(90 days)
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:
| Acceptance Criteria (Not explicitly stated as such, but inferred from Substantial Equivalence Claim) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|
| Intended Use: Process films exposed for medical purposes; automatic and continuous development, fixing, washing, drying. | Meets: Same intended use as predicate device. |
| Technological Characteristics: Mechanically transports film, immersion in chemical baths (developer, fixer), water rinse, drying, ejection. Temperature-regulated/circulated/replenished solutions, anti-crystallization, stand-by mode. Integrated software control. | Meets: Same technological characteristics as predicate device. |
| Safety and Effectiveness: No new questions regarding safety and effectiveness compared to predicate. | Meets: As safe and effective as predicate device. |
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.
§ 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.