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The intended use of the device is to produce attenuation-corrected NM images, even when attenuation coefficients are not uniform over the FOV.

To obtain attenuation corrected Nuclear Medicine images.

The VTransACT attenuation correction system is an addition to the Apex VariCam and Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected NM images for non-uniform attenuation.

Here's a summary of the acceptance criteria and study information for the VTransACT: Attenuation Correction System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage improvement, a threshold for uniformity). Instead, the "Summary of Studies" section provides a qualitative performance statement.

• Ability to produce more uniform images than regular SPECT without attenuation correction.
• Performance comparable to the predicate device (TransACT option for the CardiaL Gamma Camera). | - "Bench data and Clinical data show that the VTransACT option for the VariCam delivers more uniform images than regular SPECT without attenuation correction."
• "Comparison to TransACT images shows no significant difference." |

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

• Sample Size: The document does not specify the sample size for the "Clinical data" or "Bench data" studies.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It only states "Bench data and Clinical data."

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

The document does not provide information about the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. It states a comparison was made to the predicate device's images ("Comparison to TransACT images shows no significant difference"), but this is not described as an MRMC study and no effect size for human reader improvement is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The "Summary of Studies" focuses on the device's ability to "deliver more uniform images" and its "Comparison to TransACT images." This suggests the algorithm's performance in generating corrected images was assessed. While human interpretation of these images is the ultimate goal, the phrasing "delivers more uniform images" points to an evaluation of the algorithm's output itself, implying a standalone assessment of the image correction quality. However, it is not explicitly stated that this was a standalone performance study distinct from human interpretation.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. Given the nature of an "Attenuation Correction System" and the performance reported ("delivers more uniform images"), the ground truth likely relates to objective measures of image uniformity or accuracy against a known physical phantom (for "Bench data") or clinical images where attenuation effects are understood/quantified. However, this is not specified as expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

The document does not provide information about the sample size for a training set. The device description mentions it "comprises additional hardware and software to generate corrected NM images," implying an algorithmic approach, but no details on training data are given.

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

The document does not provide information on how ground truth for any training set was established, as no training set is mentioned.

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