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PaX-Zenith3D is a computed tomography x-ray system intended to take panoramic, cross-sectional images of the oral and craniofacial anatomy and provide diagnostic information for children and adults clinical care in dentistry. The device is operated and used by x-ray technicians and dentists including oral surgeons.

PaX-Zenith3D is a dual X-ray machine which combines cone beam CT and panoramic X-ray modality to offer high definition digital diagnostic images in multi FOV for dental practitioners. Separately embedded panorama and CT sensors capture 2D and 3D images based on digital and CT technology while the most advanced digital imaging process enables the capture S/W program to provide one of the most effective image analysis and diagnosis in real time.

The provided 510(k) summary (K102196) for the PaX-Zenith3D X-ray system does not detail specific acceptance criteria in the form of a numerical table or an explicit study proving numerical performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Picasso-Duo). This means the primary "acceptance criteria" were that the new device performs similarly enough to the legally marketed predicate device to be considered safe and effective for the stated indications for use.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, specific numerical acceptance criteria and a detailed table of device performance against these criteria are not provided in this 510(k) summary. The document emphasizes substantial equivalence based on similarity rather than on meeting specific quantitative thresholds for clinical performance.

The summary states:

• "The actual spatial resolution data for a digital panorama image for Xmarul 501CF for PaX-Zenith3D and S7199-01 for Picasso-Duo are almost identical after considering pixel binning of S7199-01. 5.0 lp/mm(Xmaru1501CF) and 5.2 lp/mm(S7199-01), respectively,"
• "The similar technical characteristics of both devices are further described in the SSXI Non Clinical Report (Tap 25, 26, and 27) in terms of MTF, DQE, and SNR comparison."
• "Finally, the sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well."

These statements indicate that the device's performance was compared to the predicate device's performance across metrics like spatial resolution, MTF (Modulation Transfer Function), DQE (Detective Quantum Efficiency), and SNR (Signal-to-Noise Ratio), and found to be "almost identical" or "similar." However, the exact acceptance thresholds for these similarities or the detailed numerical results are not included in this accessible summary.

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

The document does not specify a sample size for a test set for a clinical performance study. The statement "sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well" suggests that a collection of images was used for comparison, but the number of cases or images is not quantified.

Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned for any clinical data used for comparison.

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

This information is not provided in the summary. Since the submission relies on substantial equivalence and "similar quality of images" rather than a clinical trial with established ground truth diagnoses, details on expert panel review for ground truth are absent.

4. Adjudication method for the test set

This information is not provided. Given the nature of the submission (substantial equivalence based on technical and image quality similarity), a formal adjudication method for a clinical test set is not described.

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

An MRMC study was not performed according to the summary. This device is an X-ray imaging system, not an AI-powered diagnostic aid. The "performance" being evaluated is the image acquisition capability of the hardware, not the performance of human readers with or without AI assistance.

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

A standalone performance study for an algorithm was not done. This device is hardware (an X-ray system) that produces images for human interpretation, not an algorithm designed for standalone diagnostic performance.

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

The document does not describe the use of clinical ground truth (like pathology or outcomes data) in the context of demonstrating substantial equivalence. The comparison heavily relies on technical image quality metrics (spatial resolution, MTF, DQE, SNR) and a subjective assessment of "similar quality of images."

8. The sample size for the training set

This information is not applicable/not provided. This device is an X-ray imaging system and does not employ a machine learning algorithm that requires a "training set" in the conventional sense.

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

This information is not applicable/not provided as there is no mention of a machine learning algorithm or a training set.

Summary of the Study that Proves Device Meets Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (understood as demonstrating substantial equivalence) is primarily non-clinical technical testing and a comparison of sample clinical images.

The submission relies on:

• Technical performance data: Comparison of spatial resolution (5.0 lp/mm for PaX-Zenith3D vs. 5.2 lp/mm for Picasso-Duo, considering pixel binning), MTF, DQE, and SNR as detailed in the "SSXI Non Clinical Report" (Tabs 25, 26, and 27). The conclusion states these were "similar."
• Safety and EMC testing: Adherence to various IEC standards (IEC 60601 series) to ensure electrical, mechanical, and environmental safety, as well as electromagnetic compatibility. "All test results were satisfactory."
• DICOM compliance: Meeting NEMA PS 3.1-3.18 standards for Digital Imaging and Communications in Medicine.
• Clinical image comparison: "Sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well." This suggests a qualitative comparison of images.

