(76 days)
The Ultimax-i multipurpose digital X-ray system is designed for gastrointestinal studies, general radiography, and fluoroscopy.
The Ultimax-i system has medical applications ranging from but not limited to: contrast enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular contrast-enhanced studies, support of vascular IVR, and general radiography.
Note: This system is not intended for cardiovascular contrast studies or interventional radiology procedures for the cardiac or cerebral blood vessels. This system is not intended for mammography studies in the US.
This device is a fixed c-arm fluoroscopic device intended to provide radiographic and fluoroscopic images in a variety of studies. The unit consists of a c-arm with x-ray tube, beam limiter and digital flat panel detector (FPD); a patient table that can tilt in both directions, an 80kW x-ray generator, an image processor and both remote and table side control.
The provided text does not contain a detailed study with acceptance criteria and device performance metrics in the format requested. The document is a 510(k) premarket notification letter and a summary of safety and effectiveness for the Toshiba Ultimax-i, an image-intensified fluoroscopic x-ray system.
It states that the device is "substantially equivalent" to predicate devices (Toshiba KALARE and Siemens Artis Zee Multi-purpose) and that "Comparison of image performance criteria demonstrate that the two devices perform in a similar manner. Clinical data was used to further demonstrate the effectiveness of the Ultimax-i system." However, it does not provide specific acceptance criteria, reported performance values, or details about the clinical study (like sample size, ground truth, experts used, or MRMC study results).
Here's a breakdown of what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Missing. The document generally states that "Comparison of image performance criteria demonstrate that the two devices perform in a similar manner," but it does not specify what those criteria are or what the actual reported performance values are.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. The document mentions "clinical images" and "clinical data" were used to support efficacy and compare performance but does not specify the sample size or the provenance of this data.
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)
- Missing. The document does not describe how ground truth was established or if any experts were involved in a formal capacity for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. There is no mention of an 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
- Missing. The document does not describe an MRMC comparative effectiveness study, nor does it mention AI assistance. The device is an X-ray system, not an AI-driven image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Missing. This question is not directly applicable as the device is an imaging system, not a standalone algorithm. Performance is typically assessed on image quality and system functionality, not algorithmic output in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing. The document mentions "clinical data" was used but does not specify the type of ground truth used (e.g., if it was a comparison to existing high-quality images, pathological findings, or patient outcomes).
8. The sample size for the training set
- Missing. The document does not refer to a "training set" in the context of machine learning, as this is an imaging device submission.
9. How the ground truth for the training set was established
- Missing. See response to #8.
Summary of available information:
- Device Name: Ultimax-i
- Purpose of Study/Testing: To demonstrate substantial equivalence to predicate devices (Toshiba KALARE, Siemens Artis Zee Multi-purpose) and confirm that changes to the table and FPD mounting assembly maintain performance.
- Tests Conducted: Bench testing (for detector installation and specifications), and "additional testing... to compare the performance between the predicate device (KALARE) and the modified device that included testing directed at image quality, artifacts and motion/dynamic capabilities."
- Support for Efficacy: "Clinical images in this submission to support the efficacy of the new device" and "Clinical data was used to further demonstrate the effectiveness of the Ultimax-i system."
- Standards Followed: IEC60601-1 and its collateral standards (IEC60601-2-54, IEC60601-2-43, IEC 60601-2-28), 21 CFR Subchapter J, 21 CFR § 820, and ISO 13485.
In conclusion, while the document confirms testing was performed to demonstrate substantial equivalence and efficacy, it does not provide the detailed study information (specific acceptance criteria, sample sizes, expert involvement, and ground truth methodologies) that your request outlines. This level of detail is typically found in the full submission documents, not in the summary or FDA letter.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.