(49 days)
The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine.
The MJAS-167A is intended to be used on a Toshiba 1.5T MR System
The Octave SPEEDER Spine is a receive-only phased Array Coil that can receive NMR signal from spine. The coil consists of a 12 rectangular loop surface coil. 3 loops (1 section) are aligned perpendicular to a body axis and 4 sections are aligned to a body axis. Users select the sections according to region of interest via a system user interface. The PC board switches transmit mode and receive mode with PIN diode. This coil is detuned during transmission by our QD whole body coil by means of activating the PIN diodes (transmit mode) and tuned during no transmission by means of not activating the PIN diodes (receive mode).
The provided text is a 510(k) summary for the Octave SPEEDER Spine, a magnetic resonance diagnostic device. It details the device's classification, contact information, manufacturing site, date of submission, intended use, description, safety parameters, and substantial equivalence to a predicate device.
However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for AI/algorithm-based devices.
Here's why and what the document does provide:
- Device Type: The Octave SPEEDER Spine is a receive-only phased array coil, essentially a hardware component for an MRI system. It's not an AI or algorithm-based device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth.
- "Acceptance Criteria" in this Context: For this type of hardware, "acceptance criteria" generally refers to meeting safety standards and demonstrating that the device functions as intended within the MRI system, and that its image quality is comparable to or better than previously cleared devices.
- "Study" Information: The document refers to "testing" but not a formal study with detailed methodology, sample sizes, and expert reviews as would be expected for an AI product.
Here's a breakdown of what can be extracted or inferred based on your requested headings, with clarifications where the information is absent for an AI-focused interpretation:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance / Assessment |
|---|---|
| Safety Parameters | Maximum static field strength: 1.5 T (Matches intended use with 1.5T MR System) |
| Maximum dB/dt: 1st operation mode specified in IEC60601-2-33 (2002) | |
| Maximum SAR: 1st operation mode specified in IEC60601-2-33 (2002) | |
| Peak and A-weighted Acoustic Noise Level: Not applicable | |
| Biocompatibility: All patient contacting materials have a history of use or test data that demonstrates its biocompatibility (non-toxic, non-irritating). | |
| Functional / Performance | Image Quality: "Testing was conducted utilizing phantoms and accepted imaging quality metrics." "Sample phantom images and clinical images are presented in Appendix F & G." (Details of specific metrics or quantitative results are not provided in this summary.) |
| Substantial Equivalence | The device is claimed to be substantially equivalent to the predicate device, Atlas SPEEDER Spine [K063361]. "The new Octave SPEEDER Spine (MJAS-167A) does not change the indication for use or the intended use of the predicate device. The safety and effectiveness has been verified via risk management and application of design controls to the new Octave SPEEDER Spine." "Testing was done in accordance with applicable recognized consensus standards" (IEC60601-1, IEC60601-2, IEC60601-1-6, IEC62366, IEC60601-2-33). Note: The "acceptance criteria" here are implicitly that its performance *at least matches* the predicate device for relevant parameters, and that it adheres to specified safety standards. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The document mentions "phantom images and clinical images" but does not give a number of phantoms or patients/cases.
- Data Provenance: Not specified. "Clinical images" would imply collected data, but details like country of origin or whether it was retrospective/prospective are not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable and not mentioned. For a hardware device like an MRI coil, "ground truth" in the context of diagnostic interpretation by experts is not the primary assessment method. Image quality is typically assessed against physical phantoms (known configurations) and qualitatively by experts for clinical utility, but not in terms of diagnostic accuracy with a "ground truth" label in the way an AI would be.
4. Adjudication method for the test set
- Not applicable and not mentioned.
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. This is not an AI device. No MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the phantom imaging, the "ground truth" would be the known configuration of the phantom itself.
- For "clinical images," image quality is likely judged subjectively by imaging specialists and objectively by predefined metrics, rather than against a specific diagnostic "ground truth" derived from pathology or outcomes, as the coil's role is to acquire the image, not to interpret it diagnostically with an automated tool.
8. The sample size for the training set
- Not applicable / not mentioned. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable / not mentioned. This device does not have a "training set."
§ 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.