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510(k) Data Aggregation
(209 days)
AESCULAP VASCULAR INSTRUMENTS
Aesculap's Vascular Clamps and Instruments are indicated for use in vascular surgery. Alfa and Alfa-mini vascular clamps are designed for temporary occlusion of blood vessels during open surgical procedures. Atraumatic vascular clamps and clamp appliers/removers are designed for temporary occlusion of blood vessels during either an open or endoscopic surqical approach.
Laparoscopic vascular scissors, forceps, clamps, dissecting spatulas and needleholder are use for cutting, dissecting, clamping, fixation and suturing vessels and tubular structures. Flexible trocars provide access to the surgical site for use in laparoscopic vascular surgery.
The Vascular Instruments consist of vascular clamps, flexible trocars, and various endoscopic vascular instruments (scissors, forceps, clamps).
The provided document, K992053, is a 510(k) Premarket Notification for "Aesculap Vascular Instruments." This type of submission is for medical devices to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical studies with acceptance criteria. As such, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in a study demonstrating new device efficacy or safety.
Instead, the submission states:
- "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices."
- "Aesculap believes that the Vascular Instruments presented in this submission are substantially equivalent in design, function, and intended use to currently marketed vascular and endoscopic devices from companies such as: Aesculap, Codman, Heartport, Mueller, Walter Lorenz."
Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study demonstrating the device meets such criteria because the content is a substantial equivalence claim, not a performance study report.
Here's why each point you requested cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The submission is for substantial equivalence to predicate devices, not performance against specific criteria.
- Sample sized used for the test set and the data provenance: No test set information is provided as no performance study was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth information provided as no performance study was conducted requiring one.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication information provided.
- 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 surgical instrument, not an AI-assisted diagnostic tool.
- 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.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No performance study requiring ground truth was conducted.
- The sample size for the training set: Not applicable. This device is a surgical instrument, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth for one was established.
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