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510(k) Data Aggregation
(458 days)
The neo315 is a magnetic resonance diagnostic device which 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 resonance. Other physical parameters derived from the images and/or spectra may also be produced.
The device includes hydrogen-1 (proton) imaging, hydrogen-1 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). The intended group of patients for the neo315 can be found in the pediatric environment. The exclusion of patients is determined by the dimensions of the patient bed and excludes patients that exceed a 120 cm length and a diameter of 26 cm. The weight of the patient shall not exceed 18 kg.
The neo315 is a conductively cooled 1.5T whole body magnetic resonance diagnostic device (MRDD) which generates images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Its intended group of patients for the neo315 can be found in the pediatric environment. The neo315 consists of the Field Generating Unit (FGU), two technical cabinets (consoles) and gets operated via the operating software ScanUI.
The provided text does not contain information about specific acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies for the neo315 device.
The document primarily focuses on the FDA's 510(k) clearance for the neo315, stating its substantial equivalence to a predicate device (Siemens MAGNETOM Avanto syngo MR B19A). It outlines the device's indications for use, technological comparison, and compliance with recognized standards.
Therefore, I cannot fulfill all parts of your request based on the provided text. I can only extract information related to the device's general intended use and the standards it complies with.
Here's what can be inferred from the text, though it doesn't meet the specific requirements of your request regarding detailed study results:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in terms of metrics like sensitivity, specificity, accuracy, or specific imaging quality parameters. It generally asserts that "The performance testing results demonstrate the safety and performance as expected."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information is provided regarding the sample size used for any test set or the provenance of data (e.g., country of origin, retrospective/prospective). The document mentions "performance testing results" but does not detail the methodology or datasets used.
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):
No information is provided about the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information is provided about any adjudication method.
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:
The document does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The neo315 is described as a Magnetic Resonance Diagnostic Device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document doesn't detail performance studies of the device in isolation or as part of an algorithm. It focuses on the substantial equivalence of the hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
No information is provided regarding the type of ground truth used.
8. The sample size for the training set:
No information is provided regarding the sample size of any training set.
9. How the ground truth for the training set was established:
No information is provided on how ground truth was established for any training set.
Summary of available information related to performance and standards:
The document states that the neo315 is claimed to comply with several applicable FDA recognized standards, which implicitly define "acceptance criteria" in terms of technical performance expected of an MR diagnostic device. These standards establish various performance benchmarks for MR systems.
| Category | Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance |
|---|---|---|
| I. Imaging Performance | ||
| Signal-to-Noise Ratio (SNR) | Compliance with NEMA MS-1-2008 (R2020) - Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging. This standard defines methods for measuring SNR, and the device is expected to meet SNR levels appropriate for diagnostic use. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical SNR values reported.) |
| Geometric Distortion/Accuracy | Compliance with NEMA MS 2-2008 (R2020) - Determination of Two-Dimensional Geometric Magnostic Magnetic Resonance Images. This standard defines methods for evaluating geometric accuracy in MR images. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical distortion or accuracy values reported.) |
| Image Uniformity | Compliance with NEMA MS 3-2008 (R2020) - Determination of Image Uniformity in Diagnostic Resonance Images. This standard defines methods for evaluating the uniformity of signal intensity across an image. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical uniformity values reported.) |
| Slice Thickness | Compliance with NEMA MS 5-2018 - Determination of Slice Thickness in Diagnostic Resonance Imaging. This standard defines methods for measuring the actual thickness of acquired image slices. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical slice thickness deviation values reported.) |
| II. Safety and Electrical Performance | ||
| Acoustic Noise | Compliance with NEMA MS 4-2010 - Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices. This standard defines methods for measuring the acoustic noise generated by the MR system. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical acoustic noise levels reported.) |
| Specific Absorption Rate (SAR) | Compliance with NEMA MS 8-2016 - Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems. This standard addresses the measurement and characterization of SAR, which relates to patient heating. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical SAR values or compliance margins reported.) |
| Electrical Safety & Essential Performance | Compliance with IEC 60601-1-2 Edition 4.1, 2020-09 (EMC) and IEC 60601-1 Edition 3.2 2020-08 (General requirements for basic safety and essential performance). These standards cover electrical safety, electromagnetic compatibility, and fundamental safe operation. | "The performance testing results demonstrate the safety and performance as expected." |
| III. Software & Usability | ||
| Software Life Cycle Processes | Compliance with IEC 62304 Edition 1.1 2015-06 - Medical Device Software - Software life cycle processes. This standard defines requirements for the software development and maintenance processes of medical devices. | "The performance testing results demonstrate the safety and performance as expected." |
| Usability Engineering | Compliance with IEC 62366-1 Edition 1.0 2015-02 - Medical devices - Part 1: Application of usability engineering to medical devices. This standard ensures the device is safe and effective through proper usability design. | "The performance testing results demonstrate the safety and performance as expected." |
| IV. Biological & Risk Management | ||
| Biological Evaluation | Compliance with ISO 10993-1 Fifth edition 2018-08 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. This standard addresses the biocompatibility of materials in contact with a patient. | "The performance testing results demonstrate the safety and performance as expected." |
| Risk Management | Compliance with ISO 14971 Third Edition 2019-12 - Medical devices - Application of risk management to medical devices. This standard outlines a process for managing risks associated with medical devices. | "The performance testing results demonstrate the safety and performance as expected." |
Conclusion from available text:
The provided document asserts that the neo315 meets the "safety and performance as expected" by complying with a list of recognized industry standards for Magnetic Resonance Imaging devices. However, it does not provide granular details about the specific quantitative acceptance criteria or the numerical results of performance testing that would directly fulfill the detailed requirements of your prompt. The FDA's 510(k) clearance process often relies on substantial equivalence to predicate devices and compliance with recognized standards without requiring novel clinical performance studies unless significant differences or new risks are identified.
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