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The MISS instrument set is designed for transthoracic and transabdominal approaches to the spine.

Hand instruments, such as osteotome, elevator, hook probe, spoon, curette, punch, compunction tube with obturator, and plug applicator are used for endoscopically controlled dissection, exploration, and manipulation of tissue through natural or surgically created passages.

Rongeurs and punches are used under endoscopic control, to grasp, manipulate, and cut, as well as for the dissection and biopsy of tissue, organs, or foreign bodies.

Suction irrigation punches are used for endoscopically controlled punching and removal of tissue through natural or surgically created passages.

For examination, diagnosis, and / or therapy by personnel trained and qualified in connection with endoscopically used accessories in various medical disciplines, such as orthopedic and spinal surgery.

MISS is an acronym for Minimally Invasive Spinal Surgery. The operating technique is comparable to laparoscopic and thorascopic procedures.

Punches, rongeurs, osteotomes, elevators, spoons, curettes, probes, bone pusher, block applicator, compaction tube, and swivel arm are primarily used for transthoracic and transabdominal approaches to the spine.

The provided document describes a 510(k) submission for a Minimally Invasive Spinal Surgery Set (MISS) and does not contain information about acceptance criteria, performance data from a specific study, a test set, ground truth establishment, or any AI-related data.

Specifically, the document states:

• "No performance standards are known." (Section 5.0 Performance Data)
• "Clinical tests were not performed." (Section 6.0 Clinical Tests)

Therefore, based on the provided text, I cannot describe the acceptance criteria or a study that proves the device meets them because such information is explicitly stated as not applicable or not performed in this submission. The device received 510(k) clearance based on substantial equivalence to predicate devices, not on a new performance study with acceptance criteria.

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