The device is used for the diagnosis and quantitative. evaluation of 35 mm cine radiographic images, which i originating from radiographic imaging like Angiography.

The device contains a visible light source covered with a translucent front that is intended to be used to view medical cine radiographic images (CFR 21 part 892.1890). It also allows to be used for wall projection. The medical device is not part of a diagnostic x-ray system.

The device may only be operated in cathlabs, lecture halls and doctors' consulting rooms. The device is only for use by medical professionals.

Device Description

The ARRIPRO 35 was designed to fulfil the special requirements in view of an increasing demand for image quality and evaluation precision of 35 mm cardangiofflm material which could only be met with the innovative development of a practice-oriented projector. This projector which was developed using state-of-the-art technology for ease of operation, has an outstanding image quality for the projection, diagnosis and quantitative evaluation of 35 mm cine radiographic images.

The ARRIPRO 35 St / TV has the following functions: Rapid Film Transport and Simple Operation, Optimized Image Quality with Flicker Free Projection, High Speed Shuttle, Revolving Lamp Holder, Optimum Wall Projection, Computer and Video Connections, B&W-CCD-TV Camera.

AI/ML Overview

The provided text is related to a 510(k) submission for a radiographic film illuminator, the "Arripro 35 St / TV." However, it is a premarket notification document, which is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results with acceptance criteria and device performance metrics in the way a clinical trial or performance study report would.

Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information can be extracted:

Type of Device: This is a radiographic film illuminator, a viewing apparatus for 35mm cineradiographic images. It's a Class II device.
Regulatory Context: The document details a 510(k) submission, meaning the manufacturer is seeking to market a new device that is substantially equivalent to a legally marketed predicate device (CAP 35BIII / CINE 275). This process typically relies on demonstrating that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety or effectiveness.
"Study" Information (Implicit): The "study" in this context is the submission itself, which primarily refers to compliance with various DIN and EN standards. These standards implicitly contain performance requirements for viewing apparatus.

Extracted Information and Why Other Information is Missing:

Table of Acceptance Criteria and Reported Device Performance: This is not explicitly provided in the document. The document lists several DIN and EN standards that the device applies for, such as:
- DIN 6856, Part 1: "Demands for the manufacture and the operation of viewing apparatus for the evaluation of transparent images in medical diagnostics."
- DIN 6856, Part 2: "Quality-guaranteeing measures in medical diagnostics, - testing procedures, measuring instruments."
- EN 60950 / IEC 950: Safety of Information Technology Equipment.
- EN 61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use.
- EN 55011 / CISPR 11: Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics.
These standards contain the acceptance criteria (e.g., specific illumination levels, flicker rates, safety parameters, electromagnetic compatibility). The document states the device applies these standards, implying compliance, but does not present a table of specific criteria and the device's measured performance against them. The description of "Optimized Image Quality with Flicker Free Projection" is a qualitative claim rather than a metric.
Sample size used for the test set and the data provenance: There is no information in this document about a test set in the sense of patient data or clinical images. The "testing" referred to would be engineering tests for compliance with the listed standards.
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): This is not applicable/not provided. There is no mention of a human-read test set or ground truth establishment by medical experts for the purpose of this 510(k) submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable/not provided.
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: This is not applicable. The device is a film illuminator, not an AI software, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is not applicable. The device is a physical illuminator, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): This is not applicable/not provided.
The sample size for the training set: This is not applicable/not provided. There is no "training set" as this is not an AI device.
How the ground truth for the training set was established: This is not applicable/not provided.

In summary: The provided document is a 510(k) summary for a radiographic film illuminator. It focuses on demonstrating substantial equivalence through compliance with recognized industry standards and describing the device's technological characteristics. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically associated with clinical performance studies or AI device evaluations.

Summary

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K973115

p.1 of 2

407

ARNOLD & RICHTER CINE TECHNIK GMBH & CO. BETRIEBS KG

TÜRKENSTRASSE 89 · D-80799 MÜNCHEN

ARNOLD & RICHTER CINE TECHNIK · POSTFACH 4001 49 · D-80701 MUNCHEN

Summary of Safety and Effectiveness Information for 510 [k] Submission Radiographic film illuminator 3

