(231 days)
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.
| Feature / Characteristic | I-Max Touch (New Device) | Strato 2000 D (Predicate Device) | Acceptance (Stated Equivalence) |
|---|---|---|---|
| Intended Use | Dental radiographic examination of teeth, panoramic, TMJ, implantology, and Cephalometry. | Dental radiographic examination of teeth, panoramic, TMJ, implantology, and Cephalometry. | Substantially Equivalent |
| CEPH option | Yes | Yes | Equivalent |
| Digital acquisition Sensor | CCD | CCD | Equivalent |
| Computer Interface Board | Ethernet | USB | Different technology, but serves same function. Not deemed a difference in safety/effectiveness. |
| Digital Storage | USB memory stick | Compact flash card | Different technology, but serves same function. Not deemed a difference in safety/effectiveness. |
| High voltage value | 86 KVp max | 80 KVp max | Slight difference, likely within acceptable range for dental X-ray. Not deemed a difference in safety/effectiveness. |
| Tube current | 12 mA max | 12 mA max | Equivalent |
| Total filtration | 2.5 mmAl | 2.5 mmAl | Equivalent |
| Examination programs | Comprehensive list (Adult/Child, various panoramic, TMJ, Maxillary sinus, Ceph, Carpus) | Comprehensive list (Adult/Child, various panoramic, TMJ, Maxillary sinus, Ceph, Carpus) | Substantially Equivalent |
| X-ray exposure timing | 13.8 Sec PAN adult, CEPH variable max 15 sec | 15 Sec PAN adult, CEPH variable max 15 sec | Slight difference, likely within acceptable range for dental X-ray. Not deemed a difference in safety/effectiveness. |
| Electrical characteristics | 6.6 A at 230V 50/60 Hz | 18 A at 110V | Different electrical requirements, but device functionality maintained. Not deemed a difference in safety/effectiveness. |
| Positioning lights | Class 1 laser (EN60825-1+A1+A2) | Class 2 laser | Different class, but both are standard for positioning. Not deemed a difference in safety/effectiveness. |
| Focus receptor distance | 500 mm | 512 mm | Slight difference. Not deemed a difference in safety/effectiveness. |
| Minimum room size | 2450X2000X1450 | 2320X1900X1300 | Different physical dimensions. Not deemed a difference in safety/effectiveness. |
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.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.