(97 days)
The KODAK DirectView CR cassette holds a storage phosphor screen which is exposed by radiographic equipment for the recording of a patient radiation pattern. The cassette is loaded into a compact laser scanner capable of reading the latent image. The Kodak DirectView CR 15 x 30 cm cassette and storage phosphor screen can be used for general radiology and dental panoramic radiography applications.
The Kodak DirectView CR 15 x 30 cm cassette size is designed to perform general radiography and panoramic dental exams when used with the Kodak DirectView CR 850 and CR 950 systems. The cassette system (cassette and storage phosphor screen adhered to the cassette plate) can be used in common dental panoramic x-ray dental units designed to accept cassettes that meet the ISO 4090 standard. The CR cassette is a standard x-ray diagnostic cassette used for computed radiography. The panel materials are consistent with the current design of the CR cassette and include Corus Hylite and Toray Panel. The Corus Hylite panel includes two lavers of aluminum, with polypropylene (plastic) in the middle, and is covered with Omnova (clear viny) with printing on the second surface). On the tube side of the cassette there is Toray Carbon Fiber Panel that consists of four layers of carbon fiber. The storage phosphor plate is attached to the honeycomb panel. The lead mylar that is in place under the phosphor layer of the screen was removed in the CR 15 x 30 cm cassette in order to accommodate Automatic Exposure Control (AEC) in dental x-ray units.
This 510(k) submission (K040373) for the KODAK DirectView CR Cassette / GP / 15 x 30 cm does not describe a study with acceptance criteria and device performance in the typical sense of a diagnostic algorithm or predictive model. Instead, it focuses on demonstrating substantial equivalence of a physical medical device (an X-ray cassette) to a previously cleared predicate device. Therefore, the information provided in the input does not directly align with the requested structure for acceptance criteria and study details for an AI/algorithm-based device.
However, I can extract and present the relevant information provided in the context of substantial equivalence for a physical medical device. The "acceptance criteria" here are implicitly tied to the performance requirements for an X-ray cassette, and the "study" is the comparison made to the predicate device.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Implicit Acceptance Criteria (based on predicate) | Reported Device Performance (compared to predicate) |
|---|---|---|
| Functionality | Must hold a storage phosphor screen, be exposed by radiographic equipment, and be loaded into a laser scanner to read the latent image. | "identical in function" to the currently marketed Kodak DirectView CR cassette. |
| Radiographic Applications | Suitable for general radiology and dental panoramic radiography applications. | Can be used for general radiology and dental panoramic radiography applications. |
| Compatibility with Dental Units | Must be compatible with common dental panoramic x-ray units designed to accept cassettes that meet the ISO 4090 standard. | Can be used in common dental panoramic x-ray dental units designed to accept cassettes that meet the ISO 4090 standard. |
| Panel Materials | Materials should be consistent with current CR cassette designs, ensuring structural integrity and proper X-ray interaction. | Panel materials (Corus Hylite, Toray Panel, Omnova) "consistent with the current design." |
| AEC Compatibility | Must accommodate Automatic Exposure Control (AEC) in dental X-ray units (a design change from previous versions). | Lead mylar removed to "accommodate Automatic Exposure Control (AEC) in dental x-ray units." |
| Image Processing Software | Must function with existing image processing software without requiring modification. | "image processing software algorithm will not be modified" and remains the same as previously cleared. |
| Overall Performance | Performance should be equivalent to the predicate device for its intended use. | "identical in...performance" to the currently marketed Kodak DirectView CR cassette. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of this 510(k) submission. The "test set" here would refer to the physical cassette itself being compared. The comparison is primarily based on design specifications, materials, and functional claims relative to a predicate device, rather than a clinical trial with a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for a physical X-ray cassette's performance is established by engineering specifications, material properties, and regulatory standards, not by expert interpretation of clinical images from a "test set." The FDA reviewers evaluate the technical documentation.
4. Adjudication Method for the Test Set
Not applicable. There isn't a "test set" of cases requiring adjudication in this type of submission.
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 device is a passive X-ray cassette, not an AI or imaging interpretation algorithm. Therefore, an MRMC study related to human reading performance with or without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical X-ray cassette, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for demonstrating substantial equivalence are:
- Engineering Specifications: Design, materials, and manufacturing standards for X-ray cassettes.
- Regulatory Standards: Adherence to standards like ISO 4090 for dental panoramic cassettes.
- Predicate Device Performance: The established, cleared performance of the Kodak Ektascan SP Cassette (K925997) / Kodak DirectView CR Cassette serves as the benchmark for "truth."
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning algorithm, so there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" proving the device meets its (implicit) acceptance criteria is the Substantial Equivalence demonstration. The manufacturer asserts and provides documentation to support that the KODAK DirectView CR 15 x 30 cm cassette is substantially equivalent to the Kodak Ektascan SP Cassette (K925997) (currently marketed as the Kodak DirectView CR Cassette).
The key arguments for this demonstration are:
- Identical Function and Performance: The new cassette size is stated to be "identical in function and performance" to the predicate.
- Consistent Panel Materials: The panel materials are consistent with the current design, using Corus Hylite and Toray Panel.
- AEC Accommodation: A specific design modification (removal of lead mylar) was made to accommodate Automatic Exposure Control (AEC) in dental X-ray units, which is a functional enhancement for specific applications.
- Unchanged Image Processing Software: The device uses the same, previously cleared, image processing software algorithm, ensuring consistent image quality and processing characteristics.
- Broad Application: It maintains suitability for general radiology and dental panoramic radiography and is compatible with ISO 4090 standard dental X-ray units.
The FDA reviewed these claims and determined that the device is substantially equivalent, allowing it to be marketed. This regulatory approval serves as the "proof" that the device meets its acceptance criteria for safety and effectiveness, based on its equivalence to a device already on the market.
§ 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.