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Calcium scoring of calibrated CT images to provide quantitative measures of calcium content in the coronary arteries and aorta. The software is intended to be used under the supervision of trained physicians to monitor progression of vascular calcium which may be useful in the prognosis of Cardiovascular disease.

N-Vivo™ Calcium Score is a calibrated software program for non-invasive identification and quantification of calcified plaques in the coronary arteries and aorta using CT images. The software runs on a standard PC with basic image processing, database and reporting functions.

N-Vivo™ may be used to monitor progression of calcium which may be useful in the prognosis of cardiovascular disease.

A software package operating on a PC which facilitates non-invasive measurements of vascular calcified plaques. The device provides Agaston, Volume and Mass Scores using Phantom Calibrated CT images.

The key features include:

• Hybrid calibration with external phantom and invivo blood pool reference. .
• 사 Plaque definition which include statistical and calibrated thresholds for a calcium mass measurement.
• . Artery trace which segments regions of the heart that include the coronary arteries and aorta.
• . Automated identification, quantification, and scoring of vascular calcium.
• 내 PC workstation with web browser based interface which includes database, Dicom reports, Serial graphs and QA module.

The provided text is a 510(k) summary for the N-Vivo Calcium Score device, a software package for calcium scoring from CT images. It does not contain a detailed study description with specific acceptance criteria or an explicit comparative effectiveness study. The document focuses on establishing substantial equivalence to previously marketed devices.

However, based on the information provided, we can infer some details and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or provide a table of performance metrics. It mainly focuses on the device description and its intended use. The closest statement regarding performance is: "The calibration and software analysis improves the performance of calcium measurements from reconstructed CT images." However, no specific data demonstrating this improvement or against a defined acceptance criterion is provided.

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

This information is not provided in the document.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study, which would involve human readers improving with AI vs. without AI assistance, is not mentioned or described in this document. The focus is on the device's ability to provide quantitative measures, not on its impact on human reader performance.

6. Standalone Performance Study

While the device's function is standalone (algorithm-only), a detailed standalone performance study with specific metrics and results against a ground truth is not explicitly described in this document. The statement "The calibration and software analysis improves the performance of calcium measurements" implies a standalone capability, but without specific study details.

7. Type of Ground Truth Used

The document states that the device provides "Agaston, Volume and Mass Scores using Phantom Calibrated CT images" and uses "Hybrid calibration with external phantom and invivo blood pool reference." This suggests that phantom-based calibration and potentially in-vivo biological references are used to establish a form of ground truth for the measurements. However, the exact nature of the ground truth for an independent test set (e.g., pathology, clinical outcomes) is not detailed. It implies a focus on accuracy of measurement against calibrated standards rather than diagnostic accuracy against a clinical outcome.

8. 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. However, similar to point 7, it can be inferred that phantom-based calibration and in-vivo blood pool references played a role in the development and refinement (training) of the algorithms.

In summary, the 510(k) summary provided is a high-level overview establishing substantial equivalence. It lacks the detailed study information typically found in a clinical validation report, including specific acceptance criteria, sample sizes, expert qualifications, adjudication methods, and detailed performance metrics.

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The DXAVIEW™ Hip and Spine bone densitometry options are intended to estimate bone mineral content (BMC) and bone mineral density (BMD) in the proximal femur and spine. The BMD may be compared to DXA reference data. T-Scores and Z-Scores are calculated with respect to young normal and age matched reference data, and can be used by the physician in determining fracture risk.

The DXAVIEW™ Hip and Spine bone densitometry Options are intended to provide estimates of bone mineral density (BMD) and bone mineral content (BMC) in the proximal femur and spine. Young normal reference data taken from caucasian populations can be used to calculate T-Scores. Age matched normal reference data arc used to calculate Z-Scores. The BMD results, along with the T- and Z-Scores, can be used by physicians in their determination of fracture risk and therapy effectivencss.

The DXAView" Hip and Spine are software Options to the Image Analysis QCT-3D Plus product, which provides 3D projection measurements similar to conventional DXA. The product Options provide estimates of bone mineral content (BMC) and bone density (BMD) of the proximal femur and spine. BMC is expressed in grams and BMD in g/cm2 of calcium hydroxyapatite. DXAView™ uses phantom calibration by Quantitative Computed Tomography (QCT) on all compatible CT scanners. The computations are preformed on 3D CT volumetric image sets obtained with conventional CT protocols and radiation doses.

Here's a breakdown of the acceptance criteria and study information for the DXAView™ Hip and Spine device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" but rather describes the "Summary of Clinical Performance Data" and "Conclusions" from the validation studies, which implicitly serve as the criteria for deemed substantial equivalence.

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

• Test Set Sample Size: The document refers to "Patient validation studies" and "Clinical studies comparing DXA and DXAVIEW™ for BMD of the hip." However, the exact numerical sample size for these clinical studies (test set) is not specified.
• Data Provenance: Not explicitly stated. It refers to "clinical comparison studies," but neither the country of origin nor whether the data was retrospective or prospective is mentioned.

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

• This information is not provided in the document. The studies focused on comparing the DXAView™ software to DXA results, implying DXA itself served as a reference, but no mention of human experts establishing ground truth for the test set is given.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

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

• No, an MRMC comparative effectiveness study is not mentioned. The document focuses on comparing the algorithm's output (DXAVIEW™) to a reference standard (DXA), not on how human readers' performance might improve with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The "Clinical Performance Data" and "Conclusions" describe the performance of the DXAVIEW™ software directly (e.g., its precision, correlation with DXA), without mentioning a human-in-the-loop component. The device itself is described as "software Options to the Image Analysis QCT-3D Plus product."

7. Type of Ground Truth Used

• The ground truth used was comparison to a predicate device (DXA). The document states, "Clinical studies comparing DXA and DXAVIEW™ for BMD of the hip showed correlation coefficients R of 0.93-0.94." It also mentions the new device provides "estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from the predicate DXA device." This implies DXA measurements served as the reference standard (ground truth) for the clinical validation.

8. Sample Size for the Training Set

• The document does not specify a separate training set sample size. It describes the validation studies. Since the device uses reference data (NHANES III) for T-Scores and Z-Scores, this reference data itself could be considered a form of "training" or foundational data, but its sample size is not stated in relation to the device's development.

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

• The document does not detail how a training set's ground truth was established, as it primarily focuses on the validation against DXA. It mentions that "NHANES III Standardized Reference Data are used to calculate T-Scores and Z-Scores." The ground truth for such standardized reference data like NHANES III would typically be established through large-scale, cross-sectional population studies using direct measurements (e.g., DXA) from a diverse cohort to establish population norms.

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QCT bone densitometry is indicated for patients with suspected loss of bone to identify QCT bone delistionied I is meetar of the highly responsive spinal trabecular bone is indicated for early detection of bone loss.

QCT is useful for measuring bone loss or gain with time for monitoring osteoporsis QCT Is useful for mousaning other collect to increased fracture risk by WHO criteria.

QCT Bone Densitometer (QCT 5000 and QCT 3000)

I am sorry, but the provided text from the FDA 510(k) letter and the Indications For Use document does not contain the detailed information necessary to fully answer your request regarding the acceptance criteria and the study that proves the device meets those criteria.

The documents indicate that the "QCT Bone Mineral Analysis Software" (K992246) and "QCT Bone Densitometer (QCT 5000 and QCT 3000)" were found substantially equivalent to legally marketed predicate devices. However, they do not include the specific performance data, acceptance criteria, study design details, or expert qualifications that your questions ask for.

To answer your questions, I would need access to the actual 510(k) submission summary or other detailed performance study reports for this device.

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