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Surgify Halo is a sterile surgical burr indicated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and General Surgical procedures.

The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-grade metallic materials, designed to cut bone and other hard tissues selectively while minimizing chattering. The device is similar to conventional surgical cutting burrs but includes a ring mechanism in the burr head to reduce chattering. Like traditional burrs, the device is designed to be compatible with commonly marketed, high-speed, surgical drill systems. The Surgify Halo comprises: Shank, Locking Features, Burr Head, and Safety Mechanism (a self-centering ring and spring mechanism installed in the burr head). The moving ring, larger than the burr head, can adopt two positions: First Position (Hard Tissue Mode) where the ring protrudes, preventing cutting edges from engaging, and Second Position (Soft Tissue Mode) where the ring extends beyond the cutting edge, shielding it to minimize accidental soft tissues and an exposed position for cutting hard surfaces like bone.

The Surgify Halo is a sterile surgical burr used for shaping and removing hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures. The company performed performance testing and design validation/summative evaluation to demonstrate substantial equivalence to its predicate device (K250380).

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text states that "All tests fulfilled Design input requirements" and "All tests fulfilled Design input and user requirements." It does not explicitly state numerical acceptance criteria for each parameter (e.g., "chatter rate

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Surgify Halo is a sterile surgical burr indciated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and general surgical procedures

The Surgify Halo is a sterile-packaged, single-use rotary cutting device (a burr) made from high-grade metallic materials, designed to cut bone and other hard tissues selectively while minimizing chattering. The device is similar to conventional surgical cutting burrs but includes a ring mechanism in the burr head to reduce chattering. Like traditional burrs, the device is designed to be compatible with commonly marketed, high-speed, surgical drill systems.

The Surgify Halo comprises:

• Shank: Transfers rotary motion from the drill motor to the burr head.
• Locking Features: Located at the distal end of the shank, these features securely attach the burr to the high-speed surgical drill.
• Burr Head: Shaped with two cutting edges for cutting of bone and hard tissue.
• Safety Mechanism: A self-centering ring and spring mechanism installed in the burr head. The moving ring, larger than the burr head, can adopt two positions:
  • First Position: (Hard Tissue Mode) The ring protrudes, preventing the cutting edges from engaging with the work material.
  • Second Position: (Soft Tissue Mode) The ring extends beyond the cutting edge, shielding it to minimize accidental soft tissues and an exposed position for cutting hard surfaces like bone.

The provided text is a 510(k) summary for a medical device (Surgify Halo) and does not contain information about an AI/ML component or a study proving its performance against acceptance criteria in the context of AI/ML. The device is a surgical burr, which is a physical cutting tool, not a software or AI-driven diagnostic or therapeutic device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, or ground truth establishment related to AI/ML.

The "Performance Data" section describes functional testing for a physical device (durability, chattering, compatibility with drill systems) and sterilization/passivation validation, along with a table of "Design Verification Tests" and their result that "All tests fulfilled Design input requirements". This kind of performance data is standard for mechanical surgical tools and is not related to the performance of an AI/ML algorithm.

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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.

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