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The LifeJet™ Video Link is a video image digitizer for the acquisition and conversion into digital format of medical images codified as analogue video signal.

The LifeJet™ Video Link has been developed to be used together with LifeJet™ Printers to produce referral prints of images coming out from ultrasound systems or other medical equipment through the video signal output.

The LifeJet™ Video Link is a small box that integrates the functions and the hardware of a standard personal computer based on a Pentium architecture, for the purpose of acquisition and conversion into digital format of medical images codified as analogue video signal.

The provided text, K013395 for Ferrania S.p.A. LifeJet™ Video Link, does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting performance data from a specific study against predefined acceptance criteria.

Specifically, Section 10.9, titled "Performance data," explicitly states: "Not required for this type of device and its level of concern."

Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided input.

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Ferrania LifeRay™ Cassettes are intended for use during diagnostic X-ray procedures to provide a light-proof enclosure for direct exposure of radiographic film and to hold this radiographic film in close contact with an X-ray intensifying screen.

Ferrania LifeRay™ Cassettes are intended for use during diagnostic x-ray procedures to hold radiographic film in close contact with an x-ray intensifying screen and to provide a light proof enclosure for direct exposure of this film. The Cassettes are in a family of film sizes. The LifeRay™ KW Cassettes contain a window compatible with Kodak system, that permits data writing by a radiographic film marking system. The LifeRay™ WL Cassette is windowless. Radiographic cassettes are composed of: a light tight chamber for preventing radiographic film exposure, a compressible backplate material to assure intimate film-screen contact, a latching mechanism for removal and replacement of radiographic film, a patient oriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to x-rays assembled in a robust support structure to assure durability.

The provided text describes a 510(k) Premarket Notification for Ferrania S.p.A. LifeRay™ Cassettes. This document focuses on demonstrating substantial equivalence to a predicate device rather than a study proving performance against specific acceptance criteria for a novel AI or medical device with complex performance metrics.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in the context of this type of submission for a radiographic film cassette.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided. This 510(k) submission relies on conformity to voluntary standards and comparison to a predicate device, not on a clinical test set with patient data for performance evaluation in the way a diagnostic algorithm would.

3. 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 expert review is not relevant for this device.

4. Adjudication method for the test set

• 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

• Not Applicable. This is a physical radiographic cassette, not an AI or software device that would assist human readers.

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

• Not Applicable. This is a physical radiographic cassette, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is its compliance with established voluntary industry standards (ANSI PH1.49 - 1995 and ISO/FDIS 4090: 2000) and its functional equivalence to the predicate device (TRIMAX RADIOGRAPHIC CASSETTE, K980722). These standards inherently define the acceptable physical and performance characteristics of such a device.

8. The sample size for the training set

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

9. How the ground truth for the training set was established

• Not Applicable / Not Provided.

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The LifeJet™ Printer 400 is an ink jet printer designed to provide referral high quality color and/or gray scale hard copies of medical images generated by medical equipment. The LifeJet™ Printer 400 has been developed to be used together with LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges to achieve the best quality medical images.

The LifeJet™ Printer 400 is an inkjet printer designed to produce high quality color and gray-scale referral medical images. Together with specifically designed medical paper and inks (LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges) the LifeJet™ Printer 400 forms the LifeJet™ 400 System, which is an innovative, convenient and work-flow improving medical printing platform, based on the state of the art inkjet technology, capable of delivering superior and reliable printed images for any medical documentation requirement.

The provided text describes the 510(k) premarket notification for the Ferrania LifeJet™ Printer 400. This document focuses on demonstrating substantial equivalence to a predicate device (Kodak Digital Science 1200 Distributed Medical Imager) rather than establishing novel safety and effectiveness through the demonstration of specific acceptance criteria from a clinical study.

Therefore, many of the requested categories for a study proving device acceptance criteria are not applicable in this context. The available information relates to performance testing for comparison, not an efficacy or diagnostic accuracy study against predefined clinical acceptance criteria.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This product is an inkjet printer. The "acceptance criteria" here are largely implicit in demonstrating substantial equivalence to a predicate device, focusing on technical specifications and basic performance (printing time, optical density, image artifacts). There are no specified clinical acceptance criteria in terms of diagnostic accuracy or clinical outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test set: Not applicable for a clinical test set. The performance testing was based on printing a "203x203 mm image of a SMPTE pattern (512x512 pixel)". This implies a very limited "sample size" of images (likely a single standard test pattern) for objective measurements.
• Data provenance: Not specified, but given the company's location (Ferrania S.p.A., Italy), it is likely the testing was conducted in Italy. It's a lab-based performance test, not a clinical data set.
• Retrospective/Prospective: Not applicable, as this was a controlled laboratory performance test, not a study involving patient data.

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

Not applicable. The "ground truth" for the performance tests (printing time, optical density, mottling, bleeding) would be derived from objective measurements using calibrated instruments, not expert human assessment of diagnostic images.

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

Not applicable. The performance testing involved objective measurements of technical printing characteristics, not subjective interpretation requiring adjudication among experts.

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 a medical inkjet printer, not an AI-powered diagnostic tool. There was no MRMC study, nor any assessment of human reader improvement with or without AI assistance.

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

Not applicable. This device is a printer, not an algorithm. Its "performance" is inherent to its printing capabilities, not an algorithmic output that could be evaluated in a standalone manner.

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

The "ground truth" was based on objective physical measurements for quantitative metrics like printing time, optical density, and visual assessment of physical defects (mottling, bleeding) against a known standard (the SMPTE pattern).

8. The sample size for the training set

Not applicable. This device is an inkjet printer. It does not use a "training set" in the context of machine learning. The design and engineering process might involve iterative testing, but not a dataset used for algorithmic training.

9. How the ground truth for the training set was established

Not applicable (as there is no training set for this type of device).

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