(221 days)
The MRII Cranial Drill and accessories is intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum field strength. The MRII Cranial Drill and accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.
The MRII Cranial Drill is a hand held manual drill with a 3:1 gear ration. It is in intended for use with the drill kit accessory kits consisting of a 2.0 or 3.2 mm drill bit, lancet, depth stop and ruler.
The provided 510(k) summary for the MRII Cranial Drill does not describe acceptance criteria or a study proving that the device meets specific performance criteria.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device, the Integra Hand Drill (K961113), primarily through a comparison of technological characteristics and bench testing.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is conspicuously absent:
1. A table of acceptance criteria and the reported device performance
Not provided in the document. The submission states that "Testing to applicable standards has been completed with acceptable outcomes" and "Bench testing performed included design verification testing and comparison testing with the predicate Integra Hand Drill, with acceptable results." However, it does not explicitly list specific acceptance criteria (e.g., maximum deflection under load, specific torque requirements, material strength thresholds) or quantitative performance data against those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document. The submission mentions "Bench testing," but no details about sample size, test methodologies, or the provenance of any data (e.g., human or animal cadavers for drilling tests) are included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not provided. This type of information is typically relevant for studies involving subjective human assessment (like image interpretation). For a mechanical device like a drill, "ground truth" would be established through objective physical measurements or functional tests, not expert consensus in the diagnostic sense. The document does not describe any such expert involvement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. Adjudication methods are specific to studies involving multiple readers or assessors to resolve discrepancies, often in diagnostic imaging. This concept does not apply to the type of bench testing described for a manual cranial drill.
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
Not applicable. This section is entirely irrelevant to the MRII Cranial Drill, which is a manual surgical instrument and not an AI-powered diagnostic tool. No MRMC study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This section is entirely irrelevant to the MRII Cranial Drill. As a manual surgical instrument, it does not possess an "algorithm" in the sense of AI or software-driven performance that would operate in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided/Implied by "Bench Testing". For a mechanical device, "ground truth" would typically refer to objective measurements of physical properties, functional performance (e.g., drilling time, force required, material integrity post-drilling), and compliance with engineering specifications. The submission only states "Bench testing performed included design verification testing and comparison testing with the predicate Integra Hand Drill." It does not specify the exact parameters measured or how success was defined.
8. The sample size for the training set
Not applicable. This device is a manual cranial drill. It does not employ machine learning or AI, and therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this device, this question is not relevant.
In summary, the K122456 submission for the MRII Cranial Drill relies on demonstrating "substantial equivalence" to a predicate device through a comparison of technological characteristics and general statements about "bench testing" that yielded "acceptable results." It does not specify detailed acceptance criteria or present quantitative study data to prove the device meets pre-defined performance thresholds, which is common for 510(k) submissions for devices considered low-risk and similar to existing predicate devices.
§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories
(a)
Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.(b)
Classification. Class II (performance standards).