(30 days)
KODAK DirectView Tabletop CR Cassette holds a Storage Phosphor screen so the screen can be exposed by radiographic equipment for the recording of a patient radiation pattern. The screen is removed from the cassette and the pattern read in a laser phosphor digitizer.
The device is a cassette for holding a storage phosphor screen. It is a standard x-ray diagnostic cassette used for film screen radiography that has been modified as follows. In place of the two intensifying screens two pieces of black polycarbonate sheet are mounted on the foam presently used in the X-Omat Cassette. The storage phosphor screens is constrained by the film pocket of the cassette and held in place by the two plastic sheets when the cassette is closed.
The provided document does not contain information regarding acceptance criteria, device performance metrics, or a study design to prove the device meets specific criteria in the way typically expected for AI/software-based medical devices.
Instead, this 510(k) summary focuses on establishing substantial equivalence for a physical medical device: the KODAK DirectView Tabletop CR Cassette.
Therefore, many of the requested sections about study design, sample sizes, ground truth establishment, and AI performance metrics cannot be extracted from this document as they are not relevant to this type of device submission.
Here's an analysis of what can be extracted and why other parts are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this document. The device is a radiographic cassette, and its "performance" is primarily defined by its ability to hold a storage phosphor screen securely and allow for exposure, which is then read by a separate digitizer. The submission focuses on its physical characteristics and equivalence to existing cassettes, not quantifiable performance metrics typically associated with diagnostic accuracy or AI.
The applicable standards listed are:
- CEI IEC 60406 Ed. 3.0:1997 Cassettes for medical X-ray diagnosis – Radiographic cassettes and mammographic cassettes
- ISO 4090 Photography – Film dimensions – Medical radiography
These standards define physical and dimensional requirements, but specific acceptance criteria or reported performance against these are not detailed in this summary.
2. Sample size used for the test set and the data provenance
Not applicable. There is no "test set" of patient data in the context of a study for a physical cassette to evaluate diagnostic performance. The substantial equivalence is based on the device's design and function compared to previously marketed devices.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
Not applicable. No ground truth or expert review is mentioned for this physical device.
4. Adjudication method for the test set
Not applicable.
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 or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable. This device does not involve a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary based on the provided document:
The KODAK DirectView Tabletop CR Cassette is a physical device designed to hold a storage phosphor screen for radiographic exposure. The company established substantial equivalence to existing legally marketed devices, specifically "cassettes associated with computed radiography systems marketed by Eastman Kodak Company, Fuji Medical Systems USA and Agfa Medical Imaging."
The basis for this substantial equivalence is described as:
- The device is "basically a standard, screen-film diagnostic cassette that has been adapted to hold a storage phosphor screen."
- It is "identical in function" to the predicate devices.
- Modifications include: replacing two intensifying screens with two pieces of black polycarbonate sheet mounted on foam, and constraining the storage phosphor screen within the film pocket.
The submission points to compliance with international standards for radiographic cassettes (CEI IEC 60406 and ISO 4090). The FDA's review confirms substantial equivalence, allowing the device to proceed to market under the general controls provisions of the Federal Food, Drug, and Cosmetic Act.
§ 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.