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The InDiscal Aspiration Device and Accessories are intended for aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

The InDiscal™ Aspiration Device is a sterile, single-use device that is inserted through the InDiscal™ Aspiration Introducer into the patient to aspirate tissue disc material. The device consists of a handle, coring needle with sheath, storage chamber and activation switch. The InDiscal™ Aspiration accessories include the InDiscal™ Aspiration Introducer, InDiscal™ Aspiration Plug, InDiscal™ Aspiration Cap, InDiscal™ Aspiration Sheath

This is a 510(k) summary for a medical device called the "InDiscal™ Aspiration Kit" which includes the "InDiscal™ Aspiration Device" and its accessories. This document is a premarket notification to the FDA, asserting substantial equivalence to previously cleared devices. It does not contain a study demonstrating device performance against specific acceptance criteria in a clinical setting.

Therefore, I cannot provide the information requested about acceptance criteria and a study proving the device meets them, as this type of performance data is not typically included or required in a 510(k) summary for these types of devices. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical performance data against pre-defined acceptance criteria relevant to efficacy or accuracy in the way an AI/CADe device would.

The provided document details:

• Device Name: InDiscal™ Aspiration Kit (includes various aspiration components).
• Intended Use: Aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
• Predicate Devices: Several "Nucleotome Probe" devices manufactured by Surgical Dynamics.
• Substantial Equivalence Claim: The intended use and method of tissue removal (mechanical aspiration) are substantially equivalent to the predicate Nucleotome probes.

For devices like this, acceptance criteria would typically pertain to engineering specifications, biocompatibility, sterilization, and mechanical performance (e.g., aspiration efficiency in a lab setting), rather than clinical accuracy or effectiveness studies with human readers or AI.

If this were a submission for an AI/CADe device, the requested information would be critical. However, for this traditional medical device 510(k), such a study is not presented.

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