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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:

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.

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The SAM Junctional Tourniquet is indicated for battlefield and trauma situations:

• To control difficult bleeds in the inguinal area. .
• To immobilize a pelvic fracture. .

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.

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.

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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