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The Intermittent Urethral Catheters are sterile, single-use, flexible tubular devices that are to be inserted through the urethra and used to pass fluids to or from urinary tracts.

The Intermittent Urethral Catheters will be offered in two rne Incernitions Both styles will be offered with or without Catheter. The Standard Urethral Catheter will be hydrophilic coating. offered in three tip configurations.

The provided text is a 510(k) Summary for Intermittent Urethral Catheters and a letter from the FDA. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document focuses on establishing substantial equivalence to previously marketed devices rather than presenting performance data against defined acceptance criteria. Therefore, most of the requested information cannot be extracted from the given text.

Here is a summary of what can be inferred or is explicitly stated:

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

• This information is not present in the provided document. The 510(k) summary focuses on substantial equivalence of design and materials rather than performance metrics.

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 present. The document does not describe a performance study with a test set.

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 present. No such ground truth establishment process is described.

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

• This information is not present. No adjudication method is mentioned as there is no described test set.

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 present. The device (Intermittent Urethral Catheters) is a physical medical device, not an AI or imaging diagnostic tool, so an MRMC study is not applicable.

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

• This information is not present. As noted above, this is a physical medical device, not an algorithm.

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

• This information is not present. As no performance study is described, no ground truth is discussed.

8. The sample size for the training set

• This information is not present. No training set is applicable or described.

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

• This information is not present. No training set or ground truth establishment is applicable or described.

Information directly available from the text relevant to the device and its submission:

• Device Name: Intermittent Urethral Catheters
• Intended Use: Sterile, single-use, flexible tubular devices that are to be inserted through the urethra and used to pass fluids to or from urinary tracts.
• Classification Name: Catheter, Urological
• Predicate Devices:
  • Mentor Self-Cath - Preamendment
  • Mentor Self-Cath Plus - K003784
  • Maersk Female, Nelaton and Tiemann Catheters (originally Unoplast A/S) - K896729
  • Rüsch International SympaCath Hydrogel Coated Foley Catheter - K964575
• Basis for Equivalence: Substantially equivalent in design and materials. All predicate catheters are PVC, single-use, and intended for one-time intermittent catheterization. The submitted device also offers hydrophilic coating, similar to one of the predicate devices (Mentor Self-Cath Plus, K003784).
• Submission Type: 510(k) Premarket Notification
• FDA Determination: Substantial Equivalence to legally marketed predicate devices.

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