(49 days)
The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulation electrodes, or other instruments in the brain or nervous system.
The microTargeting® Drive System with permits the accurate positioning of microelectrodes, stimulation electrodes, lesion electrodes, biopsy probes and other instruments in the brain and nervous system and is adaptable to all major stereotactic systems. The current microTargeting® Drive System allows the user to add position display capability or add power assist and position display capabilities.
This 510(k) summary (K011992) for the FHC microTargeting® Drive System describes a device for accurate positioning of instruments in neurosurgical procedures. However, it does not contain the level of detail regarding acceptance criteria or a specific study proving the device meets those criteria, as requested in the prompt.
Therefore, I cannot provide quantitative information for most of your questions. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K003776), rather than presenting a performance study with detailed acceptance criteria and results.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., accuracy thresholds, precision ranges) or present a table of reported device performance against such criteria. The substantial equivalence argument relies on the previous device's established performance without detailing it here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe a "test set" in the context of device performance evaluation. It refers to "differences that exist between these devices, relating to technical specifications, physical appearance, and design," but does not mention specific testing data, sample sizes, or data provenance.
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)
- Cannot be provided. There is no mention of a "test set" requiring ground truth establishment by experts in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. Not applicable as no test set or expert ground truth establishment is described.
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
- Cannot be provided. This device is a mechanical stereotactic drive system, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is a mechanical device, not an algorithm. Standalone performance as typically understood for AI algorithms is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth establishment is described in the context of device performance.
8. The sample size for the training set
- Cannot be provided. No training set is mentioned as this is a mechanical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable as no training set or ground truth for it is mentioned.
Summary of available information related to the prompt:
- Device Name: microTargeting® Drive System
- Predicate Device: FHC, Inc microTargeting® Drive System (K003776), cleared Feb. 23, 2001.
- Demonstration of Effectiveness: The summary asserts that the device is "substantially equivalent" to its predicate. The phrase "Differences that exist between these devices, relating to technical specifications, physical appearance, and design do not affect the relative safety and effectiveness of the microTargeting® Drive System" implies that the company believes any changes do not negatively impact the device's performance, but no new studies are cited to prove this in a quantitative manner within this document. The effectiveness is assumed to be similar to the predicate based on technical and design comparisons, not new performance data.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).