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The indications for use of the Guideline System 3000 MP-1 Micropositioner are for procedures where a precise placement of probes, such as those used for electrophysiological recording and stimulation, lesioning, or chronic stimulation within the nervous system is required.

The MP-1 Micropositioner is a three-axis positioning device for precise manipulation of probes or electrodes in stereotactic neurosurgical procedures. The "x" and "y" axes are driven by simple micrometer screws, while the "z" or depth axis is driven by a motorized lead-screw arrangement. The positioner allows for the accurate placement of probes within the three dimensional stereotactic space once it has been mounted on a legally marketed stereotactic frame.

The provided text describes the Guideline System 3000 MP-1 Micropositioner, a device for precise manipulation of probes in neurosurgical procedures. However, the document does not contain explicit acceptance criteria in a quantitative table or a detailed study proving the device meets specific performance metrics in the way a modern AI/device study would.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This regulatory approach, common for medical devices cleared through the 510(k) pathway, means that the device is deemed safe and effective if it has the same intended use and technological characteristics as a legally marketed predicate device, or if any differences do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, addressing the requested information points where possible, and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, a detailed table of quantitative acceptance criteria and specific reported device performance meeting those criteria, as one would expect for an AI algorithm's performance, is NOT available.

The document states: "The Guideline System 3000 MP-1 Micropositioner has been demonstrated to perform as intended with accuracy and repeatability. In accordance with our development plan, the Guideline System MP-1 Micropositioner has been extensively tested in both bench test and animal test conditions. Prototype instruments meet or exceed all appropriate Feature and Engineering Specifications and tolerances."

This general statement indicates that internal specifications and tolerances were met, but the specific numerical acceptance criteria (e.g., "accuracy of X mm with a standard deviation of Y mm") and the corresponding measured performance values are not disclosed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text mentions "extensively tested in both bench test and animal test conditions," but no specific sample sizes for these tests are given, nor is the data provenance (e.g., country of origin, retrospective/prospective nature) detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable / not provided. This device is a mechanical instrument, not an AI diagnostic tool that requires ground truth established by human experts for interpretive tasks.

4. Adjudication Method for the Test Set

This information is not applicable / not provided. As above, this device's performance testing would not involve expert adjudication in the context of diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic AI tools where the goal is to evaluate if AI assistance improves human reader performance (e.g., in medical image interpretation). The MP-1 Micropositioner is a mechanical surgical instrument, not a diagnostic tool requiring human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

This question is not applicable in the context of this mechanical device. The performance of the MP-1 Micropositioner would be evaluated on its own mechanical precision and repeatability, not as an algorithm operating independently of human interaction. The "performance data" section states it "has been demonstrated to perform as intended with accuracy and repeatability," implying intrinsic device performance, but not in the sense of a standalone AI algorithm.

7. The Type of Ground Truth Used

For a mechanical device like the MP-1 Micropositioner, "ground truth" would refer to its physical measurements against a known standard or ideal. The document implies that testing involved:

• Bench test conditions: This likely involved measuring the device's movement and positioning accuracy against calibrated standards.
• Animal test conditions: This would involve using the device in a biological setting (animals) and likely assessing its ability to accurately place probes to specific anatomical targets.

The specific "type of ground truth" (e.g., specific measurement techniques, histological confirmation in animal studies) is not detailed in the provided text.

8. The Sample Size for the Training Set

This information is not applicable. The MP-1 Micropositioner is a mechanical device, not an AI system that undergoes "training" with a dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As it's not an AI system, there is no training set or ground truth in that context.

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To record from and stimulate brain motor and sensory neurons to aid in the placement of depih electrodes.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "Guideline System 3000" (GS3000). This document grants market clearance based on substantial equivalence to a predicate device and deals with regulatory aspects rather than detailed performance study reports.

Therefore, the document does not contain the acceptance criteria or the study details you are asking for. It does not describe:

• Acceptance criteria and reported device performance in a table.
• Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
• Whether MRMC studies were done, or their effect sizes.
• Whether standalone performance was evaluated.
• The type of ground truth used.
• The sample size or ground truth establishment for a training set.

The document's purpose is to inform Axon Instruments, Inc. that their device is substantially equivalent to a legally marketed predicate device, allowing them to market it subject to general controls. It does not include the detailed technical or clinical study data that would typically be found in a Premarket Approval (PMA) application or a more comprehensive summary of safety and effectiveness data for a 510(k).

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The MM-1 provides useful, quantitative measurements of several neurologically relevant movement phenomena: tremor, dexterity and reaction/movement time. The MM-1 can be useful in the diagnosis of certain movement disorders, such as essential tremor and tremor in Parkinson's disease.

Movement Monitor (MM-1)

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria, study details, and performance of the Movement Monitor (MM-1).

The document is a 510(k) clearance letter from the FDA, which indicates that the device has been found substantially equivalent to a predicate device. It defines the device's indications for use but does not include the specific study data, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment details you are looking for. These details are typically found in the 510(k) summary or the full 510(k) submission, which is not provided here.

Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria.

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