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CP Medical's synthetic, absorbable placement sleeve accessory is intended to be used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures. It is used to orient, hold, carry and maintain spacing of the radionuclide seeds and the spacer component.

The Carrier Sleeve is indicated for use in soft tissues or organ tissue but should not be used during cardiovascular or neurological procedures.

The CP Medical CARRIER SLEEVE consists of synthetic absorbable polymer or copolymer material, braided and non-braided, which is used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures.

This document is a 510(k) premarket notification for a medical device called the "Carrier-Sleeve," an accessory for brachytherapy procedures. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth generation is not applicable or not present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This 510(k) submission does not present a table of acceptance criteria or reported device performance in the manner of a formal performance study with quantitative metrics. The basis for clearance is demonstrating substantial equivalence to a predicate device.

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

Not applicable. There is no mention of a "test set" for performance evaluation in this 510(k). The submission relies on a comparison of technological characteristics to predicate devices.

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

Not applicable. Ground truth establishment for a test set is not part of this 510(k) submission.

4. Adjudication method for the test set

Not applicable. There is no "test set" or adjudication method described.

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 an accessory for brachytherapy procedures (a "sleeve"), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.

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

Not applicable. This is a physical accessory and does not involve an algorithm or standalone performance in the context of AI.

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

Not applicable. There is no mention of establishing ground truth for a performance study. The ground for substantial equivalence is based on comparing the intended use and technological characteristics to predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI or machine learning algorithm.

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

Not applicable. As above, there is no training set mentioned or implied.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as presented in this 510(k)):

The "study" or justification for the device meeting acceptance criteria (in this context, being suitable for market) is a comparison of technological characteristics and intended use to legally marketed predicate devices, demonstrating substantial equivalence.

• Predicate Device(s):

  • CP Medical, K013975, Placement Sleeve for Brachytherapy Procedures
  • RIVER Medical Absorbable Seeding PDO Spacer component (K021311)

• Comparison: The submission states, "The proposed device, the CP Medical CARRIER SLEEVE is comprised of a synthetic absorbable material and is intended to facilitate the loading, delivery and implantation of radioactive seeds and spacers. Similarly, the predicate devices are composed of synthetic absorbable material intended to facilitate the loading, delivery and implantation of radioactive seeds and spacers."

• Conclusion (from FDA letter): The FDA reviewed the 510(k) and "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This determination is the "proof" that the device meets the relevant regulatory acceptance criteria for market clearance via the 510(k) pathway.

In essence, the "acceptance criteria" for a 510(k) are met by demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through a comparison of design, materials, intended use, and other relevant characteristics. This document does not describe a traditional clinical or performance study with quantitative acceptance metrics.

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