(98 days)
The Vascular Clamp is indicated for use for temporary or partial occlusion of blood vessels during open surgical procedures.
SIBEL's vascular clamps are composed different styles and a wide variety of lengths, shapes and sizes. The length and angles are design features that can be important to the surgeon to keep the handles and shanks out of the field of vision of the operative site. The vascular clamps are reusable and have ring handles made of stainless steel or titanium with a ratchet closure to adjust the amount of tension applied to the vessel for occlusion or partial occlusion.
The provided text is a 510(k) Summary for a Vascular Clamp device. It highlights the device's technical characteristics and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics.
The document is a premarket notification for a medical device (a vascular clamp) asserting its substantial equivalence to an existing predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing extensive independent performance studies with detailed acceptance criteria.
Therefore, for your request:
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A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) summary focuses on comparing technical characteristics to a predicate device, not on presenting performance data against predefined acceptance criteria from a specific study.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided document, as no specific performance study data is included.
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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 information is not present as there is no mention of a test set or ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present as there is no mention of a test set or adjudication.
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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: This information is not present. This device is a mechanical surgical clamp, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. This device is a mechanical surgical clamp, not an algorithm, so standalone performance is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present as there is no mention of a ground truth.
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The sample size for the training set: This information is not present as there is no mention of a training set.
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How the ground truth for the training set was established: This information is not present as there is no mention of a training set or ground truth.
In summary, the provided 510(k) document is a declaration of substantial equivalence based on a comparison of device features and intended use to a predicate device, not a report of a performance study with acceptance criteria.
§ 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).