(30 days)
Intra Oral Sensor (model: IOX 1 / IOX 2) is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.
Intraoral Sensor (model: IOX 1 / IOX 2) by Dentium is a medical device that acquires digital images by detecting subject information through X-rays and converting them into electrical image signals to identify teeth and tissues in the mouth. The product consists of the Intraoral Sensor, USB Memory, Sensor Holder, Silicon Cover and Quick Guide.
The provided text describes information related to a 510(k) submission for an Intra Oral Sensor (model: IOX 1 / IOX 2) by Dentium Co., Ltd. The document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and adherence to relevant standards.
Here's an attempt to extract the requested information, noting that some details typically found in a full study report (e.g., specific sample sizes for test sets, detailed ground truth establishment for training) are not fully elaborated in this summary document.
Acceptance Criteria and Device Performance:
The document states that "Performance testing was conducted for the subject device to assess whether or not the parameter required for functionalities related to imaging properties of the dental X-ray device meets the designated acceptance criteria. All test results were satisfactory." And specifically mentions: "The tests include the MTF(Modulation Transfer Function) and DOE(Detective Quantum Efficiency) of detector. MTF of detector shows the resolution more than 30 % at 6 lp/mm and The DQE of detector shows the resolution more than 40 % at 2.5 lp/mm."
Based on the information provided, the following table can be constructed:
| Acceptance Criteria (Imaging Performance) | Reported Device Performance (Intra Oral Sensor IOX 1 / IOX 2) |
|---|---|
| MTF: More than 30% at 6 lp/mm | MTF: More than 30% at 6 lp/mm (Satisfactory) |
| DQE: More than 40% at 2.5 lp/mm | DQE: More than 40% at 2.5 lp/mm (Satisfactory) |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Sample Size (Test Set): The document does not specify the exact number of images or cases used in the performance bench testing. It refers to "bench testing" and "performance (imaging performance) testing" according to standard IEC 61223-3-4.
- Data Provenance: This was a non-clinical bench study focused on the technical performance of the device itself (sensor characteristics), not on clinical images from patients. Therefore, data provenance in terms of country of origin or retrospective/prospective clinical data is not applicable here.
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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. Since this was a non-clinical bench test of technical performance (MTF, DQE), there were no human experts involved in establishing "ground truth" for diagnostic purposes. The ground truth was based on physical measurements of the sensor's technical specifications as per established engineering standards (e.g., IEC 61223-3-4 for imaging performance).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As this was a non-clinical bench test, there was no adjudication process involving human reviewers.
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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:
- No, an MRMC comparative effectiveness study was not done. This submission is for an intraoral sensor, which is a hardware device for capturing X-ray images, not an AI-powered diagnostic software. The study focused on the technical performance equivalence of the sensor to its predicate device. Clinical data and comparative effectiveness studies involving human readers or AI assistance were explicitly stated as "Not required for a finding of substantial equivalence."
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is not applicable as this is a hardware device. This submission is for an intraoral sensor, which is a hardware device that acquires images. There is no standalone algorithm being evaluated for diagnostic performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this study was based on physical and engineering measurements of the sensor's imaging performance characteristics (MTF, DQE) according to established international standards (IEC 61223-3-4). It is a technical ground truth, not a clinical one.
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The sample size for the training set:
- Not applicable. This device is a hardware sensor, not an AI algorithm that requires a training set for machine learning.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm.
Summary of what the document implies about the study:
The study conducted was a non-clinical bench performance study designed to demonstrate that the new Intra Oral Sensor (IOX 1 / IOX 2) meets technical imaging performance specifications (MTF and DQE) that are substantially equivalent to its predicate device. This type of study focuses on the physical properties and output quality of the imaging hardware itself, rather than evaluating diagnostic accuracy with human readers or AI algorithms on clinical cases. The ground truth was based on objective physical measurements and engineering standards.
§ 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.