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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.

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.

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:

1. 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.

2. 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.

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): 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.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable/not provided.

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: This is not applicable. The device is a film illuminator, not an AI software, and no MRMC study is mentioned.

6. 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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This is not applicable/not provided.

8. 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.

9. 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.

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