Search Results

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 temperature-regulated, circulated and automatically replenished. The feed with of the LifeRay PRO 1000 is 35cm, the smallest film format of the processor is 10x10cm.

This 510(k) submission (K023801) is for a medical device called the "LIFERAY PRO 1000 Automatic Radiographic Film Processor." It is important to note that this document does not contain information about a study proving the device meets acceptance criteria.

The purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance metrics through a clinical study with acceptance criteria.

Here's why;

• Device Type: This is an automatic radiographic film processor. Its function is to develop, fix, wash, and dry X-ray films. It is a piece of equipment that processes analog data (film), not a device that generates or analyzes diagnostic information itself (like an AI model for image interpretation).
• 510(k) Process: The 510(k) pathway for medical devices focuses on demonstrating that a new device is substantially equivalent to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and safety/effectiveness profiles, rather than conducting new clinical trials with acceptance criteria for device performance.
• Content of the Document: The document explicitly states: "The comparison of similarities and differences shows that the new device LifeRay PRO 1000 Automatic Radiographic Film Processor... Have the same intended use. Have the same target user group. Have the same technological characteristics. There are no new questions about safety and effectiveness. The new device is a safe and effective as the predicate device." This statement is the core of its argument for substantial equivalence.

Therefore, most of the specific information requested in your prompt (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, standalone performance, training set) would not be relevant or present in this type of 510(k) submission for this particular device. These types of studies are typically associated with devices that perform diagnostic interpretations, especially those incorporating AI or novel diagnostic algorithms.

Based on the provided document, here's what can be extracted related to your request, with the understanding that direct "acceptance criteria" and "study results" as you've framed them are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable. This submission focuses on substantial equivalence based on technological comparison, not a performance study using a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No test set or ground truth establishment by experts is described in this submission.

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

• Not applicable. No test set described.

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:

• No. An MRMC study was not done. This device is a film processor, not an AI-assisted diagnostic tool for human readers.

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

• No. This device is a film processor, not a standalone diagnostic algorithm. Its performance is related to consistent and correct film processing.

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

• Not applicable. Ground truth, in the context of diagnostic performance, is not relevant for this device's type of submission.

8. The sample size for the training set:

• Not applicable. This device does not use a training set in the context of machine learning.

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

• Not applicable. Same as above.

In summary: This 510(k) is a declaration of substantial equivalence for an automatic film processor. The "study" here is essentially the internal analysis by the manufacturer demonstrating that their new device is technologically equivalent to an already approved predicate device, and thus, does not raise new questions of safety or effectiveness. The detailed performance metrics, test sets, and ground truth methodologies typically associated with diagnostic AI or similar advanced diagnostic devices are not part of this submission.

Ask a specific question about this device

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.

Ask a specific question about this device