(12 days)
The Automatic X-Ray Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures.
Due to the precise roller transport system, both sheet and roller films can be processed. The automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed, fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperature-regulated, circulated and automatically replenished. The feed width of the OPTIMAX is 35 cm, the bigger COMPACT 2 has 45 cm feed with. The smallest film format of both processors is 10*10 cm. The photographic processing (developing) technique employed by the Automatic X-Ray Film Processor is the same as the predicate device. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing. The processors use mechanical rollers and guides for transportation, the solutions are temperature-regulated, circulated and automatically replenished, and same additional functions (anti-crystallization cycle, stand-by mode). Both are controlled by an integrated software.
The provided text is a 510(k) Summary for PROTEC Medizintechnik GmbH & Co. KG's Automatic X-Ray Film Processor (OPTIMAX COMPACT 2). It focuses on establishing substantial equivalence to a predicate device, the DOOSAN DSP 3800 Automatic X-Ray Film Processor (K954345).
The document does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert involvement, adjudication methods, or separate standalone performance studies usually associated with AI/ML devices.
Instead, the submission relies on the argument that the new device shares the same intended use, target user group, and technological characteristics as the predicate device, stating "There are no new questions about safety and effectiveness. The new device is as safe and effective as the predicate device."
Therefore, I cannot provide the requested information in the form of a table or detailed answers as those details are not present in the provided 510(k) summary.
Here's a breakdown of what can be extracted, highlighting the absence of the requested data:
Inability to fulfill the request for Acceptance Criteria and Study Details
The provided 510(k) summary for the "PROTEC Automatic X-Ray Film Processor" focuses on demonstrating substantial equivalence to a predicate device (DOOSAN DSP 3800 Automatic X-Ray Film Processor, K954345) based on shared intended use, target user group, and technological characteristics.
It does not contain information about specific performance acceptance criteria, a study that proves the device meets such criteria, sample sizes, expert involvement, or adjudication methods. Such details are typically associated with performance studies for novel devices or AI/ML-driven systems, which this traditional film processor is not.
The claim of safety and effectiveness is based on the argument that its technology is essentially the same as a legally marketed device.
However, based on the information provided, here are the related points:
-
A table of acceptance criteria and the reported device performance:
- Not Applicable. The document explicitly states: "There are no new questions about safety and effectiveness. The new device is as safe and effective as the predicate device." This indicates that the "acceptance criterion" is effectively substantial equivalence to the predicate, rather than meeting specific performance metrics via a new study.
-
Sample size used for the test set and the data provenance:
- Not Applicable. No explicit performance test set or study data is described. The device's "performance" is inferred from its technological equivalence to the predicate device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No expert-adjudicated ground truth test set is mentioned.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is described.
-
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 an automatic X-ray film processor, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI assistance effect size is relevant or mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical/chemical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No new ground truth establishment for performance evaluation is described. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
-
The sample size for the training set:
- Not Applicable. As a traditional X-ray film processor, there is no "training set" in the context of machine learning. The design and engineering would be based on general principles of film processing and comparison to existing products.
-
How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 892.1900 Automatic radiographic film processor.
(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(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.