Search Results

The iTClamp50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas, scalp, and neck.

The iTClamp™50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin edges (similar to sutures or staples) between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal.

The iTClamp controls bleeding by sealing the skin closed to apply direct pressure to the cut edges of the skin and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair.

The device is provided sterile and is for single use.

The iTClamp consists of the following components:

• 1. Suture needles
• 2. Plastic shell
• 3. Locking mechanism
• 4. Lock release mechanism

The provided text describes a 510(k) premarket notification for the iTClamp50, a vascular clamp device. The purpose of this 510(k) is to modify the existing indication for use to include the temporary control of severe bleeding in the neck.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to demonstrating substantial equivalence for the expanded indication of use (neck wounds). The previous 510(k) (K132651) established the device's efficacy for extremities, axilla, inguinal areas, and scalp. For this new 510(k), the key performance aspect is the device's ability to control severe bleeding in the neck.

Study Details that Prove Device Meets Acceptance Criteria:

1. Sample Size used for the test set and the data provenance:

   • Cadaver Studies: The text mentions "cadaver testing" and "a second cadaver study." It does not specify the exact number of cadavers used.
   • User Assessment (previously conducted): 15 trained first responders (firefighters) were used. The provenance is not explicitly stated as country of origin, but it describes a simulated environment and users. This was a prospective simulation study.
   • Clinical Study (for neck indication): "Unsolicited case studies of OUS and off-label use" were collected. The sample size (number of cases) is not specified. "OUS" indicates external/international data. This data would be retrospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For Cadaver Studies: The text does not explicitly state the number or qualifications of experts establishing ground truth within the cadaver studies themselves. However, the studies were conducted by Innovative Trauma Care, Inc., implying internal expertise in evaluating device performance.
   • For User Assessment: The "primary assessment was external leakage of water from the wound," which is an objective measure. User needle sticks were also evaluated. This was likely evaluated by the study organizers (McKee, J., McKee, I., Gao, H., Frost, G., Kirkpatrick, A.W.). Their specific qualifications are not detailed beyond being authors of the mentioned paper.
   • For Clinical Study/Case Studies: For the unsolicited case studies, the "ground truth" (i.e., whether the device controlled bleeding) would have been established by the reporting clinicians or healthcare providers treating the patients. Their specific qualifications are not provided in this document.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • The document does not specify any formal adjudication methods (like 2+1 or 3+1) for the cadaver studies, user assessment, or the unsolicited case studies. Assessments appear to be direct observations or reports.

4. 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:

   • No MRMC or AI-assisted study was conducted. This device is a physical medical device (vascular clamp), not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as this is a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Cadaver Studies: The ground truth for performance in stopping bleeding would be direct observation and measurement of bleeding control within the cadaver model.
   • User Assessment: Ground truth included objective measures of "external leakage of water from the wound" and "user needle sticks."
   • Clinical Study (Case Studies): The ground truth would be the reported clinical outcome from the patient treatment (e.g., "controlled severe bleeding") based on healthcare provider observations and patient outcomes data.

7. The sample size for the training set:

   • This document describes a 510(k) submission, not the development of a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. All the described studies are for demonstrating performance or substantial equivalence.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

Ask a specific question about this device