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The "MICS INTERVENTION AID (MICS-MIA and MICS-MIAS)" is for use in conjunction with a Magnetic Resonance Scanner and the Machnet Bilateral Open Breast Coil to localize lesions in female breasts and perform needle biopsies accurately. For use by a trained physician.

The MR-Mammography Intervention Aid basically consists of a transparent acrylic plate containing about 600 puncture holes of 4 mm in diameter, held in a frame containing a set of MR fiduciary markers. The device can easily and firmly be attached to the Bilateral Open Breast Coil, thereby positioning and compressing the breast against a Breast Support Pad. The device comes with a (blue) Sliding Locator Plate for easy eyeretrieval of the software-established puncture hole, a detachable Fiduciary Marker Plate and sterilizable Needle Guide. The Mammography Intervention Aid comes with a PC-software package for supporting the calculation of the location and depth of puncturing. Information regarding the coordinates of a lesion and of the MR fiduciary markers should be retrieved from a relevant MR image and are input to the MICS software package. The software may calculate which hole to puncture through and how deep. A notebook PC with MIA Software Package installed is a system option

The provided document is a 510(k) summary for a medical device (MICS INTERVENTION AID) and does not contain the details of a study that directly proves the device meets specific acceptance criteria in the format requested.

The document states that the device is "substantially equivalent" to predicate devices and that "Testing was performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent." However, it does not provide:

• A table of acceptance criteria with reported device performance against those criteria.
• Details about sample size, data provenance, number/qualifications of experts, adjudication methods, or specific study types (MRMC, standalone).
• Information about training set size or how ground truth for the training set was established.

This 510(k) submission relies on demonstrating substantial equivalence to already legally marketed devices, rather than presenting a novel study with detailed acceptance criteria and performance metrics against those criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as that information is not present.

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The Machnet Bilateral Open Breast Coil, Catalog Number MICS-GSXX, is for use in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician.

The Machnet Bilateral Open Breast Coil is designed as a bilateral open breast coil which allows clinical imaging combined with very precise multiple localizations of breast lesions and subsequently small interventional breast procedures. Features: Dual channel phased array configuration. Allows bilateral and unilateral imaging of the breast and surrounding tissues. Minimal variation of contrast across images. The design allows adequate reception of signals from chest wall and axilla Ergonomic design minimizes motion artifacts. Open coil design allows virtually all sizes of breasts to be imaged. Breast support and positioning devices allow controlled positioning. High sensitivity allows thin slices. Interventional MRI possible with optional device (MICS-MIA). Accurate (2 to 3 mm) multiple computer-assisted localizations of breast lesions (with MICS-MIAS). Compatibility: GE Signa® (3X-LX) 1.5T, 1.0T, 0.5T MR scanners.

The provided text does not contain information about acceptance criteria or a study proving the device meets them in the way a typical AI/ML medical device submission would. This document is a 510(k) summary for a medical device (a breast coil for MRI) from 2002, which predates the widespread use of AI/ML in medical devices and the specific reporting requirements for such devices.

Instead, the document details the device's substantial equivalence to a predicate device based on design, function, and intended use. The "Testing information and Conclusion" section broadly states that "Testing was performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent." This is a general statement and does not provide specific acceptance criteria or details of a study with performance metrics, sample sizes, or ground truth establishment relevant to an AI/ML device.

Therefore, I cannot populate the requested table or answer the specific questions about AI/ML device study design from the provided text.

Based on the document, here's what can be extracted, acknowledging the absence of AI/ML specific information:

Acceptance Criteria and Device Performance (Not applicable for AI/ML criteria):

Specific Questions (Answers based on the provided text, indicating "Not Applicable" or "Not Provided" for AI/ML specific criteria):

1. A table of acceptance criteria and the reported device performance: See table above. It is important to note these are functional and equivalence criteria, not performance metrics for an AI/ML diagnostic output.

2. Sample size used for the test set and the data provenance: Not provided. The text mentions "Testing was performed according to internal company procedures," but gives no details on the sample size or provenance of data used in those tests. This would typically involve physical testing of the coil, not a dataset in the AI/ML sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device like an MRI coil, "ground truth" would relate to its physical properties (e.g., signal-to-noise ratio, image uniformity) rather than diagnostic interpretations of images requiring expert consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for diagnostic agreement on image interpretation, which is not described for the testing of this MRI coil.

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 document is for a non-AI medical device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a non-AI medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided, and likely not applicable in the AI/ML sense. The "ground truth" for a physical device would relate to engineering specifications and performance measurements.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of Carotid structures that can be interpreted by a trained physician. The Machnet Carotids Coil is designed to provide coverage of the carotid arteries and associated vasculature from the aortic arch through the Circle-of-Willis. Anatomic Regions: Head and Neck Vasculature. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The GE Signa system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon the density, spin lattice relaxation time Tl, spin-spin relaxation time T2) and (3) and (2) tissue. When interpreted by a trained physician, these images of the head and neck regions specifically the carotid arteries and association can be useful in the determination of a diagnosis.

The Carotids Coil Array Assembly is a receive only coil array which consists of a dual set of coils electrically connected to a quick disconnect box which interfaces the assembly to the MR scanner. Each half of the coil assembly consists of two overlapping coils to buck out the mutual inductance between the coils. Active decoupling is achieved by PIN diodes which turn the coils to a high impedance state at transmit time. A pair of fast switching crossed diodes is installed in each coil segment acting as passive switches detuning the coils to further improve the safety of the Carotids Coil Array Assembly. Each transmission line has so called "bazooka baluns" installed to minimize the outer braiding currents on the coaxial cables. Coil diameter have been chosen to optimize sensitivity at distances to about 35 mm from the coil surface while a sharp cutoff beyond 40 mm from the surface minimizes the noise from volumes outside the region of interest. This ensures maximum signal ratio from the region of the carotids arteries.

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

The provided document (K012491 510(k) Summary) does not explicitly detail the sample size or provenance of data used for testing. It generally states that "Testing was performed according to internal company procedures" and that "Test results support the conclusion that actual device performance satisfies the design intent." This suggests that the testing was likely conducted in-house by Machnet BV. Given the submission date of 2001, it is highly probable that the testing, if it involved patient data, was retrospective, but this is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The document mentions that images "can be interpreted by a trained physician," implying the eventual use by medical professionals, but it does not describe who established the ground truth for validating the device's performance during testing.

4. Adjudication method for the test set:

This information is not provided 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:

No. This document describes a medical device (a coil array for MRI) and its substantial equivalence to a predicate device, not an AI or algorithm-driven diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

No. This document concerns a physical medical device (an MRI coil), not a standalone algorithm.

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

The document does not explicitly state the type of ground truth used for testing. Given the nature of an MRI coil, "ground truth" would likely relate to image quality parameters such as signal-to-noise ratio, spatial resolution, and artifact levels, assessed against established benchmarks or comparative images from the predicate device. However, specifics are not provided beyond "Test results support the conclusion that actual device performance satisfies the design intent."

8. The sample size for the training set:

Not applicable. As this is a physical medical device (an MRI coil) and not an AI or machine learning algorithm, there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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