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510(k) Data Aggregation
(40 days)
The indication for use of the Corix 70 Plus-USV (with DPM timer) is extra oral The melodelen for use in dentistry as required for the radiographic examination and diagnosis of the dental anatomy.
Corix 70 Plus-USV is a Dental X-Ray generator; its primary use is for intra oral image receptor radiology. For such application, a peak voltage of 70 kVp has been demonstrated to give a high quality film with a good film quality/risk ratio. This is also enhanced by the fact that the tube current has the value of 8 mA, assuring effectiveness. The soft X-Ray are filtered by the inherent filtration and by an additional filter to guarantee the minimum 2 mm eq. of Al required by specifications. Exposure times are microprocessor controlled, assuring a high constancy and also repeatability. The high voltage generator is enclosed in a cover. The beam-limiting device is formed by a circular cone with a maximum diameter of 60 mm. The weight of the tubehead is 7.5 kg. The certified components may be assembled in different configurations in terms of arms and mounting. The control box assembly and the timer are combined as one and include all the electronics to power the high voltage transformer contained on the tubehead. plastic prismatic cover. X-Ray exposures are signaled by both acoustic and optical signals. The operator may choose exposure times ranging from 0.03 up to 3.00 seconds.
This is a 510(k) summary for a dental X-ray generator, the Corix 70 Plus-USV. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, the Explor-X 70. The provided document does not contain information about a study that assesses the device's performance against specific acceptance criteria relevant to AI/ML or diagnostic accuracy.
The summary primarily focuses on the technical specifications and intended use of the device, comparing them to a predicate device to establish substantial equivalence.
Therefore, many of the requested sections below cannot be populated as the provided text does not contain that information.
1. A table of acceptance criteria and the reported device performance
Based on the provided K031802 510(k) summary, the acceptance criteria are based on demonstrating substantial equivalence to a predicate device by comparing technical characteristics and intended use. Performance in terms of diagnostic accuracy (which would typically involve measures like sensitivity, specificity, AUC) is not assessed or reported for this type of device in this document.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Corix 70 Plus-USV) |
|---|---|
| Intended Use substantially equivalent to predicate | Extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth (Identical to predicate) |
| High Voltage value ($kV_p$) equivalent to predicate | 70 $kV_p$ (Identical to predicate) |
| Tube current (mA) equivalent to predicate | 8 mA (Identical to predicate) |
| X-Ray exposure time control method equivalent | Microprocessor Controlled (Identical to predicate) |
| Line Voltage Fluctuations compensation method equivalent | Automatically by software (Identical to predicate) |
| Safety features equivalent or better | Dead man command, Safety backup timer (Identical/Equivalent to predicate) |
| Signaling devices equivalent or better | Acoustic and visual signal, Optional remote signaling (Identical/Equivalent to predicate) |
| Overall functionality and technology similar | "The functionality and technology are similar" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) summary for a conventional dental X-ray generator does not describe a performance study involving a test set of data for diagnostic accuracy or AI/ML evaluation. It focuses on engineering specifications and intended use.
3. 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)
Not applicable. No diagnostic performance study for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No diagnostic performance study for a test set is described.
5. 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
Not applicable. This is a conventional dental X-ray generator, not an AI/ML device. Therefore, no MRMC study for AI assistance was conducted or would be relevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a conventional dental X-ray generator, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No diagnostic performance study is described. The "ground truth" for this submission is related to engineering standards, safety regulations, and establishing substantial equivalence based on technical specifications and intended use.
8. The sample size for the training set
Not applicable. This is a conventional dental X-ray generator and does not involve AI/ML or a training set.
9. How the ground truth for the training set was established
Not applicable. This is a conventional dental X-ray generator and does not involve AI/ML or a training set.
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