Search Results

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.

Ask a specific question about this device

The NOMOS TALON Positioning and Immobilization System is intended to provide an invasive means to repeatedly position and immobilize a patient during:

• a) diagnostic procedures in preparation for radiation therapy (RT) treatments of the head or head and neck, and
• b) during treatment procedures in the radiation therapy suite.

The NOMOS TALON Positioning and Immobilization System is intended to provide an invasive means to repeatedly position and immobilize a patient during diagnostic procedures in preparation for radiation therapy (RT) treatments of the head or head and neck, and during treatment procedures in the radiation therapy suite. Major components include the TALON Skull Mount, NOMOGrip, Target Box, CT Reference Pointer, Radiotherapy Table Adapter, and CT Head Support.

The provided text describes the NOMOS TALON Positioning and Immobilization System and its claim of substantial equivalence to predicate devices. However, it does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or details about sample sizes, ground truth establishment, or expert involvement for performance evaluation.

Therefore, I cannot populate the requested table and answer many of the questions based on the provided text.

Here's an assessment based on the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not mentioned in the document.
• Data Provenance: Not mentioned in the document. The document refers to predicate devices and their existing marketing status but gives no details about new testing data for the TALON system.

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)

• Not mentioned in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not mentioned in the document.

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. This device is a physical positioning and immobilization system, not an AI or imaging interpretation tool. There is no mention of such a study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not mentioned in the document. The document relies on similarity comparisons to predicate devices rather than direct performance testing against a defined ground truth for the TALON system itself.

8. The sample size for the training set

• Not applicable. This device is a physical system, not a machine learning model that would have a "training set."

9. How the ground truth for the training set was established

• Not applicable. See point 8.

Ask a specific question about this device

The Cosgrove Depth Electrode Kit (CDEK) allows the user to place and secure epilepsy electrodes via a lateral orthogonal surgical approach or stereotactically using Radionics CRW and BRW Stereotactic Arc Systems which have been cleared through the FDA.

The CDEK Cosgrove Depth Electrode Kit addressed in this premarket notification has similar intended use and technological characteristics as accessories provided in the commercially available Radionics Todd-Wells Stereotaxic Guide (a pre-amendment device), the Radionics CRW and BRW Stereotactic Arc Systems, and Radionics Bipolar Forceps (a pre-amendment device).

The provided text describes a medical device, the Cosgrove Depth Electrode Kit (CDEK), and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way you've outlined for an AI/CAD system.

The document is a "Summary of Safety and Effectiveness" for a traditional medical device (a kit for electrode placement), focusing on its substantial equivalence to predicate devices and general safety instructions. It doesn't involve performance metrics like sensitivity, specificity, or reader studies that would be typical for an AI-powered diagnostic device.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided input. The document discusses regulatory aspects and device characteristics, not performance evaluation data as would be generated for a software or AI-driven system.

Ask a specific question about this device

ACCISS is to be used both for quidance and localization in open craniotomies and for surgeries which are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies and electrode implants. The system may also be used to review medical images in a neurosurgical context.

The Mayfield-ACCISSTM Workstation is a computer-based system designed for use in the OR. It has a compact design, sterilizable keyboard cover and electrical isolation for patient safety. Completely self-contained on a cart, the system transfers easily between OR and offices for use not only as a clinical tool but as a desk-top based clinical research tool and image-review workstation as well. A simple yet direct user interface screen with easy-to understand graphics displays the images.

The Mayfield-ACCISSTM Workstation is intended to correlate a patient's preoperative Computed Tomography (CT) and/or Magnetic Resonance (MRI) data with a patient's anatomy to assist in planning and performing surgery. The system is composed of a medical imaging workstation and position-sensing articulated arm with a probe that acts as a localizing device. The workstation computer is loaded with the patient's CT or MRI data. The image data set is correlated to the patient on the OR table by physically matching points such as scanned fiducial markers, anatomical features or surface points with corresponding points on the imaged data set. After the correlation, the indication of the probe orientation appears on the screen and moves through the CT or MRI data in correct relation to the probe as manipulated by the surgeon.

The Mayfield-ACCISSTM Workstation consists of the following" :

• A. Workstation
• B. Software
• C. Probe Assembly
• D. Pelorus Stereotactic System

The provided text does not contain detailed information on acceptance criteria for device performance or a specific study proving the device meets those criteria. The document is a 510(k) summary for the Mayfield-ACCISS Workstation, primarily focusing on demonstrating substantial equivalence to predicate devices.

However, based on the information provided, here's a breakdown of what can be extracted and what is missing:

Description of the Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided document (a 510(k) summary for the Mayfield-ACCISS Workstation) does not explicitly state specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" of the Mayfield-ACCISS Workstation to previously cleared predicate devices. This typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness as compared to the predicate devices. This process does not usually involve presenting a separate, dedicated performance study with specific quantitative acceptance criteria in the same way a clinical trial or a performance validation study for a novel device would.

Instead, the submission states:

• "The indications for the Mayfield-ACCISSTM Workstation are the same as those for the predicate stereotactic devices."
• "The design of the Mayfield-ACCISS™ Workstation is similar in concept to the predicate stereotactic devices."
• "The materials used in the manufacture of the hardware components of the Mayfield-ACCISSTM Workstation are similar to those used in the predicate devices."
• "The manufacturing processes used in the Mayfield-ACCISS TM Workstation are similar to those used in the manufacture of predicate stereotactic devices."
• "The specifications of the Mayfield-ACCISSTM Workstation are similar to those of the predicate stereotactic device."
• "NOMOS thus considers the Mayfield-ACCISSTM Workstation substantially equivalent to the predicate devices."

The "performance" of the device, in the context of this document, is implicitly demonstrated by its similarity to predicate devices that have already been deemed safe and effective. There are no specific quantitative metrics or thresholds mentioned for accuracy, precision, or other performance characteristics of the surgical planning or guidance system itself in this summary.

Based on the provided text, the following information is either not available or cannot be fully answered:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in quantitative terms. The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to predicate devices.
• Reported Device Performance: Not detailed in quantitative metrics. The document asserts that "The specifications of the Mayfield-ACCISSTM Workstation are similar to those of the predicate stereotactic device." but does not provide those specifications or performance results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. No specific test set or study involving patient data is described as part of this 510(k) summary.

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)

• Not applicable. No ground truth establishment process for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set adjudication 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 performed or reported in this document. The device is a "computer-based stereotactic surgical planning system," not an AI-based diagnostic tool requiring MRMC studies for human reader performance improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not performed or reported in this document in the context of performance metrics. The device is described as a system that assists surgeons in planning and performing surgery, implying a human-in-the-loop operation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable. No ground truth for a performance study is described.

8. The sample size for the training set

• Not applicable. The document describes a "computer-based stereotactic surgical planning system" but does not mention any machine learning or AI components that would require a "training set" in the modern sense.

9. How the ground truth for the training set was established

• Not applicable. (See #8)

Ask a specific question about this device