(31 days)
FemoStop Femoral Compression System is indicated for use in the compression of the femoral artery or vein after vessel cannulation and in ultrasound-guided compression repair of a femoral artery pseudoaneurysm.
This combination of FemoStop™ Femoral Compression is called FemoStop™ Gold and consists of an arch with a sterile pneumatic pressure dome, an integrated pump with a digital manometer and a belt. The pressure dome, the vessel punp with a digital manometer and a belt. The pressure dome is placed over the vessel puncture site in the groin. The belt is placed around the patient. The dome applies mechanical pressure over the vessel puncture site to induce hemostasis. The dome pneumatic pressure in the dome in emiliate site to induce hemostasis. The pneumatic pressure in the dome is applica and regulated by a manual pump and displayed on a manometer. The arch and belt provide counter pressure for the dome.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in the format requested. The document is a 510(k) summary for a medical device (FemoStop™ Gold) and focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study with detailed acceptance criteria and results.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document states: "The subject version of FemoStop™ Gold functioned as intended and conformed to the required specifications." This is a general statement and does not provide specific quantitative acceptance criteria or performance metrics. The focus is on the software modification not affecting intended use or operating principles.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functioned as intended | "functioned as intended" |
| Conformed to required specifications | "conformed to the required specifications" |
| No new issues of safety and effectiveness | "No new issues of safety and effectiveness have been raised." |
| Software modification does not affect intended use, operating principle, technology or manufacturing process | Software modification reviewed by FDA and deemed substantially equivalent to predicate, implying this criterion was met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "Software validation, including black-box testing." However, it does not specify the sample size for this testing, the type of data used (real-world patient data, simulated data, etc.), or the data provenance. It's likely in-house testing was performed during development.
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):
This information is not provided. The development and testing focused on software validation, not clinical performance assessed against expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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 conducted or reported. This device is a mechanical compression system with a digital manometer, and the modifications are software updates for activation delay and error codes. It is not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone medical device. The "software modification" being discussed (10-second activation delay and additional error codes) was validated. The document implies a standalone validation of the modified software's functionality through "black-box testing." However, detailed performance metrics for this validation are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the specific software modifications (activation delay, error codes), the "ground truth" would likely be the defined functional requirements and expected behavior of the software. For example, testing would verify that the 10-second delay occurs as programmed and that error codes are triggered correctly under specific conditions. It would not involve expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.
8. The sample size for the training set:
This information is not applicable and not provided. The device does not involve machine learning or an AI model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. The device does not involve machine learning or an AI model that requires a training set.
§ 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).