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510(k) Data Aggregation
(63 days)
COMBAT READY CLAMP
The Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas.
The CRoC™ is designed to be used by emergency medical personnel in the battlefield. The device is designed to control bleeding in anatomical areas where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries. The Combat Ready Clamp is used to control a difficult bleed for up to 4 hours until the injured can be transferred to evacuation personnel or other medical personnel for further treatment.
Here's a breakdown of the acceptance criteria and study information for the Combat Ready Clamp (CRoC™) device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in terms of specific performance metrics with target values (e.g., "must stop blood flow within X seconds at Y pressure"). Instead, the performance data section describes a qualitative objective: the capability of stopping simulated vessel blood pressure.
| Acceptance Criteria (Implied/Qualitative) | Reported Device Performance |
|---|---|
| Capable of stopping simulated vessel blood pressure in the axilla area. (Implicit: Demonstrating functionality for its stated indication of controlling difficult bleeds where standard tourniquets cannot be used, specifically in the axilla, as a substantial equivalence claim to a predicate that focused on inguinal area). | The CRoC™ was "tested with a cadaver model to show that it was capable of stopping simulated vessel blood pressure in the axilla area." This demonstrates the device's ability to achieve its intended function in a relevant anatomical region. The substantial equivalence claim further implies that this performance is comparable to the predicate device's demonstrated efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states "cadaver model" (singular), implying a very small sample size, potentially a single cadaver or unquantified number of cadaveric specimens. It does not provide a specific number.
- Data Provenance: The study was conducted using a "cadaver model," which is an ex-vivo, simulated environment. The country of origin of the data is not specified, but the applicant is based in the USA. The study design is prospective in the sense that the experiment was performed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of clinical assessment or image interpretation. The evaluation was a direct mechanical test on a cadaver model to ascertain if the device could effectively stop simulated blood pressure. Therefore, there's no mention of experts establishing ground truth or their qualifications.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical or image-based test set requiring an adjudication method. The test was a direct physical demonstration of mechanical function.
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
Not applicable. The device is a physical vascular clamp, not an AI/software device involving human readers or interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical vascular clamp, not an algorithm or software. The "standalone" performance here refers to the device's physical ability to stop blood flow independently.
7. The Type of Ground Truth Used
The "ground truth" in this context was the direct, observable physical outcome: the cessation of simulated vessel blood pressure. This is a direct measure of the device's mechanical efficacy in controlling bleeding, rather than an interpretation by experts, pathology, or long-term outcomes data.
- Specific Type: Direct physical measurement/observation in a cadaver model.
8. The Sample Size for the Training Set
Not applicable. The CRoC™ is a physical medical device, not a machine learning or AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
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(23 days)
COMBAT READY CLAMP
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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