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To detect or image the distribution of radionuclides in the body or organ, using the following techniques:

• Multiplanar Reconstruction (MPR) .
• Maximum/Minimum Intensity Projection (MIP) .
• Image Contrast Manipulation .
• Image Zoom Manipulation .
• Automatic registration with Mutual Information Technique .

Clarity PET is PET intage review software. Clarity PET offers a comprehensive software solution for medical imaging tasks and applications. Clarity PET is a medical diagnostic workstation designed for display, review, 3D MPR, communication and archiving of medical images

This 510(k) submission (K032866) for the Clarity PET device does not contain a study demonstrating that the device meets specific acceptance criteria based on its performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance metrics in the provided document. The submission relies on establishing equivalency rather than meeting new performance benchmarks.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No new performance study (test set, data provenance) is conducted for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. No new performance study is conducted that involved establishing ground truth with experts.

4. Adjudication Method:

Not applicable. No new performance study requiring adjudication is conducted.

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

No, an MRMC comparative effectiveness study was not done. The submission does not present a study comparing human reader performance with and without AI assistance, as the device is image review software, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not done. The Clarity PET is described as image review software and thus its "performance" is implicitly tied to its ability to display and manipulate images, similar to predicate devices. It's not an algorithm providing a diagnostic output independently.

7. Type of Ground Truth Used:

Not applicable. No ground truth for a new performance study is established or used in this submission.

8. Sample Size for the Training Set:

Not applicable. The provided document does not describe a training set for an algorithm, as the device is image review software, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of the K032866 Submission's Approach:

The K032866 submission for Clarity PET establishes substantial equivalence by demonstrating:

• Equivalent Indications for Use: The device can "detect or image the distribution of radionuclides in the body or organ, using the following techniques: Multiplanar Reconstruction (MPR), Maximum/Minimum Intensity Projection (MIP), Image Contrast Manipulation, Image Zoom Manipulation, Automatic registration with Mutual Information Technique." These are explicitly stated as equivalent to the Medical Image Merge™ device.
• Equivalent Technological Characteristics, Performance Characteristics, and Instructions for Use: The submission asserts that Clarity PET shares these equivalencies with the Medical Image Merge™ device and other predicate devices like Syngo Multi-Modality Workstation, ADAC Laboratories Image Fusion and Review System, and GE Advantage Windows Workstation.

The core of this 510(k) is a comparison to legally marketed predicate devices, asserting that Clarity PET performs the "same functions" and has "equivalent" characteristics, rather than providing new performance data against a specific set of acceptance criteria. The FDA's letter confirms that they reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.

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SmartScore 3.5/4.0/4.5 are non-invasive software options that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. SmartScore 3.5/4.0/4.5 may be used to monitor the progression/regression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.

SmartScore 3.5/4.0/4.5 are a family of software options that runs on the Advantage Windows (AW) (K960613) workstation and allows the user to detect calcifications in CT images. These Regions of Interest can be selected manually, or semi-automatically. It provides calculation of the calcium score using multiple scoring algorithms. The software also provides the ability to generate patient reports, and maintain a patient database for future reference.

This document, K020929, describes the GE SmartScore 3.5, 4.0, and 4.5 software options, which are intended to evaluate calcified plaques in coronary arteries from CT images. The submission aims to demonstrate substantial equivalence to a predicate device (CT Coronary Artery Calcification Scoring (CACS), K982004). However, the provided text does not include specific acceptance criteria or an explicit study that proves the device meets such criteria.

The document primarily focuses on:

• Product Identification: Device name, classification, manufacturer, and distributor.
• Device Description: Software options running on the Advantage Windows (AW) workstation for detecting calcifications, calculating calcium scores using multiple algorithms, generating patient reports, and maintaining a patient database.
• Indications for Use: Non-invasive evaluation of calcified plaques in coronary arteries, monitoring progression/regression of calcium over time, and aiding in the prognosis of cardiac disease.
• Comparison with Predicate: Stating substantial equivalence to CT Coronary Artery Calcification Scoring (CACS) (K982004).
• Adverse Effects on Health: Addressed by software development processes, validation, verification, and adherence to standards.
• Conclusions: No new potential safety risks and performs as well as devices currently on the market.
• FDA Clearance Letter: Confirming the substantial equivalence determination.

Based on the provided text, the following information is either not present or cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided. The document states "Software Development, Validation and Verification Process to ensure performance to specifications," but the specifications themselves or the performance against them are not detailed.
2. Sample Size used for the test set and data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study and effect size: Not mentioned. The focus is on demonstrating substantial equivalence to a predicate device, not on comparing reader performance with and without AI assistance.
6. Standalone (algorithm-only) performance: While the device is software-only and performs calculations, a specific standalone performance study with metrics is not described. The validation and verification process is mentioned in general terms.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

In summary, the document does not contain the detailed study information regarding acceptance criteria, performance metrics, dataset characteristics (sample size, provenance, ground truth establishment, expert qualifications), or specific study designs (MRMC, standalone) that would typically be expected for a comprehensive description of device validation. The submission relies on claiming substantial equivalence to a predicate device, implying that the predicate's performance is acceptable and the new device performs similarly.

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The Data Ray Corporation DR11021 Medical Imaging Monitor is intended to be used by radiologists/trained practitioners to examine digitized x-ray images for the purpose of medical analysis.

The Data Ray Corporation DR11021 Medical Imaging Monitor is used in filmless radiology systems to display digitized x-ray images. These digitized x-ray images are viewed by trained medical providers for the purpose of diagnosing and/or treating illnesses in human beings.

The DR11021 Medical Imaging Monitor is a diagnostic display used in film-less radiology applications.

The Data Ray Corporation DR11021 Medical Imaging Monitor is a high resolution monitor with the electronic capability necessary for displaying high resolution medical images for the purpose of evaluation.

The provided document is a 510(k) Premarket Notification Summary for the "DR11021 Medical Imaging Monitor" by Data Ray Corporation. This document concerns a medical display monitor and does not contain any information about acceptance criteria or a study proving device performance for an AI/CADe device.

The document describes the monitor's intended use (displaying digitized X-ray images for medical analysis by radiologists/trained practitioners) and its technological characteristics (high-resolution display). It also lists substantially equivalent predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance, as the provided text does not contain this information.

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