(49 days)
extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
ENDOS AC – ENDOS ACP intraoral system
This document is a 510(k) summary for the ENDOS AC – ENDOS ACP intraoral system, seeking substantial equivalence to the AZTECH 70 model. The submission focuses on comparing technical specifications rather than clinical performance based on specific acceptance criteria and detailed study results. Therefore, many of the requested details about acceptance criteria, study sizes, expert qualifications, and ground truth establishment are not present in the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device, the AZTECH 70. This largely involves matching or exceeding its technical specifications and intended use. The table below outlines the key comparative elements provided in the document.
| Acceptance Criteria Focus (Implicit) | Predicate Device (Aztech 70) Performance | Subject Device (ENDOS AC-ACP) Performance | Device Meets Acceptance Criteria? (Based on Substantial Equivalence Claim) |
|---|---|---|---|
| Intended Use | extra oral source X-ray system for dental radiographic examination of the teeth | extra oral source X-ray system for dental radiographic examination of the teeth | Met: Identical intended use. |
| High Voltage Value | 70 kV | 70 kV | Met: Identical. |
| Tube Current | 8 mA | 8 mA | Met: Identical. |
| X-ray Tube Insert | CEI OCX 70-G | CEI OCX 70-G | Met: Identical. |
| Focal Spot Size | 0.8 mm (IEC 336) | 0.8 mm (IEC 336) | Met: Identical. |
| H.V. Type | Single phase, self rectifying | Single phase, self rectifying | Met: Identical. |
| X-Ray Exposure Time Control | Microprocessor Controlled | Microprocessor Controlled | Met: Identical. |
| Compensation of Line Voltage Fluctuations | Yes, automatically by software algorithm | Yes, automatically by software algorithm | Met: Identical. |
| Total Filtration | > 2.0 mm Al | > 2.0 mm Al | Met: Identical. |
| HVL | > 1.5 mm Al | > 1.5 mm Al | Met: Identical. |
| X-Ray Exposure Timing | 0.040 sec to 3.2 sec | 0.020 sec to 3.2 sec | Met: Subject device has a wider range which encompasses and expands upon the predicate. |
| Electrical Characteristics | 120 V +/- 10%, 7.6 impulsive A max | 120 V +/- 10%, 7.6 impulsive A max | Met: Identical. |
| Focus-Film Distance | > 20 cm | > 20 cm | Met: Identical. |
| 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.