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GEOMED Vascular Clamps are intended for use for temporary occlusion of blood vessels during surgical procedures.

The GEOMED Vascular Clamps are reusable devices and provided non sterile. They must be thoroughly cleaned and sterilized before use. GEOMED Vascular Clamps are made of Stainless Steel (following ASTM F 899-07). They are provided with ring handles and ratchet closures to adjust the amount of tension applied to the vessel for occlusion or partial occlusion. The GEOMED Vascular Clamps are available in a wide variety of shapes, sizes and lengths to accomodate to the individual needs of the surgeon. Based on the anatomy of the site, the surgical technique chosen, the size and type of blood vessel and occlusion desired, the surgeon decides which clamp to use. During surgery the handles and shanks need to be out of the field of vision of the operative site and therefore a wide variety of instrument figures and sizes is necessary. The Vascular Clamps occlude the arteries or veins with a tension that intends to produce minimal trauma to the vessels. They cover the vessel and stop the blood flow.

The provided text is a 510(k) Summary for the GEOMED Vascular Clamps, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through extensive clinical trials or performance studies with acceptance criteria in the way a new drug or novel medical software would.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, and AI-related studies is not present in this document. The document primarily focuses on demonstrating that the GEOMED Vascular Clamps are substantially equivalent to existing, legally marketed vascular clamps.

Here's a breakdown of why this information isn't available in the provided text, and what is discussed:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the vascular clamps in the way that would be done for a diagnostic device or AI algorithm. The "performance" assessment is based on the device's physical properties and intended use mirroring existing devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, in the context of performance metrics for an AI or diagnostic device, is mentioned or used. The "testing" referred to is for cleaning and sterilization procedures, not for clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This is not applicable. There is no "ground truth" to establish for this type of mechanical device in the same way there would be for an AI diagnostic.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This device is a mechanical surgical instrument, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding "Design Verification Performance":

• Design Verification Performance: "Tests for Cleaning and Sterilization are provided." This indicates that the device underwent testing to ensure it can be properly cleaned and sterilized for reuse, which is a critical safety and functionality aspect for reusable surgical instruments. However, the details of these tests (e.g., number of cycles, specific protocols, acceptance criteria for sterility/cleanliness) are not included in this summary.

In summary, the provided document is a 510(k) summary for a mechanical surgical device (Vascular Clamps) and, as such, does not contain the detailed performance study information typically required for devices involving complex algorithms, diagnostics, or AI. The substantial equivalence claim is based on similar design, materials, and intended use compared to predicate devices.

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To temporarily occlude an artery or vein with correct tension to produce minimal trauma to vessels. The different sizes and models are designed according to the type and size of the blood vessels, anatomical sites, and surgical techniques. Bulldog clamps are self-closing and are used for small vessels. The closing pressure of the GLOVER clamps can be adjusted using a nut and spring.

Applying forceps are used to apply bulldog clamps in deep surgical wounds.

To secure vascular occlusion of small vessels during surgery and to secure vascular occlusion during pediatric surgery.

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The provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer for "Vascular Clamps." This type of document is an approval based on substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the performance of the device against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies is not present in this document.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...".

Therefore, I cannot provide the requested information based on the provided text.

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