(144 days)
The FemoStop® 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.
The FemoStop System consists of an arch with a sterile pneumatic pressure dome, a connection tubing and belt, a reusable pump with manometer and an optional adapter for bilateral compression. The device is applied on the patient with the dome over the groin and the belt around the patient. The user controls the inflation of the dome by increasing or decreasing the pressure with the connected pump. Then the dome applies a mechanical pressure over the spot where there is a bleeding to stem, while the arch and belt absorb and evenly distribute the opposite force from the dome.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (FemoStop® System K954669 and FemoStop® II PLUS System K982182) | Device found to have the same technology and be manufactured with parts of the predicate devices. |
| Suitability for use in ultrasound-guided compression repair of pseudoaneurysm | Clinical studies conclude the subject device is suitable to replace the ultrasound-probe or other compression technique for ultrasound-guided compression repair of pseudoaneurysm. |
Important Note: The provided document does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds, sensitivity/specificity targets). Instead, the acceptance criteria are implicitly linked to demonstrating substantial equivalence to existing predicate devices and showing suitability for its intended use based on a review of published literature.
Study Details
The information provided by RADI Medical Systems AB does not describe a detailed study with specific data points or a typical "clinical trial" structure as one might expect for a new AI medical device. Instead, it relies heavily on the equivalence to predicate devices and a review of published journal articles.
Here's an analysis based on the available information:
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a prospective, controlled study of the subject device. The "test set" here refers to the data used in the published journal articles that were reviewed. No specific number of patients or cases from these articles is provided for direct testing of the subject device.
- Data Provenance: The data comes from "Published journal articles on the subject 'ultrasound-guided compression repair of pseudoaneurysm' with usage of compression devices such as FemoStop." The specific countries of origin or whether these were retrospective or prospective studies are not detailed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" implicitly comes from the findings and conclusions of the reviewed published journal articles, which would have been peer-reviewed by numerous experts in the field, but no specific number directly involved in this submission's evaluation is mentioned.
- Qualifications of Experts: Not explicitly stated for those establishing ground truth. The implied experts are the authors and reviewers of the published journal articles.
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Adjudication method for the test set:
- Adjudication Method: Not applicable. There was no direct "test set" that required adjudication by a panel for this submission. The conclusions are drawn from a review of existing literature.
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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:
- MRMC Study: No. This device is a mechanical compression system, not an AI device. Therefore, an MRMC study comparing human readers with AI assistance is not relevant or reported here.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a mechanical device, not an algorithm.
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The type of ground truth used:
- Type of Ground Truth: The "ground truth" is derived from the clinical outcomes and efficacy reported in the reviewed published journal articles regarding the use of similar compression devices (including FemoStop) for ultrasound-guided compression repair of pseudoaneurysm. This implies a reliance on clinical data and expert consensus within the scientific literature.
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The sample size for the training set:
- Sample Size for Training Set: Not applicable. The device is a mechanical system, not a machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for a mechanical device.
In summary, this 510(k) submission primarily leverages the concept of substantial equivalence to predicate devices and a review of existing clinical literature to support its claims, rather than presenting novel clinical trial data for the specific subject 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).