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The CPS LSO PET/CT HiRez Series Scanners are combined positron emission tomography (PET) and X-ray computed tomography (CT) scannesr. The LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body, and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray prounds sion data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

The CPS LSO PET/CT Hi-Rez series of scanners are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology and cardiology syotome are a signiture registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system, the and anatomic informanner and the Siemens Somatom CT (either Emotion or Sensation depending on the specific model).

The combined PET/CT scanner is intended for use as a clinical, whole-body oncology machine with high-end spiral CT and PET performance. The CT oncology maonine mans, quiet attenuation correction for PET studies as well as oomponont provided farmer through fused PET and CT images. In addition, the PET / CT system maintains independent functionality of the PET and CT scanning systems, allowing for most standard stand-alone CT and PET clinical diagnostic protocols to be available as well.

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The provided text describes a 510(k) premarket notification for the "LSO PET/CT HiRez Series" and predominantly focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria.

While the document details the device's purpose and indications for use, it does not contain information on acceptance criteria or a study proving the device meets acceptance criteria in the way one would expect for a performance evaluation study. The submission is for a new iteration of an already market-cleared device, emphasizing cost reduction and minor physical changes. Therefore, the core of the submission isn't to prove new performance claims against acceptance criteria, but to show that the modified device remains substantially equivalent to its predicates.

Given this, I cannot extract the specific information requested in the prompt, such as:

• A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the new device to predicates based on general safety and effectiveness, not specific quantitative performance metrics against predefined criteria.
• Sample size used for the test set and the data provenance: No performance test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific performance study is detailed.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical imaging device, not an AI algorithm.
• The type of ground truth used: Not applicable as no specific performance study is detailed.
• The sample size for the training set: Not applicable as this is not an AI/algorithm-based device in the context of the 510(k) summary.
• How the ground truth for the training set was established: Not applicable.

The document states: "Changes incorporated in this system are the result of a cost reduction effort combined with changes that allow the 'look' of the gantry to be modified easily. Additional changes were incorporated to improve reliability and serviceability as well as to deal with parts obsolescence. These changes were limited to the PET gantry as well as the Patient Handling System (PHS). The CT component of the system remained identical to previously commercially available systems." This indicates that the core imaging performance, particularly for the CT component, was considered unchanged and therefore, not a subject of new performance evaluations for this 510(k) submission.

Therefore, I must state that the provided text does not contain the information required to answer the prompt regarding acceptance criteria and a study proving those criteria were met.

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The CPS LSO PET/CT HiRez 64 system is a combined position emission tomography (PET) and X-ray computed tomography (CT) scanner. The LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected position emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

The CPS LSO PET/CT Hi-Rez 64 system is a combined Positron Emission Tomography and X-Ray Computed Tomography scanner. The system is an addition to the current CPS PET/CT Hi-Rez Family of PET/CT systems and is essentially identical to the commercially available CPS LSO PET / CT Hi-Rez 16 system (K033431) with the exception of a higher resolution CT system -Siemens 64 slice CT (K040665).

The system is designed for whole-body oncology, neurology and cardiology examinations. The PET / CT 64 gantry system consists of a separate PET and CT gantry that retain their independent scanning mechanisms, including mechanical and electrical components. In addition, it provides registration and fusion of high-resolution metabolic and anatomic information from the two major components of the system, the Accel Hi-Rez LSO PET scanner and the Siemens Somatom Sensation 64 CT.

The difference between the current Sjemens Sensation 16 used in the commercially available CPS PET/CT systems is the number of slices acquired per rotation. Current PET/CT's are capable of acquiring 16 slices per rotation while the Sensation 64 is capable of acquiring 64 slices per rotation, thus increasing the resolution of the acquired CT scan.

The provided text is a 510(k) summary for the LSO PET/CT HiRez 64 system, which describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

• "The system is an addition to the current CPS PET/CT Hi-Rez Family of PET/CT systems and is essentially identical to the commercially available CPS LSO PET / CT Hi-Rez 16 system (K033431) with the exception of a higher resolution CT system -Siemens 64 slice CT (K040665)."
• "The difference between the current Siemens Sensation 16 used in the commercially available CPS PET/CT systems is the number of slices acquired per rotation. Current PET/CT's are capable of acquiring 16 slices per rotation while the Sensation 64 is capable of acquiring 64 slices per rotation, thus increasing the resolution of the acquired CT scan."

This indicates that the device's approval is based on its substantial equivalence to previously cleared devices, primarily due to the upgrade of the CT component to a higher-resolution 64-slice system. It does not detail new performance studies against specific acceptance criteria for the combined system.

