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The Televere Digital Imaging System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used. Allows imaging of the skull, chest, shoulders, pelvis, and extremities. Not for mammography.

The Televere Digital Imaging System consists of a combination of digital imaging software, a flat panel display (FPD), a PC-based computer and a power supply. The imaging software has previously been cleared by FDA (i.e., K061035, TigerView Professional). This previously cleared software provides basic image adjustment features: An image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PCcompatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card. The FPD component seeking clearance (PerkinElmer Model XRPad 4343F N) has not been previously cleared by FDA. The FPD uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide (GadOx) scintillator for displaying high quality images over a wide range of dose settings and is intended to be integrated into a complete X-ray system. This premarket notification seeks clearance for a combination finished device consisting of the combination of the previously cleared digital imaging software and the FPD. The combination of the digital imaging software and the FPD does not affect the safety or efficacy of either component device alone, or in combination.

The provided document is a 510(k) premarket notification for the Televere Digital Imaging System. It describes the device, its intended use, and proposes it as substantially equivalent to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numeric fashion other than stating the new device is "as safe and effective as the predicate device" and that "Clinical images collected demonstrate equal or better image quality as compared to our predicate." However, it does provide a comparative table with performance specifications of the new device against the predicate.

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

The document mentions "Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence." It does not specify a sample size for these clinical images, nor does it provide data provenance (country of origin, retrospective/prospective). The primary basis for substantial equivalence seems to be bench testing and comparison of technical specifications.

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

This information is not provided in the document. The substantial equivalence relies on physical and performance characteristic comparisons, not on expert-adjudicated clinical image interpretations for a test set to establish ground truth in the context of device performance metrics like sensitivity/specificity. The statement "Clinical images collected demonstrate equal or better image quality as compared to our predicate" suggests a qualitative assessment, but details about who made this assessment, how many, or their qualifications are absent.

4. Adjudication method for the test set

This information is not provided. Given that quantitative clinical ground truth was not the primary method for demonstrating substantial equivalence, formal adjudication methods are not detailed.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Televere Digital Imaging System is a digital X-ray receptor, not an AI-powered diagnostic tool. The purpose of the submission is to demonstrate substantial equivalence to a predicate X-ray system, primarily through technical specifications and bench testing, for image capture. There's no mention of AI or human reader improvement with or without AI assistance.

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

This question is not applicable as the device is an X-ray imaging system, not an algorithm, and does not operate independently in a diagnostic capacity without human interpretation.

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

For the technical performance metrics (MTF, DQE), the ground truth is established by physical measurements and standardized testing according to IEC standards and FDA guidance documents for solid-state digital X-ray panels. For the qualitative assessment of "clinical images," the type of ground truth and method of establishment is not explicitly stated, but it likely refers to a visual comparison of image quality, not a formal disease presence/absence ground truth.

8. The sample size for the training set

This information is not applicable as the Televere Digital Imaging System is a hardware device (digital X-ray receptor) and not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable as the device is not an AI algorithm and does not use a training set.

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