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KHBS is an "Off the Shelf" software used for quantitative analysis of liver and gallbladder function studies obtains with a scintillation is treaters. The Dicom image data obtained with the scintillation gaments camera is transferred to the software loaded on to a network PC and analyzed by a person familiar with the use of nuclear medicine equipment.

KHBS is an Off the Shelf nuclear hepatology software written on JAVA platform that can be loaded on to a PC. It is used for quantitative analysis and display of planar dicom image data acquired using scintillation gamma camera. The system generates time activity/curves and provides quantitative results of the liver and gallbladder function. It displays images, curves and texts in grey scale or color.

The provided text describes the KHBS v1.1 (Nuclear Hepatology Software) and its 510(k) submission. However, it does not contain a detailed study or specific acceptance criteria and reported device performance in the format requested.

The document focuses on:

• Device description and intended use.
• Comparison to predicate devices, highlighting features that KHBS automates that were manual in predicate devices.
• Safety considerations (risk analysis for calculation errors).
• FDA's 510(k) clearance letter.

Therefore, for most of the requested information, the answer will be that it is not available in the provided text.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

• Not explicitly provided. The document states that "The studies obtained with the scintillation gamma camera and 1.1 were compared with the results obtained with Siemens nuclear medicine software (E.Soft) in our department." This implies a comparison was done, but no specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or agreement rates) or detailed reported performance metrics are given. The comparison table (Table 1) only lists features and whether they are present/manual/auto, not performance metrics.

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

• Not explicitly provided. The text refers to "studies obtained with the scintillation gamma camera," but no details on the number of cases (sample size) or their provenance (country, retrospective/prospective) are given.

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)

• Not explicitly provided. The document does not mention the establishment of a ground truth for a test set or the number/qualifications of experts involved. The comparison was against results from the Siemens E.Soft software.

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

• Not explicitly provided. There is no mention of an adjudication method.

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 MRMC study was described. The comparison was between the KHBS software and the Siemens E.Soft software, not involving human readers directly comparing performance with and without AI assistance to measure improvement in human interpretation. The software "provides quantitative results" and automates calculations, which can reduce manual calculation errors, but an MRMC study demonstrating reader improvement is not detailed.

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

• Implied, but not explicitly detailed as a standalone study. The device itself is a software for quantitative analysis and display. The comparison mentioned ("studies obtained with... KHBS v1.1 were compared with the results obtained with Siemens nuclear medicine software (E.Soft)") seems to be a comparison of the software's outputs (quantitative results) against the outputs of a predicate software. This functions as a standalone performance check against a reference method, but it is not described as a formal 'standalone study' with specific metrics. The software is intended to be "operated only by qualified health care professionals," indicating a human-in-the-loop for interpretation and use.

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

• Reference standard was a predicate device's output. The "ground truth" or reference for comparison was the "results obtained with Siemens nuclear medicine software (E.Soft)." This is a comparison against an existing, legally marketed device's output, rather than an independent clinical ground truth like pathology or expert consensus on clinical outcomes.

8. The sample size for the training set

• Not applicable / Not provided. The document does not describe the development of a machine learning or AI model that would typically require a training set. KHBS is described as "an Off the Shelf nuclear hepatology software" that performs "quantitative analysis and display." The primary benefit highlighted is the automation of calculations that were previously manual.

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

• Not applicable / Not provided. As no training set for an AI/ML model is mentioned, this information is not relevant to the provided text.

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