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Cutting and Dissecting Various Abdominal Tissue during . Endoscopic (inclusive of laparoscopic) Surgical Procedures.

The "3 MM Selec-Tip" Laparoscopic Surgical Instruments are a line of non-sterile, reusable small diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The device can be used with monopolar electrosurgical generators.

The provided text describes a 510(k) summary for the "3 MM Selec-Tip" Laparoscopic Instruments, a medical device. This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a study with performance metrics in the same way an AI/ML device would.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets them because it's a submission for a traditional medical device, not an AI/ML diagnostic tool that would typically involve such studies.

Specifically:

• No table of acceptance criteria and reported device performance: The document does not define specific performance metrics or acceptance criteria for the "3 MM Selec-Tip" Laparoscopic Instruments. Its purpose is to demonstrate substantial equivalence to predicate devices, not to measure specific clinical performance.
• No sample size for the test set or data provenance: No test sets or data for performance evaluation are mentioned.
• No number of experts or qualifications for ground truth: No ground truth establishment is described as there is no diagnostic or AI/ML component being evaluated.
• No adjudication method: Not applicable given the nature of the device and submission.
• No multi-reader multi-case (MRMC) comparative effectiveness study: This is not an AI-assisted diagnostic device, so such a study would not apply.
• No standalone (algorithm only) performance study: This is not an algorithm-based device.
• No type of ground truth used: Not applicable.
• No sample size for the training set: Not applicable, as there is no AI/ML model being trained.
• No description of how ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Device Identification: "3 MM Selec-Tip" Laparoscopic Instruments
• Predicate Devices: "Selecta-Tip" (K970826) and Richard Wolf Medical Instruments (K973648)
• Device Description: Non-sterile, reusable small diameter instruments for cutting and dissecting abdominal tissue in endoscopic/laparoscopic procedures, usable with monopolar electrosurgical generators.
• Substantial Equivalence: Claiming that technical specifications, materials, and physical appearance differences do not affect safety or effectiveness compared to predicates.
• Indications For Use: Cutting and dissecting various abdominal tissue during endoscopic (inclusive of laparoscopic) surgical procedures.

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