(29 days)
The FHC microTargeting™ STar Drive™ System is intended to be used with commercially available positioning 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™ STar Drive™ System allows a neurosurgeon to precisely position intracranial microelectrodes, stimulating electrodes, lesion electrodes and other instruments during functional neurosurgical procedures.
microTargeting™ STar Drive™ System Components
- microTargeting™ STar Drive™ .
- optional lower guide .
- lead holder with lead /lesion stop .
- . 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 TM STar Drive™ system and other stereotactic frames or instruments, and also include optional components to increase utility.
- Adapters to fit Radionics, Leksell, Leibinger RM, Leibinger ZD. . FHC MicroTargeting™ Platform and Medtronic-IGN NeXframe stereotactic systems
- ♥ single electrode insertion tube set
- . array electrode insertion tube set
- . lesion insertion kit and depth stops
- . custom microelectrode depth stops
The provided document, K092562, is a Special 510(k) Summary for the FHC microTargeting™ STar Drive™ System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance studies with detailed acceptance criteria and standalone algorithm performance.
Here's an analysis based on the provided text, addressing your questions to the best of its ability:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific, quantifiable acceptance criteria or a dedicated table for device performance in the way a de novo device might. Instead, it relies on demonstrating equivalence to a predicate device and states that performance testing documented in "verification and validation phases of design control" shows the device is "equivalent or improved" over the predicate.
The table in the document is a "Comparison Table" highlighting technological characteristics similarities, not acceptance criteria for performance.
| Parameter | Predicate Device Performance (microTargeting™ Drive) | Proposed Device Performance (microTargeting™ STar Drive™) |
|---|---|---|
| Indications for Use | Accurate positioning of probes in the brain or nervous system | Same (Accurate positioning of probes in the brain or nervous system) |
| Drive mechanism | Manual and/or optional motor drive | Same (Manual and/or optional motor drive) |
| Biocompatibility | ||
| Drive system & Accessories | No contact with tissue | Same (No contact with tissue) |
| Insertion Tubes | 304 stainless steel | Same (304 stainless steel) |
| Travel | 50 mm | Same (50 mm) |
| Sterilization | Steam; ethylene oxide | Steam |
| Position Indicator | Mechanical and/or digital readout capable | Same (Mechanical and/or digital readout capable) |
| Stereotactic frame adapters | Radionics, Leksell, Leibinger RM, Leibinger ZD, M-IGN NeXframe, FHC microTargeting™ Platform | Same (Radionics, Leksell, Leibinger RM, Leibinger ZD, M-IGN NeXframe, FHC microTargeting™ Platform) |
| Materials | Hardcoated Aluminum, Stainless Steel | Same (Hardcoated Aluminum, Stainless Steel) |
| Other Performance (General Statement) | Implied satisfactory performance as a legally marketed device. | "equivalent or improved over the predicate system 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 Data Provenance
The document does not specify a "test set" in the context of clinical or performance data for the purpose of establishing a new device's efficacy through primary studies. This is a 510(k) submission, specifically a Special 510(k), which streamlines the process for certain device modifications. The focus is on demonstrating equivalence to the predicate device (FHC microTargeting™ Drive System K003776).
The "Performance testing" mentioned refers to "verification and validation phases of design control" which would typically involve engineering tests, bench tests, and possibly simulated use, rather than a clinical human test set. Therefore, there is no mention of country of origin or whether data was retrospective or prospective in detail.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This type of submission for a mechanical stereotaxic instrument does not involve establishing ground truth through expert consensus on medical images or diagnoses, as would be the case for an AI/algorithm-based diagnostic device. The performance evaluation is based on engineering principles and comparison to a predicate.
4. Adjudication Method for the Test Set
Not applicable. As there is no "test set" in the sense of clinical cases requiring expert adjudication, no adjudication method 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
Not applicable. The device is a mechanical stereotaxic instrument, not an AI or imaging diagnostic algorithm. Therefore, an MRMC study related to interpretation or AI assistance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a mechanical system and does not involve a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device would be established through engineering specifications, measurements, and validation against known standards for mechanical accuracy, repeatability, and rigidity. For example, accuracy could be validated against a known target in a phantom. The document implies that such testing was performed during design control ("verification and validation phases"), but it does not detail the specific methodology or "ground truth" used for each aspect (e.g., "accuracy").
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical instrument and does not involve a "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an algorithm, the concept of establishing its ground truth is not relevant to this submission.
Summary of the K092562 document regarding acceptance criteria and studies:
The document primarily demonstrates substantial equivalence to an existing predicate device (K003776) by showing that the new device has the same intended use and similar technological characteristics, materials, and performance. The performance section broadly states that internal "verification and validation phases of design control" showed the device to be "equivalent or improved" in several mechanical and usability aspects (ease of manufacturing, mechanical and electrical quietness, ease of use, repeatability, accuracy, rigidity, and adaptability).
However, it does not provide:
- Specific, quantifiable acceptance criteria.
- Detailed reports of specific performance studies (e.g., a clinical trial, a detailed bench study with a specified number of samples).
- Any information regarding human-in-the-loop studies, multi-reader studies, AI performance, or data provenance in the context of clinical evaluation.
This is typical for a 510(k) submission for a non-AI, mechanical device that is substantially equivalent to a predicate, where the focus is on engineering verification/validation and comparison rather than new clinical efficacy trials or AI performance metrics.
§ 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).