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The Flexible Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the thoracic and lumbar spine in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Matrix 3000 Flexible Spine Coil is designed for use with the Outlook (0.23Tesla) MRI scanner manufactured by Picker International Inc.

The Flexible Spine Coil consists of two volume RF coil elements in a quadrature design. The elements and associated circuitry are enclosed in a flexible vinyl enclosure housing. The coil is wrapped around the patient and the ends are connected and locked. The coil has a fixed circumference.

The provided document is a 510(k) Premarket Notification Summary for a Magnetic Resonance Imaging Accessory, specifically the "Matrix 3000 Flexible Spine Coil." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets novel acceptance criteria through a clinical study. Therefore, the information requested about acceptance criteria and a study proving those criteria are met is largely not applicable in the context of this specific document.

This document describes the device, its intended use, and then compares its features, safety, and effectiveness to legally marketed predicate devices. The "study" here is essentially the comparative analysis presented in Section 9, demonstrating that the Matrix 3000 Flexible Spine Coil is as safe and effective as its predicate devices, or at least does not raise new questions of safety and effectiveness.

Here's a breakdown based on the provided text, highlighting what's present and what's absent due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there isn't a table of explicitly defined quantitative "acceptance criteria" for performance that a new clinical study would aim to meet. Instead, the "performance" is demonstrated by showing that the new device's characteristics are similar to or better than the predicate devices, particularly in terms of safety.

The table in Section 9, titled "Safety and Effectiveness," is the closest equivalent, though it compares characteristics rather than presenting criteria and measured performance.

Regarding a "study" that proves the device meets acceptance criteria:

The document does not describe a specific clinical study or performance trial of the Matrix 3000 Flexible Spine Coil against quantitative acceptance criteria for image quality or diagnostic accuracy. Instead, it relies on substantial equivalence to existing, legally marketed devices.

The "study" in this context is the comparison and argumentation for equivalency presented in Section 9 based on the design, function, and safety features shared with or made analogous to the predicate devices. This is a common pathway for Class II medical devices that do not introduce new technology or raise new safety/effectiveness concerns.

Specific Questions:

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

   • Not applicable / Not disclosed. This document does not describe a test set or data from a clinical performance study. The evaluation is based on design comparison and known characteristics of MRI coils and the predicate devices.

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

   • Not applicable / Not disclosed. No "ground truth" establishment for a test set is described.

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

   • Not applicable / None. No adjudication method for a test set is described.

4. 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 is for an MRI coil, not an AI-assisted diagnostic tool.

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

   • No. This is for a hardware device (an MRI coil), not a software algorithm.

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

   • Not applicable / Not described. No ground truth for a clinical dataset is mentioned. The "ground truth" for the submission is the regulatory acceptance of the predicate devices.

7. The sample size for the training set:

   • Not applicable / Not disclosed. There's no mention of a training set as this is not an AI/algorithm submission.

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

   • Not applicable / Not described. As above, no training set or ground truth for one is discussed.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for an MRI coil. It compares the safety and efficacy characteristics of the new device to already-approved predicate devices. It does not contain information about a clinical performance study with specific acceptance criteria, test sets, or ground truth establishment that would typically be found in an efficacy study for a novel diagnostic device or algorithm.

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