(84 days)
This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.
The CompressAR® SuperComfort™ Disc provides an elastomeric insert in the compression pad, and is used with a modified attachment to the CompressAR @ StrongArm™ System to provide a two-step friction fit connection. The elastomer insert contacts the patient skin providing increased friction against the skin.
The disk and supporting stand provide a mechanical means of holding external pressure at or near the site of femoral vascular access. Direct pressure is used to obtain and maintain hemostasis, in a similar fashion to direct hand pressure on the access site or at a pressure point.
The provided text describes a 510(k) summary for the CompressAR® SuperComfort™ Disc and StrongArm™ SuperComfort™ System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with detailed acceptance criteria and performance data in the format requested.
Therefore, many of the requested details are not explicitly present in the provided text.
Here's an attempt to extract and infer information based on the given text:
1. Table of acceptance criteria and the reported device performance:
The document states: "Testing was conducted to determine that the modified device provides mechanical clamping and holding functions, similar to the predicate device. It was concluded that the CompressAR & SuperComfort™ Disc and StrongArm™ System is equivalent to the predicate device."
This implies that the acceptance criterion was demonstrating "similar" mechanical clamping and holding functions to the predicate device. The reported performance is that the device met this criterion, as it was concluded to be "equivalent."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical clamping and holding functions | "Similar" to the predicate device |
| Overall equivalence to the predicate device | "Equivalent" to the predicate device (CompressAR® Universal System CompressAR® Comfort™ Disc) |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Testing was conducted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The assessment appears to be based on engineering or performance testing against the predicate device rather than expert-derived ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a mechanical medical device, not an AI or diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a mechanical hemostasis device, not an algorithm. However, the testing conducted would be considered "standalone" in the sense that it doesn't involve human interpretation of output from the device, but rather the device's direct mechanical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth (or more accurately, the benchmark) was the performance of the predicate device (CompressAR® Universal System CompressAR® Comfort™ Disc). The study aimed to show that the new device's mechanical functions were "similar" to this established predicate.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable (no training set for this type of device).
§ 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).