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The RXS 1000 is an Intraoral Digital X-ray Sensor and is intended to be used by dentists and dental technicians diagnostic diseases of the teeth, jaw and oral structures. Its use is intended for adult subjects.

The RXS1000 is intended to acquire real-time, clinical digital intraoral X-ray images using a solidstate imaging sensor. This system consists of the CMOS sensor and software for image display. This system senses the onset of the X-ray exposure and automatically acquires and save the image data to a PC(software).

This document describes the FDA's clearance of the RXS 1000, an intraoral digital X-ray sensor, based on its substantial equivalence to a predicate device (K163282). As such, the document primarily focuses on establishing "substantial equivalence" rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical performance study.

Therefore, many of the requested elements for a detailed scientific study are not applicable or not explicitly provided within this FDA 510(k) summary document.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" as pass/fail thresholds for clinical performance but instead focuses on demonstrating equivalence to a predicate device. The performance characteristics are compared between the subject device (RXS 1000) and the predicate device (Apex Dental Sensors Size #1).

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

• Sample Size for Test Set: Not applicable. This document is a 510(k) summary demonstrating substantial equivalence based on technological characteristics and adherence to standards, not a clinical trial report with a test set of patient data.
• Data Provenance: Not applicable for a clinical test set. The technical specifications listed implicitly refer to characteristics measured on the device itself.

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

• Not applicable. There is no clinical test set requiring ground truth establishment by experts mentioned in this document.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical test set mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement

• No. An MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. This type of study would typically be performed for AI-enabled diagnostic devices to assess human reader performance with and without AI assistance, which is outside the scope of this particular submission for a digital X-ray sensor itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. The RXS 1000 is an intraoral digital X-ray sensor, which is a hardware device that acquires images, not an algorithm operating in standalone mode for diagnostic interpretation. Its "performance" relates to image quality and technical specifications of the sensor hardware.

7. The Type of Ground Truth Used

• Not applicable for clinical efficacy. The "ground truth" here is implied by the technical specifications of the device itself and its equivalence to a legally marketed predicate. For example, "pixel size 20x20 µm" is a measurable characteristic of the sensor, not a clinical ground truth established by experts or pathology.

8. The Sample Size for the Training Set

• Not applicable. The RXS 1000 is a hardware sensor, not a machine learning algorithm that requires a training set of data.

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

• Not applicable. No training set is involved for this type of device.

In summary, the provided document, a 510(k) summary for an intraoral digital X-ray sensor, focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications and compliance with relevant standards (IEC 60601-1, IEC 60601-1-2, ISO 14971). It does not contain information about a clinical performance study with acceptance criteria, test sets, ground truth establishment by experts, or AI algorithm performance typically found for software-as-a-medical-device (SaMD) or AI-enabled diagnostic tools.

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The XR-01 Portable X-Ray System is intended to be used by trained dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and child subjects.

XR-01, a portable X-ray system is mainly designed for dental diagnosis via X-ray exposure with intraoral image receptors, supplied with 25.2 V DC rechargeable Li-ion polymer battery. The portable X-ray system consist of an x-ray generator with an x-ray tube, device controller, beam limiting device, AC-DC power supply, charging unit and optional back scatter shield.

The provided text contains information about the XR-01 Portable X-ray System and its substantial equivalence to predicate devices, focusing on regulatory compliance, electrical safety, battery safety, and general performance. However, it does not include the detailed results of a study demonstrating the device meets specific acceptance criteria related to its image quality or diagnostic performance. The document primarily discusses its compliance with safety and performance standards for an x-ray system, rather than a clinical study evaluating its diagnostic accuracy.

Therefore, many of the requested sections about acceptance criteria, detailed study results, sample sizes, ground truth establishment, and MRMC studies cannot be extracted from the provided text.

Here's an attempt to answer the questions based on the available information:

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

The document mentions compliance with general safety and performance standards rather than specific diagnostic acceptance criteria. The "Performance Testing" section states: "Performance test validate that accuracy, reproducibility, deviation and linearity of technical factors such as tube voltage, tube current and exposure time is meet the criteria. Safety tests in terms of HVL, leakage, x-ray field size meet Federal standard requirements."

The "criteria" are referred to as "Federal standard requirements" and "safety and performance standards", but the specific numerical acceptance values for accuracy, reproducibility, deviation, linearity, HVL, leakage, and x-ray field size are not provided.

2. Sample sized 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 in the document. The text describes general "Performance Testing" but does not detail the nature of the test set, its size, or provenance.

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 provided as there is no mention of a clinical study involving experts establishing ground truth for a diagnostic performance evaluation.

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

This information is not provided.

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

An MRMC study is not mentioned in the provided document. The device is a portable X-ray system, not an AI-powered diagnostic tool. The submission is for a traditional 510(k) for an extraoral X-ray source.

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

This is not applicable as the device is an X-ray system, not an algorithm, and the document focuses on its technical performance and safety for generating images.

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

This information is not provided. The "Performance Testing" section refers to technical measurements against defined standards for X-ray devices (e.g., accuracy of kVp, mA, exposure time, HVL, leakage) rather than a ground truth for diagnostic accuracy derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided. There is no mention of a training set for an algorithm in this submission.

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

This information is not provided. There is no mention of a training set or ground truth establishment for a training set in this submission.

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