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510(k) Data Aggregation
(205 days)
The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement.
The device under review is a family of cranial drill bits and accessories. These cranial drill bits and accessories are applied to create a hole through the skull in support of neurological procedures. Cranial drill bits are twist drill bits used for drilling holes in the skull, supporting access to the brain for brain biopsy, brain contacting electrode placement, electrode accessory placement such as Anchor Bolts or other needs as determined by the user. The cranial drill bit variations are 16 cm to 30 cm length and 2.4 mm to 3.2 mm outer diameter. Accessories to the cranial drill bits include: Drill Stop, Drill Stop Wrench, Drill Sleeve Guide, Guide Block.
The provided document is a 510(k) summary for Ad-Tech Medical Instrument Corporation's Cranial Drill Bits and Accessories. It outlines the device's indications for use, technological characteristics, and performance tests for demonstrating substantial equivalence to predicate devices. This document does not pertain to an AI/ML powered medical device, an autonomous AI device, or other medical device software. Therefore, the questions regarding acceptance criteria and studies for AI-powered devices are not applicable.
Here's an analysis of the provided information, addressing the closest relevant aspects:
Acceptance Criteria and Device Performance for (Non-AI) Cranial Drill Bits and Accessories
The acceptance criteria are not explicitly titled as "acceptance criteria" but are embedded within the "Summary of Requirement" for the performance tests conducted. The device performance is reported as "Pass" for all listed tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Summary of Requirement) | Reported Device Performance |
|---|---|
| Drill through simulated skull material in < 1 min. | Pass |
| Comparison of drilled hole diameter to the desired hole size (with Guide Block, Drill Sleeve Guide and Drill Stop). | Pass |
| Comparison of drilled hole diameter to the desired hole size (without Guide Block, Drill Sleeve Guide and Drill Stop). | Pass |
| Guide Block compatible with stereotactic frame. | Pass |
2. Sample size and data provenance for the test set
The document does not specify the sample size used for the tests or the provenance of any data (e.g., country of origin, retrospective/prospective). It only mentions "simulated skull material" for the drilling efficiency test.
3. Number of experts and qualifications for ground truth establishment
This information is not available in the provided document. As this device is mechanical and not an AI/ML product, expert review in this context would likely be related to design validation and usability, not establishing ground truth for algorithmic performance.
4. Adjudication method for the test set
This information is not available in the provided document. Given the nature of the device (mechanical drill bits), typical adjudication methods like 2+1 or 3+1 used for diagnostic AI are not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results
A multi-reader multi-case (MRMC) comparative effectiveness study was not done as this is a mechanical device, not an AI-powered device intended for diagnostic or assistive interpretation by human readers. Therefore, there is no effect size of human readers improving with AI assistance to report.
6. Standalone (algorithm only without human-in-the-loop performance) study results
A standalone performance study was not done because this is a mechanical device and does not involve an algorithm.
7. Type of ground truth used
The ground truth used for these performance tests appear to be based on engineering specifications and measurable physical properties rather than clinical outcomes, expert consensus, or pathological diagnoses. For example, "drilling through simulated skull material in < 1 min" uses a timing measurement against a specified material, and "comparison of drilled hole diameter to the desired hole size" relies on a direct physical measurement against a设计 specification.
8. Sample size for the training set
This information is not applicable as this is a mechanical device and does not involve a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not applicable as this is a mechanical device and does not involve a training set for an AI/ML algorithm.
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