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Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions.

The Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions. The CAD II accepts a variety of attachments and accessories. Synthes CAD II has a 3.2 mm cannulated center to accept a variety of wires and pins. The other accessories include drill bits, flexible shafts, adapters, saw blades, air hoses, screwdriver shafts, burrs, files, and a cleaning brush. The drill features both forward and reverse rotation with a variable speed of 0 - 900 rpm; maximum torque of 4 Nm; air consumption of 250 liters/minute. and has an air control valve and latex free double air hose connection. The push button release allows for quick exchange of various attachments.

The provided document is a 510(k) premarket notification for a medical device, the Synthes Compact Air Drive II (CAD II). This type of document focuses on establishing substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the way a clinical trial for a new drug or a novel medical AI device would.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

   • The document states: "Based on the mechanical test results, Synthes CAD II is at least equivalent to the predicate devices."
   • This implies the acceptance criterion was "at least equivalent" in mechanical performance to the predicate devices (Synthes Small Air Drill (SAD) and Synthes Universal Air Drill (UAD)).
   • No specific numerical performance metrics are provided for either acceptance criteria or the CAD II's reported performance, beyond its general operating specifications (e.g., variable speed of 0-900 rpm, maximum torque of 4 Nm, air consumption of 250 liters/minute).

   Acceptance Criteria	Reported Device Performance
   At least equivalent in mechanical performance to predicate devices (Synthes SAD and UAD)	"Synthes CAD II is at least equivalent to the predicate devices" based on mechanical test results.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • The document mentions "mechanical test results" but does not specify the sample size of devices tested or the data provenance. Mechanical testing typically involves a set number of units, but this detail is not present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • This device is a mechanical drilling tool, not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" established by human experts in a clinical context (like radiologists) does not apply here. The "ground truth" for mechanical equivalence would be derived from engineering standards and measurements. No information is provided about experts involved in validating the mechanical tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Not applicable for mechanical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable as this is a mechanical device, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. The device itself is a standalone mechanical tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • For a mechanical device like this, the "ground truth" for performance would likely be established through engineering specifications and direct measurements against known standards or the predicate device's measured performance. The document explicitly relies on "mechanical test results."

8. The sample size for the training set

   • Not applicable. This is a conventional medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

   • Not applicable.

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