(33 days)
The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.
Biomet Microfixation Twist Drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone in neurosurgical procedures. The 2.1 x 255mm Drill, 22mm Stop is manufactured from medical grade stainless steel per ASTM F899. The subject drill bit is intended for single use only and is provided non-sterilized by the end-user prior to use. The subject submission seeks to add the compatibility of the 2.1 x 255mm Drill, 22mm Stop drill with neurosurgical stereotactic instrument systems.
The provided text describes the submission of a medical device (2.1 x 255mm Drill, 22mm Stop) for FDA clearance. It details the performance testing conducted, but it does not represent a study involving AI, human readers, or ground truth establishment in the context of medical image analysis or similar diagnostic applications. Instead, it refers to the physical characteristics and usability of a surgical drill.
Therefore, many of the requested categories (e.g., sample size for test set/training set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth) are not applicable to this type of device and the information provided.
However, I can extract the relevant information regarding the device's acceptance criteria and the study performed for its clearance.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tolerance Analysis: Demonstrated compatibility with neurosurgical stereotactic placement devices through dimensional analysis. | The tolerance analyses showed that the subject device dimensions are compatible with the dimensions of the neurosurgical stereotactic placement devices; thus, the subject drill bit mates effectively. |
| Summative Usability Validation: Acceptance criteria for usability were met, proving the device can be used safely and effectively with neurosurgical stereotactic instruments. | The acceptance criteria were met and the results demonstrated the subject device can be used safely and effectively with neurosurgical stereotactic instrument. |
Study Details (as applicable to a physical surgical instrument)
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Sample size used for the test set and the data provenance: Not applicable. For the tolerance analysis, dimensional measurements of the drill were compared against the specified dimensions of neurosurgical stereotactic placement devices. For usability, a group of users (not specified in number) would have participated in the summative usability evaluation.
- Provenance: Not specified, but likely conducted by the manufacturer or a contracted lab.
- Retrospective/Prospective: The usability evaluation would have been prospective, while the tolerance analysis is a form of design verification.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of establishing "ground truth" as it relates to diagnostic accuracy. For usability testing, healthcare professionals (e.g., neurosurgeons, surgical technicians) would have been involved, but their number and specific qualifications are not detailed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device. Usability testing typically involves observing user interactions and collecting feedback against predetermined criteria.
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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: Not applicable. This study concerns the physical characteristics and usability of a surgical drill, not AI software or diagnostic image interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual surgical tool and does not involve an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in a diagnostic sense is not relevant here. The ground for the tolerance analysis was the dimensional specifications for compatibility, and for usability, it was the safe and effective operation of the device by users according to predefined usability criteria.
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The sample size for the training set: Not applicable. No training set as this is not a machine learning model.
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How the ground truth for the training set was established: Not applicable. No training set.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).