by adult and pediatric, male and female patients for draining urine from the bladder.

The ComfortGlide™ Intermittent catheter is a hydrophilic coated, synthetic polvisorene, urinary catheter used for temporary drainage of urine from the bladder. The catheter is a tube consisting of a funnel, shaft, drainage eyes and tip. The tip of the catheter enters the bladder to allow urine to drain into the drainage eyes and then through the catheter. The catheter will be offered in multiple French sizes (10-18 Fr), lengths (6", 10" and 16") and two stiffnesses (soft and firm). Product offerings include the catheter with water sachet in a pouch as a standalone product or the catheter with water sachet in a kit configuration. The kit configuration includes two dloves, drape, benzalkonium chloride (BZK) towelette, povidoneiodine (PVI) prep pad and bag. The product is Ethylene Oxide sterilized (per ANSI/AAMI/SO 11135-1:2007 Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) and for single use.

The provided text describes the 510(k) premarket notification for the ComfortGlide™ Intermittent Catheter. This document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and performance data, rather than a single study with specific acceptance criteria and performance metrics typically seen in diagnostic device evaluations.

Therefore, many of the requested points, especially those related to diagnostic performance thresholds, expert ground truth establishment, sample sizes for test/training sets, and comparative effectiveness studies (MRMC), are not applicable to the information provided for this type of medical device submission.

Here's the breakdown of what can be extracted and what cannot:

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

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document refers to "nonclinical functional performance testing" and "biocompatibility testing," but does not provide details on the number of catheters or samples tested for each.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. These were nonclinical (laboratory) tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This is a physical medical device. Ground truth as typically understood in a diagnostic study (e.g., expert consensus on images) is not relevant here. The "ground truth" would be the engineering specifications and performance standards met by the device during testing.

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

• Not applicable. This is a physical medical device. Adjudication methods are typically for subjective assessments in diagnostic studies.

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 is a physical medical device, not an AI or diagnostic imaging system.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• For this type of device, the "ground truth" is defined by adherence to established international and national standards for medical devices, specifically:
  • BS EN 1616:1997 + A1:1999 Sterile Urethral Catheters for Single Use (for functional performance).
  • ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1 (for biocompatibility).
  • The Coefficient of Friction testing would likely be compared against internal specifications or predicate device performance.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model.

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

• Not applicable. This is a physical medical device, not a machine learning model.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the ComfortGlide™ Intermittent Catheter meets acceptance criteria is a series of nonclinical functional performance and biocompatibility tests.

• Functional Performance Testing: This included adherence to BS EN 1616:1997 + A1:1999 Sterile Urethral Catheters for Single Use and Coefficient of Friction Testing. The submission states that testing was "included," implying successful compliance with the requirements of these standards.
• Biocompatibility Testing: This was conducted in accordance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1. Again, the statement "was conducted" implies successful demonstration of biocompatibility as per these guidelines.

The overall conclusion of these tests was that the collected data demonstrated the device to be safe and effective and substantially equivalent to its predicate devices (Bard® Red Rubber All-Purpose Urethral Catheter, InterGlide™ Catheter (K951260), and InCare Intermittent Catheter (K013345)). The purpose of these tests was to show that the new device performs comparably to already marketed devices that meet regulatory standards, thus proving its acceptance for market clearance.

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