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VINT is a software that allows for the viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data (in DICOM-compliant format).

It enables:

• Importing DICOM-compliant MR Images.

• Quantitative analysis of imported images.

• Visualization and analysis of blood flow characteristics of cerebral arteries in MR images.

• Advanced correction options such as offset correction, background phase correction, and anti-aliasing.

• Data visualization as a graph or output as an image or numerical data.

• Providing the right and left carotid and vertebral arteries wall signal intensity gradient (SIG), an image-based indirect marker for velocity gradient from TOF-MRA.

VINT is intended for use with adult (22 years or more) populations who can undergo MRA.

VINT is a standalone medical software device designed for processing, analyzing, viewing, and quantifying cerebral artery MR images. The software is intended to visualize and quantify MRI data imported in DICOM format. The key functions of the VINT software are 2D and 3D viewing, multiphase series support, zoom, pan, window level, rotate, ROI Markers: Ability to create preset shapes or freehand ROI for measurements or segmentations, provide heatmaps to help users understand the distribution of arterial signal intensity gradient at a glance, and show measured numbers in a table.

It can also be used to analyze multi-slice signal intensity gradient of a TOF-MRA to visualize and analyze the blood flow characteristics of cerebral arteries, without any-contrast medium for MR angiography.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document explicitly mentions:

• Human studies: Yes, for evaluating the correlation between TOF-MRA SIG and PC-MR velocity gradient.
• Tubal experiments: Yes, for evaluating the correlation between TOF-MRA SIG and PC-MR velocity gradient.

Data Provenance: The document does not specify the country of origin for the human studies or whether they were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study involved a comparative validation between the subject device and a reference device for the correlation of SIG from TOF-MRA with PC-MR velocity gradient. It also performed bench testing against Predicate Device A for general performance metrics. There is no information provided about human readers improving with or without AI assistance as part of this study.

6. Standalone Performance Study (Algorithm Only)

The document describes "Bench testing" and "comparative validation between the subject device and the reference device" which evaluates the device's technical performance. This implicitly suggests a standalone evaluation of the algorithm's output against a reference. Specifically, it states: "Bench tests were performed using the subject device and the reference device (K213583) to validate TOF-MRA SIG as a reliable measure of shear rate obtained from PC-MR data."

7. Type of Ground Truth Used

• For evaluating the correlation between TOF-MRA SIG and velocity gradient: PC-MR data served as the ground truth. The document states, "The SIG from TOF-MRA showed highly significant correlations with velocity gradient calculated from the PC-MR, both in tubal experiments and human studies," implying PC-MR velocity gradient was the reference for comparison.

8. Sample Size for Training Set

The document does not provide information about the sample size used for the training set.

9. How Ground Truth for Training Set Was Established

The document does not provide information on how ground truth was established for the training set. Given that the VINT device is described as "Medical Image Management And Processing System" and focuses on viewing, post-processing, and quantitative evaluation, it's possible that traditional "training" in the machine learning sense might not be explicitly detailed if the core functionality is based on established image processing algorithms. However, no specifics are given.

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Fabrication of all ceramic restorations except for four- or more unit bridges including molars.

Not Found

I'm sorry, but this document does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a dental product called "Vintage Prime Press," which is a porcelain powder for clinical use. It outlines the regulatory clearance process and the indications for use of this device.

The document does not describe acceptance criteria for a device's performance, nor does it detail a study that proves the device meets such criteria. It discusses the regulatory path, product classification, and general controls applicable to the device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, information about sample sizes or data provenance for a test set, details on expert roles for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

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Shade adjustment of ceramic restorations

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I am sorry, but the provided text from the FDA letter (K191794) for "Vintage Art Universal" does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) clearance letter for a dental porcelain powder, classifying it as a Class II device. It primarily discusses:

• The FDA's determination of substantial equivalence to predicate devices.
• Regulatory requirements and general controls (registration, listing, GMP, labeling, adverse event reporting).
• The intended use of the device: "Shade adjustment of ceramic restorations."

