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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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The XR-910 folds into a compact unit (20" W 54.5" L 21" H). The XR-910 is then easily transported by a van or similar vehicle, to a private residence, nursing home, medical clinic, and other such facilities. With the large 15" pneumatic wheels, and 20" wheelbase and a weight of only 78 lbs., the XR-910 can be easily maneuvered through doorways, hallways, and up and down flights of stairs. This can be accomplished by an average person. Due to the large vertical movement of the tubehead and boom arm, and rotational positions of the tubehead, radiographs may be taken with the patient standing, sitting or supine. Radiographs may be taken of the chest and extremities. The XR-910 is a 60 to 90 kVp, 10 mA unit. Using 800 speed film and screens, exposure times for most radiographs are less than 100 milliseconds.

The XR-910 Mobile X-Ray unit is a light weight (78 pounds), compact (20" W 54.5" L 21" H), X-Ray System. The system can be easily loaded into a van or similar vehicle for transporting to the site where the unit will be used.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided document is a 510(k) Summary for the Imaging Sciences International Inc. XR-910 Mobile X-Ray unit, submitted in 1998. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving unique acceptance criteria through a formal, quantitative study as might be expected in a modern AI/software device submission.

As such, many of the typical acceptance criteria and study details for an AI-powered device (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone performance) are not present or applicable. The device described is a physical X-ray unit, not an AI algorithm.

However, I can extract the closest equivalent information based on the text provided:

1. Table of Acceptance Criteria (or rather, Performance Claims) and Reported Device Performance

For this device, the "acceptance criteria" are implied by the claims of substantial equivalence and suitability for its intended use, particularly in mobility and image quality comparable to a predicate device.

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

• Sample Size: Not explicitly stated. The "test" involved evaluating the physical unit's mobility and taking radiographs of a "step wedge and a phantom." This implies a very small, controlled set of test cases, not a large patient data set.
• Data Provenance: The "evaluation process" appears to have been conducted internally by Imaging Sciences International Inc. at their facility ("throughout various parts of our building"). This is a manufacturer-conducted, non-clinical, prospective evaluation.

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. Given the nature of the tests (mobility, phantom image quality), it's highly unlikely that multiple human experts in the sense of clinical reviewers were involved to establish ground truth for a diagnostic outcome. The assessment of "comparable" image quality would likely have been made by the engineers or technical staff conducting the test.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/specified. No formal adjudication process as understood in clinical studies (e.g., 2+1 reading) is mentioned or implied for this type of non-clinical, technical evaluation.

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

• MRMC Study: No, an MRMC study was not done.
• Effect Size of AI Improvement: Not applicable, as this device is a traditional X-ray unit, not an AI-powered diagnostic tool.

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

• Standalone Performance: Not applicable, as this is a physical X-ray device, not an algorithm.

7. The type of ground truth used

• Ground Truth: For the mobility assessment, the "ground truth" was the direct observation of the unit's ability to be maneuvered through various environments by an "average person." For radiographic performance, the "ground truth" was a comparison of images from a "step wedge and a phantom" to those produced by the predicate DynaRad unit, and a qualitative assessment of whether they were "adequate for their intended use." This is essentially expert judgment based on internal technical evaluation using standard test objects.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a hardware device, not an AI algorithm that undergoes "training." Its design and engineering are based on established X-ray technology (specifically, the Keystone X-Ray Intrex VSK, K931486) and general engineering principles.

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

• Training Set Ground Truth: Not applicable for a hardware device. Its performance is validated through physical testing and comparison to established medical device standards and predicate device performance.

Summary for this specific document:

The provided document describes a traditional mobile X-ray unit and its 510(k) submission from 1998. The "studies" conducted were non-clinical performance assessments focusing on mechanical, electrical, and radiographic equivalence to a predicate device ("DynaRad Corporation Phantom Portable X-Ray system"). The assessment criteria were suitability for its intended use, mobility, and image quality on phantoms/step wedges, not AI performance metrics. Therefore, most of the requested information pertaining to AI algorithm evaluation (sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, etc.) is not present and not applicable to this device.

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