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510(k) Data Aggregation
(279 days)
MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR
The EzSensor is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
The EzSensor is a solid state x-ray imager designed for dental radiographic applications. The EzSensor provides digital image capture for conventional film/screen radiographic dental examinations. The device is used 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 provided 510(k) summary (K090526) describes a new dental X-ray imager, EzSensor, seeking substantial equivalence to a predicate device, Schick's CDR (K072134). However, the document primarily focuses on demonstrating device characteristics and safety/performance testing in comparison to the predicate, rather than providing details of a clinical study with specific acceptance criteria and outcome data for the EzSensor's diagnostic performance for the purposes of this request.
Therefore, many of the requested sections below cannot be fully populated as the document does not contain the detailed clinical study information.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) for the EzSensor. It focuses on demonstrating substantial equivalence to the predicate device through technical specifications and safety/performance testing.
| Acceptance Criteria (Diagnostic Performance) | Reported Device Performance |
|---|---|
| Not specified in the document. | Not specified in the document. |
The document mentions "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory." and "Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent." However, these refer to technical and safety performance, not diagnostic efficacy.
The comparison table provided in the document focuses on technical specifications between the predicate and proposed device:
| Feature | Predicate: CDR (K072134) (Reported Performance) | Proposed: EzSensor (K090526) (Reported Performance) |
|---|---|---|
| Common/Classification Name | Solid State X-Ray Imager | Solid State X-Ray Imager |
| Intended Use | Intra-oral x-ray examinations, instant, digital images, reducing x-ray dosage | Collect dental x-ray photons, convert into electronic impulses, stored/viewed/manipulated for diagnostic use |
| Sensor Dimensions (mm) | Size "0": 31x22, Size "1": 37x24, Size "2": 43x30 | Size "1.0": 35.7x25.2, Size "1.5": 38.7x29.2 |
| Sensor Thickness (mm) | 5 | 4.9 |
| Active Area (mm) | Size "0": 24x18, Size "1": 30x20, Size "2": 36x25.6 | Size "1.0": 20.02x30.03, Size "1.5": 24.08x31.85 |
| USB Module | Integrated USB 2.0 module | Integrated USB 2.0 module |
| Pixel Size (um) | 0.40x0.40 | 0.35x0.35 |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set or data provenance for a diagnostic performance study. The testing mentioned relates to electrical, mechanical, environmental, and software validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no diagnostic performance test set is described.
4. Adjudication method for the test set
Not applicable, as no diagnostic performance test set 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
No MRMC study is mentioned. The device is an imaging sensor, not an AI-assisted diagnostic tool as understood in current contexts.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a digital X-ray sensor, which requires human interpretation. Standalone "algorithm only" performance would not be relevant in the context of this device as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no diagnostic performance study is described. The "ground truth" used for technical testing would be established standards and specifications for electrical, mechanical, and software functionality.
8. The sample size for the training set
Not applicable. The device is a hardware sensor. While it involves software, the document does not describe machine learning or AI models that would typically require a "training set" in the diagnostic performance sense. The software validation mentioned refers to standard software engineering practices.
9. How the ground truth for the training set was established
Not applicable, for the reasons stated above.
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