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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.

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

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/scalp 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/scalp closed to apply direct pressure to the cut edges of the skin/scalp 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

Here's an analysis of the provided text regarding the iTClamp™50 device, specifically focusing on the acceptance criteria and study details:

The provided document is a 510(k) summary for the iTClamp™50, seeking to expand its indication for use to include the scalp. It is not a study proving the device meets acceptance criteria in the typical sense of a clinical trial or a performance study with defined, measurable endpoints for regulatory acceptance. Instead, it argues for "substantial equivalence" to predicate devices based on design, operation, and a cadaver study for the expanded indication.

Therefore, many of the requested fields (like specific acceptance criteria for performance metrics, sample sizes for test sets in a clinical context, expert ground truth, MRMC studies, or training sets) are not directly applicable or explicitly stated in a quantitative manner as they would be for a new or significantly modified device requiring rigorous performance evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an expanded indication based on substantial equivalence, explicit quantitative acceptance criteria for device performance (e.g., a specific percentage reduction in blood loss, time to hemostasis within a certain threshold) are not defined in the provided text. The "acceptance" argument is qualitative and based on the device's ability to effectively control bleeding on the scalp in a cadaver model, aligning with the predicate device's function.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of subjects or cases. The study used "cadaver models" which implies a limited number for this type of testing.
• Data Provenance: The study was conducted by Innovative Trauma Care, Inc. using cadaver models. There is no mention of country of origin for the cadaver data. The study is prospective in the sense that the testing was performed specifically to support this 510(k) submission, even if it utilized cadavers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It's likely that medical professionals or researchers involved in the cadaver study would have assessed the outcomes, but their specific roles or qualifications are not detailed.

4. Adjudication Method for the Test Set

• The document does not describe any formal adjudication method (e.g., 2+1, 3+1 consensus) for the cadaver study results.

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

• No MRMC comparative effectiveness study was done. This is a medical device (vascular clamp), not an AI-assisted diagnostic tool, so this type of study is not relevant or applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent in its design and how it's used by a human clinician. The cadaver study implicitly describes the standalone device's performance when applied.

7. The Type of Ground Truth Used

• For the cadaver study, the "ground truth" would be the observed effectiveness of hemostasis (stopping bleeding) in the cadaver models, assessed directly by the researchers. It's an observational outcome within the cadaveric setting. There is no mention of pathology or broader patient outcomes data for the cadaver study.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an algorithm or AI system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for a physical device, no ground truth needs to be established for it.

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

The ITClamp™ is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The ITClamp is a self-locking surgical clamp with suture needles that penetrate the skin to evert the skin edges 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 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

This document is a 510(k) summary for the iTClamp™ device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically seen for AI/ML-based devices. As such, many of the requested fields are not applicable or cannot be extracted from this type of document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes an animal study (porcine model) for performance testing.

• Sample Size: Not explicitly stated for the animal study.
• Data Provenance: Porcine (animal model). The study was prospective in nature, as it involved conducting experiments to assess the device's performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. This document describes a medical device (a clamp) and its physical and biological performance, not an AI/ML diagnostic or predictive device where expert-established ground truth for a test set would typically be required in the context of image or data interpretation. The ground truth for the animal study's outcomes (survival, blood loss, tissue damage) would be established through direct observation, measurement, and histological analysis by veterinary and scientific personnel, not human "experts" in the context of interpreting data for an algorithm.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is not an AI/ML-based device where adjudication of interpretations would be relevant. The outcomes of the animal study are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not an AI/ML-based device, so an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance Study

• No. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

• For the animal study, the ground truth was outcomes data (survival, survival time, blood loss) and histology (for tissue damage assessment).
• For biocompatibility, the ground truth was established by adherence to ISO 10993 standards and the results of specific assays (cytotoxicity, etc.).
• For bench performance and packaging, the ground truth was established by design requirements and engineering specifications.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML model, so the concept of a "training set" is not relevant.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As above, the concept of a "training set" for an AI/ML model does not apply here.

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