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This device is for use on the skull area only. This device is disposable and for single patient use only. The device is used to aid the surgeon in perforating the skull for various types of purposes. The device does not assist the surgeon during the procedure. Decisions about what to do and how to perform a procedure rest firmly with the surgeon.

The ACRA-CUT XPRESS 120 is a battery operated drill that has a skull perforator permanently attached to it. It is for one time use and is delivered charged and sterile.

This device, the ACRA-CUT XPRESS 120, is a surgical drill and perforator. Based on the provided 510(k) summary, it is being submitted for substantial equivalence to existing predicate devices.

Here's an analysis regarding acceptance criteria and supporting studies:

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

   Acceptance Criteria	Reported Device Performance
   Substantial Equivalence: The XPRESS 120 should be substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.	The device is claimed to be substantially equivalent to the Osteomed B Power System and the Stryker System II Orthopower 90 Battery Powered Instruments. It is also substantially equivalent to previously approved ACRA-CUT perforators. The key difference is the specified use area (skull only for XPRESS 120) and the permanent attachment of the perforator to the drill.
   Intended Use: For use on the skull area only, disposable, single-patient use, to aid the surgeon in perforating the skull for various purposes.	The device's stated indications for use are "for use on the skull area only. This device is disposable and for single patient use only. The device is used to aid the surgeon in perforating the skull for various types of purposes." This directly matches the acceptance criteria for its intended use. The 510(k) decision confirms that the FDA reviewed these indications for use and found substantial equivalence.
   Technological Characteristics: Similar in how the battery-operated drill operates, is used, and in technological characteristics to predicate devices. (Specifically, battery-operated drill with permanently attached skull perforator, delivered charged and sterile, single-use.)	The XPRESS 120 is described as a "battery operated drill that has a skull perforator permanently attached to it. It is for one time use and is delivered charged and sterile." It is explicitly stated that it is "very similar in how the battery-operated drill operates, is used and in technological characteristics" to the predicate devices. The primary difference noted is the area of the body treated. The perforators themselves are identical to already approved ACRA-CUT perforators, just now permanently attached.
   Safety & Effectiveness: The device must be deemed safe and effective for its intended use and equivalent to predicate devices.	The FDA's substantial equivalence determination implies that the device is considered safe and effective for its intended use, given its similarity to legally marketed predicate devices that are also considered safe and effective. No specific performance metrics (e.g., drilling speed, torque, battery life) are provided, as the basis for acceptance is substantial equivalence to existing devices.

2. Sample size used for the test set and the data provenance
   No clinical studies or test sets with human or animal subjects were conducted for this device. The submission explicitly states: "No clinicals were performed with this device." The acceptance is based on demonstrating substantial equivalence to predicate devices already on the market.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   Not applicable, as no test set or clinical studies were performed. The "ground truth" for acceptance is based on the regulatory review of substantial equivalence to predicate devices, which involves regulatory experts at the FDA.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable, as no test set or clinical studies were performed that would require adjudication.

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. This is a surgical instrument, not an AI-assisted diagnostic or imaging device. No MRMC studies were conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This is a standalone physical surgical instrument used by a surgeon. Its performance is inherent to its design and manufacturing, and its safety/effectiveness is established through comparison to similar existing devices, not through algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   The "ground truth" for the device's acceptance is its substantial equivalence to legally marketed predicate devices. This doesn't involve clinical outcomes, pathology, or expert consensus on a study dataset for this specific device. Instead, it relies on the established safety and effectiveness of the existing predicate devices (Osteomed B Power System, Stryker System II Orthopower 90 Battery Powered Instruments, and existing ACRA-CUT perforators).

8. The sample size for the training set
   Not applicable, as no training set was used. This is a physical medical device, not an AI/ML model.

9. How the ground truth for the training set was established
   Not applicable, as no training set was used.

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