There is no mention of:

• Specific performance metrics or acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic device).
• Details of a clinical study or performance study, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Any information regarding AI/human reader performance or MRMC studies.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details based on the provided text. This type of information is typically found in the 510(k) summary or the full submission, not in the clearance letter itself unless specifically highlighted for a novel device or testing paradigm.

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Build-up porcelain for fabrication of metal bonded ceramic restorations

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I am sorry, but the provided text is an FDA 510(k) clearance letter for a dental product called "Vintage Pro." It describes the regulatory classification, product code, and indications for use of this porcelain powder for clinical use.

This document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies related to an AI/device performance evaluation. Therefore, I cannot extract the requested information to fill in your table and answer your questions.

To help you, I would need a document that describes the clinical performance study of a device, particularly an AI-powered one, detailing its validation process.

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Build up porcelain for fabrication of all ceramic restorations including lithium disilicate

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The provided text is a 510(k) premarket notification letter from the FDA regarding a dental porcelain powder product (VINTAGE LD). It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is purely an administrative letter stating that the FDA has reviewed the submission and determined substantial equivalence to legally marketed predicate devices, allowing the manufacturer to market the device. It also includes the "Indications for Use" for the VINTAGE LD product, stating it is a "Build up porcelain for fabrication of all ceramic restorations including lithium disilicate."

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

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Shade adjustment of Lithium disilicate and ceramic restorations

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The provided document is an FDA clearance letter for a dental device (porcelain powder) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It discusses the device's substantial equivalence to other legally marketed devices but does not detail performance metrics, study designs, or effectiveness. Therefore, I cannot extract the requested information from this document.

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VINTAGE MP PRESS OVER is used to fabricate Press-To-Metal crowns and bridges.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a dental product called "VINTAGE MP PRESS OVER." This document confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria.

The letter focuses on regulatory approval based on "substantial equivalence" and does not describe a performance study or its results in detail. It does not provide information on acceptance criteria for a performance study, reported device performance, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

Therefore, I cannot extract the requested information from the provided text. This document is a regulatory approval letter, not a technical report detailing performance study results.

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VINTAGE MP is paste or powder porcelain intended to fabricate metal-ceramic restorations. It is used in conjunction with precious alloys for metal-ceramic restoration, metals for metal-ceramic restoration and stain materials for metalceramic restoration in order to produce natural looking restorations and prostheses.

VINTAGE MP is paste or powder porcelain

This document is an FDA 510(k) clearance letter for a dental porcelain product, "Vintage MP." It is not a study report and therefore does not contain the information requested regarding acceptance criteria and device performance studies.

The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. It outlines regulatory requirements for marketing the device but does not include any performance data or study details.

To answer your questions, one would need to refer to the actual 510(k) submission document, which is not provided here.

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Vintage Art is dental ceramic stain and is used for adjusting the shade of dental ceramic restorations or prostheses. It can reproduce natural-teeth like crown restorations and prostheses when built up on dental metal ceramic porcelain, dental porcelain, dental ceramic core material and porcelain teeth.

Vintage Art is dental ceramic stain.

I am sorry, but the context provided does not contain the information requested. The document is an FDA 510(k) clearance letter for a dental ceramic product called "Vintage Art." It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document discusses:

• Device Name: Vintage Art
• Regulation Number/Name: 872.6660 / Porcelain Powder for Clinical Use
• Regulatory Class: II
• Product Code: EIH
• Indications for Use: Dental ceramic stain for adjusting the shade of dental ceramic restorations or prostheses.

However, the provided text does not contain any information regarding acceptance criteria or the details of a study that proves the device meets such criteria. Therefore, I cannot generate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.

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Vintage ZR is high fusing porcelain used for fabricating ZrO2 framework bonded all ceramic restorations.

Vintage ZR is high fusing porcelain used for fabricating ZrO2 framework bonded all ceramic restorations.

The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for a dental device called "Vintage ZR." These documents do not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the full 510(k) submission, which is not provided here.

Therefore, I cannot answer your request based on the provided input. The documents confirm that "Vintage ZR" is a high fusing porcelain for fabricating ZrO2 framework bonded all-ceramic restorations and that it has received 510(k) clearance (K052033) from the FDA.

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