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510(k) Data Aggregation
(23 days)
The Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
The Combat Ready Clamp is designed to be used by Military medical personnel in the battlefield. The device is designed to control bleeding in the inguinal area where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries or soldiers. The Combat Ready Clamp is used to control a difficult bleed for up to 4 hours until the injured soldier can be transferred to evacuation personnel for further treatment.
The Combat Ready Clamp is a vascular clamp designed for use in battlefield settings to control difficult bleeds in the inguinal area, where standard tourniquets cannot be used. It is intended to be used by military medical personnel for up to 4 hours until the injured soldier can be transferred for further treatment.
Here's an analysis of the acceptance criteria and study data provided in the FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics or thresholds. Instead, it describes performance in relation to functional demonstrations and equivalence to a predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Ability to provide pressures equivalent to the predicate device | The Combat Ready Clamp was tested via bench testing to show that it could provide pressures equivalent to the predicate device (K002767 Compressar Femoral Access Compression Device). |
| Capability of stopping simulated vessel blood pressure | The Combat Ready Clamp was tested with a cadaver model to show that it was capable of stopping simulated vessel blood pressure. |
| Substantial equivalence to predicate device | Based on technological characteristics, the Combat Ready Clamp has been shown to be substantially equivalent to the predicate device, the Compressar Femoral Access Compression Device, for its indicated use (control difficult bleeds in the inguinal area where standard tourniquets cannot be used). |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify exact sample sizes for the bench testing or the cadaver model testing. It simply states that the device "was tested."
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission, these would typically be prospective studies conducted in a controlled environment (e.g., a laboratory for bench testing, a medical facility/lab for cadaver studies).
3. Number and Qualifications of Experts for Ground Truth
- The document does not mention the use of experts to establish "ground truth" in the way it might for an AI/diagnostic device (e.g., radiologists interpreting images). The "ground truth" for this mechanical device's performance would be the direct results of the physical tests (pressure measurements in bench testing, successful control of simulated bleeding in cadaver models).
- No specific number or qualifications of experts are reported for establishing ground truth.
4. Adjudication Method
- Adjudication methods (like 2+1 or 3+1) are typically used in studies where human interpretation or consensus is required to establish ground truth for complex data (e.g., medical images). This is not applicable to the type of performance testing described for the Combat Ready Clamp (bench testing, cadaver model for mechanical function).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of outputs (e.g., AI-assisted image reading). The Combat Ready Clamp is a medical device for direct application, not a diagnostic tool where human readers assess its output.
6. Standalone Performance Study
- Yes, standalone performance testing was conducted. The bench testing and cadaver model testing described are examples of standalone performance evaluations, demonstrating the device's capabilities independent of human interaction (beyond the initial application and operation by personnel). These tests aim to show the algorithm (device's design and mechanism) works as intended.
7. Type of Ground Truth Used
- The ground truth used was direct physical measurement and functional demonstration.
- For bench testing: The ground truth was the measured pressure exerted by the clamp and its equivalence to the predicate device.
- For cadaver model testing: The ground truth was the observation of successful cessation of simulated vessel blood pressure.
8. Sample Size for the Training Set
- The concept of "training set" is not applicable here. The Combat Ready Clamp is a mechanical medical device, not an AI/machine learning algorithm that requires a training set of data. Its design and manufacturing processes are validated, not "trained" on data.
9. How Ground Truth for the Training Set Was Established
- As explained above, there is no "training set" for this type of device. The ground truth for its performance was established through physical testing and direct observation of its functional capabilities.
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