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The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images.

Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.

The ClearVision Nuclear Medicine Imaging System acquires and processes cardiac data including gated and non-gated Single Photon Emission Computed Tomography (SPECT) studies. After completion of an acquisition, the operator can select the resulting acquisition data file to generate both qualitative and quantitative results for review by a physician. This includes processing using Release 5.6 of Segami Corporation's Mirage processing software that was previously cleared under 510(k) number K043441 dated 13-January-2005.

The acquisition system consists of either a single or dual small field-of-view detectors with each mounted on top of a tower that contains system electronics. To support the acquisition of SPECT data, the patient chair rotates up to 360 degrees in either clockwise or counterclockwise direction.

Prior to a patient scan, the following system features are used to ensure the myocardium is centered within each detector's field of view (FOV):

• . Each tower can be moved horizontally along rails mounted to the floor plate.
• . The patient chair seat pan can be moved side-to-side.
• Vertical and a horizontal beam lasers are mounted to side of detector.

The ClearVision system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.

The provided document is a 510(k) summary for the GVI Medical Devices ClearVision Nuclear Imaging System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for the ClearVision system itself.

Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, and ground truth establishment is not available in this document. The document describes a comparison of features and performance characteristics to a predicate device (Digirad Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems, K070542) to establish substantial equivalence.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather presents a "Feature Comparison Summary" to demonstrate substantial equivalence to the predicate device. The performance characteristics listed are NEMA (National Electrical Manufacturers Association) standards, which are common for SPECT systems and implicitly serve as performance benchmarks.

Note: The "Acceptance Criteria" column above is inferred from the predicate device's performance characteristics as presented for comparison in the document for demonstrating substantial equivalence.

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

Not Available. The document does not describe a clinical study with a specific test set, patient data, or data provenance (country of origin, retrospective/prospective). The comparison is based on technical specifications and performance characteristics from NEMA standards and device design.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Available. There is no mention of a human expert review or ground truth establishment process in the context of a clinical study in this document.

4. Adjudication Method

Not Available. As no expert review or human-in-the-loop study is described, no adjudication method is mentioned.

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

No. The document does not mention any MRMC comparative effectiveness study, nor any evaluation of human readers' improvement with or without AI assistance. The device is a SPECT imaging system, not an AI-assisted diagnostic tool in the sense of a software algorithm interpreting images.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly, for certain physical parameters. The performance characteristics listed (NEMA Reconstructed Spatial Resolution, NEMA System Sensitivity, NEMA Energy Resolution) are measures of the system's inherent physical performance, which can be considered "standalone" as they don't involve a human in the loop for the measurement itself. However, this is for the imaging system's hardware performance, not an "algorithm" in the sense of an AI model making diagnostic interpretations. The Segami Mirage processing software (Release 5.6) used for processing is mentioned as previously cleared (K043441), indicating its standalone processing capabilities were evaluated separately.

7. Type of Ground Truth Used

For the physical performance characteristics of the device, the "ground truth" is established through standardized phantom measurements according to NEMA (National Electrical Manufacturers Association) protocols. These are empirical measurements of physical performance metrics (e.g., resolution in mm, sensitivity in cpm/uci, energy resolution in %). For images generated, the ground truth for diagnostic interpretation would typically involve clinical data like pathology or patient outcomes, but this level of detail is not discussed for the ClearVision system in this document.

8. Sample Size for the Training Set

Not Applicable/Not Available. The ClearVision is a hardware device (SPECT scanner) combined with processing software. There is no mention of a "training set" in the context of machine learning. The system's design and engineering are based on established physics and medical imaging principles.

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

Not Applicable/Not Available. As there is no "training set" in the machine learning sense, there is no discussion of how ground truth for such a set was established.

Summary Explanation:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to an existing predicate device (Digirad Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems), rather than presenting a new clinical study with novel acceptance criteria and extensive human-in-the-loop performance evaluations. The document highlights the ClearVision's technical specifications and physical performance characteristics (e.g., NEMA standards) in comparison to the predicate, arguing that despite some differences (like detector technology and collimator type), it performs "as well as" the predicate and does not introduce new safety risks. This approach is common for demonstrating equivalence of medical devices, especially imaging hardware, where performance is often benchmarked against established industry standards and predicate device capabilities.

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The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.

The OnePass system's design is optimized for acquiring and processing cardiac first pass data. Firstpass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.

The OnePass Nuclear Medicine Imaging System acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images. After completion of acquisition, both qualitative and quantitative results are available for processing and analysis.

The device consists of a vertical support, a single small FOV detector mounted on an articulating arm, a 15 in. color LCD acquisition display, and an acquisition and processing computer workstation. The OnePass system's small field-of-view (FOV) detector and small system footprint are designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.

The provided text is a 510(k) premarket notification for a medical device and does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document states that the OnePass Nuclear Medicine Imaging System is a modification of a previously cleared device (K0233373) and that this modification provides a "slightly larger UFOV to aid the operator" and a "new software application to automatically archive system-specific data files." The submission asserts substantial equivalence based on comparable type, similar performance characteristics, same technological characteristics, identical key safety and effectiveness features, same basic design, and same intended use as the predicate device.

The FDA's letter (K051402) acknowledges the substantial equivalence to a legally marketed predicate device, allowing the device to proceed to market. However, it does not describe specific acceptance criteria or an analytical or clinical study with the details requested in your prompt.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, or ground truth for this device from the provided text. This type of information is typically found in detailed performance and clinical validation studies, which are not included in this summary of safety and effectiveness.

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The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.

The OnePass system's design is optimized for acquiring and processing cardiac first pass data. First-pass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.

The OnePass Nuclear Medicine Imaging Systems acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images. After completion of acquisition, both qualitative and quantitative results are available to the physician for analysis.

The acquisition system consists of a single small field-of-view detector mounted on an articulating arm to allow precise positioning of the detector over the patient's heart. In addition, a vertical lift adjusts the detector height position to track changes in the incline of the treadmill to ensure camera remains positioned directly over the patient's heart during acquisition.

The provided text is a 510(k) summary for the OnePass Nuclear Medicine Imaging System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, reported device performance metrics, sample sizes, ground truth establishment methods, or any details about human reader studies (MRMC or standalone).

The document primarily focuses on:

• Device identification: Name, classification, contact information.
• Device description: How it acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images using a single small field-of-view detector.
• Intended Use: Diagnostic imaging to depict anatomical distribution of radioisotopes, specifically optimized for cardiac first pass data to assess left and right ventricular function.
• Predicate Device: Scinticor SIM-400 System (K931193).
• Claim of Substantial Equivalence: The OnePass is comparable and substantially equivalent to the SIM-400 for FPRNA studies, with the primary difference being that OnePass is optimized only for FPRNA, while SIM-400 can perform other study types.
• Conclusion: No new safety risks, performs as well as the SIM-400 for FPRNA.
• FDA Clearance Letter: A formal letter from the FDA granting clearance based on the substantial equivalence claim.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, and performance metrics as they are not present in the provided text. The document is a regulatory submission, not a detailed scientific study report.

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