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510(k) Data Aggregation
(60 days)
Contour Knee
The Contour Knee is intended for use with Siemens 0.55T MR systems to produce diagnostic images of knee anatomy that can be interpreted by a trained physician.
The Contour Knee is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 0.55T MR systems. The Contour Knee is intended to be used for imaging knee anatomy.
The document K223429 outlines the Contour Knee, a 12-channel phased array coil designed for magnetic resonance imaging (MRI) of knee anatomy using Siemens 0.55T MR systems.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Signal-to-Noise Ratio (SNR) | Conform to predetermined acceptance criteria (specific quantitative criteria not provided in the document, but implicitly met for diagnostic quality). Method: NEMA MS-9 (using alternate method 2.5 from MS-6). | The SNR of the Contour Knee was measured and found to conform to predetermined acceptance criteria, implicitly demonstrating adequate signal quality for diagnostic purposes. |
| Image Uniformity | Conform to predetermined acceptance criteria (specific quantitative criteria not provided in the document, but implicitly met for diagnostic quality). Method: NEMA MS-9 (primary method from MS-6). | The uniformity of the Contour Knee was measured and found to conform to predetermined acceptance criteria, implicitly demonstrating consistent image quality across the scanned area for diagnostic purposes. |
| Diagnostic Image Quality | The Contour Knee must produce diagnostic quality images of the intended knee anatomy that can be interpreted by a trained physician. | Clinical images from volunteer scanning of knee anatomy were obtained from a Siemens 0.55T MR system. These images were used to demonstrate that the Contour Knee produces diagnostic quality images of the intended anatomy. The images were presumably interpreted by trained physicians (implied by the "intended for use" statement in the Indications for Use). No adverse events were reported or recorded during this testing. |
| Electrical Safety | Compliance with relevant electrical safety standards. | Electrical safety data support the safety of the Contour Knee. Bench testing was performed per IEC standards, demonstrating compliance. |
| Electromagnetic Compatibility (EMC) | Compliance with relevant EMC standards. | Electromagnetic compatibility data support the safety of the Contour Knee. Bench testing was performed, demonstrating compliance. |
| Comparison to Predicate Device | The Contour Knee performs as well as or better than the predicate device (Contour 24). | The testing performed (bench testing and diagnostic quality sample clinical images) demonstrates that the Contour Knee performs as well as or better than the predicate device. This is based on the technical changes and the successful fulfillment of functional and performance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "clinical images from volunteer scanning of knee anatomy were obtained."
- Sample Size: Not explicitly stated for the "volunteer scanning." It refers to "sample clinical images," implying a limited but representative set, rather than a large cohort. It does not provide specific numbers of volunteers or images.
- Data Provenance: The data was obtained from "a Siemens 0.55T MR system." The country of origin is not specified but is implied to be where Quality Electrodynamics, LLC conducts its testing. The data is prospective in nature, as it involves active "volunteer scanning" with the device for the purpose of demonstrating diagnostic quality.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The indication for use states that the images "can be interpreted by a trained physician." This implies that the images demonstrating diagnostic quality were assessed by at least one, and likely more, trained physicians. No specific specialties (e.g., radiologist) or years of experience are provided, but "trained physician" is a general qualification required for interpreting medical images.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The assessment of diagnostic quality appears to be based on the general ability of the images to be interpreted by a trained physician, rather than a multi-reader consensus process.
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
- No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was reported or indicated.
- The Contour Knee is a hardware device (an MRI coil) and not an AI/software device. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable to this product. The study focused on the coil's ability to produce diagnostic quality images compared to a predicate device, not on diagnostic accuracy improvements for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No standalone (algorithm-only) performance was done.
- As noted above, this is an MRI coil, not an algorithm or AI. Its performance is inherent in the quality of the raw images it produces.
7. The Type of Ground Truth Used
The ground truth for the device's performance was established via:
- Bench Testing: For SNR, uniformity, electrical safety, and EMC, the ground truth was based on objective measurements against established engineering standards (NEMA MS-9, IEC standards).
- Expert Interpretation: For diagnostic image quality, the ground truth was based on the ability of "trained physicians" to interpret the images of knee anatomy, implying a subjective assessment of diagnostic interpretability by medical professionals. This is a form of expert consensus/opinion, though a formal consensus process is not detailed. There is no mention of pathology or outcomes data being used as ground truth.
8. The Sample Size for the Training Set
No information about a "training set" is provided. Since this is an MRI coil and not an AI or machine learning algorithm, the concept of a training set is not applicable. The device's design and engineering would be based on physical principles, not data-driven training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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