(63 days)
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.
§ 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).