The overall approach is to show that the PaX-Zenith3D performs as well as or comparably to the predicate device across key technical specifications and relevant safety standards, thereby establishing substantial equivalence. There is no mention of a formal clinical trial with defined endpoints, statistical analysis, or ground truth establishment for diagnostic accuracy.

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The Picasso-Duo is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images(optionally with panoramic) for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

E-WOO Dental Imaging system Picasso-Duo is a Computed Tomography X-ray System. Computed Tomography (CT) provides valuable 3-D imaging of the dental and maxillofacial structures for diagnosis and treatment planning. Uses of CT imaging include for assessment of impacted teeth, root configurations and mandibular condyle evaluation. This technology allow for 3-D imaging but at lower equipment cost, simpler image acquisition and lower patient radiation dose.

Model Picasso-Duo is diagnostic equipment which consists of panoramic dental x-ray system and computed tomography x-ray system. The panoramic dental x-ray is a system based on digital and computed tomography (CMOS CT Sensor to Capture 3D x-ray Computerized tomogram scanned image)

The provided text is a 510(k) summary for the Picasso-Duo Computed Tomography X-ray System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or performance metrics from such a study.

The summary focuses on regulatory compliance, electrical, mechanical, and environmental safety, and performance testing according to established IEC standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-2-44, and IEC 60601-1-2 for EMC). It states that all test results were satisfactory, implying the device meets the safety and performance requirements of these standards.

Without a dedicated study section, specific details regarding acceptance criteria for diagnostic accuracy, sample sizes for test or training sets, ground truth establishment methods, or expert qualifications are not present in this document.

Therefore, I cannot populate the requested table or answer most of the questions as the information is not provided in the input text.

However, based on the information provided, here are the answers I can deduce or explicitly state:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy for a particular condition). The implied acceptance criteria are compliance with the referenced IEC safety and performance standards.
• Reported Device Performance: "All test results were satisfactory" for electrical, mechanical, environmental safety, and performance testing according to the specified IEC standards. The device is also stated to provide "high quality digital image" and "A clear Tomography image upto minimum 0.1mm at any directions."

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• 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 mention of an MRMC study or AI assistance. This device is a Computed Tomography X-ray system, not an AI-powered diagnostic tool in this context.

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

• Not applicable, as this is a medical imaging device, not a standalone algorithm in the context of diagnostic performance evaluation mentioned in the request.

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

• Not specified. (Likely relies on physical measurements and image quality metrics rather than clinical ground truth for a diagnostic accuracy study, as none is described).

8. The sample size for the training set:

• Not specified. (Not applicable for this type of device submission which doesn't describe an AI training process).

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

• Not specified. (Not applicable).

Summary of what the document DOES state regarding performance/testing:

The device's safety and performance are affirmed by compliance with a series of IEC standards:

• IEC 60601-1 (General requirements for basic safety and essential performance)
• IEC 60601-1-1 (Safety requirements for medical electrical systems)
• IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment)
• IEC 60601-2-7 (Particular requirements for the safety of high-voltage generators for diagnostic X-ray equipment)
• IEC 60601-2-28 (Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies)
• IEC 60601-2-32 (Particular requirements for the safety of associated equipment for X-ray equipment)
• IEC 60601-2-44 (Particular requirements for the safety of X-ray equipment for computed tomography)
• IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)

The document asserts that "All test results were satisfactory" for these standards tests. It also mentions features like "high quality digital image" and "A clear Tomography image upto minimum 0.1mm at any directions."

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The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The device is operated and used by physicians, dentists, and x-ray technologists.

The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The device is operated and used by physicians, dentists, and x-ray technologists.

The provided document pertains to a 510(k) premarket notification for the PaX-Reve3D, a Computed Tomography X-Ray System for dental use. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or multi-reader multi-case (MRMC) studies.

