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510(k) Data Aggregation
(51 days)
The Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and adjacent regions in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Shoulder Coil is designed for use with the Rhapsody (1.0Tesla) MRI scanner manufactured by Siemens Medical Systems Inc.
The Shoulder 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 provided text is a 510(k) summary for a Magnetic Resonance Imaging (MRI) Shoulder Coil. It does not describe a study involving "acceptance criteria" and "reported device performance" in the way one would for a new AI/software device that needs performance metrics like sensitivity, specificity, etc. This document is a premarket notification for a physical medical device (an MRI coil) based on substantial equivalence to predicate devices, not a study proving effectiveness with specific performance criteria against a ground truth.
Therefore, many of the requested fields are not applicable to this type of submission. However, I will extract the relevant comparative information provided.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence for a physical medical device (MRI coil), there are no explicit "acceptance criteria" in terms of performance metrics commonly associated with AI/software devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the features and intended use being similar or identical to legally marketed predicate devices. The "reported device performance" is the assertion of these similarities.
| Feature / Criteria (Implied) | Reported Device "Performance" (Comparison to Predicate) |
|---|---|
| Intended Use | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Indications for Use | Identical to routine MRI imaging; Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Coil Enclosure Material | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Coil Design | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Decoupling | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Prevention of RF Burns | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Radio Frequency Absorption | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Formation of Resonant Loop | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study with a "test set" of data in the context of an AI/software device. The submission focuses on technical and functional equivalence to predicate devices.
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. No "ground truth" derived from expert consensus on a test set (e.g., image annotations) is discussed for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 device is an MRI coil, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate devices, and the demonstration that the new device shares similar characteristics and intended use.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an AI/software device.
9. How the ground truth for the training set was established
Not applicable.
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