(14 days)
Ferrania LifeRay™ Cassettes are intended for use during diagnostic X-ray procedures to provide a light-proof enclosure for direct exposure of radiographic film and to hold this radiographic film in close contact with an X-ray intensifying screen.
Ferrania LifeRay™ Cassettes are intended for use during diagnostic x-ray procedures to hold radiographic film in close contact with an x-ray intensifying screen and to provide a light proof enclosure for direct exposure of this film. The Cassettes are in a family of film sizes. The LifeRay™ KW Cassettes contain a window compatible with Kodak system, that permits data writing by a radiographic film marking system. The LifeRay™ WL Cassette is windowless. Radiographic cassettes are composed of: a light tight chamber for preventing radiographic film exposure, a compressible backplate material to assure intimate film-screen contact, a latching mechanism for removal and replacement of radiographic film, a patient oriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to x-rays assembled in a robust support structure to assure durability.
The provided text describes a 510(k) Premarket Notification for Ferrania S.p.A. LifeRay™ Cassettes. This document focuses on demonstrating substantial equivalence to a predicate device rather than a study proving performance against specific acceptance criteria for a novel AI or medical device with complex performance metrics.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in the context of this type of submission for a radiographic film cassette.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformity to ANSI PH1.49 - 1995 | Ferrania LifeRay™ Cassettes conform to ANSI PH1.49 - 1995. |
| Conformity to ISO/FDIS 4090: 2000 | Ferrania LifeRay™ Cassettes conform to ISO/FDIS 4090: 2000. |
| Safety and Effectiveness (as compared to predicate device) | "Ferrania S.p.A. concluded that the LifeRay™ Cassettes are safe, effective and perform as well as the predicate device." |
| Functionality: Light-tight enclosure | Designed with a light-tight chamber for preventing radiographic film exposure. |
| Functionality: Intimate film-screen contact | Designed with a compressible backplate material to assure intimate film-screen contact. |
| Functionality: Latching mechanism | Designed with a latching mechanism for removal and replacement of radiographic film. |
| Functionality: X-ray transparent patient oriented surface | Designed with a patient oriented surface transparent to x-ray energy. |
| Functionality: Lead shielding | Designed with lead shielding to prevent unwanted exposure to x-rays. |
| Durability | Assembled in a robust support structure to assure durability. |
| Compatibility (KW Cassette only): Data writing system | The LifeRay™ KW Cassettes contain a window compatible with Kodak system, that permits data writing by a radiographic film marking system. |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This 510(k) submission relies on conformity to voluntary standards and comparison to a predicate device, not on a clinical test set with patient data for performance evaluation in the way a diagnostic algorithm would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. Ground truth in the context of expert review is not relevant for this device.
4. Adjudication method for the test set
- Not Applicable / Not Provided.
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 a physical radiographic cassette, not an AI or software device that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical radiographic cassette, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device's performance is its compliance with established voluntary industry standards (ANSI PH1.49 - 1995 and ISO/FDIS 4090: 2000) and its functional equivalence to the predicate device (TRIMAX RADIOGRAPHIC CASSETTE, K980722). These standards inherently define the acceptable physical and performance characteristics of such a device.
8. The sample size for the training set
- Not Applicable / Not Provided. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided.
§ 892.1850 Radiographic film cassette.
(a)
Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.