(28 days)
These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.
Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail are ultraviolet activated rare earth intensifying screens. The phosphor is niobium activated lutetium tantalate.
The provided 510(k) summary for K974423 (Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail) describes a comparison to a predicate device but does not contain a study or detailed acceptance criteria as one would expect for a modern AI/CAD device.
This submission is for radiographic intensifying screens, which are hardware components, not a software algorithm or AI device. Therefore, the questions related to AI/CAD performance (like MRMC studies, standalone performance, training sets, expert ground truth adjudication) are not applicable to this type of device.
Here's the information that can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but provides a comparison table against a predicate device, implying that performance similar to or better than the predicate is the basis for substantial equivalence. The "reported device performance" are the values for the new devices from this comparison.
| Metric | Acceptance Criteria (Implied by Predicate) | Ultra-Vision® Mammography Detail | Ultra-Vision® Mammography Fast Detail |
|---|---|---|---|
| Phosphor | Gadolinium Oxysulfide | Lutetium Tantalate | Lutetium Tantalate |
| Speed | 1.0 | 1.17 | 1.53 |
| MTF @ 4cycles/mm | .635 | .675 | .635 |
| X-ray Absorption @ 25 kVp | .60 | .61 | .83 |
| Imaging Application | Mammography | High Image quality | High Image quality |
Explanation: The "Acceptance Criteria (Implied by Predicate)" column represents the performance characteristics of the predicate device (Microvision™ Detail). The new devices are considered substantially equivalent because their performance in these metrics is comparable or improved. For example, the new devices show higher speed and potentially higher MTF and X-ray absorption, which are considered improvements for a mammography intensifying screen. The change in phosphor material is noted but acceptable if the performance metrics are met.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This submission is for hardware components (intensifying screens). Performance metrics like Speed, MTF, and X-ray Absorption are typically measured in a laboratory setting using standardized testing methods, not a "test set" of patient data in the context of AI. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of expert review is for diagnostic accuracy of an AI or human reader on patient images. This device is an intensifying screen, whose performance is measured through physical properties, not diagnostic interpretation.
4. Adjudication method for the test set:
- Not applicable. See point 3.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device. The measurements of Speed, MTF, and X-ray Absorption are inherent standalone performance characteristics of the screen itself.
7. The type of ground truth used:
- Laboratory measurements/Physical properties. The "ground truth" for this device's performance relies on rigorous physical measurements of parameters like spectral sensitivity, light output, spatial resolution (MTF), and x-ray absorption, typically conducted under controlled laboratory conditions using established standards for radiographic screen testing.
8. The sample size for the training set:
- Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 892.1960 Radiographic intensifying screen.
(a)
Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.