(14 days)
The E-scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
The E-scan is a magnetic resonance diagnostic device. The Multipurpose Flexible Receiving Coil improves the system performance and does not alter the fundamental scientific technology of the cleared device.
The provided 510(k) summary does not contain the detailed information typically required to describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device submission. This document pertains to an MRI system (E-Scan) and a new receiving coil, filed in 2001, long before the widespread use and regulatory frameworks for AI/ML in medical devices.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will address what information is available and explain why other fields are missing or not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Study for E-Scan MRI System (Receiving Coil)
The submission focuses on establishing substantial equivalence to a predicate device, primarily through demonstrating that the addition of a "Multipurpose Flexible Receiving Coil" does not alter the fundamental scientific technology of the cleared device (Esaote E-Scan K001894). The acceptance criteria are implicitly tied to maintaining the safety and effectiveness profile of the predicate device.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintain existing diagnostic capabilities of the predicate MR system. | The E-scan, with the Multipurpose Flexible Receiving Coil, is intended for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, and forearm. It produces sectional images displaying internal structure. If interpreted by a medical expert, these images can provide diagnostically useful information. |
| The Multipurpose Flexible Receiving Coil should not negatively impact safety or fundamental technology. | "The Multipurpose Flexible Receiving Coil improves the system performance and does not alter the fundamental scientific technology of the cleared device." The coil is noted to be usable for shoulder and knee, especially for patients with painful or plastered limbs, suggesting improved patient access/comfort. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document does not describe a clinical study or test set in the way an AI/ML validation would. It primarily focuses on the technical characteristics of the new coil and its intended use.
- Data Provenance: Not applicable. There's no mention of specific data used for a test set that would have provenance like country of origin or whether it was retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The submission states that images, "If interpreted by a medical expert, these images can provide diagnostically useful information," but doesn't detail their role in a specific test for the coil.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. No specific test set or adjudication process is described.
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:
- MRMC Study: No, an MRMC study was not done.
- Effect Size of AI assistance: Not applicable. This submission is for an MRI system and a mechanical coil, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an AI/ML algorithm. The device produces images that "If interpreted by a medical expert, these images can provide diagnostically useful information," clearly indicating human interpretation is part of its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not explicitly stated as part of a formal validation study. For an MRI system, the "ground truth" for image quality and diagnostic utility is typically established by comparing the images produced to established anatomical knowledge, clinical expectations, and the ability of human experts to make diagnoses from them. No specific methodology for establishing such ground truth in the context of this specific submission (for the new coil) is detailed beyond its intended use for diagnostic imaging.
8. The sample size for the training set:
- Sample Size: Not applicable. This is not an AI/ML algorithm that required a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable. This is not an AI/ML algorithm that required a training set.
Summary of what can be gleaned about the "study" for this device:
The "study" for this 510(k) submission primarily involved demonstrating that the new Multipurpose Flexible Receiving Coil is consistent with the established safety and effectiveness of the predicate E-Scan MRI system (K001894). The key "performance" claim is that the new coil "improves the system performance and does not alter the fundamental scientific technology of the cleared device," and that it can be used for various anatomical regions, including those that might be challenging with other coils (e.g., painful or plastered limbs). This substantial equivalence argument is based on technical specifications and comparison to existing devices rather than a formal clinical trial or AI/ML validation study.
§ 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.