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EzSensor P, 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.

The EzSensor P digital intra oral sensor is a solid state x-ray imager designed for dental radiographic applications. The EzSensor P digital intra oral sensor provides digital diagnostic image capture to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to personal computer via USB interface port.

The acceptance criteria and the study proving the EzSensor P device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain specific acceptance criteria with numerical targets. Instead, it claims substantial equivalence to a predicate device, EzSensor T, by comparing technical characteristics. Performance is implicitly evaluated by demonstrating these characteristics are either the same or superior.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set for evaluating the imaging performance of the EzSensor P directly through clinical or non-clinical image analysis against a ground truth.

The "Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed, and "All test results were satisfactory." However, details on the specific nature of these "clinical considerations," the data provenance (e.g., country of origin, retrospective or prospective), or the number of images/cases used are not provided. The study primarily relies on a comparison of technical specifications to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. As detailed above, a specific test set requiring expert ground truth establishment for a diagnostic performance study is not explicitly described.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted (or at least, not reported in this summary). The device is an imaging sensor, not an AI-assisted diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not applicable to this submission.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is an imaging sensor, not an algorithm, so a "standalone" algorithmic performance study as typically understood for AI/ML devices is not applicable. The performance is inherent to the sensor's ability to capture images based on its technical specifications.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for evaluating the imaging performance beyond physical and electrical measurements. The "Non-clinical & Clinical considerations" mention that "all test results were satisfactory," implying some form of objective assessment was conducted, but the specific nature of the ground truth (e.g., expert consensus, pathology, outcomes data) for image quality or diagnostic accuracy is not detailed. The primary ground for acceptance appears to be substantial equivalence to a predicate device based on technical specifications and conformance to safety and EMC standards.

8. The Sample Size for the Training Set

This information is not applicable as the EzSensor P is a digital X-ray sensor, not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the EzSensor P is a digital X-ray sensor, not an AI/ML device that requires a training set.

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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.

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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