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The Mark 5000 Phased Array Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Mark 5000 Phased Array Shoulder Coil is designed for use with the Outlook (.23 Tesla) MRI scanner manufactured by Picker International. The indications for use are the same as for standard imaging: The Picker Outlook 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 NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Mark 5000 Phased Array 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 positioned on the patient's shoulder, by means of straps, during imaging.

The provided text describes the Mark 5000 Phased Array Shoulder Coil, a magnetic resonance imaging accessory. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like accuracy, sensitivity, or specificity.

The document is a "Summary of Safety and Effectiveness" submitted to the FDA for 510(k) clearance, which means the device is being compared to a legally marketed predicate device to establish substantial equivalence. The focus is on demonstrating that the new device is as safe and effective as existing devices, rather than establishing de novo performance criteria.

Therefore, many of the requested details cannot be extracted from this document. Here's a breakdown of what can and cannot be answered based on the provided text:

Acceptance Criteria and Device Performance

Explanation: The "acceptance criteria" here are largely implied by the comparison to predicate devices, focusing on design, safety features, and functional equivalence rather than specific quantitative performance metrics of image quality or diagnostic accuracy. The "reported device performance" are statements of its design and function that align with the predicates.

Study Details

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

   • Not provided. The document does not describe a clinical study with a test set of patient data. The safety and effectiveness are established through comparison to predicate devices and engineering design rationale.

2. 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 / Not provided. No specific test set with ground truth established by experts is mentioned. The ultimate interpretation of images for diagnosis is stated to be by a "trained physician," but this is for clinical use, not for a performance study of the device itself.

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

   • Not applicable / Not provided. No test set or adjudication process 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:

   • Not applicable. This device is an MRI accessory (a shoulder coil), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

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

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

   • Not applicable / Not provided. No ground truth data for a performance study is mentioned. The "ground truth" for this type of submission is essentially the proven safety and effectiveness of the existing predicate devices.

7. The sample size for the training set:

   • Not applicable / Not provided. This is not an AI device, so there is no "training set."

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

   • Not applicable / Not provided. As there is no training set, this question is not relevant.

Summary of what the document does provide:

• Intended Use and Indications for Use: Clearly stated, and are identical to routine MRI imaging.
• Device Description: Detailed information about the physical characteristics and components.
• Comparison to Predicate Devices: Extensive comparison of its features and safety aspects to previously cleared devices. This is the primary method of demonstrating safety and effectiveness in a 510(k) submission.
• Safety Features: Emphasizes that it is a receive-only coil, has decoupling to prevent RF burns, and incorporates a non-conductive housing.
• Regulatory Classification: Class II, procode 90 MOS.
• FDA Clearance: The device received 510(k) clearance based on substantial equivalence to predicate devices.

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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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The Movable Add-on Couch is designed to be used with the Outlook MRI system and in an X-Ray environment. The indications for use are the same as for standard MR imaging.

The Movable Add-on couch augments the patient handling capabilities of the Outlook MRI system. It interfaces directly with the Outlook patient couch.

The Movable Add-on Couch enables transfer of the patient together with the upper couch plate to and from a movable base directly into the Outlook patient handling system. This makes it possible to do MR imaging without having to lift patient from the supporting surface. The patient can be transported to other imaging modalities using the movable base.

The movable couch also has a radio-translucent upper part making it possible to do fluoroscopic examinations, e.g. with an X-Ray C-arm system, of the patient while on the couch.

The upper couch plate is made of sandwiched bakelite/PVC-foam material. The movable base has two parts; the X-Ray transparent part made of bakelite and the load-carrying parts and coMwrs made of aluminum.

The provided text describes a 510(k) pre-market notification for a medical device, the "Movable Add-on Couch for Outlook." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner typically seen for algorithmic software.

Therefore, the requested information elements related to an algorithm's performance study (such as sample size for test sets, expert consensus, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this submission. The submission is for a physical device, an MRI patient couch, and its evaluation relies on direct comparisons of physical specifications and intended use.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a patient couch, "acceptance criteria" are generally based on meeting specified physical and functional parameters, often compared to a predicate device. The submission presents a Substantial Equivalence Chart which effectively serves as the comparison against these parameters.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., demonstrating substantial equivalence) is the comparison presented in the "Substantial Equivalence Chart" itself. This is a direct comparison of physical and functional specifications between the Movable Add-on Couch for Outlook and its identified predicate devices:

• Outlook standard couch (K945827) for most physical dimensions, patient weight, and MR-related functions.
• NRF X-Ray Table (K944973) for the X-Ray Absorption parameter.

The narrative emphasizes that the Movable Add-on Couch "augments the patient handling capabilities of the Outlook MRI system" and has a "radio-translucent upper part" for X-ray examinations. The stated performance (e.g., length, width, max patient weight, X-ray absorption) is presented as meeting or being comparable to the predicate devices. The differences (portability, vertical movement, X-ray capability, handle width) are highlighted as enhancements or different features that do not raise new questions of safety or effectiveness.

Regarding the other requested information for algorithm performance, these are NOT APPLICABLE as the submission is for a physical device:

• 2. Sample size used for the test set and the data provenance: Not applicable. No test set of data (images, etc.) was used for an algorithm.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review of algorithm output was conducted.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No adjudication of algorithm output was conducted.
• 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 is not an AI/algorithm-enabled device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would refer to accurate measurements and engineering specifications, not clinical data for an algorithm.
• 8. The sample size for the training set: Not applicable. No algorithm training was performed.
• 9. How the ground truth for the training set was established: Not applicable. No algorithm training was performed.

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