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The CCD area image sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.

The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. All the systems include a scintillator coupled to a digital image sensor, electronic circuits to analyze the digital image and transmit the digital image to a personal computer for viewing and further management of the file.

The provided document is a 510(k) premarket notification for the Dentron Sensor. This type of submission is a declaration of substantial equivalence to a predicate device, not typically a full clinical study with detailed performance data against specific acceptance criteria.

Based on the document, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, resolution targets) for the Dentron Sensor. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.

The "Comparison Table" provided in the document outlines technical characteristics of the Dentron Sensor and its predicates. Here's a summary of those technical characteristics, which could be considered "performance" in the context of a 510(k) in comparison to predicates, but not against predefined acceptance criteria for a novel clinical claim.

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

• The document does not report specific sample sizes for a test set in the context of clinical performance evaluation.
• The document refers to mechanical, electrical, and electromagnetic compatibility testing standards (UL 60601-1, EN 60601-1-2, IEC 60601-1-4) with associated test reports (e.g., IMQ S.p.A. Test report nº 27SE00094). These tests typically involve device units, not patient-derived data sets.
• Data provenance is not applicable in the sense of clinical data (e.g., country of origin, retrospective/prospective) because such a study is not described.

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

• Not applicable. The submission does not describe a clinical study requiring ground truth derived from expert consensus on a test set. The focus is on technical equivalence and compliance with safety standards.

4. Adjudication method for the test set:

• Not applicable. No clinical test set and subsequent adjudication method are described in this 510(k) submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a digital intraoral X-ray sensor, not an AI-powered diagnostic aid. No MRMC study is mentioned or expected for this type of device.

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

• Not applicable. This device is hardware (a sensor) for capturing images, not a standalone algorithm.

7. The type of ground truth used:

• For the technical characteristics comparison, the "ground truth" implicitly relies on established specifications and performance of the predicate devices and general industry standards for intraoral imaging. There is no specific clinical "ground truth" (e.g., pathology, outcomes data) reported for this 510(k) submission. Compliance with international safety and electrical standards (UL, EN, IEC) forms part of the "ground truth" for safe operation.

8. The sample size for the training set:

• Not applicable. This device is a hardware sensor; therefore, there is no "training set" in the context of machine learning or AI models.

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

• Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply here.

In summary:

This 510(k) submission for the Dentron Sensor focuses on demonstrating substantial equivalence to predicate devices based on:

1. Similar intended use: Capturing intraoral X-ray images for dental diagnostic purposes.
2. Similar technological characteristics: As detailed in the comparison table regarding sensor type, resolution, connection, etc.
3. Compliance with recognized voluntary standards: UL 60601-1, EN 60601-1-2, and IEC 60601-1-4 for safety and EMI/EMC.

The phrase "The proposed and predicated devices are substantially equivalent, similar devices that have been used by dentists in the US since 1989 and well accepted" directly addresses how the device meets the regulatory hurdle for market entry, rather than through a traditional clinical study with defined acceptance criteria for diagnostic performance metrics.

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VixWin PRO controls capture, display, treatment, analysis and saving of X-ray digital images from DenOptix®, Visualix®/GX-S, Orthoralix 9200 DPI and DDE digital imaging systems produced by Gendex. It can also handle other types of digital images, e.g. color images from an intraoral dental camera, such as the Gendex Concept IV series, or images acquired by digitizing film with a flat bed scanner

Vix Win is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, treatment, analysis and saving of xray digital images from DenOptix ®, Visualix ® / GX-S, KaVo Dig eXam, Orthoralix DPI & DDE series imaging systems by Gendex ®. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from an intraoral or extraoral dental camera such as the AcuCam Concept IV and eZ1 series. When properly installed in your computer, VixWin lets you:

• Control scanning and intake of x-ray images from image plates with the DenOptix . scanner (*).
• Control the direct capture of x-ray images from the intraoral sensor Visualix / GX-S, 미 KaVo Dig eXam, Orthoralix DPI & DDE series systems (*).
• View and capture color images from certain cameras, such as a dental camera, via a suitable video capture card (*).
• Export and import digital images (such as those obtained by scanning a film) in several 프 standard file formats.
• Process images with dental specific tools, to enhance their diagnostic value. 제
• Analyze and manipulate images in order to gather additional diagnostic information . which may not be immediately apparent on initial visual inspection.
• Create a database of patients and easily store images in patient folders .. .

The provided text describes a 510(k) premarket notification for the "VixWin Pro" dental image management system. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth is not explicitly available in the provided text.

Here's an analysis of the available information:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present specific performance-based acceptance criteria in the typical sense of a clinical study (e.g., sensitivity, specificity thresholds). Instead, it compares the technical specifications and functionalities of VixWin Pro to two predicate devices: DentalEye 2 (K012439) and KaVo ERGOcom®/ERGOcam® (K050744).

General Acceptance Criteria (Implied by 510(k) process for this device):

• Substantial Equivalence: The primary acceptance criterion for a 510(k) device like VixWin Pro is demonstrating that it is as safe and effective as a legally marketed predicate device. This is achieved by showing that it has the same intended use and the same technological characteristics as the predicate, or, if there are different technological characteristics, that the different characteristics do not raise new questions of safety and effectiveness and are shown to be at least as safe and effective as the predicate device.
• Compliance with Product Specifications: The document states, "This is based on testing to verify compliance with product specifications." This implies that internal testing was conducted to ensure the software met its defined functional and performance requirements. However, the specific product specifications and the results of this internal testing are not elaborated upon in the provided summary.
• Intended Use Compatibility: The device must effectively control capture, display, treatment, analysis, and saving of X-ray digital images as specified in its Indications for Use. The comparison table implicitly supports this by showing similar image handling capabilities to predicate devices.

