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.

Device Description

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.

AI/ML Overview

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.

Summary

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K023825

510(k) Safety and Effectiveness Summary.

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807.92(a)

Submitter Information

FERRANIA USA INC., Official Corrispondent Ferrania Imaging Technologies 2700-EAST FRONTAGE ROAD WEATHERFORD, OK 73096 Phone: (580) 774-3623 Fax: (580) 774-3658 Contact Person: Mr Doug Hale

S.a.i.e.p. S.r.l., Manufacturer Via Stalingrado 4/32 17014 Cairo Montenotte - GENOVA - ITALY Phone: 0039 019 506108 Fax: 0039 019 5091323 Contact Person: Mario Daniel

Date: 2002-10-29

Trade Name:	LIFERAY PRO 2500
Common Name:	Automatic Radiographic Film Processor
Classification Name:	Automatic Radiographic Film Processor

Regulation Number: 892.1900

Product Code: IXW

Predicate Device

Protec Medizintecnick OPTIMAX K992818

Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table

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· Device Description:

• Intended Use:

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 dryng of films.

Summary of Substantial Equivalence Comparison: .

The comparison of similarities and differences shows that the new device LifeRay PRO 2500 Automatic Radiographic Film Processor, which is intended to market and the predicate device:

1. Have the same intended use.
1. Have the same target user group.
1. 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.

The Automatic Radiographic Film Processor is substantially equivalent to the Protec Optimax Automatic X-Ray Film Processor.

· Technological Characteristics:

The photographic processing (developing) technique employed by the Automatic Radiographic 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 eiected 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

S.A.I.E.P. S.r.1. % Mr. Mario Daniel Ferrania USA, Inc. Ferrania Imaging Technologies 2700 East Frontage Road WEATHERFORD OK 73096-6104 FEB 1 2 2003

Re: K023825

Trade/Device Name: LifeRay PRO 2500 Regulation Number: 21 CFR 892.1900 Regulation Name: Automatic radiographic film processor Regulatory Class: II Product Code: 90 IXW

Dated: October 29, 2002 Received: November 14, 2002

Dear Mr. Daniel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for use.

Applicant:

510(k) Number (if known): _

Device Name: Automatic Radiographic Film Processor LifeRay PRO 2500.

Indication For Use: 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. Typical users of this system are trained medical professionals, including but not limited to physicians. nurses, and lab technicians.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE).

Prescription Use

David a. Segner

Section 10

Regulation Number and Section

§ 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.