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The Imaging Sciences International Inc. i-CAT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.

The i-CAT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The i-CAT Scanner can measure distances and thickness on two dimensional images. Images produced by the i-CAT Scanner can be printed or exported on magnetic and optical media.

The i-CAT Scanner gantry is comprised of an X-ray source, image detector, and motorized gantry. The gantry facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector, transforms them into three dimensional images and displays them on the workstation monitor for viewing.

This 510(k) summary for the i-CAT Scanner does not contain specific acceptance criteria or details about a study designed to prove the device meets those criteria. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific, quantifiable metrics.

Therefore, many of the requested information points cannot be extracted from this document.

However, I can provide what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not define specific performance acceptance criteria (e.g., accuracy, resolution benchmarks) for the i-CAT Scanner, nor does it report performance metrics against such criteria. The "Conclusions" section broadly states that potential hazards are controlled by the design, verification, and validation process, and that the device complies with 21 CFR 807.87 and poses no new safety risks or effectiveness issues.

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

Not specified. The document does not describe a clinical or technical test set used to evaluate the device's performance.

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

Not applicable, as no described test set with ground truth is mentioned.

4. Adjudication method for the test set:

Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

No MRMC study is mentioned. The document focuses on the device's technical specifications and intended use in comparison to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) study:

Not applicable. This is an imaging device, not an AI algorithm for interpretation. Its performance is inherent in the image acquisition and reconstruction process, which is then interpreted by a human.

7. The type of ground truth used:

Not explicitly stated for any performance evaluation. The document implies that the device's ability to "construct a three dimensional model" and "measure distances and thickness" is a functional truth, but it doesn't detail how the accuracy of these functions was verified against a "ground truth."

8. The sample size for the training set:

Not applicable. This device is an X-ray scanner, not a machine learning algorithm that requires a "training set."

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

Not applicable.

Summary of what is available from the document:

• Device Name: i-CAT Scanner
• Intended Use: Constructs a three-dimensional model from images taken during a rotational X-ray sequence. Intended for use whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects, specifically for TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
• Substantial Equivalence: Claimed against NewTom QR - DVT 9000 (K003787) and 3D Accu-I-tomo XYZ Slice View Tomograph (K030450).
• General Compliance: The device is stated to comply with 21 CFR 807.87 and does not pose any new safety risks or effectiveness issues. Potential hazards are reportedly controlled by design development, verification, and validation processes, including a risk management system.

The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive performance testing and acceptance criteria. For devices like this X-ray scanner, the performance is often assessed through bench testing and verification activities that ensure the device meets its design specifications (e.g., image quality, dose, measurement accuracy), but these specific details are not included in this summary.

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The Imaging Sciences International Inc. DVT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The DVT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The DVT Scanner is optimized for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, the maxillofacial complex, temporal bone, etc.

The DVT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional that aod a boo adgrounde and produces two dimensional views of this volume. The matix of the oxamined stances and thickness on two dimensional images. Images produced by the DVT Scanner can be printed or exported on magnetic and optical media.

The DVT Scanner gantry is comprised of an X-ray source, image detector, and motorized gantry. The gantry facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector, sonward. The bormal images and displays them on the workstation monitor for viewing.

This 510(k) submission (K051980) for the DVT Scanner by Imaging Sciences International Inc. primarily focuses on substantial equivalence to predicate devices and does not include a comparative study or detailed acceptance criteria with performance metrics in the provided document. The submission is a premarket notification to establish that the DVT Scanner is at least as safe and effective as a legally marketed device.

Therefore, many of the requested sections below cannot be populated as the information is not present in the provided text.

Acceptance Criteria and Study Details for DVT Scanner (K051980)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria or quantitative performance metrics for the DVT Scanner. The approval is based on substantial equivalence to predicate devices, implying that its performance is considered comparable to those devices.

The document states, "The DVT Scanner complies with the requirements of 21 CFR 807.87 and does not pose any new safety risks or effectiveness issues." This is a high-level statement and not a specific performance metric.

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

The provided document does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective or prospective) for a standalone device performance study. The approval is based on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided document does not describe any study involving experts to establish ground truth. The submission is focused on substantial equivalence to existing devices.

4. Adjudication Method for the Test Set

Since no specific test set or study for ground truth establishment is described, there is no mention of an adjudication method in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The submission focuses on device equivalence, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

The provided document does not describe a standalone performance study for the DVT Scanner's algorithm. The device is described as an X-ray imaging system that reconstructs 3D models and displays them for interpretation by a dentist, oral surgeon, or other physician, inherently implying human-in-the-loop use.

