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.

Device Description

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.

AI/ML Overview

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.

Summary

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K992392

510(K) Summary

Date Prepared: June 7, 1999 Name of Contact Person: Ralph J. Flatau Address: InfiMed, Inc 121 Metropolitan Drive Liverpool NY 13088 Phone: (315)453-4545 x224 Fax: (315)453-4550

Device trade name: RTLX Common name: Digital Imaging System Classification Name: Extraoral source x-ray system ( as per 872.1800)

Device Description:

Intended Use:

Conclusions drawn from comparison:

The RTLX performs the same functions in the same environment as the predicate devices. The RTLX uses the same sensor technology as the Schick Technologies and the Trophy Radioligie systems and has the same real time image functionality and generator specifications as that of the HDLX system. There are some new features offered with the RTLX, but these are built on the same basic functionality offered by the three predicate devices listed and raise no new questions of efficacy or substantial risk.

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Feature/System	Panoramic RTLX	Panoramic HDLX	SchickTechnologies CDR	Trophy RadiologieRVG-S
510(k) number	N/A	K943532	K933455	K881133
X-ray Energy Source	70kV/ 100μA	70kV/ 100μA	N/A (X-ray sourcedependent)	N/A (X-ray sourcedependent)
Image Acquisition speed( maximum)	24 frames/second	30 frames/second	N/A (Still Frames only)	N/A (Still Frames only)
Display image resolution	128x160 @ 24fps -256x320 @ 6 fps	768 x 494	N/Available	N/Available
Sensor Sizes	20.1 x 30.1 mm	18 mm diameter	25.2 x 36.5 mm19.2 x 34.6 mm14.7 x 20.9 mm	18.2 x 27.5
X-ray Image AcquisitionDevice	CCD Sensor withScintillator	Image Intensifier withCCD Camera	CCD Sensor withScintillator	CCD, fiberoptics andscintillator.
Sensor Type	Intraoral Sensor	Intraoral Sensor	Intraoral Sensor	Intraoral Sensor
X-ray Source	Extraoral	Extraoral	Extraoral	Extraoral
"Window / level"features	Yes	Yes	Yes	Yes
Forward / Reverse / Stillcapability	Yes	Yes (Via attached VCR)	Still only	Still only
Hard copy Capability	Yes	Yes	Yes	Yes
Image Processor/DataStorage	Personal Computer	Personal Computer	Optional PersonalComputer	Personal Computer
Disinfection /Sterilization	Cold Sterilization andDisposable sheaths.Cold sterilization using3.4% gluteraldehdeSheath constructed oflow density polyetheleneinjected with ethyl /methyl acrylate by BantaHealthcare Group	Not Specified	Cold Sterilization andDisposable sheathsSheath constructed oflow density polyetheleneinjected with ethyl /methyl acrylate by BantaHealthcare Group(formerly Ling Products(Applied Technology)	Cold Sterilization andDisposable sheaths.Cold sterilization using3.4% gluteraldehdeSheath constructed oflow density polyethyleneinjected with ethyl /methyl acrylate by BantaHealthcare Group(formerly Ling Products)

Serjo

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2000

Ralph J. Flatau Quality Assurance Manager InfiMed, Inc. 121 Metropolitan Drive Liverpool, NY 13088

Re:

K992392 InfiMed RTLX Extraoral Dental System Dated: January 19, 2000 Received: January 21, 2000 Regulatory class: II 21 CFR 872.1800/Procode: 90 MUH

Dear Mr. Flatau:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions, Failure to comply with the GMP regulation may result in regulatory action. In the announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/dsmamain.html".

Sincerely yours,

David G. Satin, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Indication for Use

510(K) Number ( if known): 99 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3

Device Name: RTLX

Indication for Use:

( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation ( DOE)

Prescription Use

Over the counter Use _

Per 21 CFR 801.109

( Optional format 1-2-96)

David A. Seymon

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

Regulation Number and Section

§ 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.