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ERI Handheld Dental X-Ray System (Model AG100) is intended for the purpose of using it for both adult and pediatric patients by qualified operators (e.g. dentist and/ or radiographer, etc.) regulated by competent authority of each country for producing diagnostic dental X-ray images.

It can be used with computed radiography (CR) detection film, digital radiography (DR) detection film or traditional film (dental film) to take intraoral X-rays and provide the information needed by the dentist for diagnosis. As a preoperative, intraoperative, and postoperative evaluation for identifying dental caries or auxiliary root canal treatment, as well as confirming the position of the implant during dental implant surgery. It can take pictures of the front and back teeth, as well as the bite of the back teeth. Applicable objects include adults and children. Due to the medical software included in radiation-emitting device. ERI handheld system is of Moderate level of concern.

The provided text details the 510(k) summary for the ERI Handheld Dental X-ray System (Model AG100), evaluating its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, ground truth establishment, or any comparative effectiveness studies with human readers.

The document focuses on non-clinical test data and performance evaluations.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states that "The function and performance of the AG100 have been evaluated through non-clinical design verification and validation tests" and that "The results of the AG100 performance evaluations demonstrate that the device design is well suited for its intended use." However, it does not specify what those performance evaluations were in terms of acceptance criteria or quantitative performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided. The document states that "Clinical testing has not been conducted on this product," implying that no test set of patient data was used to evaluate its clinical performance. The testing mentioned is "non-clinical design verification and validation tests" and "electrical performance evaluations and usability test," which do not typically involve patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable/provided as no clinical test set with ground truth established by experts was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/provided as no clinical test set was used.

5. 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:

This information is not applicable/provided. The device is an X-ray system, not an AI diagnostic tool. No AI component or MRMC study is mentioned.

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

This information is not applicable/provided. The device itself is an X-ray system, not an algorithm, and the document explicitly states "Clinical testing has not been conducted on this product".

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable/provided. As clinical testing was not conducted, no ground truth based on patient diagnoses was established. The performance evaluations were non-clinical.

8. The sample size for the training set:

This information is not applicable/provided. Since clinical testing was not done and the device is not an AI algorithm, there is no mention of a training set of data.

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

This information is not applicable/provided for the same reasons as above.

Summary of what is provided regarding testing:

The document lists several international and national standards that testing was performed in accordance with, including:

• IEC 62304 (Medical device software - Software life cycle processes)
• AAMI ES60601-1 (General Requirements For Basic Safety And Essential Performance)
• IEC 60601-1-2 (Electromagnetic Compatibility)
• IEC 60601-1-3 (Radiation protection in diagnostic X-ray equipment)
• IEC 60601-2-65 (Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment)
• IEC 61223-3-4 (Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray)
• ISO 14971 (Risk management)
• ISO 10993 (Biological evaluation of medical devices - Parts 2, 5, 10, 12 for animal welfare, cytotoxicity, irritation/sensitization, and sample preparation)
• 21 CFR 1020.30 & 1020.31 (Diagnostic x-ray system requirements)

These standards typically define safety, performance, and manufacturing quality requirements for medical devices. The document essentially states that the device was tested to meet these standards through "non-clinical design verification and validation tests," including "electrical performance evaluations and usability test." However, the specific results against particular quantitative acceptance criteria from these tests are not detailed in this summary.

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