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Vantage ExSPECT II is intended to provide quality assurance enhancements to nuclear medicine images acquired using the ADAC Gamma Camera Systems.

Vantage ExSPECT II is a software program, which will be marketed as an optional addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510k K971878.

Vantage ExSPECT II is a computer program that provides a patient's functional information, which is further improved by using the anatomical information, obtained using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510k K943596 for Vantage 1.0.

Vantage ExSPECT II is a modification of Vantage 2.0 ExSPECT and is designed to provide the user with additional quality assurance (QA) to improve the consistency and usability of the Vantage 2.0 ExSPECT product. The Post Acquisition QA tool provides the user with feedback regarding the quality of the acquired images in that it alerts the user as to the level of any banding or truncation in the data as well as the level of counts acquired in each data set. The other improvement is two user-selectable iterative reconstruction methods for reducing the noise level in the transmission image.

The Vantage ExSPECT II is a software program designed to provide quality assurance (QA) enhancements to nuclear medicine images. It is a modification of the Vantage 2.0 ExSPECT software package.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Reported Device Performance": The provided text is a 510(k) summary, which outlines the device's features and intended function rather than providing quantitative performance metrics from a specific study. The "reported device performance" directly reflects the claims made for the device's capabilities in the summary. No numerical or statistical performance data (e.g., sensitivity, specificity, accuracy, or reduction in banding magnitude) are provided to objectively "prove" these claims in a quantitative sense. The acceptance appears to be qualitative based on the functionality descriptions.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The text only mentions "Images were processed using both the Post Acquisition QA tool and the transmission iterative reconstruction methods." It does not specify the number of images or cases used for testing.
• Data Provenance: Not explicitly stated. It is not mentioned if the data was retrospective or prospective, or the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The document does not mention the use of experts or how ground truth was established for the testing.

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

• Not specified. There is no mention of an adjudication method.

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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device focuses on quality assurance enhancements for image acquisition and reconstruction, not on assisting human readers in interpretation.

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

• Yes, the testing described appears to be a standalone evaluation of the algorithm's functionality. The statement "Images were processed using both the Post Acquisition QA tool and the transmission iterative reconstruction methods" implies an assessment of the algorithm's output without direct human interaction as part of the primary test of its claimed QA and noise reduction features.

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

• Not explicitly stated. Given the nature of the device (quality assurance and noise reduction), the "ground truth" would likely be related to objective measures of image quality, such as quantifiable levels of banding, truncation, or noise reduction as assessed against a reference standard or known simulated data. However, the document does not elaborate on how these were defined or measured.

8. The sample size for the training set:

• Not applicable/Not specified. This is a 510(k) summary for a software modification, not a machine learning or AI-based device that would typically involve a distinct "training set" in the context of supervised learning. The modifications are described as "improvements" to existing algorithms (Post Acquisition QA tool and iterative reconstruction methods), suggesting development or refinement of rule-based or model-based algorithms rather than data-driven AI training.

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

• Not applicable/Not specified, as it is not an AI/ML device with a training set.

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Vantage 2.5 is a software program, which will be marketed as an addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510k K971878.

Vantage 2.5 is intended to provide quality assurance enhancements to nuclear medicine images acquired using the gold Gama Camera Systems. It includes scatter correction capability for scatter correction capability for

Vantage 2.5 is a software program, which will be marketed as an optional addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510(k) K971878.

Vantage 2.5 is a computer program that provides a patient's anatomical information using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510(k) K943596 for Vantage 1.0 and in 510(k) K971878 for Vantage 2.0 ExSPECT.

The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 2.0 ExSPECT, but adds Quality Assurance (QA) Tools by using Pre-Scan, Automatic Energy Window Checking and Transmission QA Reference.

This 510(k) summary for the Vantage 2.5 Gamma Camera System does not contain the detailed information necessary to complete the acceptance criteria table and answer all the questions regarding the study. The document primarily focuses on demonstrating substantial equivalence to a predicate device and describes the general function of the software.

Here's what can be extracted and what information is missing:

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

This information is not provided in the document. The 510(k) summary states, "Images were acquired using the protocol outlined in the Vantage user manual," but it does not specify any acceptance criteria or present performance data for the Vantage 2.5 itself. The basis for clearance appears to be substantial equivalence to the Vantage 2.0 ExSPECT, which implies a similar performance profile, but no specific metrics are given for Vantage 2.5.

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.

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.

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

This information is not provided in the document.

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

An MRMC study is not mentioned in the document. Given the description, Vantage 2.5 is a software program that enhances quality assurance for nuclear medicine images and provides scatter correction. It is not described as an AI-assisted diagnostic tool for human readers.

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

A standalone performance study focused on specific metrics is not explicitly described. The document states that the "Vantage 2.0 ExSPECT and Vantage 2.5 devices have the same indications for use, source type and geometry, system hardware, operating principles, and reconstruction algorithms, with the exception of minor modifications to the acquisition software." This implies that its performance is presumed to be similar to Vantage 2.0, which was previously cleared, rather than providing new standalone performance data for Vantage 2.5 itself. The "Quality Assurance (QA) Tools" are functions, not necessarily requiring a standalone performance study in the way an AI diagnostic algorithm might.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. The submission focuses on modifications to existing software rather than the development of a new algorithm with a distinct training set.

