(144 days)
extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
extra oral source X-ray system for dental radiographic examination of the teeth
The provided text is a 510(k) summary for a medical device called ENDOS DC, which is an extraoral source X-ray system for dental radiographic examination. It compares the ENDOS DC to a predicate device, the GENDEX DENTSPLY model 765DC.
Based on the information provided, here's an analysis of the acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a typical quantitative performance metric sense (e.g., sensitivity, specificity, accuracy) for a medical imaging device's diagnostic capability. Instead, it focuses on technical specifications and safety features to demonstrate substantial equivalence to a predicate device.
The premise of this 510(k) is that if ENDOS DC meets or performs comparably to the predicate device in these technical areas, it is considered safe and effective for its intended use. Therefore, the "acceptance criteria" are implied to be the specifications of the predicate device.
| Acceptance Criteria (Predicate Device K992610: GENDEX 765 DC) | Reported Device Performance (ENDOS DC) |
|---|---|
| Intended use: extra oral source X-ray system for dental radiographic examination | Intended use: extra oral source X-ray |
| system for dental | |
| radiographic examination | |
| of the teeth | |
| High Voltage value: 65 kVp +/- 3kV | High Voltage value: 65 kVp+/-5% |
| Tube current: 7 mA +/- 5% | Tube current: 4-5 mA +/-5% |
| Focal spot size: 0.4 mm (IEC 336) | Focal spot size: 0.7 mm (IEC 336) |
| Anode inclination: 12.5° | Anode inclination: 19° |
| Total filtration: 2.0 mm Al | Total filtration: > 2.0 mm Al |
| HVL: 2.0 mm Al | HVL: > 1.5 mm Al |
| H.V. generator: High frequency | H.V. generator: High frequency |
| X-Ray exposure time control: Automatic - pre-programmed Microprocessor Controlled | X-Ray exposure time control: Automatic - pre- |
| programmed | |
| Microprocessor | |
| Controlled | |
| X-Ray exposure timing: 0.020 sec to 2 sec | X-Ray exposure timing: 0.010 sec to 2 sec |
| Electrical characteristics: 120 V, 5 impulsive A max | Electrical characteristics: 120 V, |
| 4.5 impulsive A max | |
| Focus film distance: > 20 cm or > 30cm | Focus film distance: > 20 cm |
| or > 30cm | |
| Leakage radiation: |
§ 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.