(21 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular system that can be interpreted by a trained physician.
Model CAC-127-8 Cardiac Array Coil
Here's an analysis of the provided text regarding acceptance criteria and study information:
Based on the provided text, it is a 510(k) clearance letter for a medical device: Model CAC-127-8 Cardiac Array Coil. This document is a regulatory clearance and does not contain the detailed study information typically found in a clinical study report or a scientific publication.
Therefore, most of the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific study designs (MRMC, standalone) cannot be extracted from this 510(k) clearance letter.
The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices. This substantial equivalence is based on the device's technical characteristics and performance being similar to existing devices, implying that it meets the same safety and effectiveness standards. However, the specific details of how that performance was proven are not included.
Here's what can be inferred or directly stated from the document, along with what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in this document. A 510(k) clearance letter does not detail specific acceptance criteria or quantitative performance metrics. It confirms that the device has been reviewed and found substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance
Not available in this document. The letter does not describe any specific test set or the characteristics of the data used for performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not available in this document. The letter does not mention ground truth establishment or the involvement of experts in a testing phase.
4. Adjudication Method
Not available in this document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not available in this document. The letter does not discuss MRMC studies or the effect size of human readers with/without AI assistance. Given the device is a cardiac array coil (a hardware component for an MRI scanner), it's highly unlikely that an MRMC study for AI assistance would be relevant or performed for this specific device.
6. If a Standalone Performance Study Was Done
Not available in this document. The letter does not provide details of any standalone performance study. For a hardware component, standalone performance would likely relate to signal-to-noise ratio, homogeneity, artifact levels, etc., which are not detailed here.
7. The Type of Ground Truth Used
Not available in this document.
8. The Sample Size for the Training Set
Not available in this document. This device is a hardware component and not an AI/ML algorithm that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not available in this document. (Not applicable for this type of device and document)
Summary of what is known from the document:
- Device Name: Model CAC-127-8 Cardiac Array Coil
- Intended Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular system that can be interpreted by a trained physician."
- Regulatory Status: Substantially Equivalent (K051512) to a predicate device.
- Regulatory Class: Class II
- Product Code: MOS
- Date of Clearance: June 28, 2005
To obtain the detailed information you are requesting (acceptance criteria, study design, sample sizes, ground truth, expert qualifications), you would typically need to consult:
- The original 510(k) submission document: This document, submitted by Invivo Corporation to the FDA, would contain the technical specifications, performance data, and comparison to predicate devices. These are usually not publicly available in their entirety.
- Publicly available summaries of 510(k)s: The FDA sometimes publishes summaries, but often these do not include granular study details.
- Scientific publications: If the performance data was significant enough, it might have been published in a peer-reviewed journal.
- Clinical trial reports: If any specific trials were conducted beyond typical substantial equivalence testing, their reports would contain this data.
§ 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.