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This x-ray unit is designed for use in the dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the "RX DC" device.

The document is a 510(k) premarket notification letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects, product classification, and general controls. It also includes the "Indication for Use" for the device.

However, it does not contain the specific details requested in your prompt, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone performance.
• Type of ground truth used.
• How ground truth for the training set was established.

This kind of detailed performance study information is not typically included in the FDA's 510(k) clearance letter itself, but would be part of the documentation submitted by the manufacturer to the FDA for review.

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The C-U2 is a digital intraoral camera system specifically designated for easy intraoral dental examinations, with an extremely lightweight handpiece, automatic brightness adjustment and fixed focus. It is conceived to assist the dentist during the day-by-day communications with the patient, to explain the treatment and to improve the patient's awareness.

The C-U2 is a digital intraoral camera system specifically designated for easy intraoral dental examinations, with an extremely lightweight handpiece, automatic brightness adjustment and fixed focus.

The provided text is a 510(k) clearance letter from the FDA for a dental operative unit and accessories (C-U2). It does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss device performance metrics, sample sizes, ground truth establishment, or any AI-related studies.

The letter essentially states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for market clearance based on its equivalence to existing products, not necessarily through a detailed performance study with specific acceptance criteria as might be expected for novel AI-powered devices or those requiring a PMA.

Therefore, I cannot fulfill your request for the detailed information you've asked for, as it is not present in the provided document.

To summarize the requested points in relation to the provided text:

1. A table of acceptance criteria and the reported device performance: Not present in the document.
2. Sample sized used for the test set and the data provenance: Not present in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in the document.
4. Adjudication method for the test set: Not present in the document.
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 present in the document. The device is an intraoral camera, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present in the document. The device is an intraoral camera, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present in the document.
8. The sample size for the training set: Not present in the document.
9. How the ground truth for the training set was established: Not present in the document.

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the wireless digital RX sensor is intended to capture an intraoral digital RX image, when exposed to X-Rays, for diagnostic purposes. The process is automatic and continues transmitting to a Personal Computer the digital image by wireless Bluetooth connection.

WDS is a wireless digital X-ray sensor for intraoral radiography.

The provided text is a 510(k) summary for the WDS Wireless Digital X-ray Sensor, indicating its intended use and establishing substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot provide the requested table or detailed answers to the specific questions regarding acceptance criteria and study particulars, as this information is not present in the provided document.

The document primarily focuses on:

• Device Description: WDS is a wireless digital X-ray sensor for intraoral radiography.
• Intended Use: To capture intraoral digital X-ray images for diagnostic purposes and transmit them wirelessly to a PC.
• Substantial Equivalence Comparison: Claiming substantial equivalence to predicate devices (K031448 RSV VISIODENT, K050693 ACCENT, K990002 QUICKRAY DSX730) based on similar components, design, technical characteristics, and mode of operation.

To answer your request, information regarding performance studies and acceptance criteria would need to be in a different section of a full 510(k) submission, typically in a "Performance Data" or "Clinical Data" section, which is not included here.

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