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510(k) Data Aggregation
(27 days)
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 < X dB"). The performance is reported as meeting these general design input requirements.
2. Sample Size and Data Provenance for the Test Set
- Sample Size:
- For Functional Testing: Not explicitly stated as a number of devices or trials. The "Results" column simply indicates that "All tests fulfilled Design input requirements."
- For Design Validation/Summative Usability Testing: Not explicitly stated as a number of participants or cases, only that "production equivalent Surgify Halo (4 mm)" was used.
- Data Provenance (Country of Origin and Retrospective/Prospective Data): Not specified in the provided document.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: For the Summative Usability Testing, it is mentioned that "Surgeons Summative Testing" was performed. Specific qualifications (e.g., years of experience, specialty beyond "Surgeons") are not provided.
4. Adjudication Method (Test Set)
- Adjudication Method: Not specified in the document. The usability testing was conducted as "Surgeons Summative Testing," implying direct user evaluation against scenarios, rather than an independent adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No, the document does not mention an MRMC study or any comparison of human readers with vs. without AI assistance. The device is a surgical burr, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- Standalone Performance Done? N/A. The device is a physical surgical tool, not an algorithm. Its performance is intrinsically linked to its use by a human operator in a surgical setting.
7. Type of Ground Truth Used (Test Set)
- Ground Truth Type:
- For Functional Testing: The "ground truth" was likely defined by engineering specifications and design input requirements for physical properties and operational performance (e.g., durability, cutting effectiveness, chatter, noise, thermal output).
- For Summative Usability Testing: The "ground truth" was established by user requirements and validated through hazard-related use scenarios, assessing whether "user requirements were met" and "user errors" were minimized. This is a form of expert consensus/observation of appropriate use based on human factors principles.
8. Sample Size for the Training Set
- Sample Size: N/A. As a physical medical device (surgical burr) that is not an AI/ML algorithm requiring training data, the concept of a "training set" in the context of machine learning does not apply. The development would involve engineering design, material science, and iterative physical prototyping/testing.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: N/A, for the same reasons as #8.
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