The document primarily focuses on:

• Device Identification: Name (PaX-Reve3D), common name, classification, and predicate devices.
• Description: General overview, product features including input conditions, capture modes (Panoramic, Cephalometric, CT), and X-ray generator specifications.
• Intended Use/Indications for Use: Diagnostic imaging for dental examination and diagnosis of diseases of teeth, jaw, and oral structure.
• Comparison to Predicate Devices: Stating substantial equivalence based on intended use, form factor, material, performance, and safety.
• Safety, EMC, and Performance Data: General statement that testing according to relevant EN/IEC standards was performed and results were satisfactory. This is a very high-level statement and does not provide detailed acceptance criteria or study results.
• Conclusion: Claim of safety, effectiveness, and substantial equivalence.
• FDA Clearance Letter: Official communication from the FDA clearing the device for market.

Therefore, based solely on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and performance study details.

The document only states that "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, EN/IEC 60601-2-32 and EN/IEC 60601-1-44 was performed, and EMC testing was conducted in accordance with a standard EN/IEC 60601-1-2. All test results were satisfactory." This is not specific enough to extract acceptance criteria or performance metrics for image quality or clinical efficacy studies.

To answer your request, detailed performance report documents, which are typically referenced in a 510(k) but not always fully included in the publicly available summary, would be needed.

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The CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options is indicated for head and whole body x-ray computed tomography applications. These options are modifications which can be added to the existing family of ProSpeed Systems. The options include Warp Scan Option which is intended to provide 0.8 second 360-degree helical or axial scans.

Fluoro Scan Option is an almost "real time" reconstruction (Smart Recon) with a display latency of 0.8 to 1.6 seconds. An in-room monitor provides an image display with either a 3 frame/sec or 6 frame/sec display of 90 one second rotation scans. Controls are provided for the control of the table and gantry by a physician or their assistant during procedures that require imaging.

SmartPrep Option is a tool to aid in triggering a helical or axial series of scans after contrast is injected. It allows the operator to monitor contrast as it enhances. A series of images, acquired immediately after injection, is automatically displayed along with pre-selected regions of interest. A graph plots the increase in CT numbers. When the region of interest begins approaching peak enhancement the operator can see that happen on the graph and initiate the CT series.

The ProSpeed Family of Systems are x-ray computed tomography scanners based on the ProSpeed Plus platform consisting of a gantry, patient table, console, computer and associated accessories.

Materials: Materials and construction are equivalent to the CT ProSpeed Plus and are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J.

Design: The design is essentially the same as the CT ProSpeed with Hillight detector (K944013) the difference being that the Fluoro Scan option includes an in-room monitor and a control pedestal. The control pedestal allows for gantry tilt and table positioning as well as initiation and termination of scanning.

Energy Source and Exposure Levels: The energy source and exposure levels are the same as those previously submitted for ProSpeed with HiLight Detector.

Principals of Operation: The same as ProSpeed with HiLight Detector.

This document is a 510(k) summary for a medical device called the "CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options." The purpose of this summary is to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, the document focuses on regulatory submission and does NOT contain information regarding acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, or details of a study proving device performance against specific criteria.

The document primarily describes:

• Product Identification: Name, manufacturer, distributor.
• Marketed Devices: States that it's comparable and substantially equivalent to existing CT systems.
• Device Description: Discusses the components (gantry, patient table, console, computer, accessories), materials (equivalent to CT ProSpeed Plus, compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J), design (similar to CT ProSpeed with Hilight detector, with added Fluoro Scan option features), energy source and exposure levels (same as ProSpeed with HiLight Detector), and principles of operation (same as ProSpeed with HiLight Detector).
• Indications for Use: Head and whole body x-ray computed tomography applications. It also details the specific options:
  • Warp Scan Option: 0.8 second 360-degree helical or axial scans.
  • Fluoro Scan Option: "Real time" reconstruction (Smart Recon) with 0.8 to 1.6 seconds display latency, in-room monitor with 3 or 6 frame/sec display.
  • SmartPrep Option: Aids in triggering scans after contrast injection, displays images with regions of interest, graphs CT numbers.
• Comparison with Predicate: States the device is substantially equivalent to currently marketed head and whole body x-ray CT systems in design, material, energy source, and radiation characteristics.
• Adverse Effects on Health: Identifies potential hazards and controls (Fault Tree Analysis, system evaluation, adherence to standards).
• Conclusions: Claims no new safety risks and performs as well as or better than market devices.

Therefore, it is impossible to complete the requested table and answer the study-related questions based on this document. The text focuses on establishing substantial equivalence for regulatory purposes, not on presenting performance metrics against defined acceptance criteria from a specific study.

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