(27 days)
The Toshiba J-Advanced I.I. is designed to capture x-ray images on a phosphor, and convert the xray pattern into a corresponding light image of a higher energy density. The intended use of this product is commensurate with other products currently in the marketplace.
The J-Advanced I.I., Model RTP9211J-G11 is a modification to a previously cleared device, 6' I.I. system [K771298].
This 510(k) submission describes the Toshiba J-Advanced I.I., Model RTP9211J-G11, which is a modification to a previously cleared X-ray image intensifier system. The submission does not contain a detailed study with acceptance criteria and device performance as typically seen for novel AI/software devices. Instead, it relies on substantial equivalence to a predicate device.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "A comparison of the performance characteristics of the new intensifier to the previous models shows nominally improved resolution and contrast specifications. There are no new claims of effectiveness and no new intended uses offered with this new intensifier."
Since this is an image intensifier, common performance specifications would revolve around image quality. However, specific numerical acceptance criteria and reported values are not explicitly stated in this summary. Instead, a qualitative "nominally improved" is provided.
| Acceptance Criterion (Inferred from "nominally improved") | Reported Device Performance |
|---|---|
| Improved Resolution | Nominally improved resolution compared to predicate. |
| Improved Contrast | Nominally improved contrast compared to predicate. |
| Compliance with Federal Diagnostic X-ray Equipment Standard (21 CFR Subchapter J) | Met (as per Safety and Effectiveness Concerns section). |
| Compliance with IEC-60601 Medical Device Safety Standards | In conformance with applicable parts (as per Safety and Effectiveness Concerns section). |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not describe a clinical study in the form typically seen for new AI/software devices with a specific "test set" in the context of diagnostic accuracy. The device is a hardware component (an image intensifier), and its performance assessment is likely based on engineering specifications, bench testing, and potentially laboratory comparisons rather than a clinical trial with patient data. Therefore, this information is not applicable/not provided in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there is no clinical "test set" described for diagnostic accuracy, this information is not applicable/not provided.
4. Adjudication Method for the Test Set
As there is no clinical "test set" described for diagnostic accuracy, this information is not applicable/not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
The device described is an X-ray image intensifier, a hardware component for image acquisition, not an Artificial Intelligence (AI) or software-based diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is an X-ray image intensifier, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The type of Ground Truth Used
Given the nature of the device as an image intensifier, "ground truth" would likely refer to objective physical performance characteristics measured through engineering and quality control tests (e.g., MTF for resolution, contrast-to-noise ratio). The specific methods for establishing ground truth for resolution and contrast are not detailed in this summary but would be based on instrument-based measurements.
8. The Sample Size for the Training Set
This device is not an AI/machine learning model, so there is no training set in the typical sense. Performance is based on the physical characteristics and design of the intensifier.
9. How the Ground Truth for the Training Set was Established
As there is no training set, this information is not applicable.
Summary of the Study (as described in the 510(k) submission):
The submission for the Toshiba J-Advanced I.I., Model RTP9211J-G11, is based on demonstrating substantial equivalence to a previously cleared predicate device (Toshiba 6" I.I. System [K771298]). The "study" here is not a typical clinical trial but rather a comparison of technological characteristics and compliance with regulatory standards.
- Rationale for Equivalence: The document states, "This device employs the same technological characteristics as the predicate device. The changes to the device are a result of continuing technological development towards the goals of increasing efficiency and reducing cost."
- Performance Comparison: "A comparison of the performance characteristics of the new intensifier to the previous models shows nominally improved resolution and contrast specifications." This suggests direct comparison of technical specifications and possibly bench testing rather than clinical trials.
- Safety and Effectiveness Concerns: The device's safety and effectiveness are supported by its design and manufacture under Quality System Regulations (21 CFR § 820) and compliance with the Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33) and applicable parts of IEC-60601 Medical Device Safety standards.
In essence, the submission relies on the fundamental similarity of the technology, documented nominal improvements in key image quality metrics (resolution and contrast), and adherence to established regulatory and quality standards, rather than a specific clinical study with patient data and statistical endpoints.
§ 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.