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Bright View VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView VCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the VCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView VCT Imaging System should only be used by trained healthcare professionals.

BrightView VCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView VCT is defined as a low dose, high resolution SPECT/CT system with CT-like image quality used to perform attenuation correction and localization. The overall system includes the SPECT gantry, patient table, detectors for emission, flat panel xray detector for attenuation correction and localization, acquisition system, processing workstation, image processing/analysis and fusion software, and all other accessories required for the functionality of the system.

The BrightView VCT is designed to provide extended imaging functionality relative to a ring style gantry. It is designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, display panel, two detectors, a collimator storage unit, an acquisition computer unit (with an optional customer desk), a patient imaging table (includes pallet catcher), and a hand controller. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies. The table may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys. The pallet includes removable arm, leg/knee, shoulder and headrest supports for patient positioning during studies that require support. The flat panel x-ray detector can be folded into the gantry to accommodate collimator exchange or bed imaging.

The BrightView VCT is designed to allow acquisition of a broad range of imaging studies using single or dual detectors. When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), BrightView VCT can be used to perform static, dynamic, gated, total body, circular-orbit and non-circular orbit SPECT studies, gated SPECT (circular and non-circular) studies. A flat panel x-ray detector and x-ray tube are mounted to the SPECT gantry to provide attenuation correction and localization capability.

This document provides information from a 510(k) premarket notification for the Philips Medical Systems (Cleveland) Inc. BrightView VCT Imaging System. The primary purpose of this submission is to demonstrate substantial equivalence to predicate devices, rather than an independent study proving performance against specific acceptance criteria.

The submission claims substantial equivalence based on identical indications for use, technological comparison, and overall system performance. However, it does not present a detailed study with specific acceptance criteria and metrics of device performance. Instead, it focuses on comparing the new device's features and intended use with previously cleared devices.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not present in this 510(k) summary. The document is primarily a regulatory filing for market clearance, not a scientific publication of a performance study.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance

The provided text does not contain a table of explicit acceptance criteria with corresponding device performance metrics. The submission argues for "overall system performance" being substantially equivalent to predicate devices, but no quantitative performance data is present in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission does not detail a specific "test set" for performance evaluation in the manner of a clinical study. It focuses on technological comparison and indications for use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. No "ground truth" establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No adjudication method is mentioned, as no specific test set or study design is detailed in this regulatory summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted or reported in this document. The device is a diagnostic imaging system, not an AI assistance tool for human readers in the traditional sense discussed by this question. The submission focuses on the imaging system's capabilities for attenuation correction and localization.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the device as an "imaging system" that produces images for "trained healthcare professionals" to use. It inherently involves a human-in-the-loop for interpretation and diagnosis. The primary "algorithm only" aspect would be image reconstruction and correction, which is part of the system's function, but not typically evaluated as a "standalone" performance metric in this context. The focus is on the integrated system's capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document. The filing does not describe a performance study with an established ground truth.

8. The sample size for the training set

This information is not provided in the document. The filing does not mention a "training set" in the context of an algorithm's development or evaluation.

9. How the ground truth for the training set was established

This information is not provided in the document. As no training set is mentioned, the method for establishing its ground truth is also absent.

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