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The SAM Junctional Tourniquet addresses the issue of non-tourniquetable inguinal hemorrhage. The device is designed to control bleeding in the inguinal 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 point pressure device (PPD) 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.

AI/ML Overview

The SAM Junctional Tourniquet (SJT) is a medical device designed to control difficult bleeds in the inguinal area and immobilize pelvic fractures, particularly in battlefield and trauma situations. The FDA cleared its 510(k) submission (K123694) in 2013, determining it substantially equivalent to the Combat Ready Clamp (CRoC).

Here's an analysis of the acceptance criteria and the studies conducted to demonstrate this:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for the SAM Junctional Tourniquet (SJT) is based on substantial equivalence to a predicate device, the Combat Ready Clamp (CRoC). This means the focus of the acceptance criteria isn't on a predefined set of performance metrics that the SJT must achieve independently, but rather on demonstrating that the SJT is as safe and effective as the predicate device and that any differences do not introduce new safety or performance concerns.

Given the information provided, the acceptance criteria are implicitly linked to the attributes where the SJT is compared to the CRoC, particularly in terms of functionality and safety. The reported device performance is demonstrated through non-clinical testing.

Acceptance Criteria (Implied from Predicate Comparison & Testing)	Reported Device Performance (SJT)
Control difficult bleeds in the inguinal area	Demonstrated through Cadaver and Human Simulation Testing. The device provides point pressure via a pneumatic mechanism, designed for arterial occlusion. While specific bleed control metrics aren't detailed, the testing supports its intended function in this area.
Immobilize pelvic fractures	Demonstrated through Cadaver and Human Simulation Testing. The device can be used as a circumferential pelvic belt for immobilization. CRoC does not have this indication, so SJT's performance in this area establishes its additional utility without introducing new safety concerns, as supported by the testing.
Functional equivalence to CRoC in inguinal bleeding control	The SJT's design, involving a circumferential belt and point pressure, is conceptually similar to CRoC. Differences in the point pressure mechanism (pneumatic vs. screw) and force control (spring-controlled buckle vs. none) were assessed and did not introduce new safety or performance concerns, as stated in the conclusion.
Biocompatibility	Meets ISO 10993-1 requirements. This ensures the materials used in the device are safe for contact with the human body.
Structural Integrity of PPD	PPD Burst Pressure Test and PPD Four Hour Stability Test were performed to ensure the inflatable point pressure device (PPD) can withstand operational pressures and maintain integrity over the intended use duration (up to 4 hours for bleeding control). Specific numerical results are not provided, but the successful completion of these tests indicates performance adequacy.
Material Safety	Raw materials meet USP Plastic Class VI and ISO 10993-1 requirements.
Sterility	Non-sterile product. This is consistent with the predicate device and does not introduce new safety concerns.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: The document explicitly mentions "Cadaver" and "Human Simulation Testing." However, it does not provide specific numerical sample sizes for either of these tests.
Data Provenance: The document does not specify the country of origin for the cadaver or human simulation testing data. It is implied that these are prospective tests conducted specifically for the purpose of demonstrating the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not specify the number of experts used or their qualifications for establishing ground truth in the cadaver or human simulation testing. Given the premarket notification context, such testing would likely involve trained medical professionals, but this is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the test set. Given the non-clinical nature of the testing described (cadaver and human simulation), it is more likely that performance was assessed based on observation and measurement rather than human reader adjudication.

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. The provided information pertains to a physical medical device (a tourniquet), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. As stated above, this is a physical medical device, not an algorithm. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing appears to be based on:

Direct observation and measurement during cadaveric studies: To assess the device's ability to achieve arterial occlusion and pelvic immobilization.
Performance metrics in human simulation: Likely involving simulated scenarios to evaluate ease of use, application technique, and effectiveness under specified conditions.
Material specifications and standard testing: For biocompatibility (ISO 10993-1, USP Plastic Class VI) and PPD integrity (burst pressure, stability).

8. The Sample Size for the Training Set

Not applicable. The SAM Junctional Tourniquet is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set was used.

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