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Used as accessories in general laparoscopic diagnostic and surgical procedures for manipulating tissue (grasping, cutting, coagulating, dissecting and suturing).

The Allegiance Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders are composed of a reusable handle and shaft assembly and a removable tip assembly. These instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures.

I am sorry, but based on the provided text, there is no detailed information about the acceptance criteria or a specific study proving the device meets those criteria.

The document is a 510(k) premarket notification for "Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders." It states that:

• "All materials used in the composition of the Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders were subjected to performance and physical tests to evaluate the safety, effectiveness and reliability of the device. All test results were acceptable." (Page 1, "Summary of Testing")

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
5. Whether a standalone (algorithm only) performance study was done.
6. The type of ground truth used.
7. Sample size for the training set.
8. How ground truth for the training set was established.

This document serves as an FDA clearance letter and a summary of substantial equivalence to a predicate device, rather than a detailed technical report of device performance testing.

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