(85 days)
EzSensor T, Intra-oral Imaging System, is 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.
EzSensor T is a solid state x-ray imager designed for dental radiographic applications. EzSensor T 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.
Here's an analysis of the provided text regarding the EzSensor T device, focusing on acceptance criteria and study details:
Interpretation of the Document:
The provided document is a 510(k) summary for the EzSensor T, an intra-oral imaging system. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove performance against a set of predefined clinical acceptance criteria using a standalone clinical study. The "acceptance criteria" here largely refer to demonstrating the new device's performance is comparable to or better than the predicate device and meets relevant safety and performance standards.
The document emphasizes non-clinical and clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices". This implies that the 'study' likely involved technical performance tests and comparative analyses against the predicate, rather than a prospective clinical trial with specific diagnostic accuracy endpoints.
Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state quantitative "acceptance criteria" in the typical sense of diagnostic metrics (e.g., sensitivity, specificity, AUC) for a clinical study. Instead, it focuses on demonstrating equivalence to a predicate device based on technical specifications and adherence to safety and performance standards. The "reported device performance" is primarily a comparison of technical characteristics to the predicate.
| Acceptance Criteria (Implied from Substantial Equivalence and Standards) | Reported Device Performance (Comparison with Predicate EzSensor) |
|---|---|
| Functional Equivalence: Intended to collect dental x-ray photons and convert them into electronic impulses stored, viewed, and manipulated for diagnostic use by dentists. | Equivalent: Both EzSensor T and EzSensor share the exact same Indications for Use. |
| Device Description Equivalence: Solid state x-ray imager for digital image capture in general dental diagnostic procedures, transferring images via USB. | Equivalent: Both EzSensor T and EzSensor share the same fundamental device description and method of operation. |
| Technical Specifications (Spatial Resolution): Comparable or better spatial resolution. | Comparable: EzSensor T: 14.28 lp/mm (Intrinsic Property), EzSensor: 14.3 lp/mm (Intrinsic Property). Pixel size and pitch are identical (35x35 µm, 0.035 mm x 0.035 mm). |
| Safety and EMC Standards Compliance: Adherence to relevant electrical, mechanical, and environmental safety standards (e.g., IEC 60601-1, IEC 60601-1-2). | Compliant: "Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A1+A2, 1995), IEC 60601-1-1(2ª edition, 2000) [...] and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007. All test results were satisfactory." |
| FDA Guidance Compliance: Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices". | Compliant: "Non-clinical & Clinical considerations according to FDA Guidance [...] was performed. All test results were satisfactory." |
| Image Quality (Implied): Production of images suitable for diagnostic use. | Not explicitly quantified in terms of clinical diagnostic performance metrics (e.g., sensitivity/specificity for specific dental conditions) in this summary, but implied by technical equivalence and satisfactory non-clinical/clinical considerations as per FDA guidance. |
| Primary Differences Justification: Any differences in materials or dimensions should not negatively impact safety or effectiveness. | Justified: Primary differences (sensor size, active area, scintillator material: GOS for EzSensor T vs. CsI for EzSensor) are acknowledged and deemed not to compromise substantial equivalence. |
Study Details
Given the nature of a 510(k) summary for substantial equivalence, especially for an imaging device replacing another with similar function, the "study" is primarily a series of non-clinical technical tests and a comparative analysis against the predicate, guided by FDA regulations. It is not presented as a traditional clinical trial.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a 'test set' with a specific number of images or patients for diagnostic accuracy assessment. The "all test results were satisfactory" refers to engineering and performance tests.
- Data Provenance: Not applicable in the context of a retrospective/prospective clinical data set for diagnostic performance. The data provenance is from laboratory and engineering testing.
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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. The document does not describe a study involving expert readers establishing ground truth for a diagnostic test set. The focus is on technical performance and equivalence.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of a diagnostic test set requiring adjudication in this summary.
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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 performed or mentioned. The device is a direct-capture digital X-ray sensor, not an AI-powered diagnostic aide designed to enhance human reader performance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, effectively. The "standalone" performance in this context refers to the intrinsic technical performance of the imaging device itself (e.g., resolution, pixel size, EMC compliance) without a human interpreting images. The listed technical specifications (resolution, pixel matrix, etc.) are characteristics of the device operating in a standalone capacity. "All test results were satisfactory" under "Safety, EMC and Performance Data" implies this.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the typical sense of clinical ground truth. The "ground truth" for the engineering performance tests would be defined by established calibration standards, physical measurements, and regulatory requirements for safe and effective operation of X-ray imaging devices.
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The sample size for the training set:
- Not applicable. The EzSensor T is a hardware device (digital X-ray imager for dental applications), not an AI algorithm requiring a training set of data.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this hardware device.
Summary of the "Study" from the document:
The "study" referenced in this 510(k) summary primarily consists of:
- Engineering and Performance Testing: Compliance with electrical, mechanical, and environmental safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2). This includes verifying technical specifications like resolution, pixel size, etc.
- Comparative Analysis: Side-by-side comparison of technical specifications and Indications for Use with the predicate device (EzSensor K090526) to demonstrate substantial equivalence.
- Compliance with FDA Guidance: Adherence to "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices," which likely includes non-clinical and some clinical considerations, but without detailing a full-scale clinical trial with diagnostic endpoints in this summary.
The conclusion is that the EzSensor T is "safe and effective and substantially equivalent to predicate device." This means it meets the regulatory hurdle for market entry based on its similarity to an already approved device and its satisfactory performance in compliance tests.
§ 872.1810 Intraoral source x-ray system.
(a)
Identification. An intraoral source x-ray system is an electrically powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located inside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.