(268 days)
The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is indicated for use to control bleeding in the pelvis, inguinal area, axilla and for pelvic fracture stabilization.
The AAJT-S device is a wedge-shaped bladder that when inflated pushes in on the body Over the target area of application. One of the target areas is the lower abdomen, over the umbilicus, compressing all the structures within, including the descending aorta, to achieve the physiological effects of aortic compression. The other two areas are over the inguinal region or the axilla. In these two areas the region is compressed with the wedge- shaped bladder including the major vasculature that runs through that area.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study to Prove |
|---|---|---|
| Pressure Maintenance: The AAJT-S must stay inflated and maintain the same pressure over the target area for at least a 4-hour period. | Confirmed successful inflation and pressure maintenance for at least a 4-hour period. | Pressure Testing |
| Component Bond Strength: The bonds of components to the hard cover must withstand normal tensile forces during clinical use. | Demonstrated ability to withstand normal tensile forces. | Force Testing |
| Biocompatibility (Cytotoxicity): No cytotoxic effects. | Passed ISO 10993-5 (in vitro cytotoxicity). | Biocompatibility Testing |
| Biocompatibility (Irritation & Skin Sensitization): No irritation or skin sensitization. | Passed ISO 10993-10 (irritation and skin sensitization). | Biocompatibility Testing |
| Wear Time (Stated Intended Use): Abdominal use: up to 1 hour; Junctional use: up to 4 hours. | Not explicitly stated as a test result, but the pressure test confirms the device maintains pressure for the maximum stated junctional use duration (4 hours). The increased wear time of 1 hour is also noted as a difference from the predicate device. | Pressure Testing implicitly supports junctional wear time. |
| Pelvic Fracture Stabilization: Indication for use. | Not explicitly stated what testing was conducted to prove this particular indication. The document refers to it as an "additional pelvic stability indication" compared to the predicate. | Not explicitly detailed in the provided text. |
Important Note: The provided text does not include specific numeric acceptance values (e.g., "maintain pressure within X mmHg of initial pressure"). It states the qualitative criteria and that the tests were performed to confirm or evaluate these criteria.
Missing Information:
- There are no explicit quantitative acceptance criteria or specific performance values reported for the pressure testing (e.g., pressure drop over time).
- Similarly, for force testing, no specific force values or deformation limits are given.
- The document doesn't detail how the "pelvic fracture stabilization" indication was specifically proven or what criteria were used for that.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for the performance tests (Pressure Testing, Force Testing, Biocompatibility Testing). It mentions these tests were "performed" but not the number of units or replicates used.
Data Provenance: Not applicable in the context of these non-clinical performance tests. These are laboratory tests conducted on the device itself, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. These are non-clinical performance tests conducted on the device, not clinical studies involving expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. This concept applies to clinical studies where experts might disagree on ground truth, requiring an adjudication process. The tests described are objective, non-clinical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided text describes non-clinical performance tests of the device itself (pressure, force, biocompatibility), not a clinical study involving human readers or comparative effectiveness with or without AI assistance. The device is a physical medical device (tourniquet), not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the sense that the described tests are standalone device tests. The device's performance was evaluated independently without human-in-the-loop interaction as part of the test (beyond operating the test equipment). However, it's important to clarify that this refers to mechanical device performance, not AI algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests is based on objective physical measurements and established international standards:
- Pressure Testing: The ground truth is the measured pressure (e.g., using a pressure sensor) and its change over time.
- Force Testing: The ground truth is the applied force and the device's structural integrity under that force, measured by mechanical testing equipment.
- Biocompatibility Testing: The ground truth is determined by the results of standardized assays (e.g., cytotoxicity assays, irritation/sensitization tests) as per ISO 10993 standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a physical device, not an AI model.
§ 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).