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The Automatic Radiographic 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 temperatureregulated, circulated and automatically replenished. The feed with of the LifeRay PRO 2500 is 35cm, the smallest film format of the processor is 10x10cm.

This looks like a 510(k) premarket notification for a medical device: "LIFERAY PRO 2500 Automatic Radiographic Film Processor." The document focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study proving performance against acceptance criteria in the way envisioned by your request.

Based on the provided text, there is no specific study that proves the device meets acceptance criteria in the traditional sense of a clinical trial or performance evaluation with quantifiable metrics. The submission primarily argues for substantial equivalence to an existing predicate device.

Here's an analysis based on your requested information, highlighting what is and is not present in the provided text:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. The document does not define specific performance acceptance criteria (e.g., image quality metrics, processing speed within a certain tolerance, chemical residue levels) nor does it report quantifiable performance results against such criteria for the LIFERAY PRO 2500.
• Instead, the submission states that the device "Have the same technological characteristics" and uses the "same photographic processing (developing) technique" as the predicate device. This implies that the performance is expected to be equivalent to the predicate, but no specific data is presented.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. There is no mention of a "test set" in the context of a performance study for the LIFERAY PRO 2500.
• The comparison is conceptual and based on the established equivalence of the device's design and operating principle to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment by experts is described, as there is no performance study with a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No adjudication method is mentioned, as there is no performance study with a test set.

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 an automatic radiographic film processor, not an AI-powered image analysis tool or diagnostic aid. Therefore, MRMC studies or AI-related effectiveness are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, implicitly, but not as a formal study. The LIFERAY PRO 2500 is a standalone physical device. Its "performance" would be its ability to process films according to its design. The submission argues for this standalone performance based on its technological equivalence to the predicate, rather than through a dedicated performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. No ground truth of this nature is used or discussed, as the submission focuses on technological equivalence rather than diagnostic accuracy or clinical outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this device is a mechanical/chemical processor, not a learning algorithm.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set, there is no ground truth for one.

Summary of Device Acceptance (based on the provided text):

The acceptance of the LIFERAY PRO 2500 Automatic Radiographic Film Processor by the FDA, as indicated by the 510(k) clearance (K023825), is based on its substantial equivalence to a legally marketed predicate device (Protec Medizintecnick OPTIMAX K992818).

The rationale for equivalence includes:

• Same intended use.
• Same target user group.
• Same technological characteristics, including the photographic processing technique (mechanical transport, two chemical baths with temperature regulation, circulation, and automatic replenishment, rinsing, drying, ejection for viewing), rollers, guides, and additional functions (anti-crystallization, stand-by mode).
• Both are controlled by integrated software.

The FDA's review concluded that "There are no new questions about safety and effectiveness" and that "The new device is as safe and effective as the predicate device." This means the device met the regulatory bar for market clearance through the 510(k) pathway, but this acceptance was not based on a study demonstrating quantifiable performance against a predefined set of acceptance criteria specific to the LIFERAY PRO 2500. Instead, it relied on the argument that its design and function are sufficiently similar to an already cleared device.

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