(15 days)
The Agfa Film Cassettes are indicated 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 lightproof enclosure for direct exposure of radiographic film.
There are three product lines of Agfa Film Cassettes covered by the present 510(k): (1) The Mamoray Mammography Cassettes, (2) the metal-bodied CAWO Cassettes, and (3) the ABS Plastic Curix and Lightweight Cassettes.
The provided text is a 510(k) summary for Agfa Film Cassettes, focusing on establishing substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of imaging performance or diagnostic accuracy. Instead, it describes manufacturing and design standards, and the intended use.
Therefore, many of the requested categories for acceptance criteria and study details cannot be answered from this document.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Intended Use | The Agfa Film Cassettes are indicated 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 lightproof enclosure for direct exposure of radiographic film. | This is an intended use statement, not necessarily a quantifiable performance criterion. The document states it is the "same compared to those of the legally marketed predicate devices." |
| Technological Characteristics | The technological characteristics of the Agfa Film Cassettes are the same as those of the predicate devices. | This is a statement of equivalence, not a specific performance metric. |
| Standards Compliance | Designed and manufactured to meet the requirements of ANSI/NAPM 1.49-1995, DIN 6832, Parts 2 and 3; and IEC 406. | These are manufacturing and design standards, not direct performance data for diagnostic accuracy or device efficacy. The document implies compliance with these standards serves as an "acceptance criteria" for manufacturing and design. |
| Radiographic Film Contact | To hold a radiographic film in close contact with an x-ray intensifying screen. | This is part of the intended function and implied as an acceptance criterion for proper cassette design. No quantitative performance is given. |
| Lightproof Enclosure | To provide a lightproof enclosure for direct exposure of radiographic film. | This is part of the intended function and implied as an acceptance criterion for proper cassette design. No quantitative performance is given. |
| Substantial Equivalence | Demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. | This is the overarching "acceptance criteria" for the 510(k) process, meaning the new device is as safe and effective as a legally marketed device. |
2. Sample sized used for the test set and the data provenance: Not applicable. No test set involving patient data or images was used for this submission as it focuses on demonstrating substantial equivalence for a physical medical device (film cassettes) based on design and standards compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in a diagnostic sense was performed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was performed.
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 document is about film cassettes and does not involve AI or human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about film cassettes and does not involve algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic performance. The "ground truth" for this submission revolved around demonstrating that the physical characteristics and performance (e.g., light-tightness, film contact) of the new cassettes met the same standards and intended use as the predicate devices, likely through engineering tests and compliance with recognized standards.
8. The sample size for the training set: Not applicable. This document does not describe the development or training of an AI algorithm or a diagnostic system.
9. How the ground truth for the training set was established: Not applicable.
§ 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.