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510(k) Data Aggregation
(154 days)
FLEXIBLE PHASED ARRAY SPINE COIL
The Flexible Phased Array Spine Coil is designed to provide coverage of the thoracic and lumbar spinal regions of the body. The indications for use are the same as for standard MR imaging.
The Flexible Phased Array Spine Coil is a phased array coil package consisting of a solenoid and a saddle coil element. All elements and associated circuitry are enclosed in a flexible vinyl enclosure.
The patient is wrapped with the coil allowing for ease of patient positioning. The coil has a fixed circumference and attaches by snapping the ends together.
This document describes a medical device called the "Flexible Phased Array Spine Coil," a Class II Magnetic Resonance (MR) Imaging System component. The submission is a "Summary of Safety and Effectiveness" (K960497) from 1996, which is typically a premarket notification 510(k). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the modern sense.
Therefore, the requested information about acceptance criteria and a study proving device performance as understood in a contemporary context (e.g., AI/software performance) is not directly applicable to this document. This document, being from 1996 for an MRI coil, relies on comparing its physical and functional characteristics to a predicate device to establish safety and effectiveness.
Here's an analysis based on the provided text, highlighting why many of the requested points cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance:
There are no explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy mentioned in this document. The submission focuses on demonstrating substantial equivalence to a predicate device by comparing design and safety parameters.
| Parameter | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Flexible Spine Coil) |
|---|---|---|
| Coil Enclosure Material | Must be comparable to predicate's material for safety/functionality. | Vinyl fabric (Same as material used in Picker Extended Coverage Head Coil (K893619)) |
| Coil Design | Must be comparable to predicate's design for intended use. | Two-channel receive-only phased array coil (Predicate: Outlook Body Coil is a receive-only phased array coil (K945827)) |
| Decoupling | Must provide equivalent RF isolation. | Active PIN diode decoupling (Same as Body Coil for Outlook (K945827)) |
| Formation of Resonant Loops | Must prevent dangerous looping. | The length of the cable and its stiffness does not permit looping. (Predicate: N/A - implies lack of issue) |
| Potential for RF burns | Must minimize RF burn risk. | Does not transmit RF power. Coil elements and associated circuitry encased in non-conductive material. Decoupling isolates the coil elements from transmitted RF. (Same as other Outlook Coils (K945827)) |
| Radio Frequency Absorption | Must limit power deposition to safe levels. | Power deposition during imaging is limited by the SAR algorithm. (Algorithm used on Outlook system (K945827)) |
| Intended Use | Must align with predicate's intended use. | Thoracic and Lumbar spine regions. (Predicate: Body Coil for Outlook (K945827)) |
| Indications for Use | Must align with predicate's indications for use. | Same as for standard MR imaging. (Predicate: Body Coil for Outlook (K945827)) |
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 evaluating diagnostic performance on a dataset of images. It's a submission for an MRI coil. There is no "test set" of patient data in the context of diagnostic performance evaluation. The data provenance would relate to the manufacturing and testing of the physical coil components, not patient data for algorithm evaluation.
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 for a test set is established as this is a physical device, not an AI/software algorithm evaluated on diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set requiring adjudication in the context of diagnostic interpretation.
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 or software component. There is no human reader interaction with an "AI" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a passive receive-only coil; it does not perform any "algorithm-only" functions in the diagnostic sense. The SAR algorithm mentioned is part of the MRI system, not the coil itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. There is no diagnostic ground truth established for this device, as it is a component designed to acquire MR images, not interpret them. The ground truth, if one could apply the term, would be in engineering specifications and safety testing confirming the coil meets its intended design and safety standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. No training set is involved.
In summary: The provided document is a 510(k) summary for a physical medical device (an MRI coil) from 1996. The submission's primary goal is to demonstrate substantial equivalence to a previously cleared predicate device, focusing on material, design, safety features, and intended use. It does not involve performance evaluation against specific diagnostic acceptance criteria, multi-reader studies, or AI/ML training concepts, which are more relevant to contemporary software or AI-enabled device submissions.
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