(27 days)
EzSensor P, Intra-oral Imaging System, is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
The EzSensor P digital intra oral sensor is a solid state x-ray imager designed for dental radiographic applications. The EzSensor P digital intra oral sensor provides digital diagnostic image capture to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to personal computer via USB interface port.
The acceptance criteria and the study proving the EzSensor P device meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain specific acceptance criteria with numerical targets. Instead, it claims substantial equivalence to a predicate device, EzSensor T, by comparing technical characteristics. Performance is implicitly evaluated by demonstrating these characteristics are either the same or superior.
| Characteristic | Acceptance Criteria (Implied) | Reported EzSensor P Performance |
|---|---|---|
| Indication for Use | Same as predicate device (EzSensor T) | EzSensor P, Intra-oral Imaging System, is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. (Identical to predicate) |
| Device Description | Same as predicate device (EzSensor T) | EzSensor P is a solid state x-ray imager designed for dental radiographic applications. The EzSensor P digital intra oral sensor provides digital image capture to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port. (Similar to predicate) |
| Sensor Dimension (mm) Size "1.5" | Within acceptable range, compared to predicate (EzSensor T) | 38.7 x 29.2 (Identical to predicate) |
| Sensor Dimension (mm) Size "2.0" | Within acceptable range, compared to predicate (EzSensor T) | 42.8 x 31.5 (Identical to predicate) |
| Sensor Thickness | Same as predicate device (EzSensor T) | 4.95 (Identical to predicate) |
| Active Area (mm) Size "1.5" | Within acceptable range, compared to predicate (EzSensor T) | 24.01 x 33.04 (Identical to predicate) |
| Active Area (mm) Size "2.0" | Within acceptable range, compared to predicate (EzSensor T) | 26.04 x 36.05 (Identical to predicate) |
| USB Module | Same as predicate device (EzSensor T) | Integrated USB 2.0 module (Identical to predicate) |
| Pixel Size (µm) | Equal to or improved over predicate device | 20x20 (Improved compared to 35x35 of predicate) |
| Pixel Matrix Size "1.5" | Equal to or improved over predicate device | 1200x1650 pixel (Improved compared to 686x944 of predicate) |
| Pixel Matrix Size "2.0" | Equal to or improved over predicate device | 1300x1800 pixel (Improved compared to 744x1030 of predicate) |
| Pixel Pitch (Spacing) | Equal to or improved over predicate device | 0.02 mm x 0.02 mm (Improved compared to 0.035 mm x 0.035 mm of predicate) |
| Theoretical Resolution | Equal to or improved over predicate device | 25 lp/mm (Improved compared to 14.1 lp/mm of predicate) |
| Scintillator materials | Acceptable as a design difference that does not alter fundamental scientific technology or safety/effectiveness (Implied) | Cesium iodide (CsI) (Different from GOS(Gd2O2S:Tb) of predicate, but deemed substantially equivalent) |
| Safety and EMC | Compliance with relevant standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2) | Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A1+A2, 1995), IEC 60601-1-1(2nd edition, 2000) for use with IEC60601-1(Al+A2, 1995) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007. All test results were satisfactory. |
| Non-clinical & Clinical Considerations | Compliance with FDA Guidance for Solid State X-ray Imaging Devices submissions | Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set for evaluating the imaging performance of the EzSensor P directly through clinical or non-clinical image analysis against a ground truth.
The "Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed, and "All test results were satisfactory." However, details on the specific nature of these "clinical considerations," the data provenance (e.g., country of origin, retrospective or prospective), or the number of images/cases used are not provided. The study primarily relies on a comparison of technical specifications to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As detailed above, a specific test set requiring expert ground truth establishment for a diagnostic performance study is not explicitly described.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted (or at least, not reported in this summary). The device is an imaging sensor, not an AI-assisted diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not applicable to this submission.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is an imaging sensor, not an algorithm, so a "standalone" algorithmic performance study as typically understood for AI/ML devices is not applicable. The performance is inherent to the sensor's ability to capture images based on its technical specifications.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for evaluating the imaging performance beyond physical and electrical measurements. The "Non-clinical & Clinical considerations" mention that "all test results were satisfactory," implying some form of objective assessment was conducted, but the specific nature of the ground truth (e.g., expert consensus, pathology, outcomes data) for image quality or diagnostic accuracy is not detailed. The primary ground for acceptance appears to be substantial equivalence to a predicate device based on technical specifications and conformance to safety and EMC standards.
8. The Sample Size for the Training Set
This information is not applicable as the EzSensor P is a digital X-ray sensor, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the EzSensor P is a digital X-ray sensor, not an AI/ML device that requires a training set.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.