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510(k) Data Aggregation
(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 | < 25 mR/h at 1 meter from focus | < 25 mR/h at 1 meter from focus | Met: Identical. |
| X-ray Beam Dimension at 20cm | < 6cm | < 6cm | Met: Identical. |
| Safety Features | Dead man command | Dead man command | Met: Identical. |
| Signaling Devices | Acoustic and visual signal | Acoustic and visual signal | Met: Identical. |
| X-Ray Exposure Time Control (specifics) | Automatic - pre-programmed | Automatic - pre-programmed in the ACP model; manual in the AC model | Met: Subject device offers both automatic (like predicate) and manual options. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of diagnostic accuracy. The comparison provided is based on technical specifications and functional attributes of the device itself against a predicate device. Therefore, no information on sample size or data provenance (country, retrospective/prospective) for a clinical test set is available.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Given that no clinical "test set" or diagnostic accuracy study is described, there is no information on the number or qualifications of experts used to establish ground truth. The technical specifications listed are likely verified through engineering testing and quality assurance checks by the manufacturer.
4. Adjudication Method for the Test Set
As there is no described clinical test set, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned in the document. The submission focuses on substantial equivalence based on technical specifications and intended use, not on a comparative effectiveness study involving human readers with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Since the device described is an X-ray system (hardware) and not an AI algorithm for image analysis, the concept of "standalone performance" for an algorithm is not applicable here and no such study is mentioned. The "standalone" performance here refers to the system's ability to produce X-rays according to its specifications.
7. Type of Ground Truth Used
For the technical specifications, the "ground truth" would be established through:
- Engineering measurements and calibration data: For parameters like kV, mA, focal spot size, filtration, HVL, leakage radiation, beam dimension, and exposure timing.
- Design specifications and regulatory standards: Ensuring the device adheres to established safety features and electrical characteristics.
- Comparison against the predicate device's documented specifications.
8. Sample Size for the Training Set
This document does not describe an AI algorithm or a "training set." The device is an X-ray system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI algorithm or training set is mentioned.
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