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I-MAX Touch 3D, panoramic X-ray imaging system with cephalostat, is an extra-oral source Xray system which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry. It also has the capability, using the CBVT technique, to generate dentomaxillofacial 3D images. The device uses a cone shaped X-ray beam projected on a flat panel detector; the examined volume image is reconstructed to be viewed on 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals

The I-MAX Touch 3D is a panoramic x-ray system utilizing digital imaging. It can be equipped with a cephalostat. The device can be equipped with accessories to fulfill different diagnostic needs. The images are acquired by a flat panel detector and are displayed on a monitor; image processing, manipulation, archiving, communication and 3D reconstruction (starting from cross-sectional images taken using CBVT (Cone Beam Volumetric Tomography) technique) are performed using a computer.

The provided 510(k) summary for the I-MAX Touch 3D does not contain specific acceptance criteria or an analytical study comparing its performance against predefined metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on a standalone (algorithm only) performance study.
• Type of ground truth used for testing.
• Sample size for the training set.
• How ground truth for the training set was established.

Rationale for this conclusion based on the provided text:

The submission focuses entirely on substantial equivalence to a predicate device (Villa Sistemi Medicali Rotograph EVO 3D, K111152). Key statements supporting this include:

• "The I-MAX Touch 3D has the same indication for use as the predicate device."
• "It is identical to the predicate device except for the design of some of its external plastic covers and for the control panel."
• "It shares the same technological characteristics as the predicate device."
• "The minor technological and design differences do not raise any new questions regarding safety or effectiveness of the device; both devices are used in the same identical way."
• "Conclusion: The I-MAX Touch 3D performs the same identical functions in the same environment as the predicate device. It uses the same technology as the predicate device, based on well-known technology. It is as safe and effective as the predicate device. We believe it does not introduce any new potential safety risks and is substantially equivalent and identical to the predicate device."

For devices seeking 510(k) clearance based on substantial equivalence, especially for a new device that is nearly identical to a predicate (as described here), a detailed performance study with specific acceptance criteria and ground truth evaluations like those requested are often not explicitly required in the 510(k) summary itself. The assumption is that since the technology and intended use are the same, the performance would be equivalent. The "testing" mentioned refers to compliance with safety standards (IEC 60601-1) and internal verification/validation, not a clinical or image quality comparison with a gold standard or human readers.

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The I-MAX Touch (PAN and CEPH) is intented for dental radiographic examination of the teeth and specifically for panoramic examinations, TMJ studies, implantology and Cephalometry. It is to be only used by dental practitioners and/or radiologists.

The I-Max Touch (PAN and Ceph) is a digital image acquisition system to be used in conjunction with a Villa Sistemi Medicali Digital Panoramic X-ray System, such as I-Max Plus or Strato D, to capture images by a sensor, digitalize the image, review images and format images to be sent to a PC, according to a standard protocol, through the existing acquisition board of panoramic system.

Extra oral source X-Ray System

The provided text is a 510(k) summary for the OWANDY I-MAX Touch, a dental X-ray system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel AI-powered diagnostic device would.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and human reader performance are not present in this type of document because the regulatory pathway for this device does not typically require them.

However, I can extract the information that is available and clarify what is not.

1. Table of Acceptance Criteria and Reported Device Performance

This document describes a substantial equivalence comparison rather than a study with defined acceptance criteria and performance metrics (e.g., sensitivity, specificity, accuracy). The "performance" assessment is based on comparing the technological characteristics and intended use of the I-MAX Touch to a predicate device, the STRATO 2000 D and OWANDY digital acquisition device.

The acceptance criteria here are implicitly that the new device is as safe and effective as the predicate device by demonstrating similar fundamental technological characteristics and intended use. The "reported device performance" is the direct comparison of features.

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

This notification does not describe a clinical study with a "test set" in the context of an AI/algorithm performance evaluation. The substantial equivalence is based on engineering comparisons and intended use declarations, not on a dataset of clinical cases. Therefore, there is no mention of sample size or data provenance for a test set.

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

Not applicable. No test set requiring expert-established ground truth is described.

4. Adjudication method for the test set

Not applicable. No test set or ground truth adjudication is 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

Not applicable. This device is an X-ray system, not an AI-assisted interpretation tool. The document does not describe any MRMC studies or AI integration.

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

Not applicable. This device is an X-ray system, not a standalone algorithm.

7. The type of ground truth used

Not applicable. No clinical ground truth is discussed in this regulatory document for establishing device equivalence. The "ground truth" for the submission is that the predicate device is legally marketed and has established safety and effectiveness.

8. The sample size for the training set

Not applicable. This document does not describe the development or training of any algorithms or AI components.

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

Not applicable. No training set or ground truth for a training set is described.

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