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Multiple clip appliers are indicated for ligation of tubular structures. Vanguard intends to reprocess multiple clip appliers one time. Reprocessed multiple clip appliers are single use devices.

Vanguard Medical Concepts, Inc., intends to market Reprocessed Disposable, Multiple Clip Appliers with non changeable reloads. Reprocessing Multiple Clip Appliers is performed by Vanguard to Vanguard Potocol Number 40017. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). Vanguard is a "third party reprocessor" and reprocesses used single-used medical devices. Appliers are sold new by the original manufacturers to the hospital. The hospital uses the appliers, collects them and ships them to Vanguard for reprocessing. Appliers are reprocessed by Vanguard as described in our reprocessing protocol Control Document Number 40017, and returns them to the hospital to be reused as a single-use device again.

The provided document is a 510(k) summary for a reprocessed medical device, specifically Reprocessed Multiple Clip Appliers. It does not contain information on acceptance criteria, a study proving device performance against such criteria, or details regarding AI/algorithm performance.

Therefore, I cannot extract the requested information as it is not present in the provided text.

The document discusses:

• The classification and general information about the device (Vanguard Reprocessed Multiple Clip Appliers).
• The reprocessing process by Vanguard.
• The claim of substantial equivalence to a legally marketed predicate device (Ethicon disposable surgical and endoscopic Ligaclip Multiple Clip Appliers).
• The FDA's 510(k) clearance letter.
• Indications for Use for the reprocessed device.

There is no mention of:

1. Acceptance criteria or device performance metrics.
2. Any study that would test device performance against such criteria, including sample sizes, data provenance, ground truth, or expert involvement.
3. Any AI or algorithm-related components or studies (standalone or MRMC).

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