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The PerfIC Cath™ is intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

The PerfiC Cath™ is a straight single-use urinary catheter for intermittent use. The catheter is made of a simple piece of polyvinylchloride (PVC) tubing approximately 450 millimeters in fength, with two (2) oval eyelet holes for intra-bladder urine collection at the proximal tip. The tip, to be inserted through the urethra, is sealed and rounded for patient comfort and safety. Liquid enters the catheter only via the lateral eyelets. The distal end of the catheter is connected to a PVC urine collection bag (volume = 900 ml). Thus, the PerfiC Cath™ device facilitates its essential function by providing a channel for the drainage of urine from the bladder into a collection bag, via a straight piece of PVC tubing. Adapta Medical, Inc. supplies the PerfIC Cath™ in one size, 14 Fr.

The provided text describes the 510(k) summary for the PerfIC Cath™ urinary catheter. It mainly focuses on demonstrating substantial equivalence to a predicate device and fulfilling biocompatibility, sterilization, packaging, and basic bench testing requirements.

This document describes a medical device (a urinary catheter), not an AI/algorithm-driven device. Therefore, many of the requested criteria related to AI/algorithm performance, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

However, I can extract information related to the acceptance criteria and supporting "study" (bench and biocompatibility testing) for the PerfIC Cath™ as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated for any of the tests. The document refers to "bench testing" and "biological reactivity tests" without specifying the number of units or samples used for each test.
• Data Provenance: Not explicitly stated. These would typically be laboratory tests conducted by the manufacturer or contracted labs.

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

Not applicable. For a physical medical device submission, ground truth is established through validated laboratory tests and engineering specifications, not expert interpretation of data in the way it is for AI algorithms.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" are relevant for reviewing human-interpreted data, not for laboratory or bench test results.

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 device is a urinary catheter, not an AI-assisted diagnostic or therapeutic tool.

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

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

7. The type of ground truth used

For the PerfIC Cath™, the "ground truth" is defined by:

• Established Biocompatibility Standards: As defined by ISO 10993-1:2009 for externally communicating devices with limited patient contact.
• Established Sterilization Standards: As defined by the ISO 11137 series of standards.
• Device Design Specifications: Internal engineering specifications for dimensions, mechanical integrity, etc.
• Predicate Device Performance: Used as a benchmark for substantial equivalency in mechanical integrity and force to advance the catheter.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this type of medical device submission.

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