(23 days)
The FHC microTargeting™ XL STar™ Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
When used in conjunction with commonly available stereotactic systems, the microTargeting "M XL STar™ Drive System allows a neurosurgeon to precisely position intracranial microelectrodes, stimulating electrodes, lesion electrodes and other instruments during functional neurosurgical procedures.
microTargeting™ XL STar™ Drive System Components
- microTargeting™ XL STarTM Drive .
- insertion tubes
- verification probe ●
- sterilization case ●
- cleaning brushes .
Device Mounting Hardware and other Components
Additional components for device mounting include hardware specifically designed to interface between the microTargeting™ XL STar™ Drive system and other stereotactic frames or instruments, and also include optional components to increase utility.
- Adapters to fit Radionics and Leksell stereotactic systems .
- microTargeting controller firmware based on user specifications of drive travel.
This document is a 510(k) summary for the FHC microTargeting™ XL STar™ Drive System, a medical device. The purpose of this summary is to demonstrate substantial equivalence to a predicate device, not to present a comprehensive study proving the device meets specific acceptance criteria in the context of a typical AI/software performance study.
Therefore, many of the requested items (e.g., sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, specific acceptance criteria for a clinical study) are not applicable or not provided in this type of regulatory submission. The submission focuses on comparing the new device's technological characteristics and performance to a legally marketed predicate device to establish substantial equivalence.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" in the format typically seen for algorithm performance studies with numerical metrics like sensitivity, specificity, or accuracy. Instead, it uses a "Comparison Table" to demonstrate substantial equivalence based on technological characteristics and states that performance testing documented in verification phases shows "equivalence or improvement" over the predicate.
| Parameter | Acceptance Criteria (Implied: Equivalent or Improved vs. Predicate) | Reported Device Performance (microTargeting™ XL Star™ Drive) |
|---|---|---|
| Indications for Use | Same as predicate | Same |
| Drive mechanism | Same as predicate | Same |
| Biocompatibility (Drive system & Accessories) | No contact with tissue (same as predicate) | No contact with tissue (same) |
| Biocompatibility (Insertion Tubes) | 304 stainless steel (same as predicate) | 304 stainless steel (same) |
| Travel | Equivalent or improved, specifically, increased from 50mm | Maximum of 125mm (Improved, larger travel) |
| Sterilization | Steam (same as predicate) | Steam (same) |
| Position Indicator | Manual, mechanical and/or digital readout capable (same as predicate) | Same |
| Stereotactic frame adapters | Equivalent or improved, specifically, compatible with Radionics and Leksell | Radionics and Leksell (Note: The predicate lists more adapters; the XL version appears to have a more focused compatibility initially, but this is assessed as "equivalent" overall). |
| Materials | Hardcoated Aluminum, Stainless Steel (same as predicate) | Same |
| General Performance | Equivalent or improved over predicate | Documented in verification phases to be equivalent or improved in ease of manufacturing, mechanical and electrical quietness, ease of use, repeatability, accuracy, rigidity, and adaptability. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As a 510(k) for a hardware device, the "performance testing" refers to engineering and design verification/validation directly on the device, not clinical data or patient data.
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)
This information is not provided and is not applicable to this type of device submission. There is no clinical "ground truth" to establish in the context of this 510(k) summary, as it describes a mechanical stereotaxic instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable.
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
An MRMC study was not done and is not applicable. This is not an AI-assisted device for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The "performance testing" for this device likely involved engineering measurements and tests (e.g., measuring travel distance, repeatability, accuracy of positioning) against design specifications, rather than clinical ground truth from patient data.
8. The sample size for the training set
This is not applicable. This is a hardware device; there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
This is not applicable.
§ 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).