Search Results
Found 2 results
510(k) Data Aggregation
(27 days)
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo
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
| Test Type | Acceptance Criteria (Design Input Requirements) | Reported Device Performance (Results) |
|---|---|---|
| Functional Testing | ||
| Durability | Device functions as intended, all design and functional specifications met | All tests fulfilled Design input requirements |
| Cutting Effectiveness | Device functions as intended, all design and functional specifications met | All tests fulfilled Design input requirements |
| Chatter Rate | Device functions as intended, all design and functional specifications met | All tests fulfilled Design input requirements |
| Noise | Device functions as intended, all design and functional specifications met | All tests fulfilled Design input requirements |
| Thermal | Device functions as intended, all design and functional specifications met | All tests fulfilled Design input requirements |
| Design Validation/Summative Evaluation | ||
| Summative Usability Testing | User requirements met, consistent with predicate evaluation approach, addressed use errors and hazard-related use scenarios, in accordance with IEC 62366-1:2015 and FDA's 2000 Guidance "Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management." | All tests fulfilled Design input and user requirements |
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
Ask a specific question about this device
(30 days)
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo
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.
Ask a specific question about this device
Page 1 of 1