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510(k) Data Aggregation
(72 days)
The Apex HRI Digital Radiography System is designed to replace standard intraoral xray film and film development chemicals used for patient diagnostics in dental practices.
Digital dental Intraoral Xray sensor
The provided text is a 510(k) summary for the Apex HRI Digital Radiography System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and study results for device performance. As such, much of the requested information regarding acceptance criteria, specific performance metrics, and study details is not available in the provided document.
Acceptance Criteria and Device Performance
The document does not explicitly state acceptance criteria or a formal study demonstrating the device meets these criteria in terms of image quality or diagnostic accuracy. Instead, the entire submission is based on the premise of substantial equivalence to predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not Explicitly Stated) | Device Performance (Inferred from Substantial Equivalence) |
|---|---|
| Image Acquisition: Produce intraoral diagnostic X-ray images. | Device is used to take dental intraoral diagnostic x-rays, detecting emitted radiation and transmitting data for grayscale image display. |
| Safety: Device operates safely within dental practice settings. | Implied by substantial equivalence to predicate devices, subject to general controls provisions of the Act (21 CFR Part 807, 801, 820) and electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. |
| Functionality: Replacement for standard intraoral X-ray film and chemicals. | Designed to replace standard intraoral X-ray film and film development chemicals. |
| Technological Characteristics: Similar to predicate devices in key aspects. | "Identical to the Mediadent HDXMMD HDX SP xray sensor in size, type, and materials used to manufacture the product... virtually identical to the Trophy Radiologie RVG Portable Radiovisiography sensor in size, manufacture and materials." |
| Intended Use: Used for dental intraoral diagnostic X-rays. | Stated intended use matches predicate devices. |
Study Details (Based on Substantial Equivalence Claim)
The document does not describe a specific clinical study undertaken to establish the device's performance against predefined acceptance criteria. Instead, it relies on demonstrating substantial equivalence to pre-existing, legally marketed devices.
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Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of an independent performance study is described. The comparison is against predicate devices based on their established characteristics and intended use.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No independent ground truth establishment for a test set is described.
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Adjudication method for the test set: Not applicable. No "test set" and corresponding adjudication process are described.
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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. The device is an intraoral digital X-ray sensor, not an AI-assisted diagnostic tool for which MRMC studies assessing reader improvement would be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a digital X-ray sensor, which is a hardware component with associated imaging software, not an algorithm, and intrinsically involves a human operator (dentist/radiographer) in its use.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an independent performance study. The "ground truth" for the substantial equivalence claim is the performance and regulatory acceptance of the predicate devices.
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The sample size for the training set: Not applicable. The device is a digital X-ray sensor; it does not explicitly describe an algorithm that requires a "training set" in the machine learning sense.
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How the ground truth for the training set was established: Not applicable, for the same reasons as point 7.
Summary of the K023292 Submission:
The K023292 submission for the Apex HRI Digital Radiography System is a 510(k) Premarket Notification. This regulatory pathway is used to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use and the same technological characteristics, or, if it has different technological characteristics, the differences do not raise different questions of safety and effectiveness.
The core of this submission is the statement: "The Apex HRI Digital Radiography sensor is identical to the Mediadent HDXMMD HDX SP xray sensor in size, type, and materials used to manufacture the product... The Apex HRI Digital Radiography sensor is virtually identical to the Trophy Radiologie RVG Portable Radiovisiography sensor in size, manufacture and materials. The only difference between these and the Computed Oral Radiology System is the type of sensor employed... This is a minor difference in design. All four products are used in exactly the same manner and circumstances."
Therefore, the "proof" that the device meets acceptance criteria is the argument that it is the same or substantially similar to devices already accepted as safe and effective by the FDA. The submission does not detail independent studies with new performance data.
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