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The Alara T210 Computed Radiography System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic filmscreen systems in all general-purpose diagnostic procedures. The T210 is not indicated for use in mammography.

The Alara T210 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor imaging plates exposed using standard x-ray systems and techniques. The system consists of a CR read or iposeing plates, and cassettes. A computer workstation and OC Acquisition software, will be optionally provided by either Alara or the distribution channel.

The provided document describes the Alara T210 Computed Radiography System as a modification of a predicate device (CRystalView T-Series Computed Radiography System, K071682). The rationale for substantial equivalence is based on the new device having the same indications for use and similar technological characteristics, with the main change being image size and system form factor.

The document does not provide detailed information on specific acceptance criteria or a dedicated study with performance metrics for the Alara T210. Instead, it states that "Alara has performed laboratory studies comparing the T210's performance characteristics to those for the predicate," and concludes that "Performance testing of the Alara T210 Computed Radiography system has demonstrated that it is substantially equivalent to the predicate device."

Therefore, I cannot fill out all parts of your request as the information is not present in the provided text.

Here's a summary of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided. The document states that the new device's performance characteristics were compared to the predicate device, but no specific performance metrics or acceptance criteria are detailed.

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

Not provided. The document mentions "laboratory studies" and "performance testing" but does not specify sample sizes or data provenance.

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

Not provided. There is no mention of expert involvement in establishing ground truth for any test set.

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

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

No. The device is a Computed Radiography System, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

Yes, implicitly. The "performance testing" and "laboratory studies" would have evaluated the device itself (the CR system's image generation capabilities) which is a standalone performance by definition for such a device. However, no specific metrics or study details are provided.

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

Not provided. Given that the device generates radiographic images, the "ground truth" for evaluating image quality would likely involve metrics such as spatial resolution, contrast resolution, detective quantum efficiency (DQE), MTF (Modulation Transfer Function), and noise characteristics, which are objectively measurable rather than based on expert consensus for clinical findings, pathology, or outcomes for a diagnostic claim. However, the document does not specify which of these or other metrics were used.

8. The sample size for the training set

Not applicable. This device is a Computed Radiography system for image acquisition, not an AI or machine learning algorithm that requires a training set in the conventional sense.

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

Not applicable. (See point 8)

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