(91 days)
The IntraOs 70 (with Autoset Timer) is intended for the dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth. Such a device makes use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.
IntraOs 70 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.
The beam-limiting device is formed by a circular cone, which grants a source skin distance of 20cm and has a round output field of 6cm diameter. The weight of the tubehead is 6.4 kg. The certified components may be assembled in different configurations in terms of arms and mounting.
Exposure times are microprocessor controlled, assuring a high constancy and also repeatability. The operator may choose exposure times from 60 ms to 3,2 s by object selection. Manual setting possibility or exposure time from 60 ms to 3,2 s (plus or minus, 18 steps: 0.06; 0.08; 0.10; 0.12; 0.16; 0.20; 0.25; 0.32; 0.40; 0.50; 0.64; 0.80; 1.00; 1.25; 1.60; 2.00; 2.50; 3.20 s) if required.
Timer and hand switch can be remotely mounted. The hand-switch is provided with a 3 m-coiled cord.
This entry describes an X-ray system, IntraOs 70, for dental radiographic examination. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
Therefore, the following information, particularly regarding acceptance criteria, performance data, and detailed study methodologies, is not available within the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document is a 510(k) summary establishing substantial equivalence, not a detailed performance study with specific acceptance criteria and reported results. It highlights technological characteristics of the IntraOs 70 compared to the predicate device Explor-X 70.
| Acceptance Criteria | Reported Device Performance (IntraOs 70) |
|---|---|
| Not specified in document | Not specified in document |
The summary does provide a comparison of technological characteristics with the predicate device, which implicitly serves as the "performance" benchmark for substantial equivalence. Key characteristics include:
- Intended Use: Extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth (Matches predicate).
- High Voltage value: 70 kVp (Matches predicate).
- Tube current: 7mA (Predicate: 8 mA).
- Tube insert: OCX 70-G / RF8G070 (Predicate: CEI OCX 70-G).
- H.V. type: Single phase, self rectifying (Matches predicate).
- X-Ray exposure time control: Microprocessor Controlled (Matches predicate).
- Compensation of Line Voltage Fluctuations: Yes, automatically by software algorithm (Matches predicate).
- Safety features: Dead man command, Safety backup timer (Matches predicate).
- Signaling devices: Acoustic and visual signal, Optional remote signaling (Matches predicate).
The summary explicitly states: "The main differences of the IntraOs 70 with respect to SE device are mainly aesthetics; the functionality and technology are similar."
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) application, which typically focuses on technical specifications and comparison to a predicate device for substantial equivalence, rather than a clinical performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical performance study with a test set requiring ground truth established by experts is described in this 510(k) summary.
4. Adjudication method for the test set
Not applicable. No clinical performance study with a test set requiring adjudication is described in this 510(k) summary.
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 device is an X-ray generator, not an AI-powered diagnostic tool, and the document does not describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an X-ray generator, not an algorithm, and the document does not describe any standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth definition is mentioned as part of a performance study in this 510(k) summary.
8. The sample size for the training set
Not applicable. This device is an X-ray generator; there is no mention of an algorithm or training set in this 510(k) summary.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, there is no discussion of how ground truth would be established for it.
§ 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.