(286 days)
The Sentinelle Endo Coil Array is a receive-only MRI coil array which must be used by a qualified medical professional to obtain images of (including spectroscopy images) the prostate, cervix and colon and the surrounding tissues in the pelvis. The Coil Array is a reusable transrectal or transvaginal device that can be high level disinfected. This product is for exclusive use on adult populations with clinically present anus and rectum or vagina. For use with GE, Toshiba and Siemens 1.5T MR systems.
The Endo Coil Array is a reusable, rigid transrectal or transvaginal receive-only MRI coil array similar to other products. The Coil Array housing has a cylindrical shape similar to transrectal and transvaginal ultrasound probes.
The Coil Array is held by an articulating Stabilization Arm that is attached to a Patient Support. The Patient Support is available in both Transporter and Tabletop versions, which dock to the scanner or are placed on top of the scanner's existing couch respectively.
The provided document is a 510(k) summary for the Sentinelle Endo Coil Array for Pelvic Imaging. It describes the device, its intended use, and provides a comparison to predicate devices, but does not include detailed performance study data such as acceptance criteria, specific reported device performance metrics, sample sizes, expert qualifications, or details about standalone/MRMC studies.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "Non-clinical performance testing was done to ensure the device performed equivalently to predicates in the areas of SNR comparison, spectroscopy, and image uniformity per NEMA 9:2008 with no additional concerns of safety or effectiveness." However, it does not specify explicit acceptance criteria (e.g., minimum SNR ratio, uniformity percentage) or the quantitative reported performance values of the device against these criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "Non-clinical performance testing," which typically refers to bench testing rather than clinical study data. It does not provide any information about a "test set" in terms of subject or image samples, nor their provenance.
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)
- Cannot be provided. No information regarding experts or ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No information regarding adjudication methods for a test set is 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, an MRMC study was not done. This device is an MRI coil array, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be applicable. The performance testing described is for the coil's physical imaging characteristics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an "algorithm." As this is an MRI coil, "standalone performance" refers to the coil's physical imaging capabilities in isolation from a human interpreter, which is what the non-clinical performance testing (SNR, spectroscopy, image uniformity) would assess. However, specific results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No information regarding ground truth used for any testing is mentioned.
8. The sample size for the training set
- Cannot be provided. No information about a "training set" is mentioned as this is not an AI/algorithmic device in the traditional sense that requires training data.
9. How the ground truth for the training set was established
- Cannot be provided. No information about a "training set" or its ground truth establishment is mentioned.
§ 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.