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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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