Search Results

These titanium clamps are used for temporarily occlusion of blood vessels during surgery.

Vitalcor Featherweight clamps are made from Grade 5 titanium, Vitalcor Featherweight clamps are calibrated to have a clamping pressure that will minimize the possibility of vessel damage. As a guide, the following Vitalcor Featherweight sizes should be used for the vessels size range indicated.
VA079-06 0.4mm-1.0mm .
. VA115−09 0.6mm−1.5mm
VA140-09 1mm-2mm .
VA240-18 1.5mm-3mm .
VA300-24 2mm-4mm .
VA375-30 3mm-5mm .

The provided text describes a 510(k) submission for the Vitalcor Featherweight Vascular Clamps. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document focuses on establishing substantial equivalence through a comparison of physical characteristics, indications for use, and bench testing, rather than a clinical trial or performance study against pre-defined acceptance criteria in the way one might evaluate an AI-powered diagnostic device.

Therefore, for aspects of your request related to acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies, the provided text does not contain the necessary information.

However, I can extract the relevant information from the document related to the comparison with the predicate device and the non-clinical testing performed.

Here's an attempt to answer your questions based solely on the provided text, acknowledging the limitations:

1. A table of acceptance criteria and the reported device performance

Based on the 510(k) summary, the device's "performance" is primarily assessed against the characteristics of the predicate device to establish substantial equivalence, rather than against explicit numerical acceptance criteria for clinical outcomes or diagnostic performance. The key performance characteristic mentioned is clamping pressure.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "non-clinical and bench testing data." It does not specify sample sizes for these tests, nor does it describe data provenance in terms of country of origin or retrospective/prospective nature. These tests are typically performed on the device itself (e.g., mechanical testing) rather than clinical data.

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

The document does not mention the use of experts to establish ground truth for performance data in the context of a clinical or retrospective study. The "ground truth" for this device's evaluation is primarily its adherence to established engineering principles and comparison to a legally marketed predicate device's characteristics and performance.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of clinical or image-based assessment as described in your request.

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 reported. This type of study is not relevant for the evaluation of a mechanical vascular clamp. The submission focuses on substantial equivalence to a predicate device.

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

Not applicable. This device is a surgical instrument, not an algorithm. Therefore, "standalone algorithm-only performance" is not relevant.

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

For this type of device, the "ground truth" for safety and effectiveness is established through:

• Bench Testing: Verifying mechanical properties such as clamping pressure, material integrity, and sterility.
• Biocompatibility Testing: Ensuring the material is safe for contact with human tissue.
• Comparison to Predicate Device: Demonstrating that the new device shares fundamental technological characteristics and performance with an already legally marketed device that has a known safety and effectiveness profile.

The document states, "The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices. Biocompatibility and sterilization studies were successfully completed."

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Ask a specific question about this device

The Coronary Artery Perfusion Cannula with Self-Inflating Balloon is indicated for use in delivery of cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass surgery.

The Coronary Artery Perfusion Cannula with Self-Inflating Balloon consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tubing for purposes of receiving the infused cardioplegia solution. The subject device is provided for in five sizes based upon the diameter of the cuff consisting of 4, 5, 6, 7 & 8 mm in diameter. Furthermore, the cannula is pre-shaped into two configurations both straight and right angle.

The provided document is a 510(k) summary for a medical device called the "Coronary Artery Perfusion Cannula with Self-Inflating Balloon." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set information.

Instead, the document focuses on:

• Claim of Substantial Equivalence: The key assertion is that the new device is substantially equivalent to a predicate device (California Medical Laboratories, Inc. Aortic Root Cannula) based on similar intended use and technologic characteristics (material, dimensional specifications, and performance characteristics).
• Intended Use: Both the new device and the predicate device are indicated for use in the delivery of cardioplegia solution during cardiopulmonary bypass surgery.
• Technological Characteristics: A general statement that the new device's characteristics are "substantially equivalent" to the predicate.

In summary, this 510(k) submission relies on a comparison to an existing device rather than presenting new performance data against pre-defined acceptance criteria from a study.

Ask a specific question about this device