7. Type of Ground Truth Used

The provided document does not mention the type of ground truth used as no specific performance study against a ground truth is detailed.

8. Sample Size for the Training Set

The provided document does not specify any training set size as it does not describe the development or validation of a machine learning or AI algorithm in the context of a training set. The device is an imaging system, not an AI-driven diagnostic tool in the sense of modern AI/ML submissions.

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

As no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established in the provided document.

Summary of Information from the Provided Text:

The K051980 submission for the DVT Scanner is a premarket notification for a Computed Tomography X-ray System. It asserts substantial equivalence to three predicate devices: NewTom QR - DVT 900 (K003787), Advantage 3-D XR (K945375), and 3D Accu-l-tomo XYZ Slice View Tomograph (K030450). The DVT Scanner is described as a device that acquires a 360-degree rotational X-ray sequence to reconstruct a three-dimensional model, producing two-dimensional views for dentists, oral surgeons, or other physicians to obtain 3D information of high-contrast objects. Its intended uses include TM Joint studies, mandible & maxilla for implant planning, sinuses, the maxillofacial complex, and temporal bone studies. The document concludes that the device complies with regulations and does not pose new safety risks or effectiveness issues, based on its design, development, verification, and validation process, which includes a risk management system. However, specific performance metrics, study designs, sample sizes, or ground truth methodologies are not detailed in this 510(k) summary.

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SurgPLAN and PanPLAN are Software packages that scan film using optical scanner or Direct Digital Capture using Solid State Sensors (from the Sensor) and store images produced by Imaging Sciences International's (or other manufacturer's) Tomographic, Panoramic and Cephlometric imaging machines. Additionally, the software has the ability to import DICOM images from volumetric data sets for analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of the imaging modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.

SurgPLAN / PanPLAN is a comprehensive software package that can scan films or certain solid state detectors, read DICOM images or DICOM volumetric data sets and display the images for the practitioner to perform analysis, measurements and surgical demonstrations for dental implants.

The provided text is a 510(k) Summary for the SurgPLAN / PanPLAN software, a device for dental implant planning and analysis. While it mentions performance testing and validation, it does not explicitly detail specific acceptance criteria or the study that proves the device meets those criteria. The summary focuses on establishing substantial equivalence to predicate devices and addressing potential hazards.

Therefore, for several of your requested points, the information is not available in the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Information Not Available in the Document. The document states: "The performance testing of the Imaging Sciences International Inc. SurgPLAN / PanPLAN would indicate that the system is substantially equivalent to both predicated devices." However, it does not provide specific performance metrics or acceptance criteria for these metrics.

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

Information Not Available in the Document. The document mentions "performance testing" but does not specify the sample size, type of test data (e.g., patient cases), or its provenance.

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)

Information Not Available in the Document. The document does not describe how ground truth was established for any testing, nor does it mention the involvement or qualifications of experts in that process.

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

Information Not Available in the Document. The document does not describe any adjudication method used for testing or ground truth establishment.

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

Information Not Available in the Document. The document does not mention an MRMC study or any study comparing human reader performance with and without AI assistance. The device's primary function described is analysis and planning, not necessarily aiding human readers in interpretation.

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

Information Not Available in the Document. While the software performs analysis and measurements, the document does not distinguish between standalone algorithm performance testing and performance in a human-in-the-loop scenario. The overall context suggests it's a tool for the practitioner: "The software allows the practitioner to perform analysis, measurements and surgical demonstrations..."

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

Information Not Available in the Document. The document does not specify the type of ground truth used for performance testing or validation.

8. The sample size for the training set

Information Not Available in the Document. The document does not mention a training set or its size. While software often involves training data (especially if it uses AI/machine learning, which isn't explicitly stated here), this information is not provided.

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

Information Not Available in the Document. As no training set or its ground truth establishment is mentioned, this information is not provided.

Summary of what is available:

The 510(k) summary for SurgPLAN / PanPLAN focuses on:

• Substantial Equivalence: Claiming substantial equivalence to SimPlant (Materialise/Columbia Scientific) and CDRPan and CDR DICOM (Schick Technologies Inc.).
• Device Description: A software package that scans films or solid-state detectors, reads DICOM images/volumetric data, and displays images for analysis, measurements, and surgical demonstrations for dental implants.
• Intended Use: Providing a convenient method for visualization in planning (implants, cephlometric analysis, bone graft), facilitating communication, and demonstrating treatment plans.
• Hazards Control: Stating that potential hazards (e.g., incorrect measurements, imprecision) are controlled by the software development and validation system.

The document is a regulatory submission demonstrating a belief in equivalence and safety, but it is not a detailed technical report of performance criteria and empirical study results.

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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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