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510(k) Data Aggregation
(123 days)
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
HDI 2000 / HDI 2000A, an Intra-Oral 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 HDI 2000 / HDI 2000A Intra-oral imaging system is a device which acquires digital image. Direct digital systems acquire images with a solid-state sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. The sensor is connected by a wire to an analog-to-digital USB box, which is connected to the computer. Images are produced within seconds of sensor exposure. The wire length from a direct sensor is about 3 meters and less. The USB box connects to the USB 2.0 port of the computer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the HDI 2000 / HDI 2000A device:
This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (EzSensor P) rather than presenting a de novo clinical study with explicit acceptance criteria for diagnostic performance. Therefore, many of the typical clinical study details are not present.
1. Table of Acceptance Criteria and Reported Device Performance
Because this is a 510(k) submission for substantial equivalence based on technological characteristics, explicit numerical diagnostic performance acceptance criteria (e.g., sensitivity, specificity, AUC) are not defined or reported for diagnostic accuracy. The acceptance criteria revolve around meeting established safety and performance standards for medical electrical equipment and X-ray imaging devices, and demonstrating that the new device does not raise new questions of safety or effectiveness compared to the predicate.
| Acceptance Criteria Category | Specific Standard/Guidance | Reported Device Performance / Compliance |
|---|---|---|
| Electrical, Mechanical, Environmental Safety & Performance | IEC 60601-1:2005 + CORR.I(2006) + CORR(2007) | "All test results were satisfactory." |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2007 | "EMC testing were conducted in accordance with standard IEC 60601-1-2:2007." |
| Non-clinical & Clinical Considerations for Solid State X-ray Imaging Devices | FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices | "Non-clinical & Clinical considerations... was performed." |
| Technological Equivalence (Primary justification) | Comparison to predicate device (EzSensor P) | "The indications for use, material, form factor, performance, and safety characteristics of HDI 2000 / HDI 2000A described in this 510(k) are the same as that of the predicate device... The difference in the physical dimension of the sensor does not present any new concerns in terms of safety and effectiveness." |
| Software Risk Analysis | Not explicitly stated, but implied by "design control risk analysis for ProraView" | "All risks are mitigated and any residual risks are determined acceptable." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set in the traditional sense of a clinical trial for diagnostic performance. The testing described is primarily for engineering standards compliance (safety, EMC) and performance characteristics relevant to sensor operation, rather than a clinical evaluation of diagnostic accuracy using a test dataset of patient images.
- Sample Size for Test Set: Not applicable in the context of diagnostic performance. The document refers to "test results" for electrical, mechanical, environmental, and EMC testing, which would involve laboratory testing of device units.
- Data Provenance: Not applicable for diagnostic performance as no clinical diagnostic test set is described. The engineering tests would be performed in a controlled laboratory environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As no clinical test set for diagnostic performance is described, there's no mention of experts establishing a ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process for diagnostic interpretations is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) submission. The submission focuses on demonstrating substantial equivalence based on technological characteristics and engineering tests, not a clinical comparison of diagnostic efficacy.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an intra-oral imaging system (sensor and software), not an AI algorithm designed to interpret images independently. Therefore, the concept of "standalone performance" for an AI algorithm without human-in-the-loop is not applicable to this submission. The device's function is to acquire and display images for diagnostic use by dentists.
7. The Type of Ground Truth Used
The concept of "ground truth" for diagnostic accuracy (e.g., pathology, outcomes data) is not applicable in this submission, as no diagnostic performance study is described. The "truth" being evaluated relates to the device's adherence to engineering standards and its functional performance as an imaging system (e.g., image capture, viewing) being equivalent to the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is an imaging sensor and viewer software; it is not an artificial intelligence (AI) or machine learning (ML) algorithm that requires a "training set" of data for learning diagnostic patterns.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm described.
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