FP - 2 1997

General Information:
Proprietary name:	Arripro 35 St / TV
Common name:	--
Classification Name:	Radiographic film illuminator
Classification:	Class II
Classification Number:
Intended use:	The device is intended to be used for the projection, diagnosis and quantitative evaluation of 35 mm cineradiographic images
Legally marketed device:	CAP 35BIII / CINE 275
Proprietary Name:	Cineangiogram projector
Common Name:	--
Classification Name:	Class II
Classification:
Classification Number:	K 971128
Date of submission:	--
DIN-Standards applied for the Arripro 35 St /TV
1. DIN 6856, Part 1Demands for the manufacture and the operation	6. EN 60950IEC 950

	Demands for the manufacture and the operationof viewing apparatus for the evaluation oftransparent images in medical diagnostics.		- IEC 950- DIN EN 60950- VDE 0805
2.	DIN 6856, Part 2Quality-guaranteeing measures in medicaldiagnostics,- testing procedures, measuring instruments	7.	EN-61010-1
3.	DIN 19045, Part 8Projection of still pictures and motion picturesfor educational and home use.	8.	EN-60555-2
4.	EN 55011- CISPR 11	9.	EN 60555-3

DIN NDE 0875-TI I
VDE 0875-TII

ડ. EN 50082-2

DIN EN 20082-2

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Image /page/1/Picture/0 description: The image shows the logo for ARRI, a motion picture technology company. The logo is in black and white and features the company name in bold, sans-serif letters. To the right of the name is a small circle with the letters "ARR" inside.

K4 73115 p. 2 of 2

Technological Characteristics and the intended use of the device

The ARRIPRO 35 St / TV has the following functions:

Rapid Film Transport and Simple Operation

Film transport via a patented internittent film drive system enables a film transport interval of less than 0.01 sec. regardless of projection speed. Constant film tension and reliable film transport is guaranteed through the use of a computer-controlled drive system for the film platter motors.

Film loading is both fast and simple as a result of the computer-controlled system.

Optimized Image Quality with Flicker Free Projection

Image brightness, frame steadiness and image clarity have been optimized for all applications.

High Speed Shuttle

High speed winding and quick localization of specific film frames is accomplished by using the projector's high speed shuttle mode.

Revolving Lamp Holder

The ARRIPRO 35 is equipped with a revolving lamp holder containing three (3) lamps, two (2) 300 W halogen lamps and one (1) 400 W HTI-lamp for bright wall projection.

Optimum Wall Projection

The ARRIPRO 35 also functions as an excellent quality wall projection unit.

Computer and Video Connections

A video output enables the connection of additional monitors, video recorder and video printer.

B&W-CCD-TV Camera

B& W-CCD-TV camera with motor-driven x-y zoom carriage as well as motor driven focusing. TV-image can be panned in all directions and zoomed up to 3.0 times.

DIN-Standards applied for the Arripro 35 St /TV

1.	DIN 6856, Part 1Demands for the manufacture and the operationof viewing apparatus for the evaluation oftransparent images in medical diagnostics.	5.	EN 60950- IEC 950- DIN EN 60950- VDE 0805
2.	DIN 6856, Part 2Quality-guaranteeing measures in medicaldiagnostics,- testing procedures, measuring instruments	6.	EN-61010-1
3.	DIN 19045, Part 8Projection of still pictures and motion picturesfor educational and home use.	7.	EN-60555-2
4.	EN 55011- CISPR 11- DIN VDE 0875-T11- VDE 0875-T11	8.	EN 60555-3
		9.	EN 50082-2- DIN EN 50082-2- VDE 839-T82-2

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arnold & Richter Cine Technik GmbH & Co. Betriebs KG c/o Carole Stamp TUV Product Service ... 1775 Old Highway 8 New Brighton, MN 55112-1891 Re: K973115

Arrioro 35 St / TV (35 mm film viewer) Dated: August 18, 1997 Received: August 20, 1997 Regulatory Class: I 21 CFR 892.1890/Procode: 90 LXC

SEP - 2 1397

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 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). 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class 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 requirement, as set forth in the Quality System Regulation (OS) 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 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 regulation 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/dsmamain.html".

Sincereiv yours

h.J. Liao Yin
Lillian Yin, Ph.D.

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Radiographic Film Illuminator

Indications For Use:

The device is used for the diagnosis and quantitative. evaluation of 35 mm cine radiographic images, which i originating from radiographic imaging like Angiography.

The device may only be operated in cathlabs, lecture halls and doctors' consulting rooms. The device is only for use by medical professionals.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiologigel Du

Radiological Devices
510(k) Number_k972115

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-7

Regulation Number and Section

§ 892.1890 Radiographic film illuminator.

(a)
Identification. A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.