(31 days)
This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.
This device handle is similar to the Compass handle, but of a different shape. The ComfortPress device provides an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following femoral vascular catheterization procedures. The ComfortPress handle mates with the SuperComfort™ Disc, one of which is provided with each handle. The device is provided as sterile, with a SuperComfort disc attached. The handle with the disc is manually positioned at the femoral vascular access site. The medical practitioner then applies holding force sufficient to obtain hemostasis.
The provided document is a 510(k) summary for the ComfortPress™ Vascular Compression Assist Handle. It describes the device and its intended use, and states that it is substantially equivalent to a predicate device. However, it does not contain the detailed acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or performance study report typically would.
The "testing" mentioned is very limited and focused on mechanical fit and applying pressure, rather than broader clinical effectiveness.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, sample sizes, expert involvement, or comparative effectiveness with AI assistance, as this information is not present in the provided text.
Here's what I can extract based on the limited information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance Statement |
|---|---|
| Mechanical fit to SuperComfort™ Disc | "determined that the ComfortPress device provides mechanical fit to the CompressAR SuperComfort™ Disc" |
| Ability to apply pressure | "may be used to apply pressure." |
| Equivalence to predicate device (Compass™ Compression Assist Handle) | "It was concluded that the ComfortPress Compression Assist Handle, used with the SuperComfort™ Disc, is equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size used for the test set: Not specified.
- Data provenance: Not specified. The document states "Market testing determined that the use of a handle and disc for holding manual pressure...was more comfortable and less stressful to the care giver," implying some form of user feedback, but no details on the participants or methodology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified.
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 MRMC study was done, and AI assistance is not mentioned or relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a mechanical device; a standalone algorithm study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the equivalence claim appears to be based on the assessment that it effectively performs the same mechanical function (applying pressure and fitting the disc) as the predicate device. For the "more comfortable and less stressful" claim, the ground truth was "Market testing" which likely involved user feedback, but the specifics are not provided.
8. The sample size for the training set
- Not applicable/not specified. There's no mention of a training set in the context of an algorithm or machine learning.
9. How the ground truth for the training set was established
- Not applicable/not specified.
Summary of Device Performance Test and Conclusion:
The document states: "Testing was conducted to determine that the ComfortPress device provides mechanical fit to the CompressAR SuperComfort™ Disc and may be used to apply pressure. It was concluded that the ComfortPress Compression Assist Handle, used with the SuperComfort™ Disc, is equivalent to the predicate device."
This suggests the testing was a functional assessment of the device's ability to mate with its intended consumable and to physically allow pressure application. The conclusion of equivalence is based on these functional aspects being comparable to the predicate device, the Compass™ Compression Assist Handle. No detailed study protocols, results, or statistical analyses are provided in this 510(k) summary.
§ 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).