(55 days)
The SAM Junctional Tourniquet is indicated for battlefield and trauma situations:
- . To control difficult bleeds in the inguinal area.
- . To control difficult bleeds in the axilla area.
- To immobilize a pelvic fracture. .
The SAM Junctional Tourniquet addresses the issue of non-tourniquetable inguinal hemorrhage and axilla hemorrhage. The device is designed to control bleeding in the inguinal area or axilla area where standard tourniquets cannot be used. The SAM Junctional Tourniquet is used to control bleeding for up to 4 hours.
A key feature of the device is a belt/buckle system which provides feedback to the user after a minimum circumferential force around the patient is obtained, after which an inflatable Target Compression Device (TCD) is manually activated to occlude an artery or to provide compressive force over a Hemostatic agent.
The SAM Junctional Tourniquet can also be used as a Circumferential Pelvic belt for pelvic fracture immobilization.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Control difficult bleeds in the inguinal area | The SAM Junctional Tourniquet (SJT) is indicated for and shown to control difficult bleeds in the inguinal area through substantial equivalence to K123694 and performance testing (Cadaver, Bench). |
| Control difficult bleeds in the axilla area | The SJT is indicated for and shown to control difficult bleeds in the axilla area, supported by substantial equivalence to K123694 (for other indications) and performance testing (Cadaver, Bench). This was the new indication for this submission. |
| Immobilize a pelvic fracture | The SJT is indicated for and shown to immobilize a pelvic fracture through substantial equivalence to K123694 and performance testing (Cadaver, Bench). |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not explicitly state a specific "test set" or its sample size in the context of device performance. The testing mentioned is "Cadaver" and "Bench" testing, which implies laboratory or simulated environments rather than a traditional clinical test set with human patients. The data provenance is not further specified beyond these testing types.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not provided in the document. The nature of "Cadaver" and "Bench" testing typically involves controlled measurements and evaluations by engineers or medical professionals involved in the product development, rather than a panel of external experts establishing ground truth in the way described for clinical studies.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of "Cadaver" and "Bench" testing, a formal adjudication method for a test set as seen in clinical trials is unlikely to have been implemented in the traditional sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed."
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. This device is a physical medical device (tourniquet), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is irrelevant.
7. Type of Ground Truth Used:
For the performance testing, the "ground truth" would be established through direct physical measurements and observations during the "Cadaver" and "Bench" tests, comparing the device's ability to achieve its stated functions (e.g., occlude arteries, immobilize a pelvic fracture) against predetermined technical specifications or physiological outcomes in the simulated environments. This is a form of technical or functional validation rather than expert consensus, pathology, or outcomes data from human subjects.
8. Sample Size for the Training Set:
Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device's design and functionality are developed through engineering processes, material science, and iterative testing.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical device. The "ground truth" for the device's design and development comes from engineering principles, relevant medical knowledge (e.g., anatomy, physiology of bleeding control and fracture immobilization), and results from iterative bench and cadaver testing during the product development cycle.
§ 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).