(86 days)
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
A stereotactic system with an electromechanical, multijointed arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software and utilizes ultrasonic registration. The system is intended for use by neurosurgeous to guide standard neurosurgical instruments.
The provided text is a 510(k) summary for the Frameless NeuroMate Stereotactic System. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study demonstrating the device meets specific performance acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this document.
Here's what can be gathered and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document does not provide specific quantitative acceptance criteria or corresponding performance data for the device itself. It primarily states that the device has "no substantive change in materials, basic components, or method of manufacture" compared to the predicate, and that the registration system is "similar to that currently used in other medical devices." It also mentions "commercially available imaging software for stereotactic planning, which has been developed, verified and validated to applicable standards, and guidance documents." These are general statements of compliance or similarity, not specific performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (retrospective or prospective, country of origin).
Explanation: No clinical or performance study with a test set is described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
Explanation: No test set or ground truth establishment is described.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
Explanation: No test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No.
- Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable.
Explanation: The document describes a medical device for surgical guidance, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study: No.
Explanation: The device is a stereotactic system intended for use by neurosurgeons to manually guide instruments. Its function inherently involves human interaction, and there's no mention of a standalone algorithm performance measurement.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable.
Explanation: Since no performance study is detailed, no ground truth is described.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable.
Explanation: The device involves "imaging software for stereotactic planning," which is stated to be "commercially available" and "developed, verified and validated to applicable standards." However, there is no mention of a separate "training set" or "algorithm training" in the context of this 510(k) submission. The focus is on the substantial equivalence of the overall system and its components.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable.
Explanation: As no training set or specific algorithm training is detailed in this document, the method for establishing its ground truth is not provided.
§ 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).