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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 < 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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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.

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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