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

• Not Applicable: The provided 510(k) summary does not describe a clinical study with a "test set" of patient data in the context of diagnostic performance (e.g., for sensitivity/specificity). The testing mentioned refers to verification of compliance with product specifications, which is typically internal engineering and software testing, not patient-level data analysis. Therefore, information on sample size or data provenance is not provided for such a "test set."

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

• Not Applicable: As there's no diagnostic performance study with a "test set" of patient data described, there is no mention of experts establishing ground truth for such a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable: Given the absence of a diagnostic performance study, no adjudication method for a test set is mentioned.

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: The document does not describe an MRMC comparative effectiveness study, nor does it mention AI assistance. VixWin Pro is described as a "Dental Image Management System" that processes, analyzes, and manipulates images, but there's no indication of AI algorithms for diagnostic assistance that would necessitate an MRMC study to evaluate human reader improvement.

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

• No: The document describes VixWin Pro as a software system for image management, display, and processing. It is inherently a tool for human users (dentists/maxillofacial diagnosticians). There is no mention of a standalone algorithm for automated diagnosis or a standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable: Since no diagnostic performance study is described, no specific "ground truth" for patient data is mentioned in this document. If any "ground truth" was involved in the "testing to verify compliance with product specifications," it would likely relate to objective technical parameters of image quality or software functionality, rather than clinical diagnoses.

8. The sample size for the training set:

• Not Applicable: As VixWin Pro is presented as an image management and processing software without explicitly stated AI or machine learning components requiring a "training set" for model development, this information is not provided.

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

• Not Applicable: For the reasons stated above (no defined AI/ML training set), there's no information on how ground truth for a training set would be established.

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VISTADENT™ AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis.

VISTADENT™ AT COMPLETE software is designed for use as an imaging database for storage and organization of orthodontic patient digital images and x-ray records. Features include resizing, cropping, and rotating of images; data and image sharing with practice management systems and digital x-ray systems; cephalometric analysis with auto-tracing capability; and virtual treatment objectives. VISTADENT™ AT COMPLETE can operate as a stand-alone software or interface with other systems software.

This 510(k) submission for VISTADENT™ AT COMPLETE is a premarket notification for an imaging database software and does not contain information related to an AI/ML medical device performance study, acceptance criteria, or an MRMC comparative effectiveness study. The device is described as software for storing, organizing, manipulating, and analyzing orthodontic patient digital images and x-ray records, including cephalometric analysis with auto-tracing and virtual treatment objectives.

Therefore, I cannot provide the requested information from the provided text, as it does not include:

1. Acceptance criteria and reported device performance: The submission focuses on substantial equivalence to predicate devices based on technological characteristics and intended use, not on specific performance metrics or acceptance criteria for an AI/ML component.
2. Sample size and data provenance for a test set: No test set is described.
3. Number and qualifications of experts for ground truth: No ground truth establishment process is mentioned for evaluation.
4. Adjudication method for the test set: Not applicable as no test set is described.
5. MRMC comparative effectiveness study: This type of study is not mentioned. The features described (auto-tracing, virtual treatment objectives) suggest potential AI/ML capabilities, but no study evaluating human reader improvement with AI assistance is presented.
6. Standalone performance study: No standalone performance study for an algorithm is discussed.
7. Type of ground truth used: Not applicable as no performance evaluation study is detailed.
8. Sample size for the training set: No training set is mentioned.
9. How ground truth for the training set was established: Not applicable as no training set is described.

The document is a 510(k) summary focusing on demonstrating substantial equivalence to predicate devices for a digital imaging database and analysis software, rather than reporting on the performance of a novel AI/ML algorithm against specific acceptance criteria.

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The Scan300fp / Retropan (VDC) Digital X-ray Conversion Kit is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.

The Scan300fp sensor produces instant digital images. The Scan300fp allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K012439, which gives post processing capabilities to enhance images.

lt is faster to obtain images with the Scan300fp / Retrofit (VDC) than with conventional film since no chemical nor any other type of processing is required.

Not Found

This document is a 510(k) clearance letter from the FDA for the Scan300fp/Retropan (VDC) Digital X-ray Conversion Kit. It primarily focuses on the regulatory approval and indications for use, rather than a detailed study report describing acceptance criteria and device performance. As such, most of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or stated from the document:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary criterion for 510(k) clearance. However, specific performance metrics or acceptance criteria for that substantial equivalence are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided 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

This information is not provided in the document. The device is a digital X-ray conversion kit, not an AI-assisted diagnostic tool.

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

This information is not explicitly stated, but the device is a hardware component (conversion kit) that integrates with software. Its performance would be evaluated in the context of producing images for human interpretation, not as a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary from the provided text:

The provided document is a regulatory clearance letter. It confirms that the Scan300fp/Retropan (VDC) Digital X-ray Conversion Kit has been deemed substantially equivalent to predicate devices for its intended use.

Indications for Use:
The device is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films. It produces instant digital images, allowing for less exposure time than conventional films, thereby lowering patient dose. The sensor connects to DentalEye software, #K012439, which provides post-processing capabilities to enhance images. The device is faster than conventional film because no chemical or other type of processing is required.

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