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The indicated use for the Cruz Catheter is for patients requiring a catheter for long term peritoneal dialysis.

Cruz™ Catheter

The provided documents are a 510(k) clearance letter and an "Indications For Use" statement for the Cruz® Peritoneal Dialysis Catheter (K964514). These documents do not contain any information regarding acceptance criteria or a study proving device performance against such criteria. They primarily state that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them based on these documents.

Here's why and what kind of information would be needed:

• Acceptance Criteria: Acceptance criteria for medical devices typically involve performance metrics such as safety, effectiveness, biocompatibility, durability, and specific technical specifications (e.g., tensile strength, flow rate). These would be defined by the manufacturer and assessed by testing.
• Study Data: A study proving device performance would involve details about:
  • Clinical trials or bench testing: Protocols, results, statistical analysis.
  • Sample sizes: How many devices were tested or how many patients were enrolled.
  • Ground truth: How outcomes were determined (e.g., clinical diagnosis, pathology).
  • Expert involvement: If human readers/experts were involved in assessing performance.
  • Comparative studies: If the device was compared to a predicate or alternative treatment.

The documents refer to "general controls provisions of the Act" and "Current Good Manufacturing Practice requirements," which are regulatory frameworks for manufacturing quality and safety, but do not detail specific performance criteria or studies.

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Peritoneal dialysis connectors are used to connect the peritoneal dialysis catheter to the dialysate line.

Peritoneal dialysis connectors are used to connect the peritoneal dialysis catherer to the dialysate line. Medigroup intends to market titanium connectors for use with their large diameter, low duromoter (Flex Neck™) cathere only. Those connectors have the same intended use, general configuration, and materials as titanium connectors marketed by Accurate Surgical Instruments.

The provided text describes a Premarket Notification (510(k)) for a Peritoneal Dialysis Catheter Connector. This is a medical device submission seeking a determination of "substantial equivalence" to a legally marketed predicate device, rather than a study proving the device meets acceptance criteria in the same way a new, novel device might. Therefore, many of the requested elements for a typical study (like sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone performance evaluation of an AI algorithm) are not applicable in this context.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" are generally tied to demonstrating substantial equivalence to the predicate device. The performance is shown through functional testing.

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

The document does not specify the sample size for the functional testing. It only states "Functional testing has been performed". Data provenance is not applicable as this concerns mechanical device testing, not data generated from patients or populations.

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

Not applicable. Ground truth as typically defined for AI/diagnostic studies (e.g., expert labels on images) is not relevant for this type of mechanical device testing. The performance is assessed against engineering specifications and functional requirements.

4. Adjudication method for the test set

Not applicable. There's no indication of multiple human readers or adjudication processes in a medical image/diagnostic context.

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 mechanical device, not an AI or diagnostic tool where a MRMC study would be relevant.

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

Not applicable. This is a mechanical medical device, not an algorithm. The "standalone" performance refers to the device's functional testing as described.

7. The type of ground truth used

For this device, the "ground truth" or reference standard for testing would be engineering specifications, functional requirements, and performance characteristics established for similar predicate devices. The testing verifies if the new device meets these pre-defined physical and mechanical criteria.

8. The sample size for the training set

Not applicable. This is a physical device being tested functionally; there is no "training set" in the machine learning sense.

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

Not applicable. As there's no training set, there's no ground truth for it. The standards for device performance are derived from industry standards and the predicate device's established performance.

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