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ERI Portable X-ray System is a portable x-ray source with a fixed tube current and voltage for producing x-ray images of extremities using computed radiography (CR) detection plate or digital radiography (DR) detector, and the applicable objects are adults. This product is for use by qualified personnel.

It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.

ERI Portable X-ray System generates and controls X-ray with a fixed tube current and voltage (kV). It uses X light source to produce X-ray images of human anatomical structures for diagnosis, and the applicable objects are adults. It operates on 14.4VDC supplied by a rechargeable Lithium-Ion Polymer battery pack.

The ERI Portable X-ray System, is a portable x-ray device that comes in three models: CVX-air, CVX-lite and CVX-E. The differences is as follows:
X-ray tube voltage: CVX-air 70kV, CVX-lite 67 kV, CVX-E 60 kV
X-ray tube current: CVX-air 1mA, CVX-lite 0.8mA, CVX-E 0.6mA
Power Consumption: CVX-air 70 W, CVX-lite 53.6 W, CVX-E 36W
Others are the same as CVX-air
The main model and series models have the same internal and external appearance, only the X-ray irradiation parameter settings are different

The X-ray tube head, X-ray controls and power source are assembled in a portable case. The ERI Portable X-ray System is comprised of the following components:

• (1) X-ray module
• (2) Oscillating circuit board
• (3) Control board
• (4) Beam limiting device
• (5) LCD screen
• (6) Extension wire control
• (7) rechargeable battery.

The provided text details the FDA 510(k) clearance for the ERI Portable X-ray System and includes information about non-clinical testing and comparison to a predicate device. However, it does not contain the specific acceptance criteria for a study or a detailed description of a study that explicitly proves the device meets those criteria with quantitative outcomes like sensitivity, specificity, or improvement effect sizes. The document focuses on demonstrating substantial equivalence to a predicate device through technological comparisons and adherence to relevant standards.

Here's a breakdown of the information that is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document. The document states "The results confirm that the device's design is appropriate and effective for its intended use" and "clinical trials were conducted to compare the imaging results of the ERI Portable X-ray System with those obtained from commercially available X-ray devices. These trials demonstrated that the image quality produced by the ERI system is on par with that of the comparison devices, supporting its substantial equivalence as a portable X-ray system."

However, neither specific numerical acceptance criteria (e.g., minimum diagnostic accuracy, image quality scores) nor quantifiable performance metrics (e.g., sensitivity, specificity, observer agreement, SNR, CNR values) are reported in the text for the subject device or the predicate.

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

Not explicitly provided. The document vaguely states "clinical trials were conducted" but does not give the sample size (number of images, number of patients) of the test set, nor the country of origin of the data, or whether it was retrospective or prospective.

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

Not explicitly provided. The document refers to "clinical trials" and "image quality produced by the ERI system is on par with that of the comparison devices," which implies some form of assessment, likely by experts. However, the number and qualifications of these experts are not specified.

4. Adjudication Method for the Test Set

Not explicitly provided. Due to the lack of detail on how the "clinical trials" and "image quality" assessments were performed, the adjudication method (e.g., 2+1, 3+1 consensus, or independent review) is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not explicitly mentioned as an MRMC study. The document states "clinical trials were conducted to compare the imaging results of the ERI Portable X-ray System with those obtained from commercially available X-ray devices." While this implies a comparison, it doesn't specify if it was a formal MRMC study or if it measured an effect size of human readers improving with AI vs. without AI assistance. The device described is an X-ray source and system, not an AI-assisted diagnostic tool, so an MRMC study related to AI might not be applicable here.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not provided. The ERI Portable X-ray System is an X-ray hardware system, not a software algorithm that performs standalone diagnostic tasks without human interaction. Therefore, a standalone algorithm performance study, as typically done for AI/CAD devices, is not relevant to this submission and is not described.

7. Type of Ground Truth Used for the Test Set

Not explicitly provided with specifics. The statement "image quality produced by the ERI system is on par with that of the comparison devices" suggests that the ground truth for image quality was likely established by expert assessment or comparison against an accepted standard for diagnostic image quality. However, the exact nature (e.g., expert consensus on diagnostic usability, specific phantoms, or clinical outcomes) is not detailed.

8. Sample Size for the Training Set

Not applicable/Not provided. As this is a hardware device for X-ray imaging, there isn't a "training set" in the context of machine learning. The device's performance is validated through engineering tests and clinical evaluations, not by training a model on a dataset.

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

Not applicable/Not provided. See the explanation for point 8.

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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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