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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 Medtronic Neurosurgery Clip Gun Raney-type clips provide hemostasis during cranial surgery by preventing arterial bleeding from small vessels of the skin and deeper vessels under the scalp.

The Clip Gun Kit contains Raney-type clips intended to provide hemostasis during cranial surgery by preventing arterial bleeding from vessels under the scalp. The Clips are a non-implantable transient use device.

The provided text describes a 510(k) submission for the Medtronic Clip Gun Kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the input document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

Instead, the submission states:

• Technological comparison: "Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications of the Clip Gun Kit are the same as the previously reviewed and cleared Clip Gun with Raney Type Scalp Clips (K896723)."
• Substantial Equivalence: "Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Clip Gun Kit products based upon the predicate and currently marketed devices."

The FDA's letter confirms: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent... to legally marketed predicate devices."

In summary, there is no clinical study data with specific acceptance criteria or performance metrics provided in this 510(k) submission. The device was cleared based on its substantial equivalence in design, materials, intended use, and performance characteristics to a previously cleared predicate device.

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The STORZ Raney Scalp Clip is a device designed to stop bleeding during surgery on the scalp.

Not Found

This is a 510(k) premarket notification for a medical device called "Scalp Clips." The provided document is a letter from the FDA to the manufacturer, Rudolf Storz GmbH, stating that their device has been found substantially equivalent to a legally marketed predicate device.

The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) summary or a more detailed technical submission, which is not included in the provided pages.

Therefore, I cannot answer the request with the provided input.

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Aesculap's Scalpfix clip system is indicated for use in temporary hemostasis of the scalp edge.

Aesculap's scalp clip gun (FF012R) is a hand held manual instrument. It is used in conjunction with Aesculap's scalp clip (FF013P) to insert sterile plastic scalp clips at the margin of scalp wounds during operations on the cranium. The gun consists of a handle, trigger, magazine lock, and a maqazine suspension pin.

The scalp clips are used for temporary hemostasis of the opened scalp. It has proven useful to use plastic clips to ligate the scalp during trepanation or large exposures of relatively long duration, thereby avoiding bleeding at the wound margin. Aescular scalp clips are intended for single use only. They may not be resterilized. The scalp clips are packaged as 10 scalp clips per magazine in a box of 20 magazines.

This K017219 premarket notification for the Scalpfix Clip System does not include specific acceptance criteria or a study that proves the device meets such criteria.

The document states:

• "No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices."
• "The new Scalptix conforms to applicable ASTM and ISO standards." However, it does not specify which ASTM and ISO standards, nor does it provide data demonstrating compliance with them.

Therefore, the requested information elements cannot be extracted from the provided text for this specific device. The submission relies on substantial equivalence to predicate devices rather than independent performance studies with defined acceptance criteria.

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