(234 days)
REXTAR LCD is a portable X-ray systems to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.
The REXTAR LCD consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The REXTAR LCD is an extraoral source x-ray system with a DC-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, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.
The provided text describes a 510(k) submission (K122016) for the REXTAR LCD, a portable X-ray system. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader agreement.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth establishment is not available in the provided document. The document primarily highlights compliance with performance standards and a comparison of technical specifications with predicate devices.
However, based on the information provided, here's what can be inferred and what is explicitly stated:
Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide a table of explicit "acceptance criteria" for clinical performance metrics (e.g., sensitivity, specificity, or diagnostic accuracy) or "reported device performance" against such criteria. Instead, it demonstrates compliance with recognized electrical and safety standards and compares technical specifications to predicate devices to establish substantial equivalence.
| Parameter (from Comparison Table) | Acceptance Criteria (Implied by Predicates) | Reported Device Performance (REXTAR LCD) |
|---|---|---|
| Intended Use | Similar to predicate devices | Portable X-ray system for diagnostic x-ray imaging using intraoral image receptors, for adult and pediatric subjects. |
| Indications | Similar to predicate devices | X-ray system for images of patients for dental procedures (Bite wing, periapical, occlusal, panoramic images). |
| X-ray Generator | High-Frequency | High-Frequency |
| Tube Power | Approx. 60-70kV / 2mA | 70kV / 2mA |
| Tube Type | Stationary | Stationary |
| Tube Focal Spot | 0.4mm - 0.8mm | 0.4mm |
| Target Angle | 12° - 20° | 12° |
| Exposure Time | Within a range (e.g., 0.01 - 2.00 sec) | 0.01 ~ 1.3 (sec) (43 Steps) |
| Power Requirement | DC 11.1V - 24V | DC 11.1 V |
| Weight | Around 1.80 kg - 2.95 kg | 1.88 kg |
| Picture Quality | "Normal" | "Good" |
| Battery Type | Rechargeable | Rechargeable |
| Digital Sensor Compatibility | Yes (implied by "X" for predicates) | Compatible with all Digital Sensors |
| LCD | Present ("X" for predicates mean not present) | LCD Panel Display (4 Digits, 0.5 Inch Character Height) |
Study and Data Information:
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Sample size used for the test set and the data provenance:
- Not provided. The document does not describe a clinical study with a test set of images or patients for performance evaluation. The submission relies on technical comparisons and compliance with standards.
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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/Not provided. No clinical test set or ground truth establishment by experts is described for performance evaluation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical test set involving expert adjudication is described.
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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. This device is an X-ray system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device for image acquisition, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. The substantial equivalence claim is based on comparison of technical specifications and compliance with safety and electrical standards, not on clinical ground truth.
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The sample size for the training set:
- Not applicable/Not provided. This is not an AI/algorithm-based device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of what the document explicitly states regarding compliance/testing:
- Compliance with performance standards: "All components to which the standard applies are certified to conform to diagnostic equipment standards, 21 CFR 1020.30 and 1020.31." (Section 8)
- The device "will comply with applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32." (Section 11)
- "EMC testing was conducted by (EMC Compliance Co., Ltd. in accordance with Standard EN/IEC 60601-1-2). All test results were satisfactory." (Section 11)
The "study" in this context is the comparison to predicate devices and the demonstration of compliance with various electrical, safety, and diagnostic equipment standards, rather than a clinical performance study. The "acceptance criteria" are implied by the requirements of these standards and the characteristics of the predicate devices.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-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 outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.