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The Imaging Sciences International Inc. Panatome Imaging system is a multifunction computer controlled Tomographic X-Ray device for taking radiographs of the head and neck region. This device has the ability to provide panoramic and pluridirectional Tomographic images. The operators manual describes the computerized operator interface for selecting and executing the various radiographic procedures.

The panoramic function of this unit produces the same standard panoramic image as numerous other units in use for past several decades.

The tomographic function is also similar to other units in use for past few decades, except it employs complex motion to produce tomographic slices as opposed to more commonly used linear motion. Slices produced by a complex tomographic motion are superior and more accurate as compared to linear slices. Complex motion has been used by a few other units in the recent past.

Tomographic imaging is commonly used for TM Joint studies, mandible & maxilla for implant planning, sinuses, etc.

The Imaging Sciences International Inc. Panatome is a free standing Tomographic X-Ray machine that may also be affixed to the wall during installation for added stability. All of the Panatome functions such as kVcp, mA, exposure time and all motor functions are computer controlled. There is a touch screen monitor that will display the various technique factors.

The provided text describes a 510(k) summary for the Imaging Sciences International Inc. Panatome Tomographic X-Ray machine. This summary establishes substantial equivalence to a predicate device and includes an assessment of non-clinical performance. However, it does not contain the specific details required to complete all sections of your request regarding acceptance criteria and a study proving device performance against those criteria.

Specifically, the document focuses on:

• Device Description and Intended Use: Explains what the Panatome does and its clinical applications.
• Technological Characteristics: Details the electrical and mechanical aspects of the device.
• Substantial Equivalence Claim: States that the Panatome is substantially equivalent to the CommCAT IS 2000.
• Non-Clinical Performance Assessment: Mentions that the Panatome produced radiographs of a step wedge and a phantom that were comparable with the CommCAT IS 2000 and are adequate for their intended use. This is the extent of the performance data provided.

The document does not include:

• A table of specific acceptance criteria.
• Detailed quantitative performance metrics (e.g., sensitivity, specificity, accuracy, resolution, signal-to-noise ratio).
• Information on sample size, data provenance, number or qualifications of experts, adjudication methods, or ground truth for a test set.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only study.
• Sample size or ground truth details for a training set.

Therefore, I can only provide information based on what is available in the text.

Here's the breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The "non-clinical performance" refers to the device producing radiographs of "a step wedge and a phantom." It does not indicate a large-scale test set of patient data.
• Data Provenance: Not specified. It's a non-clinical evaluation using phantoms, not human data.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The evaluation states "radiographs... were comparable with the CommCAT IS 2000 and are adequate for their intended use," implying some form of expert qualitative assessment, but no details are provided.

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

• Adjudication Method: Not specified.

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, an MRMC comparative effectiveness study was not mentioned. The device is a traditional X-ray machine, not an AI-assisted diagnostic tool.

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

• No, a standalone algorithm-only performance study was not mentioned. The device is a hardware X-ray machine; there is no mention of an embedded AI algorithm.

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

• For the non-clinical evaluation, the "ground truth" was likely derived from the known properties of the step wedge and phantom, which serve as standardized objects used to assess imaging quality (e.g., resolution, contrast, artifact presence). Comparison was made against images from the predicate device (CommCAT IS 2000).

8. The sample size for the training set

• Not applicable. This device is a hardware X-ray machine. There is no mention of an algorithm requiring a "training set."

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

• Not applicable. (See #8)

Summary of what's provided related to "acceptance criteria" and "study":

The document presents a non-clinical performance assessment designed to demonstrate "substantial equivalence" to a predicate device. The "study" involved generating radiographs of a step wedge and a phantom using the Panatome and comparing them to those produced by the CommCAT IS 2000. The "acceptance criteria" appear to be a qualitative assessment that the Panatome's images were "comparable" and "adequate for their intended use" when compared to the predicate. This is a common approach for 510(k) submissions for devices asserting substantial equivalence, especially for mature technologies like X-ray machines. This type of submission generally does not require the extensive clinical trial data or detailed performance metrics that would be associated with novel diagnostic algorithms or higher-risk devices.

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