CROC

• K Number: K141685
• Device Name: CROC
• Manufacturer: COMBAT MEDICAL SYSTEMS, LLC
• Date Cleared: 2015-01-26 ( 217 days)
• Product Code: DXC
• Regulation Number: 870.4450
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K130482

Intended Use

The CRoC™ is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The CRoC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery.

Device Description

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 CRoC™ 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.

AI/ML Overview

The Combat Ready Clamp (CRoC) device is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The new indication is for life-threatening bleeds of the carotid artery, as a last resort.

Acceptance Criteria and Reported Device Performance

The acceptance criterion for the CRoC device, specifically for the additional indication of controlling life-threatening bleeds of the carotid artery, is that it must be capable of stopping simulated vessel blood pressure on neck area wounds.

Acceptance Criteria	Reported Device Performance
Capable of stopping simulated vessel blood pressure on neck area wounds	The CRoC was tested with a cadaver model to show that it was capable of stopping simulated vessel blood pressure on neck area wounds.

Study Information

1. Sample Size and Data Provenance for Test Set:

   • The document states that the CRoC was tested using a "cadaver model." This implies a limited sample size, likely involving a small number of cadavers. The exact number is not explicitly stated.
   • The data provenance is not specified, but it can be inferred that it would be from a controlled laboratory setting where the cadaver model was used. It is a prospective study as it was conducted to demonstrate the device's capability.

2. Number and Qualifications of Experts for Ground Truth:

   • The document does not provide information on the number or qualifications of experts used to establish ground truth for this specific performance test.

3. Adjudication Method:

   • An adjudication method is not mentioned for this performance testing. The description suggests a direct measurement of "stopping simulated vessel blood pressure."

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was performed or mentioned. This is a medical device designed for direct physical intervention, not an AI diagnostic tool, so such a study would not be relevant.

5. Standalone (Algorithm Only) Performance Study:

   • No standalone algorithm performance study was done. The CRoC is a physical medical device, not a software algorithm.

6. Type of Ground Truth Used:

   • The ground truth used was the direct observation and measurement of the device's ability to "stop simulated vessel blood pressure on neck area wounds" in a cadaver model. This can be considered a direct performance measurement against a simulated physiological condition.

7. Sample Size for Training Set:

   • Not applicable. The CRoC is a physical medical device and does not involve an AI algorithm that requires a training set.

8. How Ground Truth for Training Set Was Established:

   • Not applicable, as no training set was used.

Regulation Number and Section

§ 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).