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

This information is not provided in the document.

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To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
Tomographic imaging (SPECT) for non Positron emitter

The TRANSVIEW (Transmission system), model NDTR-701A is an option designed to be used with Toshiba's GCA-7200 gamma camera systems to acquire transmission CT data (TCT). When the external flood source of this system is combined with a parallel-hole collimator, this system can generate anatomic frame attenuation maps and perform attenuation corrections on SPECT images.

The provided text is a 510(k) Summary for the Toshiba TRANSVIEW (Transmission System), Model NDTR-701A. The document describes the device, its intended use, and its technological characteristics. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the device's accuracy or efficacy.

The 510(k) summary explicitly states:
"Toshiba America Medical Systems, Inc. believes that this device is safe and effective in that it offers no new intended uses that are not in use on existing marketed devices."
"This device employs the same technological characteristics as the predicate devices, differing only in the specifics of subassembly component composition and algorithms used. All systems employ the use of a transmission source to provide the attenuation map. This attenuation map is then used to perform attenuation corrections on SPECT images along with scatter correction. Non uniform attenuation correction using transmission systems is well understood and is documented in peer reviewed scientific publications."

These statements indicate that the submission likely relied on the substantial equivalence to predicate devices, and the well-established nature of the technology, rather than presenting a new study with specific performance metrics and acceptance criteria for this particular device's functionality.

Therefore, I cannot provide the requested table and study details based on the given input, as this information is not present in the provided document.

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The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient.

Vantage 2.0 ExSPECT is a software program which will be marketed as an optional addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 1.0 software package, cleared in 510k K943596.

Vantage 2.0 ExSPECT is a computer program that provides a patient's anatomical information using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510k K943596 for Vantage 1.0.

The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 1.0, but adds image quality enhancements by correcting for the Photopeak scatter, Downscatter, and Resolution Recovery (RR).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vantage 2.0 ExSPECT device.

Acceptance Criteria and Study Details for Vantage 2.0 ExSPECT

Based on the provided documentation, the Vantage 2.0 ExSPECT is a software program designed to enhance image quality in ADAC Gamma Camera Systems by correcting for attenuation effects, Photopeak scatter, Downscatter, and Resolution Recovery (RR). The 510(k) submission primarily focuses on demonstrating substantial equivalence to its predicate device, Vantage 1.0.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantifiable acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) or detailed reported device performance metrics tied to such criteria. The submission focuses on demonstrating that the modifications (Vantage 2.0 ExSPECT) maintain the same indications for use and do not introduce new safety or effectiveness concerns compared to the predicate device (Vantage 1.0).

Implicit Acceptance Criteria:

Given the nature of a 510(k) submission for a software modification, the implicit acceptance criteria would revolve around:

• Maintaining existing image quality and diagnostic utility: The enhanced images from ExSPECT 2.0 should be at least as good as, if not better than, those from Vantage 1.0, without degrading diagnostic information.
• Safety equivalence: The modifications should not introduce new safety hazards (e.g., increased radiation dose, misinterpretation risk).
• Functional equivalence: The system should perform its intended function (producing images depicting anatomical density and correcting attenuation) as effectively as the predicate.

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

The provided document does not specify the sample size for any test set (e.g., number of patients or images). It only states, "Images were acquired using the protocol outlined in the Vantage user manual."

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective nature of data collection). However, given that it's a 510(k) for a modification to an existing device (Vantage 1.0), it's plausible that the testing involved data typical of SPECT imaging performed on ADAC Gamma Camera Systems, potentially from internal testing or clinical sites where the predicate device was in use.

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

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth for any test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

An MRMC comparative effectiveness study was not described or referenced in the provided text. There is no mention of comparing human reader performance with or without AI assistance, nor any effect size provided.

6. Standalone (Algorithm Only) Performance

The document does not explicitly describe a standalone performance study in terms of quantitative metrics. The submission focuses on the software program integrating with existing gamma camera systems to produce enhanced images. The "performance" described is the functionality of the software in correcting for scatter, resolution recovery, and attenuation, which are image processing enhancements rather than a direct diagnostic output that would typically have standalone performance metrics like sensitivity/specificity for a disease.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated. However, for a device that enhances image quality for anatomical density and attenuation correction, ground truth could implicitly refer to:

• Physical phantoms: Used to validate the accuracy of attenuation, scatter, and resolution corrections against known properties.
• Clinical expert consensus: Radiologists or nuclear medicine physicians would visually assess the improved quality and diagnostic utility of the enhanced images compared to unenhanced images or images from the predicate device.
• Quantitative image quality metrics: Such as contrast-to-noise ratio, spatial resolution, or artifact reduction, which can be measured and compared.

The text does not specify which, if any, of these were formally established as ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This is consistent with the era (1997) and the nature of the device as a software modification for image enhancement, which might not rely on machine learning models requiring explicit "training sets" in the modern sense. The "training" might refer to the development and tuning of the image processing algorithms using various image data.

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

As no training set is explicitly mentioned, how its ground truth was established is also not provided. If the algorithms involved development and tuning, the performance improvement (e.g., better correction of scatter) would have likely been validated against known physics models or simulated data, or visually assessed by experts.

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