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The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncolgy, Cardiology, Neurology and other clinical diagnostic imaging applications.

The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT . Gated SPECT . Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multiisotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation corrcction and functional anatomic mapping.

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The provided text is a 510(k) summary for the GE Quasar System, a nuclear medicine imaging system. It details the device's name, submitter, classification, and intended use. However, it does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth establishment, sample sizes, or expert qualifications.

Therefore, I cannot provide the requested information based on the given document.

The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices for the purpose of FDA clearance. It does not include the detailed performance study results that would typically contain acceptance criteria and performance metrics.

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To obtain attenuation corrected Positron Emission Tomography (PET) images, by a Gamma Camera.

The CoDe AC attenuation correction system is an addition to the Apex VariCam and Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected Positron Emission Tomography images for non-uniform attenuation.

Here's a breakdown of the acceptance criteria and study information for the CoDe AC: Attenuation Correction System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage improvement, a threshold for artifact reduction). However, the overarching acceptance criterion is demonstrating substantial equivalence to the predicate device, VTransACT option for the Apex VariCam (K980659), in terms of safety and effectiveness.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Bench data and Clinical data" were used, but no specific number of cases or patients is given for the clinical data.
• Data Provenance: Not explicitly stated. However, the manufacturer is ELGEMS Ltd., located in Tirat Hacarmel, Israel, suggesting the data may have originated from Israel. It is not specified if the data was retrospective or prospective.

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

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 and Effect Size

• Was an MRMC study done? It is not explicitly stated that an MRMC comparative effectiveness study was performed. The phrasing "Comparison to VTransACT images shows no significant difference" suggests a comparison, but not necessarily with human readers involved or an MRMC design.
• Effect size of human reader improvement: This is not applicable as an MRMC study with human readers assessing improvement with human-AI assistance is not mentioned. The device's primary function is to correct images, not to directly assist human interpretation in a comparative effectiveness study of the AI system itself.

6. Standalone (Algorithm Only) Performance

• Was a standalone performance study done? Yes, implicitly. The statement "Bench data and Clinical data show that the CoDe AC option for the VariCam delivers more uniform images than regular coincidence imaging system without attenuation correction. Comparison to VTransACT images shows no significant difference" refers to the performance of the device's algorithm in generating corrected images. It is assessing the algorithm's output directly.

7. Type of Ground Truth Used

The ground truth used for image uniformity and attenuation correction is implicitly based on:

• Comparison to a legally marketed predicate device (VTransACT): The "no significant difference" claim implies that the VTransACT's corrected images served as a de-facto "ground truth" or a benchmark for acceptable performance.
• Improvement over uncorrected images: The statement "delivers more uniform images than regular coincidence imaging system without attenuation correction" suggests that the physical reality of non-uniform attenuation and its correction served as the ground truth against which uniformity was assessed. This would likely involve phantom studies (bench data) where the true attenuation is known or controlled.

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. Given the nature of an attenuation correction system (a signal processing and image reconstruction task), the "training" might involve developing algorithms to correct known physical phenomena rather than training on a large dataset with expert-labeled ground truth in the same way an AI diagnostic system would. However, the document does not elaborate on the development or training process.

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To obtain attenuation corrected emission images and to provide registration of anatomical and physiological images.

The Hawkeye Option is an addition to the Apex VariCam / Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected NM images for non-uniform attenuation and to facilitate localization of the emission images in the patient anatomy.

The provided 510(k) summary for the Hawkeye Option for Dual-Head Variable Angle Gamma Camera (K991841) is very brief and lacks detailed information about specific acceptance criteria and the comprehensive study design.

Here's an analysis based on the available text, addressing your points as much as possible, and noting where information is not provided:

Acceptance Criteria and Device Performance

The 510(k) summary does not explicitly state quantitative acceptance criteria or provide specific numerical performance metrics. Instead, it offers a qualitative summary.

Study Details

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

   • Not provided. The document refers to "clinical data" but does not specify the number of patients, scans, or their origin, nor whether the study was retrospective or prospective.

2. 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)

   • Not provided. There is no mention of experts or how ground truth was established for "uniformity" or "localization capabilities." Given the nature of the device (image correction and display), it's possible that the "ground truth" for uniformity was visual assessment or phantom studies, and for localization, it might have involved co-registration with anatomical images, but none of this is detailed.

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

   • Not provided. The document does not describe any expert adjudication process.

4. 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

   • Not provided, and unlikely given the device type. The Hawkeye Option is described as an "additional hardware and software to generate corrected NM images" and "to facilitate localization." This suggests it's an image processing and display tool for a gamma camera, not an AI-assisted diagnostic tool that would typically involve human reader performance improvement metrics. The summary focuses on the technical qualities of the images (uniformity, localization) rather than diagnostic efficacy in a human-in-the-loop setting.

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

   • Implied, but not explicitly detailed. The "Summary of Studies" mentions "bench and clinical data show that Hawkeye attenuation-corrected images are more uniform... The images also demonstrate the localization capabilities..." This suggests that the performance observed relates to the algorithm's output (the corrected images) without necessarily involving a human's diagnostic interpretation as the primary endpoint. The qualitative statements about "uniformity" and "localization capabilities" are assessments of the algorithm's direct output.

