(93 days)
The Contour Shoulder is intended for use with Siemens 0.55T MR systems to produce diagnostic images of shoulder anatomy that can be interpreted by a trained physician.
The Contour Shoulder is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRJ) using the Siemens 0.55T MR systems. The Contour Shoulder is intended to be used for imaging Shoulder anatomy. The Contour Shoulder is a reusable, non-invasive device with regard to duration of contact with the body. The central coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and has been tested for biocompatibility. The flexible wing coll elements are encapsulated in polycarbonate and aramid felt which is fire-rated, has impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.
The provided text describes a 510(k) premarket notification for a medical device called "Contour Shoulder." This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance because the document does not present them in that manner. The information available is high-level and focused on general performance and safety.
However, I can extract the available information regarding the "study" that supports the device:
Study Information Pertaining to Contour Shoulder (K233656):
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit/General):
- Signal-to-noise ratio (SNR) and image uniformity (per NEMA MS-9 and MS-6 methods) meet pre-determined acceptance criteria. (The specific numerical criteria are not provided).
- Produce diagnostic quality images of shoulder anatomy.
- Electrical safety and electromagnetic compatibility (per IEC standards).
- Performance is "as well as or better than the predicate device."
- Reported Device Performance:
- SNR and image uniformity were measured and analyzed according to NEMA standards. (The specific numerical results are not provided).
- Clinical images from volunteer scanning demonstrated that the Contour Shoulder produces diagnostic quality images of the intended anatomy.
- Electrical safety and electromagnetic compatibility data support the safety of the device.
- Bench testing and clinical images demonstrate performance and effectiveness.
- Acceptance Criteria (Implicit/General):
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: "volunteer scanning" is mentioned for clinical images. The exact number of volunteers is not specified.
- Data Provenance: The study involved acquiring clinical images from a Siemens 0.55T MR system. The country of origin is not explicitly stated, but the company (Quality Electrodynamics) is based in Mayfield Heights, Ohio, United States. The images were obtained from "volunteer scanning," implying a prospective collection for the purpose of this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states that the images "can be interpreted by a trained physician."
- The number of experts involved in assessing diagnostic quality for the clinical images is not specified.
- The qualifications are generally stated as "trained physician," with no further specifics (e.g., years of experience, subspecialty).
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Adjudication method for the test set:
- The document does not specify any adjudication method. It only mentions that images can be interpreted by a trained physician.
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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, an MRMC comparative effectiveness study was not done. This device is a hardware component (a coil for an MRI system), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is a hardware device (an MR coil), not an algorithm. Therefore, no standalone algorithm-only performance was assessed.
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The type of ground truth used:
- For the clinical images, the ground truth was based on the ability of the images to be "interpreted by a trained physician" to demonstrate "diagnostic quality images of shoulder anatomy." This implies expert interpretation/consensus as the ground truth for image diagnosticity. No pathology or outcomes data are mentioned.
- For the technical performance (SNR, uniformity, electrical safety), the ground truth was based on bench testing against NEMA and IEC standards.
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The sample size for the training set:
- This is a passive imaging device (MR coil) and not an AI/machine learning algorithm that requires a training set. Therefore, no training set was used or is applicable.
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How the ground truth for the training set was established:
- As there is no training set, this question is not applicable.
§ 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.