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Surgify Halo is a sterile surgical burr indicated for shaping and bone in neurosurgical, spinal, ENT, and general surgical procedures.

The Surgify Halo is a rotary cutting device made of high-grade metallic materials. It cuts bone and other hard tissues selectively while reducing chattering. The device is similar to conventional surgical cutting burrs with the addition of a ring mechanism installed in the burr head to reduce chattering. Similar to conventional burrs, the device is designed for use with compatible high-speed surgical drill systems. The Surgify Halo comprises: A shank, which transfers rotary movement of the drill motor to the head. Locking features at the distal end of the shank which allow the burr shank to be locked to a high-speed surgical drill. A head that is shaped to have two cutting edges to cut bone and hard tissue. A safety mechanism consisting of a ring and spring installed in the burr head. The mechanism is self-centering and comprises a spring and a moving ring that is bigger than the burr head. The moving ring can have two different positions: In the first position, the ring protrudes to a level higher than cutting edges and prevents the cutting edges from cutting into the work material. In the second position, the ring retracts into the groove to a level lower than the cutting edges to allow the burr to cut the work material

The provided text describes the Surgify Halo, a sterile surgical burr, and its performance evaluation to demonstrate substantial equivalence to a predicate device (Adeor HiCut Highspeed Instrument).

Here's an analysis of the acceptance criteria and the study details:

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

The document does not explicitly present a table of formal acceptance criteria with specific numerical thresholds. Instead, it states that "All tests fulfilled Design input requirements" and that the "performance of the Surgify Halo burr was comparable to that of the conventional diamond and fluted burrs." This implies that the acceptance criteria were defined by the product's design input requirements and the performance of established devices.

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 does not specify the sample sizes used for any of the individual tests. Similarly, there is no information provided regarding the provenance of the data (e.g., country of origin, retrospective or prospective nature). The testing appears to be primarily laboratory-based "Design Verification Test" and "Design Validation Testing." The "Performance Testing Animal" section suggests an animal model was used, but details are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document mentions "Nurses Summative Testing" and "Surgeons Summative Testing" for Design Validation/Usability. These tests involved a "series of tests based on hazard-related use scenario, user interface." However, the number of nurses and surgeons involved, their specific qualifications, or how their input established a "ground truth" (beyond fulfilling design input requirements for usability) is not detailed.

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

No information is provided regarding an adjudication method. The testing seems to be based on meeting predefined design input requirements and comparative performance, rather than a system requiring expert adjudication of ambiguous cases.

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

This section is not applicable. The Surgify Halo is a physical surgical burr, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

This section is not applicable. The Surgify Halo is a physical surgical burr. Its performance is inherent to the device itself (e.g., cutting efficiency, durability), not a standalone algorithm.

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

The "ground truth" for the performance evaluation appears to be based on:

• Design Input Requirements: The device was tested against its own design specifications (e.g., durability, cutting efficiency, noise levels, geometrical features).
• Predicate Device Comparability: The performance of the Surgify Halo was compared to that of "conventional diamond and fluted burrs," implying these established devices served as a benchmark for acceptable performance.
• Biocompatibility Standards: Compliance with ISO 10993-1:2018.
• Sterilization Standards: Compliance with EN/ISO 11137-1/2 (2015).
• Usability Feedback: Input from nurses and surgeons during summative testing to ensure the device meets intended use and user needs.
• Animal Performance: Comparison to conventional burrs in an animal model.

8. The sample size for the training set

This section is not applicable. The Surgify Halo is a physical surgical burr, not a machine learning or AI model that requires a training set.

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

This section is not applicable, as there is no training set for this device.

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