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

   • Not explicitly stated, but likely based on visual assessment or phantom studies for uniformity, and image registration accuracy for localization. For "uniformity," the ground truth might be a predefined standard of image homogeneity for nuclear medicine scans or comparative visual assessment against uncorrected images. For "localization capabilities," the ground truth would likely involve the accuracy of aligning emission images with anatomical landmarks or images, potentially verified against known anatomical structures.

7. The sample size for the training set

   • Not applicable/Not provided. The Hawkeye Option appears to be a traditional image processing and correction algorithm, not a machine learning or AI algorithm that typically requires a distinct "training set." If any parameters were learned or optimized, the training data details are not disclosed.

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

   • Not applicable/Not provided. As above, a specific "training set" and associated ground truth establishment methods are not mentioned, consistent with a non-AI image processing device.

Summary of Deficiencies in the Provided Information for your Request:

The 510(k) summary is extremely brief and provides very high-level declarative statements rather than detailed study methodology. It lacks specific numerical data, sample sizes, expert qualifications, clear definitions of ground truth for performance metrics, or any information typical of modern clinical performance studies, especially those involving AI. This is characteristic of older 510(k) summaries, which often focused on demonstrating substantial equivalence through more general statements and less detailed technical reporting than is now common.

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To obtain Nuclear Medicine images based on high-energy photons from an administered positron-emitting radioactive agent in the human body.

The VPC-94 high-energy (511 KeV) collimators and cart is an option for the Apex VariCam and Millennium VG gamma camera (K953801). It comprises two high-energy collimators and a collimator cart.

The provided text describes a 510(k) submission for a medical device and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a detailed study proving performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

The document states: "Bench data and Clinical data show that the VPC-94 option achieves its intended use," but it does not elaborate on the nature or results of these studies.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or directly stated, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to generally as "Bench data and Clinical data."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned or described. This submission is for a collimator for a gamma camera, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: Not applicable/not discussed in the context of this device (a collimator). The device itself (collimator) is a physical component, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not specified. The "Clinical data" would likely involve patient imaging but the method for confirming findings (e.g., pathology, other imaging modalities, clinical follow-up) is not detailed.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable/not specified. This device is a passive component (collimator), not a machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of what is known about the study:

• The submission refers to "Bench data and Clinical data" as evidence that the device achieves its intended use.
• The device (VPC-94 collimator) is stated to have "better" resolution at comparable sensitivity compared to its predicate device (Dyna Camera 2C - 615-211 high-energy collimator), partly because the VPC-94 uses two detector heads instead of one.
• The overall conclusion is that the VPC-94 is "substantially equivalent" to the predicate device, has the "same intended use," and raises "no new safety or effectiveness concerns." This suggests the studies were primarily designed to demonstrate this equivalence rather than to establish new performance benchmarks against specified acceptance criteria.

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The intended use of the device is to produce attenuation-corrected NM images, even when attenuation coefficients are not uniform over the FOV.

To obtain attenuation corrected Nuclear Medicine images.

The VTransACT attenuation correction system is an addition to the Apex VariCam and Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected NM images for non-uniform attenuation.

Here's a summary of the acceptance criteria and study information for the VTransACT: Attenuation Correction System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage improvement, a threshold for uniformity). Instead, the "Summary of Studies" section provides a qualitative performance statement.

• Ability to produce more uniform images than regular SPECT without attenuation correction.
• Performance comparable to the predicate device (TransACT option for the CardiaL Gamma Camera). | - "Bench data and Clinical data show that the VTransACT option for the VariCam delivers more uniform images than regular SPECT without attenuation correction."
• "Comparison to TransACT images shows no significant difference." |

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

• Sample Size: The document does not specify the sample size for the "Clinical data" or "Bench data" studies.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It only states "Bench data and Clinical data."

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

The document does not provide information about the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. It states a comparison was made to the predicate device's images ("Comparison to TransACT images shows no significant difference"), but this is not described as an MRMC study and no effect size for human reader improvement is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The "Summary of Studies" focuses on the device's ability to "deliver more uniform images" and its "Comparison to TransACT images." This suggests the algorithm's performance in generating corrected images was assessed. While human interpretation of these images is the ultimate goal, the phrasing "delivers more uniform images" points to an evaluation of the algorithm's output itself, implying a standalone assessment of the image correction quality. However, it is not explicitly stated that this was a standalone performance study distinct from human interpretation.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. Given the nature of an "Attenuation Correction System" and the performance reported ("delivers more uniform images"), the ground truth likely relates to objective measures of image uniformity or accuracy against a known physical phantom (for "Bench data") or clinical images where attenuation effects are understood/quantified. However, this is not specified as expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

The document does not provide information about the sample size for a training set. The device description mentions it "comprises additional hardware and software to generate corrected NM images," implying an algorithmic approach, but no details on training data are given.

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

The document does not provide information on how ground truth for any training set was established, as no training set is mentioned.

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