(256 days)
The RTLX is a digital dental X-ray system with an intra-oral electronic sensor. Its intended use is to provide real-time x-ray images for dentists with a low X-ray dose By producing real-time imaging, the RTLX provides immediate information in the course of operative treatment, such as information on the position of instruments in internal structures.
RTLX, for "Real-Time, Low-Intensity X-ray" is the first X-ray imaging system that provides capabilities for instant, full motion, digital radiographs designed specifically for the dental imaging marketplace. RTLX provides capabilities for X-ray generation, radiograph capture, image storage, and image display at up to 24 fps. The full motion, digital radiographs enhance a clinicians ability for "point-and-view" radiographs reducing patient X-ray exposure and time in the chair and improving speed and accuracy for procedure performance. Product appearance and mechanical structure is designed to provide a user friendly system for sensor placement and video control. In addition, printouts can be made of individual video frames.
The RTLX includes an X-ray source and X-ray sensor assembly for generation and acquisition of X-ray signals. Additionally, power and X-ray control electronics are provided, and an image processor is utilized for radiograph acquisition, processing, and display. Mechanical design emphasizes appearance and functionality. Switches, LEDs, and a printer are provided for user input and feedback.
The provided 510(k) summary for the InfiMed RTLX Digital Imaging System does not contain information about specific acceptance criteria or a dedicated study proving the device meets them.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This is a common approach for 510(k) clearances, where a new device is shown to be as safe and effective as a legally marketed device. The information presented is primarily a comparison of features and technical specifications rather than performance metrics against predefined acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement are not available in the provided text.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the submission does not define explicit acceptance criteria or report performance against them in the way one might expect for a study. Instead, it provides a comparative table of features and specifications against predicate devices to demonstrate substantial equivalence.
| Feature/System | RTLX Reported Performance (or Specification) | Acceptance Criteria (Not explicitly stated/derived from predicate) |
|---|---|---|
| X-ray Energy Source | 70kV/ 100μA | Equivalent to predicate devices (HDLX: 70kV/ 100μA). Implies that the X-ray output parameters are within acceptable ranges for dental imaging and comparable to established safe devices. |
| Image Acquisition speed (max) | 24 frames/second | Equivalent to or exceeding the real-time capability of the predicate HDLX (30 frames/second). For still-frame devices (Schick, Trophy), this is a new capability that needs to be shown as safe and effective, which is implied by the "real-time imaging" intended use. |
| Display image resolution | 128x160 @ 24fps - 256x320 @ 6 fps | Comparable to predicate HDLX (768 x 494) considering the different framerates, or sufficient for the intended use of real-time imaging for instrument positioning. The submission doesn't specify if this resolution is considered adequate for diagnostic purposes at specific framerates, but rather that it can display images. The "N/Available" for Shik and Trophy for display resolution implies their primary output might be print or higher resolution still frames, so a direct comparison is difficult for the display resolution aspect. The key here is the functionality of real-time imaging versus still frames. |
| Sensor Sizes | 20.1 x 30.1 mm | Functionally comparable to predicate device sensor sizes (e.g., HDLX: 18 mm diameter, Schick: 25.2 x 36.5 mm, Trophy: 18.2 x 27.5 mm). The exact size might vary, but the general concept of an intraoral sensor of appropriate size for dental imaging is the implied criterion. |
| X-ray Image Acquisition Device | CCD Sensor with Scintillator | Similar sensor technology to predicate devices (Schick: CCD Sensor with Scintillator; Trophy: CCD, fiberoptics and scintillator). The predicate HDLX uses 'Image Intensifier with CCD Camera' which is different, but the overall function of acquiring X-ray images is deemed equivalent. |
| Intended Use (Real-time imaging) | Provides "immediate information in the course of operative treatment, such as information on the position of instruments in internal structures." | The ability to provide real-time X-ray images that are sufficiently clear and timely for a dentist to observe instrument position during operative treatment, specifically at a low X-ray dose. This is essentially the core functional acceptance criterion inferred from the intended use statement. |
| X-ray Dose | "low X-ray dose" | Implied acceptance criterion: The dose should be low and comparable to or lower than predicate devices for equivalent imaging tasks, without compromising diagnostic utility. (No numerical dose reported to compare). |
| Disinfection / Sterilization | Cold Sterilization and Disposable sheaths, using 3.4% gluteraldehde and low density polyethylene sheaths. | The disinfection/sterilization methods must be effective and comparable to those of predicate devices (Schick, Trophy also use cold sterilization and disposable sheaths with similar materials/methods), ensuring patient safety and preventing cross-contamination. This indicates compliance with established medical device hygiene practices. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not provided. The submission does not describe a performance study with a test set of images or patients.
- Data provenance: Not applicable, as no specific test data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable, as no ground truth establishment for a test set is described.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable, as no test set requiring adjudication is described.
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
- MRMC study: No. This submission pre-dates widespread AI integration and focuses on substantial equivalence of a new imaging modality itself, not an AI enhancement for readers.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Not applicable. The device is an integral system for image acquisition and display, designed for human-in-the-loop use by dentists. There is no "algorithm only" performance reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not applicable, as no formal ground truth was established for a performance study. The comparison is feature-based against existing predicate devices.
8. The sample size for the training set
- Sample size for training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. It's a hardware and software system for image capture and display.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable, as there is no training set for an AI/ML model for this device.
In summary: The K992392 submission for the InfiMed RTLX is a 510(k) premarket notification that relies on demonstrating substantial equivalence to predicate devices. It does not include a performance study with explicit acceptance criteria, test sets, or ground truth establishment in the manner of an AI or diagnostic algorithm submission. The justification for clearance is based on the device having similar technological characteristics and intended use as existing legally marketed devices, implying that if the predicates are safe and effective, then the RTLX, being substantially equivalent, also is.
§ 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.