(49 days)
The Octave SPEEDER Head is intended for imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest.
The MJAH-167A is intended to be used on a Toshiba 1.5T MR System
The Octave SPEEDER Head is a receive-only phased Array Coil that can receive NMR signal from head, cervical region and upper chest. The coil consists two parts of a head base, a removable anterior coil. The head base includes 7 coil elements, which are divided into 3 sections. The removable anterior coil includes 4 coil elements, which are divided into 2 sections: 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).
This document is a 510(k) summary for the Octave SPEEDER Head (MJAH-167A), an MRI receive-only phased array coil. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (Atlas SPEEDER Head/Cervical coil, K083014) rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a novel AI algorithm might.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not explicitly stated in the provided text. The submission relies on "testing utilizing phantoms and accepted imaging quality metrics" and demonstrating that the new device does not change the indications for use or intended use.
Here's an analysis based on the provided text, addressing the points where information is available and noting when it's not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics in a table. It instead relies on demonstrating "substantial equivalence" to a predicate device through conformity to recognized consensus standards and general statements about imaging quality.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (Atlas SPEEDER Head/Cervical coil, K083014) | "The new Octave SPEEDER Head (MJAH-167A) does not change the indication for use or the intended use of the predicate device." "Sample phantom images and clinical images are presented in Appendix F & G." (Appendices not provided) |
| Conformity to recognized consensus standards (e.g., IEC60601-series) | "Testing was done in accordance with applicable recognized consensus standards as listed below." |
| Biocompatibility | "All patient contacting materials have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating." |
| Safety Parameters (Magnetic Field, dB/dt, SAR) | Conforms to 1st operation mode specified in IEC60601-2-33 (2002) for dB/dt and SAR, and 1.5 T static field strength. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "sample phantom images and clinical images" but does not give a number for either.
- Data Provenance: Not specified. Based on the manufacturing site in Japan and the U.S. agent's location, the clinical images could be from either region, or a combination. The document mentions "clinical images," implying prospective or retrospective data from human subjects, but no specifics are given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this 510(k) summary. The evaluation focuses on physical device performance and equivalence, not diagnostic accuracy requiring expert interpretation for ground truth. The "testing was conducted utilizing phantoms and accepted imaging quality metrics," suggesting engineering and physics evaluations rather than clinical diagnostic assessments with expert reads.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation is not based on diagnostic performance that would require adjudication.
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
Not applicable. This device is an MRI coil, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (MRI coil), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation largely refers to physical measurements and imaging metrics against established standards for MRI coil performance. For example:
- Phantoms: Phantoms are used as a controlled "ground truth" to measure parameters like signal-to-noise ratio (SNR), uniformity, and image artifact levels.
- Accepted Imaging Quality Metrics: These would be objective measurements of image quality, not derived from expert consensus on pathology or outcomes.
- Biocompatibility Testing: Demonstrates non-toxicity and non-irritation, which are established through standardized laboratory tests.
- Safety Parameters: Ground truth established by international standards (e.g., IEC60601-2-33) for dB/dt, SAR, and static field strength.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning, so there is no training set in that context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no 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.