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The SmartLight Digital Film Viewer System is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films.

The Digital Film Viewer is a radiographic film illuminator with the following new indications for use:

• The Digital Film Viewer substantially improves the ability to detect and discern radiographic objects recorded on film compared to unmasked and masked light boxes.
• The Digital Film Viewer substantially improves the ability to detect and discern clinical information recorded on radiographic film compared to unmasked and masked light boxes.
• The Digital Film Viewer mitigates the age-dependent degradation in the ability to detect or discern radiographic objects recorded on film for readers over 30 years of age, as experienced on unmasked and masked light boxes.

The Digital Film Viewer is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films.

The device senses the size, location, and density of films mounted on its faceplate and automatically adapts film-viewing conditions, as described below:

• Adaptive Light Intensity The device automatically adapts the intensity of the back illumination system according to film density. Back light intensity ranges from 500-10,000 nits.
• Masking The device enables electro-optical collimation of the back illumination such that those parts of the faceplate covered by films are illuminated, while the rest of the faceplate remains dark, eliminating extraneous glare.
• Film Scatter Suppression The device incorporates an optical grid, which projects light in the forward direction to suppress optical scatter within the film (Callier effect).
• Ambient Light The device reduces the ambient light level when films are mounted on its faceplate.
• Pupil Diameter The device emits a dark blue light from its faceplate to control pupil dilation.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with the requested metrics. It primarily focuses on the device description, intended use, and substantial equivalence determination for regulatory clearance.

However, based on the information available, I can extract and infer some points regarding the claims made about device performance, which would typically be linked to acceptance criteria in a detailed study.

Here's an attempt to answer your questions based on the provided text, acknowledging where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a quantitative table of acceptance criteria. However, it states the "new indications for use" which implicitly serve as performance claims that a study would aim to prove. The reported performance is a qualitative statement of improvement.

2. Sample Size Used for the Test Set and Data Provenance

• Sample size for test set: "a large number of observers" is mentioned. The exact number is not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the study is described as a "controlled, statistical study," implying a prospective design for performance evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the text. The document refers to "observer ability to detect and discern radiographic information," which implies human observers were involved in the study itself, but it does not detail how the ground truth for the test cases was established (e.g., who determined the presence or absence of specific radiographic objects or clinical information that observers were asked to find).

4. Adjudication Method for the Test Set

This information is not provided in the text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Yes, a comparative effectiveness study involving multiple readers was performed. The text states:

• "The new indications for use relate to device performance and are based on data from a controlled, statistical study of a large number of observers."
• The study compared performance "when using the Digital Film Viewer compared to either an unmasked or masked light box."

Effect Size: The text states "substantial and significant improvement." However, specific quantitative effect sizes (e.g., AUC increase, sensitivity/specificity gains) or metrics on how much human readers improved with the AI (device) vs. without the AI are not provided.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This device is a film illuminator designed to enhance human viewing of radiographic films. It "automatically adapts film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films."

Therefore, it is not a standalone AI algorithm. Its stated purpose is to improve human performance, meaning a "human-in-the-loop" is integral to its function and evaluation.

7. Type of Ground Truth Used

This information is not explicitly provided. Given the nature of a radiographic film illuminator improving "detection and discernment," the ground truth for cases in the study would likely involve:

• Expert consensus: Multiple radiologists or clinicians confirming the definitive presence or absence of specific objects/findings.
• Pathology or surgical correlation: For certain definitive findings.
• Clinical outcomes data: Though less likely for immediate detection tasks on an illuminator, it could be used for confirming clinical significance.

The document states "observer ability to detect and discern radiographic information," which suggests a 'reference standard' was used to determine what was truly present or absent on the films.

8. Sample Size for the Training Set

The device is described as a "Digital Film Viewer" that uses electro-optical and physical mechanisms to adapt viewing conditions. It's not a machine learning model in the modern sense that typically has a "training set" to learn from data. The device's adaptive mechanisms (e.g., adaptive light intensity, masking, film scatter suppression) are based on pre-programmed rules and optical principles, not on being "trained" on a dataset.

Therefore, the concept of a "training set" for this device is not applicable.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, there is no "training set" for this type of device. Its functionalities are engineered and implemented based on known principles of human visual perception and physics, not through machine learning.

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Radiographic Film Reading

The SL800001 is a motorized radiographic film illuminator which enables electro-optical masking of the back illumination in such a way that those parts of the face plate which are covered by films are illuminated, and exposed parts of the face plate are masked (dark). The SL80000 is designed to minimize problems which are associated with glare induced degradation of visual perception capacity and fatigue of film readers. The SL800000 is is comprised of a motorized belt assembly, fluorescent backlight assembly, electro-optical shutter asembly, CCD based film detection assembly and PC-based control hardware and software.

The provided text describes the Smart Motorized Viewer SL8000DLX, a device designed to improve radiographic film reading by electro-optical masking of back illumination. However, the document does not contain information about specific acceptance criteria, a formal study design with performance metrics, sample sizes for test or training sets, details on expert readers, adjudication methods, or MRMC study results.

