(63 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Safe for use on the scalp | Cadaver study identified no additional risks. |
| Effective in controlling severe bleeding on the scalp (hemostasis) | Cadaver study demonstrated effectiveness and safety on the scalp. |
| Performs as intended | Cadaver study ensured the device performed as intended; results indicate suitability for use on the scalp. |
| Substantially equivalent to predicate devices for scalp use | Performs similarly to predicate devices by applying pressure to control bleeding on scalp wounds. |
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.
§ 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).