(16 days)
Air Techniques High Frequency Intra-Oral X-Ray is to be used as an extraoral source of X-Rays in Dental radiography.
Air Techniques High Frequency Intra-Oral X-Ray is an X-Ray System with an extraoral X-Ray source for dental diagnostic radiography. The system houses two microprocessors, one for control / supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output. Air Techniques High Frequency Intra-Oral X-Ray consists of the following main components: Base Unit, Tube Housing, Beam Limiting Device-inbuilt with tube Housing, Control Console, 9.84 Ft (3 m) coiled cord, Rotating yoke for tube housing mounting, Extension arm, Scissor arm. Optional Components: Long Cone 11.8in (300mm), 9.84 Ft (3m) coiled cord with exposure switch. The Power supply is regulated to provide a selectable 50 to 70 kVp in step of 1kV at a selectable tube current of 4, 6, 7, or 8 mA. The range of exposure times is 0.04 to 4.00 seconds with 1:15 duty. Predefined exposure parameters kV, mA & exposure time values may be stored in, selected & operated via the operator control panel.
The provided text describes a pre-market notification (510(k)) submission for an X-ray device, not an AI/ML powered device. As such, it does not contain the specific information requested in your prompt regarding acceptance criteria and studies that prove a device meets those criteria for an AI/ML product.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details as these are not relevant to the provided text.
The document discusses the following:
- Device Name: Air Techniques High Frequency Intra-Oral X-Ray
- Intended Use: As an extraoral source of X-Rays in Dental radiography.
- Safety and Effectiveness: Demonstrated through compliance with various electrical, mechanical, environmental safety, and performance standards (UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-1-2 EMC, FDA 21 CFR 1020.30, 21CFR1020.31).
- Predicate Devices: INTRA SKAN DC (K103579), Progeny PREVA (K043092), Dentsply Gx-770 (K935046), Gendex 765DC (K992610). The device is stated to have "Same indications for use as predicate devices."
The FDA's letter confirms substantial equivalence to legally marketed predicate devices, allowing the device to proceed to market. However, it does not detail performance acceptance criteria in the context of AI/ML metrics (like sensitivity, specificity, AUC) or the type of studies typically conducted for AI/ML 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.