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The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

I am sorry, but the provided text from the FDA 510(k) summary for the SOPIX device does not contain information about acceptance criteria, device performance metrics, study design (sample sizes, data provenance, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies (MRMC or standalone).

This document is primarily a letter from the FDA confirming the substantial equivalence of the SOPIX device to existing legally marketed devices, along with the device's indications for use. It details regulatory information rather than a performance study.

Therefore, I cannot provide the requested table and study details based on the input text.

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The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

Since the A.C.E technology affects exposure time, when used in combination with X-Mind Unity X-Ray generator, the SOPIX Inside and SOPIX2 Inside A.C.E feature is an automatic exposure control technology.

The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

Since the A.C.E technology affects exposure time, when used in combination with X-Mind Unity X-Ray generator, the SOPIX Inside and SOPIX2 Inside A.C.E feature is an automatic exposure control technology.

I am sorry, but the provided text from the FDA 510(k) summary for the SOPIX INSIDE and SOPIX2 INSIDE devices does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving device performance.

The document is a clearance letter from the FDA, confirming that the devices are substantially equivalent to legally marketed predicate devices. It covers regulatory information, product codes, and indications for use.

Crucially, it does NOT include details about:

• Acceptance criteria table and reported device performance: This type of information would be found in the manufacturer's performance studies, which are summarized within the 510(k) submission itself, but not typically in the FDA clearance letter.
• Sample size and data provenance for the test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results (effect size).
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

To find this type of information, you would typically need to refer to the full 510(k) submission (if publicly available, often through a Freedom of Information Act request or directly from the manufacturer), which contains the technical specifications and detailed study reports supporting the substantial equivalence claim. The provided document is merely the FDA's formal clearance notice.

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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.

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