(350 days)
The SOPIX 2 SYSTEM is intended to be used by qualified dentist in general to provide instant X-Ray images, typically of tooth, bone and surrounding tissues.
The SOPIX2 system is a digital x-ray sensor system for human and non human use in dental and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues.
This document is a 510(k) summary for the SOPRO SOPIX2 system, an intraoral digital X-ray sensor for dental applications. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study with specific acceptance criteria and performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text. The document acts more as a regulatory submission for market clearance based on equivalence rather than a detailed performance study report.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document's purpose is to argue for substantial equivalence to a predicate device, implying that its performance should be comparable to the predicate. There are no quantitative performance goals or thresholds mentioned.
- Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) are reported for the SOPIX2 system. The document generally states that "Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPIX2." This is a qualitative statement of equivalence, not a quantitative performance report.
2. Sample size used for the test set and the data provenance
- Sample Size: Not mentioned. No specific test set or study size is described.
- Data Provenance: Not mentioned. There is no information about the origin of any data used for testing (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Reasoning: Since no specific performance study with a test set generating ground truth is described, information on experts is absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned.
- Reasoning: Similar to the above, no specific ground truth establishment or adjudication process 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
- MRMC Study: No, there is no indication that an MRMC comparative effectiveness study was done.
- AI Assistance: The device described is an X-ray sensor system, not an AI-based diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not explicitly done in the context of an algorithm. The device is a hardware sensor. Its performance is inherent to its image acquisition capabilities, which are argued to be equivalent to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not mentioned. No formal ground truth establishment is described in the provided summary.
8. The sample size for the training set
- Sample Size: Not applicable. This device is a hardware sensor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable, as there is no training set for this hardware device.
In summary, the provided document is a regulatory submission for market clearance based on substantial equivalence to a predicate device. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in reports for novel diagnostic algorithms or devices requiring extensive clinical validation beyond equivalence to an existing product.
§ 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.