Therefore, I cannot provide the requested table and information as the input document does not contain this data.

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The CTI PET Systems Inc. ECAT HRRT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.

The CTI PET Systems ECAT HRRT is a new positron emission tomography (PET) scanner system. The ECAT HRRT PET scanners utilize flat panel detector heads, combined LSO (Lutetium Oxyortho-Silicate) / LYSO (Lutetium Yttrium Oxyortho-Silicate) crystal detector technology. The HRRT consists of eight detector panels in an octagonal arrangement completely encircling the bore of the Gantry. A Patient Handling System (PHS) will be offered as an optional accessory with the scanner. This PHS is similar to other PHS systems currently marketed with the exception that it has been specifically designed for use with the HRRT. Modifications have been made to accommodate the different size gantry bore and shorter horizontal travel associated with this gantry. The acquisition computer system is comprised of an Intel based acquisition PC, a Raid system disk and a console connected via fibre channel to the HRRT electronics. This is the same as is used in the ECAT ACCEL (K002584) with the exception of the RAID disk. Software is based on the Standard ECAT software (7.x), which is used with the ECAT ACCEL system. Modifications have been made to accommodate the new acquisition system, enlarged data sets (due to increased resolution) and user interface to allow clinician flexibility in reconstruction.

Acceptance Criteria and Study for ECAT HRRT PET Scanner (K040933)

Based on the provided 510(k) summary for the ECAT HRRT PET Scanner (K040933), the device's acceptance criteria and the study proving its performance are described below. It is important to note that the provided document is a summary and does not contain detailed study protocols or comprehensive data.

1. Acceptance Criteria and Reported Device Performance

The 510(k) summary states that "Performance of the ECAT HRRT system has been tested by CPS and found to meet its predetermined PET performance specifications." However, the specific quantitative acceptance criteria or detailed performance specifications are not explicitly listed in the provided document. The document asserts substantial equivalence to predicate devices, implying that the HRRT's performance is at least comparable to or better than the predicate devices (ECAT ACCEL and E.CAM LSO 311).

Without explicit criteria, a table cannot be fully populated. However, based on the general description of PET scanners, typical performance specifications would include:

The document mentions "enlarged data sets (due to increased resolution)" as a modification handled by the software, suggesting an improvement in resolution compared to the predicate devices.

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

The 510(k) summary does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing is described generically as "tested by CPS."

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

The provided document does not mention the use of experts or the establishment of ground truth for any test set. The performance assessment appears to be based on technical specifications rather than diagnostic accuracy studies involving expert interpretation of images.

4. Adjudication Method

As there is no mention of a test set involving human interpretation or diagnostic outcomes, an adjudication method is not described.

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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The focus is on the device's technical specifications and substantial equivalence to predicate devices. Therefore, no effect size for human reader improvement with AI assistance is provided.

6. Standalone Performance Study

The summary states, "Performance of the ECAT HRRT system has been tested by CPS and found to meet its predetermined PET performance specifications." This implicitly describes a standalone performance evaluation of the algorithm-only (or system-only) without human-in-the-loop performance. However, the details of this testing are not provided.

7. Type of Ground Truth Used

Given that the performance evaluation appears to be based on meeting "predetermined PET performance specifications" rather than diagnostic accuracy, the type of "ground truth" would likely be based on physical phantom measurements, simulated data, or predefined technical benchmarks typically used to characterize PET scanner performance (e.g., measuring spatial resolution from a point source, sensitivity from a uniform phantom). The document does not specify the exact methods.

8. Sample Size for the Training Set

The document does not mention any training set or machine learning components with a quantifiable sample size. The software is based on "Standard ECAT software (7.x)" with modifications for the new acquisition system and larger data sets. This indicates that the software is likely an updated version of a commercially available and established application, rather than a newly developed AI/ML model requiring a specific training set to establish its core functionality.

9. How Ground Truth for the Training Set Was Established

As no training set is described, the method for establishing its ground truth is not applicable or provided.

