(81 days)
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 CP-Sleeve is indicated for use in soft tissues or organ tissue but should not be used during cardiovascular or neurological procedures.
The CP Medical CP-SLEEVE consists of 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 "CP-Sleeve," an accessory for brachytherapy procedures. It declares the device to be substantially equivalent to previously marketed predicate devices.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of acceptance criteria or reported device performance data in the typical sense of quantitative metrics for device functionality or clinical outcomes. This submission is a 510(k), which focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo performance data.
The "performance" described is in terms of the device's functional characteristics and intended use being similar to the predicate:
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance (Summary) |
|---|---|
| Material Composition | Comprised of absorbable polymer or copolymer material, braided and non-braided. |
| Functionality | Used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body. |
| Mechanism of Action | Used to orient, hold, carry, and maintain spacing of radionuclide seeds and the spacer component. |
| Intended Use Compatibility | Intended for use in brachytherapy procedures, specifically in soft tissue or organ tissue (not cardiovascular or neurological). |
| Sterility/Use | Supplied non-sterile as a single-use device. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to the I-125 Rapid Strand's accessory Sleeve (K940632 and K010821) and the CP Medical Absorbable Seeding Spacer component (K010621). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" or provide sample sizes for performance studies. 510(k) submissions typically rely on a comparison to predicate devices, and sometimes include bench testing or limited clinical data if necessary to prove equivalence. This document primarily focuses on the description of the device and its intended use in relation to predicates. Therefore, there's no information on:
- Sample size for a test set.
- Country of origin of data.
- Retrospective or prospective nature of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since there is no described test set or performance study involving human interpretation of data, there is no information about experts used to establish ground truth.
4. Adjudication Method for the Test Set
As no test set involving human interpretation is described, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, and consequently any associated effect size of human readers improving with AI assistance, was not performed or reported in this 510(k) submission. This is a traditional medical device (an accessory sleeve), not an AI/software device.
6. Standalone (Algorithm Only) Performance Study
As this is a physical medical device and not an algorithm/software, a standalone AI algorithm performance study was not conducted.
7. Type of Ground Truth Used
Given the nature of this 510(k) submission for a physical accessory device, the "ground truth" is established through bench testing and comparison to the known performance and characteristics of the predicate devices. There isn't a "pathology, outcomes data, etc." ground truth in the context of an algorithm or diagnostic device. The ground truth here is the established safety and effectiveness of the legally marketed predicate devices, which the CP-Sleeve claims to be substantially equivalent to in material, function, and intended use.
8. Sample Size for the Training Set
There is no mention of a training set or its sample size. This type of information is relevant for AI/machine learning models, not for a physical brachytherapy sleeve.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, there is no information on how its ground truth was established.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.