(146 days)
The radial compression device is designed to apply compression in order to achieve temporary hemostasis of the radial artery after a percutaneous transradial procedure.
The Radial Compression Device (RC-001) is designed to promote hemostasis of the radial artery post percutaneous puncture. The radial compression device is fixed on the arm and the square pad of the device is pressed against the puncture site. The square cushion is adjusted to apply pressure and temporarily compress the puncture site of the radial artery to achieve rapid hemostasis. The product is primarily composed of a plate, turn cap, screw rod, hook and loop band, tapered cushion, and square cushion. The Radial Compression Device is available in one model, RC-001.
This document describes a 510(k) premarket notification for the Ningbo DIZENGENS Medical Science Co., Ltd. Radial Compression Device (K232577). The document presents a summary of non-clinical performance testing to support the claim of substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and study results in the format requested.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance with specific metrics.
- Sample sizes used for a "test set" in the context of an algorithm's performance.
- Data provenance, number of experts, adjudication method, or ground truth details for an AI/algorithm study.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Sample size or ground truth establishment for a "training set."
The document primarily focuses on non-clinical performance testing for a physical medical device (a radial compression device), not an AI/software algorithm. The tests conducted are typical for a physical medical device.
Here's a breakdown of what is provided and what elements are missing or not applicable based on the provided text, in the context of your request for AI/algorithm study details:
1. Table of Acceptance Criteria and Reported Device Performance:
- Provided: A list of performance tests conducted. For each test, it states "All testing met the requirements and passed."
- Missing from provided text: Specific numerical acceptance criteria for each test and the corresponding numerical results obtained by the Radial Compression Device. For example, for "Bond strength testing," it doesn't state "Acceptance criteria: > X N, Result: Y N."
2. Sample size used for the test set and the data provenance:
- Not Applicable in the provided text: This question is relevant for AI/algorithm performance evaluation. The document describes tests for a physical device (e.g., visual inspections, bond strength, biocompatibility), not an AI model. Therefore, there's no "test set" of data in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the provided text: This question is relevant for AI/algorithm performance. Ground truth for a physical device's non-clinical performance tests is typically established through established engineering standards, laboratory procedures, and physicochemical measurements, not through expert consensus on images or clinical data.
4. Adjudication method for the test set:
- Not Applicable in the provided text: This is relevant for AI/algorithm performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No: The document does not mention any MRMC study, as it's for a physical device and not an AI assistant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No: The device is a physical Radial Compression Device, not an algorithm.
7. The type of ground truth used:
- Implicitly: For the physical device tests, the "ground truth" is based on engineering specifications, standardized test methods (e.g., ISO standards for biocompatibility and sterilization), and validated laboratory measurements. For instance, biocompatibility is evaluated per ISO 10993, and sterilization per ISO 11135.
- Missing from provided text: No explicit mention of ground truth in the context of expert consensus, pathology, or outcomes data, as these are typically for diagnostic AI/software.
8. The sample size for the training set:
- Not Applicable: There is no AI/algorithm training set.
9. How the ground truth for the training set was established:
- Not Applicable: There is no AI/algorithm training set.
Summary of Provided Non-Clinical Performance Testing:
The provided document lists the following non-clinical performance tests conducted for the Radial Compression Device:
- Visual inspections
- Dimensional inspections
- Bond strength testing
- Turn Cap and Screw Function
- Distribution and Packaging Tests
- Device and Packaging Aging Evaluation
- Pressure applied at puncture site (to demonstrate adequate compression)
- Biocompatibility evaluation per ISO 10993 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis)
- Sterilization (EO gas, SAL of 10-6 per ISO 11135, EO/ECH residuals assessment per 10993-7)
For all of these tests, the document states: "All testing met the requirements and passed."
Conclusion:
The provided text serves as a 510(k) summary for a physical medical device. It details non-clinical performance testing for that physical device to establish substantial equivalence. It does not provide the information requested regarding acceptance criteria and studies for an AI/algorithm device, as the product is not an AI/algorithm.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).