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The STV PRO 2 is:

• a camera which delivers color images of the oral cavity,
• a communication tool which allows the patient and dentist to view the patient's oral cavity

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The provided text is a 510(k) premarket notification letter from the FDA regarding the STV PRO 2 dental operative unit and accessories. It confirms the device's substantial equivalence to a legally marketed predicate device.

The document discusses the regulatory aspects of the device, its classification, and requirements for marketing. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the manufacturer's 510(k) submission, but they are not present in the FDA's response letter provided.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information regarding the study.

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The TROPHYPAN Panoramic Dental X-Ray System is to be used as an external source of X-ray for imaging of the dento-maxillo-facial area and provides digital radiographic images only through the built-in DIGIPAN ( K012514), digital imaging system.

TROPHYPAN Panoramic Dental X-Ray System

This document is an FDA 510(k) clearance letter for the TrophyPan Panoramic Dental X-Ray System. It does not contain the acceptance criteria or a study proving the device meets those criteria. Instead, it states that the device is substantially equivalent to a legally marketed predicate device for its indicated use.

Therefore, I cannot provide the requested information based on this document. The document primarily focuses on regulatory approval and classification rather than detailed performance study results.

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The Trophy Radiologie digital imaging kit, DIGIPAN, can replace the conventional film for primary diagnostic purpose. The image generated is displayed on a computer monitor. The image can then be archived through computer storage and archival means. Referral copies of the image can be obtained with optional hard copy systems.

DIGIPAN/DPI Digital Kit for Panoramic X-ray Device

This document is a 510(k) clearance letter from the FDA for the Trophy Radiologie DIGIPAN/DPI Digital Kit for Panoramic X-ray Device, dated December 21, 2001. It is a clearance for market, based on substantial equivalence to a predicate device.

The document does not contain information about acceptance criteria, device performance, sample sizes used for testing, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used, or training set details.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encience of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)." This means the device met the criteria for substantial equivalence to an existing device, rather than going through a de novo review that would typically involve establishing new acceptance criteria and conducting detailed performance studies against those criteria.

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The OS1000 serie is software controlled diagnostic panoramic dental x-ray equipment for producing high quality images of dentition with multiple orbit, TMJ, sinus. Cross section radiography is also possible. Theses models can be applied widely to not only orthodontic, prothesis, oral surgery, implant treatment, but also ortorhinolaryngology, orthodontics.

The OS1000 is a Panoramic and Tomographic unit. The OS1000E is only a Panoramic unit. The OS1000C is a Panoramic, Tomographic and Cephalometric unit. The OS1000EC is only a Panoramic and Cephalometric unit.

The input describes a 510(k) notice for the Trophy Radiologie Panoramic Orthoslice OS1000 series, which are dental X-ray devices. However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a standard FDA 510(k) clearance letter and the "Indications for Use" statement from the manufacturer. These documents typically confirm that a device is substantially equivalent to a legally marketed predicate device but do not detail the specific studies, metrics, or performance data used to demonstrate that equivalence.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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The Trophy Radiologie digital imaging kit is now designed for use with the following panoramic X-ray units : OP100, manufacturer Instrumentarium, K912893 ; OrthoSlice OS1000, manufacturer ASAHI, K991455 pending ; Panoura Ultra, manufacturer YOSHIDA, K number unknown to us ; X-Caliber, manufacturer ASAHI, K number unknown to us. The image generated is displayed on a computer monitor and can replace the conventional film for primary diagnostic purpose. The image can then be archived through computer storage and archival means. Referal copies of the image can be obtained with optional hard copy systems.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the DIGIPAN Digital Kit for Panoramic X-Ray and its Indications for Use. It does not contain specific details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA's decision was based on a comparison to existing devices, not necessarily on a de novo study proving specific performance metrics against pre-defined acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated from the document, with the understanding that most of the requested information regarding a detailed study is not present:

1. Table of acceptance criteria and the reported device performance

• Cannot be provided from the text. The document does not define specific acceptance criteria or report performance metrics (e.g., sensitivity, specificity, spatial resolution, contrast resolution). The clearance is based on substantial equivalence to predicate devices, implying that its performance is considered comparable enough for its intended use.

2. Sample size used for the test set and the data provenance

• Not mentioned. The document does not describe a test set or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not mentioned. The document does not indicate that a ground truth was established by experts for a test set.

4. Adjudication method for the test set

• Not mentioned. No adjudication method 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

• No. This device is a "Digital Kit for Panoramic X-Ray," which digitizes existing panoramic X-Ray units to replace conventional film. It is not an AI-based diagnostic tool, and therefore an MRMC study comparing human readers with and without AI assistance is not applicable or discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not mentioned. As noted above, this is a digital imaging kit, not an AI algorithm. No standalone algorithm performance is discussed.

7. The type of ground truth used

• Not mentioned. No specific ground truth methodology is described. The basis for clearance is substantial equivalence to predicate radiography devices, implying that the diagnostic capability of the images produced is considered equivalent to those from conventional film.

8. The sample size for the training set

• Not mentioned. The document describes a "digital imaging kit," not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable/Not mentioned. No training set or ground truth establishment for a training set is discussed.

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Ask a specific question about this device

Ask a specific question about this device