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The Insight 7000 Phased Array Torso Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the torso region (chest, abdomen and hips anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Insight 7000 Phased Array Torso Coil is designed for use with the Esteem 1.5T MRI scanner manufactured by Elscint MR.

The Insight 7000 Phased Array Torso Coil is designed to provide Magnetic Resonance Images of the torso region. The Insight 7000 Phased Array Torso Coil is designed for use with the Elscint MR's Esteem 1.5T scanner.

Anatomic Regions: Torso Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The Esteem 1.5T 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 Insight 7000 Phased Array Torso Coil is a four loop receive-only coil. The coil consists of two sections: an upper and lower section, which are positioned above and below the patient torso respectively. The bottom section, which contains two loop coils and the accessory coil electronics, is enclosed in a vacuum formed housing which is covered with a foam pad. The housing and foam pad is entirely covered by a cover made of Naughahyde and Cordura Plus® ( fabric material). The upper section, which contains two upper loop coils, is covered by a jacket made of identical materials as the bottom section.

The provided document is a 510(k) premarket notification for a Medical Resonance Imaging Accessory, specifically the Insight 7000 Phased Array Torso Coil. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's standalone efficacy or conducting extensive clinical trials as might be seen for novel technologies.

Therefore, the study conducted is primarily a comparison of the new device's parameters and performance characteristics against a predicate device to establish that it is "substantially equivalent" in terms of safety and effectiveness for its intended use.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy for a diagnostic algorithm). Instead, the "acceptance criteria" can be inferred as "same as predicate device" across various functional and safety parameters. The reported device performance is presented as the characteristics of the Insight 7000 Phased Array Torso Coil itself.

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

The document does not mention a specific 'test set' with patient data or images in the context of a clinical performance evaluation. The substantial equivalence is based on engineering design, material specifications, and fundamental operating principles when compared to the predicate device. Therefore, details like sample size, country of origin, or retrospective/prospective nature of data are not applicable in this 510(k) summary as no such clinical testing is described for performance evaluation.

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

Not applicable, as no clinical test set requiring expert ground truth establishment is described in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication is described.

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 (assessing human reader improvement with AI assistance) is not relevant for an MRI accessory like a coil, which is a hardware component and not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only) Performance Study was done

No, a standalone performance study in the context of an algorithm's performance was not done. The device is an MRI accessory (a coil), not a software algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" here is the established safety and performance characteristics of the predicate device, against which the new device's engineering and functional parameters are compared for substantial equivalence. There is no clinical "ground truth" (e.g., pathology, outcomes data) as this is not a diagnostic algorithm.

8. The Sample Size for the Training Set

Not applicable, as this is a hardware device (MRI coil), not an algorithm that requires a training set.

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

Not applicable, as this is a hardware device.

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The Quadrature Extremity Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the elbow anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Extremity Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.

The Quadrature Extremity Coil consists of two volume RF coil elements in a quadrature design. The elements and circuitry are enclosed in a durable covering made of vinyl naughahyde which is fire rated.

The provided text describes a Magnetic Resonance Imaging Accessory, specifically the Maxim 7000 Quadrature Extremity Coil, and compares its safety and effectiveness to predicate devices. However, the document does not contain information about acceptance criteria, device performance metrics, or a study design to prove these criteria.

Therefore, I cannot fulfill the request as the necessary information is absent in the provided text. The document focuses on comparing the design and features of the new device to previously cleared devices (predicates) to establish substantial equivalence for regulatory purposes, rather than detailing specific performance criteria or a study that rigorously tests against them.

Here's why I cannot provide the requested information based on the input:

• No Acceptance Criteria or Reported Performance: The document lists various design and safety features but does not define quantitative acceptance criteria for image quality, diagnostic accuracy, signal-to-noise ratio, or any other performance metric. Consequently, there are no "reported device performance" figures to populate against such criteria.
• No Study Description: There is no mention of a clinical trial, technical validation study, or any other type of study that would involve a test set, expert readers, ground truth establishment, or statistical analysis.
  • Sample Size (Test Set/Training Set): No sample sizes are provided for any dataset.
  • Data Provenance: No information about the origin of data (if any were used for testing) is present.
  • Number of Experts/Qualifications: No experts are mentioned as being involved in assessing performance or establishing ground truth.
  • Adjudication Method: Not applicable as no assessment is described.
  • MRMC Comparative Effectiveness Study: Not mentioned.
  • Standalone Performance: Not mentioned.
  • Type of Ground Truth: Not applicable as no ground truth is established or used.
  • Training Set Sample Size/Ground Truth: Not applicable.

The provided text is a summary of safety and effectiveness, which, in the context of a 510(k) submission, primarily focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and fundamental operating principles, rather than presenting a detailed performance study with quantitative results against specific criteria.

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