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The CCD area image sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.

The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. All the systems include a scintillator coupled to a digital image sensor, electronic circuits to analyze the digital image and transmit the digital image to a personal computer for viewing and further management of the file.

The provided document is a 510(k) premarket notification for the Dentron Sensor. This type of submission is a declaration of substantial equivalence to a predicate device, not typically a full clinical study with detailed performance data against specific acceptance criteria.

Based on the document, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, resolution targets) for the Dentron Sensor. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.

The "Comparison Table" provided in the document outlines technical characteristics of the Dentron Sensor and its predicates. Here's a summary of those technical characteristics, which could be considered "performance" in the context of a 510(k) in comparison to predicates, but not against predefined acceptance criteria for a novel clinical claim.

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

• The document does not report specific sample sizes for a test set in the context of clinical performance evaluation.
• The document refers to mechanical, electrical, and electromagnetic compatibility testing standards (UL 60601-1, EN 60601-1-2, IEC 60601-1-4) with associated test reports (e.g., IMQ S.p.A. Test report nº 27SE00094). These tests typically involve device units, not patient-derived data sets.
• Data provenance is not applicable in the sense of clinical data (e.g., country of origin, retrospective/prospective) because such a study is not described.

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

• Not applicable. The submission does not describe a clinical study requiring ground truth derived from expert consensus on a test set. The focus is on technical equivalence and compliance with safety standards.

4. Adjudication method for the test set:

• Not applicable. No clinical test set and subsequent adjudication method are described in this 510(k) submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a digital intraoral X-ray sensor, not an AI-powered diagnostic aid. No MRMC study is mentioned or expected for this type of device.

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

• Not applicable. This device is hardware (a sensor) for capturing images, not a standalone algorithm.

7. The type of ground truth used:

• For the technical characteristics comparison, the "ground truth" implicitly relies on established specifications and performance of the predicate devices and general industry standards for intraoral imaging. There is no specific clinical "ground truth" (e.g., pathology, outcomes data) reported for this 510(k) submission. Compliance with international safety and electrical standards (UL, EN, IEC) forms part of the "ground truth" for safe operation.

8. The sample size for the training set:

• Not applicable. This device is a hardware sensor; therefore, there is no "training set" in the context of machine learning or AI models.

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

• Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply here.

In summary:

This 510(k) submission for the Dentron Sensor focuses on demonstrating substantial equivalence to predicate devices based on:

1. Similar intended use: Capturing intraoral X-ray images for dental diagnostic purposes.
2. Similar technological characteristics: As detailed in the comparison table regarding sensor type, resolution, connection, etc.
3. Compliance with recognized voluntary standards: UL 60601-1, EN 60601-1-2, and IEC 60601-1-4 for safety and EMI/EMC.

The phrase "The proposed and predicated devices are substantially equivalent, similar devices that have been used by dentists in the US since 1989 and well accepted" directly addresses how the device meets the regulatory hurdle for market entry, rather than through a traditional clinical study with defined acceptance criteria for diagnostic performance metrics.

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