(24 days)
extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
Aztech 70 is a Dental X-Ray generator; its primary use is for intra oral image receptor radiology. with a peak voltage of 70 kVp and a tube current of 8 mA. The soft X-Ray are filtered by 2 mm eq. of Al. The high voltage generator is enclosed in a plastic cover, with an apparently cylindrical aspect. The beam limiting device is formed by a circular cone with a maximum diameter of 6 cm. The tubehead is mounted on a oval shaped scissors arm, spring balanced. The scissors arm has a length of about 60 cm for each arm. The arm is mounted on an extension arm, that on the standard version has a length of 90 cm: optional configurations are available using extension arm of different lengths (75 and 60 cm). The unit is marketed as a wall mount permanent equipment. The electronic control of the VCA timer offers operator the possibility to select between automatic and manual selection of exposure times. In the automatic mode, selected exposure times according to the tooth. patient type (adult or child) and patient size to be filmed can be selected. With the manual mode of the VCA timer, the operator has the possibility to choose exposure times in steps ranging from 0.02 up to 3.2 seconds in discrete step increments. The exposure time is displayed on the timer main box by a three digit LEDs display, both for automatic and manual selection. This display is also used to show error codes, to inform the operator about the various possible faults. The microprocessor has also the job to compensate the line voltage fluctuations by changing the exposure time. This feature is accomplished by a mathematical algorithm. with a non linear function. X-Rav exposures are signaled by both acoustic and optical devices.
The provided document is a 510(k) summary for a dental X-ray generator called Aztech 70. It primarily focuses on demonstrating substantial equivalence to a predicate device (Aztech 65 with CCD timer) rather than providing a detailed study proving performance against acceptance criteria for a new, AI-powered diagnostic device.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment for AI, and MRMC studies is not present in this document because it describes a traditional medical imaging device, not an AI/ML-based diagnostic system.
However, I can extract the information that is available and clarify what is missing based on the document's content.
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Table of Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria in the format of specific thresholds for performance metrics (like sensitivity, specificity, accuracy) for a diagnostic output. Instead, it demonstrates "substantial equivalence" to a predicate device.
The "performance" is implicitly deemed acceptable because it is substantially equivalent to a legally marketed device. The comparison table (page 1) highlights technical specifications.Feature Predicate Device (Aztech 65 with CCD Timer, K950667) Proposed Device (Aztech 70 with VCA Timer) "Acceptance Criteria" (Implicit) Reported Device Performance (Aztech 70) Intended Use 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 and diagnosis of diseases of the teeth. Must be equivalent Equivalent High Voltage (kVp) 65 kVp 70 kVp Functionally similar 70 kVp Tube Current 8 mA 8 mA Equivalent 8 mA Tube Insert CEI OCX 70-G CEI OCX 70-G Equivalent CEI OCX 70-G H.V. Type Single phase, self rectifying Single phase, self rectifying Equivalent Single phase, self rectifying X-Ray Exposure Time Control Microprocessor Controlled Microprocessor Controlled Equivalent Microprocessor Controlled Compensation of Line Voltage Fluctuations Yes, automatically by software algorithm Yes, automatically by software algorithm Equivalent Yes, automatically by software algorithm Safety Features Dead man command Improved controls, with feedback sensors; Dead man command; Safety backup timer (HW) Enhanced/Equivalent Improved/Enhanced Signaling Devices Acoustic and visual signal Acoustic and visual signal; Optional remote signaling Enhanced/Equivalent Improved/Enhanced The specific performance of the Aztech 70 is described as having a peak voltage of 70 kVp and a tube current of 8 mA. The soft X-Rays are filtered by 2 mm eq. of Al. The performance is deemed acceptable because it is within the same functional principle as the predicate device, with some improvements in control and safety features.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable/not provided as this submission is for a conventional X-ray generator, not an AI/ML diagnostic software. There is no "test set" of images or patient data in the context of AI performance evaluation. The evaluation is based on technical specifications and safety features. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable/not provided as the device is not an AI/ML diagnostic system requiring expert-established ground truth on a test set of images. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided for the same reasons as above. -
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:
This information is not applicable/not provided. An MRMC study is relevant for AI-assisted diagnostic tools. This submission is for an X-ray hardware device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. This device does not involve an "algorithm" in the sense of AI for diagnostic interpretation. Its "algorithm" refers to software controlling hardware features like line voltage compensation. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/not provided. For an X-ray generator, the "ground truth" relates to its physical performance characteristics (e.g., kVp output, mA, exposure time accuracy, radiation safety) meeting design specifications and regulatory standards, not diagnostic outcomes. -
The sample size for the training set:
This information is not applicable/not provided as this is not an AI/ML device requiring a training set. -
How the ground truth for the training set was established:
This information is not applicable/not provided as this is not an AI/ML device requiring a training set with established ground truth.
§ 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.