(31 days)
The DS Cassette is 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. It is not intended for mammography use.
The DS Cassette is 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. The cassette is in a family of film sizes. The sizes are as follows; 35 x 43cm, 35 x 35cm, 40 x 40cm, 30 x 40cm, 30 x 35cm, 24 x 30cm, 24 x 24cm, 20 x 40cm, 18 x 43 cm, 18 x 24cm, 15 x 40cm, 15 x 30cm, 14 x 17inch, 14 x 14inch, 12 x 15inch, 11 x 14inch, 10 x 12inch, 8 x 10inch, 6.5 x 8.5inch, 7 x 17inch. The exposed film is taken out from the Cassette manually or automatically for processing by X-ray film processor such as Konica DS-7 automatic X-ray film processor, 510(k) number K931316.
The provided text is a 510(k) Summary for a radiographic film cassette. This type of document is for a medical device and typically demonstrates substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or AUC as might be done for AI/ML-based diagnostic devices.
Therefore, much of the requested information (like sample size for test/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes) is not applicable to this type of device and submission. The submission focuses on product specifications and conformance to an existing standard.
Here's the information that can be extracted or deduced from the provided document:
Acceptance Criteria and Device Performance for DS Cassette
| Criterion | Reported Device Performance |
|---|---|
| Intended Use Conformance | The DS Cassette is 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. It is not intended for mammography use. |
| Conformance to ISO 4090:2001 (Standard) | The DS Cassette conforms to ISO 4090:2001. A certification by the manufacturer, Okamoto Manufacturing Co., Ltd., is attached as proof. |
| Substantial Equivalence to Predicate | The DS Cassette is substantially equivalent to Konica Mammography Cassettes; Models CM and CM DS-7 (510(k) number: K963914) in terms of technological characteristics and intended use (excluding mammography for the DS Cassette). |
| Device Specifications (Physical Sizes) | Available in various sizes: 35x43cm, 35x35cm, 40x40cm, 30x40cm, 30x35cm, 24x30cm, 24x24cm, 20x40cm, 18x43cm, 18x24cm, 15x40cm, 15x30cm, 14x17inch, 14x14inch, 12x15inch, 11x14inch, 10x12inch, 8x10inch, 6.5x8.5inch, 7x17inch. Product specifications by the manufacturer are attached. |
| Light-proof Enclosure | Designed to provide a light-proof enclosure for direct exposure of radiographic film. |
| Film Contact | Designed to hold a radiographic film in close contact with an x-ray intensifying screen. |
Study Information (based on available text):
- Sample size used for the test set and the data provenance: Not applicable. This submission doesn't describe a clinical "test set" in the context of performance metrics for an AI/ML device. It relies on design specifications and conformance to standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 passive device (cassette), not an AI/ML diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" here is adherence to design specifications, the physical characteristics of the device, and conformance to the ISO standard.
- The sample size for the training set: Not applicable. This device does not involve training data as it is not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary of Acceptance Criteria and Evidence from Text:
The acceptance criteria for the DS Cassette are primarily based on its physical characteristics, intended use, and conformance to an international standard, rather than performance metrics derived from clinical studies with ground truth. The study that "proves the device meets the acceptance criteria" is implicitly the design and manufacturing process certified to meet ISO 4090:2001 and the demonstration of substantial equivalence to a previously cleared predicate device (Konica Mammography Cassettes; Models CM and CM DS-7, K963914) for its non-mammography intended use. The submission includes a "certification by a manufacturer of the cassette" as evidence of compliance.
§ 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.