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The Acute Bone Screw is a general purpose screw intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the thorax (ribs, sternum, clavicle, scapula).

The Acute Bone Screws consists of bone screws of varying lengths. The screws are partially and fully threaded, have a head with a hex drive, are cannulated or solid, and can be used with or without a plate or washer. The screws are manufactured out of titanium per ASTM F-136 and are provided non-sterile.

The provided text does not describe acceptance criteria, device performance metrics, or a study to prove the device meets acceptance criteria.

Instead, the document is a 510(k) summary for a medical device called "Acute Bone Screw." This type of submission to the FDA focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than reporting on specific performance studies or acceptance criteria for the new device.

Here's why the requested information cannot be extracted from this document:

• No acceptance criteria or device performance reported: The document explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This means the submission did not include performance metrics or acceptance criteria as it was deemed unnecessary for demonstrating substantial equivalence for this type of device.
• Focus on substantial equivalence: The core argument of the 510(k) is that the "Acute Bone Screw" is "substantially equivalent" to predicate devices (Macropore OS Reconstruction System K024169 and Acumed Cortical Bone Screw K942340) based on shared technological characteristics (Titanium per ASTM F-136) and similar intended use.
• No studies described: Since performance data and tests were deemed "not applicable," there is no mention of a study, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, it is not possible to fill out the requested table or answer the questions based on the provided text.

The document concludes that "Based upon the similarities of the Acute Bone Screw and the predicate devices studied, the safety and effectiveness of the Acute Bone Screw is substantially equivalent to the predicate devices referenced." This implies that the 'acceptance criteria' were met by demonstrating sufficient similarity to already approved devices, rather than through novel performance testing.

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