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The Velocity Alpha™ Drill System is indicated for trepanating, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and bone replacement materials.
Applications: Cutting, removing, shaping and sawing hard and soft tissue, bone, and bone replacement materials.
Areas of use: Neurosurgery and spinal surgery.

The Velocity Alpha™ Highspeed Surgical Drill System is an electric AC powered surgical motor drill system for rapid cutting, sawing, drilling and manipulation of soft tissue and bone.
The Subject Device has several components, such as an electric motor hand piece connected to and driven by an AC-powered control unit, a foot control unit (wired or wireless (Bluetooth)) and several adapters and nosepiece attachments, e.g. straight & angled nosepiece attachments, craniotome attachments, speed reducer attachments and sawing attachments.
The device has an optional irrigation pump that can supply irrigation through sterile tubing. Speed is variable from 1.000 RPM up to 80.000 RPM in order to adjust the speed to the surgeon's requirements. The direction of rotation can be pre-selected to the left and to the right.

The provided text describes the "Velocity Alpha Highspeed Surgical Drill System" and presents a summary of its substantial equivalence to a predicate device, including performance data. However, it does not contain a typical study design with acceptance criteria and results in the format implied by your request for "device performance" in relation to specific clinical outcomes or diagnostic accuracy.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance (510(k)). The "Performance data testing" section refers to engineering and functional tests rather than clinical studies or those involving expert review of diagnostic output.

Here's an analysis of the provided information based on your requested headings:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify a "test set" in the context of clinical data, diagnostic images, or patient-specific results. The performance data presented are for the device itself (e.g., motor speed, temperature, electrical safety). Therefore, there is no information on sample size or data provenance in that regard.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The "ground truth" for the engineering performance tests (motor speed, temperature, etc.) would be established by technical specifications and validated measurement equipment, not by clinical experts.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as the tests performed are technical and do not involve subjective interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document does not describe any studies comparing human reader performance with or without AI assistance.

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

Not applicable. This device is a surgical drill system, not an AI algorithm or diagnostic tool. The performance tests are for the physical device's operation.

7. The Type of Ground Truth Used

The ground truth for the performance data testing was based on technical specifications and established international standards (e.g., IEC 60601-1, IEC 60601-1-2) which define acceptable limits for motor speed, torque, temperature, noise, electrical safety, and electromagnetic compatibility.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical/electrical surgical system and does not utilize a "training set" in the AI/machine learning sense.

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reason as above.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The document describes a series of engineering and functional performance tests conducted on the Velocity Alpha Highspeed Surgical Drill System. These tests evaluated various technical aspects of the device, including:

• Motor speed and torque analysis: To confirm the motor performs within its specified range.
• Temperature analysis: To ensure the motor temperature remains within safe and specified limits during activity.
• Lifetime testing: To verify the system's durability and functionality over its expected operational lifespan.
• Noise level analysis: To confirm the noise generated by the device does not exceed specified limits.
• Electrical Safety testing: Conducted to ensure compliance with IEC 60601-1:2005, a standard for medical electrical equipment safety.
• Electromagnetic Compatibility (EMC) testing: Conducted to ensure compliance with IEC 60601-1-2:2014, a standard for EMC of medical electrical equipment.
• Wireless Foot Control testing: Included software verification/validation (IEC 62304:2006), EMC (IEC 60601-1-2:2007), and Electrical Safety (IEC 60601-1-1:2005) tests.
• Software Validation: Met requirements according to IEC 62304:2006.
• Biocompatibility testing: Performed on patient-contacting components (attachments/nosepieces) to meet ISO 10993 and EN ISO 10993-1 requirements.

Conclusion of the study: All tests "Passed," indicating that the device met its specified technical and safety acceptance criteria, demonstrating its substantial equivalence to the predicate device (Aesculap ELAN 4 Electro Motor System) based on technological characteristics, functionality, and intended use, without negative effects on safety or effectiveness. The document explicitly states "No clinical data is required for this device classification submission."

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