(71 days)
The Abdominal Aortic and Junctional Tourniquet is indicated for use in the battlefield to control difficult bleeding in the pelvis, inguinal area and axilla.
The Abdominal Aortic and Junctional Tourniquet (AAJT) is designed to be used by military medical personnel in the battlefield to control bleeding in the pelvis, inguinal area and axilla where standard tourniquets cannot be used. The device may be used instead of "mechanical pressure", allowing the medic to attend to other injuries or soldiers.
Here's an analysis of the provided text regarding the Abdominal Aortic and Junctional Tourniquet (AAJT) and its performance data:
The provided text describes a 510(k) submission for the Abdominal Aortic and Junctional Tourniquet (AAJT). The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices. The performance testing for this device focuses on its ability to stop blood flow.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the predicate devices' presumed ability to stop blood flow. The AAJT's performance is demonstrated by its effectiveness in stopping blood flow in a human study.
| Acceptance Criteria (Implicit from Predicate Devices) | Reported Device Performance (AAJT) |
|---|---|
| Effective in controlling difficult bleeding | Blood Flow Cessation: In 13/13 subjects, blood flow in both the Popliteal Femoral Artery (PFA) and Abdominal Aorta (AA) was stopped (no spectral Doppler flow). |
| Bladder Pressure at Flow Cessation: | |
| - PFA: 148.5 mm Hg (SD 44.8, max 230, min 80) | |
| - AA: 168 mm Hg (SD 52.5, max 250, min 80) | |
| Acceptable Pain Levels During Use | Pain at Flow Cessation (Average Maximum): |
| - PFA: 3.6 | |
| - AA: 4.1 | |
| Pain After Device Removal: Returned to 0 |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 13 human subjects.
- Data Provenance: The study was a "human data study," implying it was a prospective study conducted specifically for this device. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting it was likely conducted in the US or under US regulatory standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth (cessation of blood flow) was established by direct measurement using "no spectral Doppler flow in the distal artery." This type of measurement does not typically require a panel of experts for interpretation but rather trained medical professionals or technicians to perform the Doppler ultrasound and interpret the real-time results. No specific number or qualifications of experts are mentioned for establishing this ground truth.
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Adjudication method for the test set:
- No adjudication method (e.g., 2+1, 3+1) is mentioned as the "ground truth" was established through objective measurement (Doppler flow).
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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:
- No MRMC comparative effectiveness study was conducted. This device is a physical medical device (tourniquet), not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was conducted. This is a physical device, not an algorithm.
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The type of ground truth used:
- The ground truth for effectiveness was direct physiological measurement (cessation of blood flow via spectral Doppler) and subjective patient reporting (pain levels).
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The sample size for the training set:
- There is no mention of a "training set" as this is a physical device and not an AI/machine learning algorithm. The study described is a performance study for the device itself.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of 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).