(82 days)
The Phased Array Neck Coil is designed to provide coverage of the neck, from the cerebellum to the upper thoracic spine region. The intended use is the same as for standard MR imaging.
The Phased Array Neck Coil is a phased array coil consisting of two coil elements. All = elements and associated circuitry are covered by ABS and polycarbonate enclosures.
The provided text describes a medical device, the Phased Array Neck Coil, and largely focuses on demonstrating its substantial equivalence to predicate devices rather than reporting on a specific study for meeting acceptance criteria.
Therefore, many of the requested sections about acceptance criteria, study design, ground truth, and expert involvement are not explicitly detailed in the provided text. The document is a "Summary of Safety and Effectiveness" which often serves as a regulatory submission (e.g., 510(k) in the US) to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This type of submission relies heavily on comparisons rather than de novo clinical trials with predefined acceptance criteria.
However, I can extract the information that is present and indicate where the requested information is not available in the given text.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, image quality scores) that the device must meet through a new study. Instead, it demonstrates substantial equivalence to predicate devices. The "performance" is implicitly tied to being the same or similar to the predicate device in key safety and engineering parameters.
| Parameter | Acceptance Criteria (Implicit from Predicate Device) | Reported Device Performance (Phased Array Neck Coil) |
|---|---|---|
| Enclosure Material | Polyurethane (Predicate: K945827 & K925987) | ABS and Polycarbonate |
| Coil Design | Two-channel receive-only phased array coil | Same |
| Decoupling | Active PIN diode decoupling | Same |
| Formation of Resonant Loops | The length of the cable and its stiffness does not permit looping. | Same |
| Potential for RF burns | Does not transmit RF power. | Same |
| Coil elements and associated circuitry encased in non-conductive material. | Same | |
| Decoupling isolates the coil elements from transmitted RF. | Same | |
| Radio Frequency Absorption | Power deposition during imaging is limited by the SAR algorithm. | Same |
| Indications for Use | Head and cervical spine (Predicate: K945827 & K925987) | Neck, from the cerebellum to the upper thoracic spine region. |
| Intended Use | Same as the Picker International, Inc. Outlook system's general NMR imaging purpose for diagnostic information when interpreted by a trained physician. | Same |
Note: The "Acceptance Criteria" column above is inferred from the characteristics of the predicate devices. The "Reported Device Performance" column shows how the Phased Array Neck Coil compares to these predicate characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" or specific patient data used for evaluating the Phased Array Neck Coil's performance against predefined acceptance criteria. The evaluation is a comparison against predicate device specifications and intended use. Therefore, information on sample size, data provenance, retrospective/prospective, or country of origin is not provided.
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. The document does not describe a study involving a test set that required ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring 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 applicable. The document describes an MRI coil, not an AI device or software, and therefore no MRMC study or AI-assisted improvement effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an MRI hardware component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No specific ground truth for performance evaluation of the new device is described, as the submission focuses on substantial equivalence to predicate devices based on design and safety characteristics.
8. The sample size for the training set
Not applicable. As a hardware device, there is no "training set" in the context of an algorithm or AI.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned for this device.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.