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.

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 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.

AI/ML Overview

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.

Summary

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1 1999

Section 7

PROTEC Medizintechnik GmbH & Co. KG · Lichtenberger Stroße 35 · D.71720 Oberstenfeld

510(k) Summary

Lichtenberger Straße 35 D-71720 Oberstenfeld

Telefon +49 70 62-92 55-0 Telefax +49 70 62-2 26 85 e-mail protec@protec-med.com internet http://www.protec-med.com

made in Germany

ાં

From Contact Person Mr. Frank Baisch e-mail frank.baisch@protec-med.com Telephone +49-7062-9255-17 Date May 17, 1999

This Summary of Safety and Effectiveness is in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Device:

Automatic X-Ray Film Processor Common name:

Trade name:

OPTIMAX COMPACT 2

Processor, Radiographic-Film, Automatic Classification name:

Predicate Device:

The Predicate Device is a legally marketed, postamendments device:

K954345 DOOSAN DSP 3800 Automatic X-Ray Film Processor

Device Description

Geschäftsführer: Erhard Fichtner Reg. Gericht Vaihingen/Enz

7-1 Bankverbindungen: Baden-Württembergische Bank AG Reutlingen BLZ 640 200 30, Kto.-Nr. 1 401 737 000

Dresdner Bank AG, Filiale Heilbronn BLZ 620 800 12, Kto.-Nr. 7 195 47300 Raiffeisenbank Oberstenfeld eG BLZ 600 697 27, Kto.-Nr. 324 703 007

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Image /page/1/Picture/0 description: The image shows the word "PROTEC" in large, bold, white letters with a black outline. Below the word, there is a black swoosh design. Underneath the swoosh, there is some smaller text that says "Performance Lubricants" and "made in Germany."

PROTEC Medizintechnik

892.1900 - IXW - Class II

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 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.

Summary of Substantial Equivalence Comparison

The comparison of similarities and differences shows that the new device PROTEC Automatic X-Ray 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 as safe and effective as the predicate device.

The Automatic X-Ray Film Processor is substantially equivalent to the DOOSAN DSP 3800 Automatic X-Ray Film Processor.

Technological Characteristics

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.

PROTEC Medizintechnik GmbH & Co KG

Frank Baisch

(R&D Manager)

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1999 SEP

PROTEC Medizintechnik GmbH & Co. KG C/O Carole Stamp TUV Product Service. Inc. 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891

RE: K992818 OPTIMAX/COMPACT 2 Dated: August 19, 1999 Received: August 20, 1999 Regulatory Class: II 21 CFR 892.1900/Procode: 90 IXW

Dear Ms. Stamp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Dan Letitia

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 2

VERTRAULICH
CONFIDENTIAL

Page 1 of

510(k) Number (if known):

Automatic X-Ray Film Processor Device Name:

Indications For 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 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)

Daniel A. Seymann

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use √

Over-The-Counter Use_

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.