The 510(k) summary only states that the device is designed to minimize problems associated with glare-induced degradation of visual perception and fatigue. It also mentions compliance with MDD93/42/EEC standards for electrical and mechanical safety.

The summary concludes by stating, "Based on the above, it is SmartLight's opinion that the SL80000445 is substantially equivalent to the predicate devices." This implies that the device's acceptance criteria are implicitly met by demonstrating substantial equivalence to its predicate devices, which are AMS/Planilux Rotolux and Mammolux (K922079), S&S/RADX MV220/MV400, and SmartLight's Digital Film Viewer SL4000°LCS (K952188). The key difference highlighted is the method of restricting back illumination (electro-optical shutters vs. manual mechanical shutters).

Therefore, a table of acceptance criteria and a detailed study proving the device meets those criteria, as typically found in modern medical device submissions with quantitative performance claims, cannot be extracted from this document. The submission focuses on demonstrating substantial equivalence primarily through a qualitative comparison of design and intended use with predicate devices.

Summary of available information regarding acceptance criteria and study data:

• Acceptance Criteria/Performance Goal: Not explicitly stated as quantitative metrics. The implicit goal is to provide a radiographic film reading experience that minimizes glare-induced degradation of visual perception and fatigue, similar to or better than predicate devices, and to comply with electrical and mechanical safety standards.
• Reported Device Performance:
  • Functionality: Restricts back illumination to film areas by electro-optical shutters.
  • Benefit: Designed to minimize glare-induced degradation of visual perception capacity and fatigue of film readers.
  • Safety: Designed to comply with MDD93/42/EEC standards of electrical and mechanical safety.
  • Hazard Mitigation: Failure in electro-optical masking is immediately observed by the operator, who can reset the device.
• Study Details (Not explicitly present in the document):
  • Sample size for the test set and data provenance: No information.
  • Number of experts used to establish the ground truth for the test set and their qualifications: No information.
  • Adjudication method for the test set: No information.
  • MRMC comparative effectiveness study: No information on such a study or effect size.
  • Standalone (algorithm only without human-in-the-loop) performance: Not applicable, as this is an illuminator, not an AI algorithm. Its performance is inherent in its design and operation for human readers.
  • Type of ground truth used: Not applicable, as no diagnostic study with "ground truth" is described.
  • Sample size for the training set: Not applicable, as no AI model requiring a training set is described.
  • How the ground truth for the training set was established: Not applicable.

In essence, the 510(k) relies on a qualitative argument for substantial equivalence rather than a quantitative performance study with explicit acceptance criteria.

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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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The Diffuser Panel is designed to diffuse the light source in Radiographic Film Illuminators.

The Diffuser Panel consists of layers of light diffusing and brightness enhancer films, plus a clear polycarbonate panel that is coated with a scratch guard to protect the surface of the brightness enhancer from scratching.

The provided text describes a 510(k) premarket notification for a "Diffuser Panel" used in a Radiographic Film Illuminator. It's important to note that this is a very basic accessory device, not an AI or advanced medical imaging device. Therefore, many of the requested categories for acceptance criteria and study details (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of device.

This document focuses on establishing substantial equivalence to a predicate device for a relatively simple component. The acceptance criteria would primarily revolve around basic functional performance (light diffusion, brightness, evenness) rather than complex clinical accuracy.

Here's an attempt to extract and infer the information based on the provided text, with clear indications where information is not available or not applicable.

Acceptance Criteria and Device Performance

Explanation: The document does not provide specific numerical acceptance criteria (e.g., "brightness uniformity less than X%") or quantitative performance metrics. The "performance" is implicitly stated through the device's design and intended function, claiming equivalence to a predicate device.

Study Details

1. Sample size used for the test set and the data provenance:

   • Not Applicable / Not Provided. This is a device component (diffuser panel) where "test sets" of patient data in the clinical sense are not relevant. Testing would likely involve optical measurements or comparisons with the predicate, not clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable / Not Provided. Ground truth (in the context of clinical accuracy) is not established for this type of device. The evaluation would be engineering/performance-based, not clinical interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable / Not Provided. Adjudication methods are relevant for clinical interpretations, not for a diffuser panel.

4. 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 is not an AI device, and an MRMC study is completely irrelevant for a radiographic film illuminator component.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is not an algorithm or an AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. Ground truth, in the clinical sense, is not relevant for this device. The "ground truth" would be the engineering specifications and performance of the predicate device.

7. The sample size for the training set:

   • Not Applicable / Not Provided. This is not a machine learning or AI device that requires a "training set."

8. How the ground truth for the training set was established:

   • Not Applicable / Not Provided. (See point 7)

Summary for this specific 510(k) document:

The provided 510(k) is for a simple component (a diffuser panel) of a medical device (radiographic film illuminator). The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device based on material composition, intended use, and functional characteristics (light diffusion, evenness, brightness, scratch resistance). The detailed clinical study data, expert consensus, and AI-related metrics requested are not applicable to this type of device submission.

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