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The LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez tomographic scanner systems are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez scanners are intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

The LSO PET/CT HiRez is a family of combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. These dual modality tomographs are modified versions of the ECAT LSO PET/CT (K013504) and ECAT LSO PET/CT 16 (K023518) and will utilize the same Siemens SOMATOM CT scanner components as their respective predicate PET/CT scanners. However, on this new family of CPS PET/CT HiRez systems, the ACCEL PET scanner electronics has been modified to appreciably increase PET count rate capability, with front-end acquisition electronics processing speed being significantly improved. The modified ACCEL PET scanner component will also incorporate a new version block detector utilizing a 13 by 13 LSO crystal matrix in place of the previously used 8 by 8 LSO crystal matrix which will provide a significant improvement in the spatial resolution of PET images. As with the predicate systems, 2D PET acquisition septa and PET transmission sources are not included in the modified LSO PET/CT HiRez systems. PET emission data are acquired only in 3D and PET attenuation correction map data are obtained from the CT. The PET and CT components of each system are contained within a unified housing similar to the predicate ECAT LSO PET/CT and ECAT LSO PET/CT 16 scanners to create an integrated PET, CT and combined PET/CT, tomographic imaging system.

The outward appearance of this family of modified PET/CT HiRez systems remains the same as the similarly configured preceding models. The LSO PET/CT HiRez gantry structure, patient handling system (PHS), advanced computational system (ACS 3) and workstation will be the same as those used with the LSO PET/CT and ECAT LSO PET/CT 16 systems. Software used in these scanners will be the most recent version of the previously used PET/syngo software with minor changes to accommodate the revised PET acquisition electronics and modified crystal configuration detectors. User operating instructions have been revised accordingly.

The LSO PET/CT HiRez scanners are intended for use primarily as clinical, whole-body oncology machines with medium to high-end spiral CT performance and fast patient-throughput clinical PET performance. As on the predicate systems, the CT component will also enhance PET scans by allowing fast, essentially noise-free attenuation correction for PET studies, and by providing precise anatomical reference through fused PET and CT images. In addition, the LSO PET/CT HiRez scanners will retain mechanical isolation and independent functionality of the PET and CT scanning systems, thereby allowing for most standard CT and PET clinical diagnostic protocols to be available on these PET/CT systems.

The purpose of introducing this family of modified LSO PET/CT HiRez tomographic systems is to offer a series of PET/CT scanners having a varied range of CT performance combined with the fast patient throughput of the modified ACCEL PET, as an even higher performance alternative to the presently distributed ECAT LSO PET/CT and ECAT LSO PET/CT 16 PET/CT systems.

The provided text is a 510(k) summary for the LSO PET/CT HiRez and LSO PET/CT 16 HiRez systems. It describes the device, claims substantial equivalence to predicate devices, and outlines its intended use. However, it does not contain detailed information about acceptance criteria or a specific study proving the device meets said criteria in the format requested.

The document states: "The combined PET/CT system has been tested by CPS and found to meet its predetermined performance requirements." but does not elaborate on what these requirements are, how they were tested, or the specifics of the study.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can be inferred or stated based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While the manufacturer is US-based (Knoxville, TN), the origin of any test data is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and 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. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? Not mentioned. The document focuses on the technical modifications and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
• Effect size of human readers with vs. without AI: Not applicable, as no MRMC study or AI assistance is discussed for improving human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Not explicitly stated as a "standalone study" in the context of an algorithm. The text refers to the "combined PET/CT system... tested by CPS and found to meet its predetermined performance requirements," which implies performance testing of the device itself. However, it's not a standalone algorithm performance in the modern sense of AI evaluating images without human intervention, as this is a medical imaging device for human interpretation.

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes a medical imaging device (hardware and associated software), not an AI algorithm trained on a dataset. Therefore, there is no "training set" in the context of machine learning.

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

• How Ground Truth Was Established: Not applicable (see point 8).

Summary of what the document does provide regarding "acceptance criteria" indirectly:

The document primarily proves "substantial equivalence" to existing predicate devices (ECAT LSO PET/CT (K013504) and ECAT LSO PET/CT 16 (K023518)). This is the primary "acceptance criterion" for 510(k) clearance. The study that proves this is the comparison made within the 510(k) submission itself, where the new device's design, material, composition, energy source, radiation safety, and performance characteristics are shown to be similar to legally marketed devices.

The key modifications and performance improvements mentioned are:

• Increased PET count rate capability: Due to modified ACCEL PET scanner electronics with significantly improved front-end acquisition electronics processing speed.
• Improved spatial resolution of PET images: Due to a new version block detector utilizing a 13 by 13 LSO crystal matrix (vs. the previously used 8 by 8 LSO crystal matrix).

While these are stated as improvements, the specific quantitative acceptance criteria and the detailed study data that verified these improvements are not provided in this summary. The text indicates that these improvements lead to "even higher performance" as an alternative to the predicate systems, implying that performance was assessed and deemed superior or equivalent in relevant aspects.

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The PET/CT Patient Handling System (PHS) is a system component of CPS ECAT PET/CT tomographic scanner systems, which are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The PET/CT Patient Handling System is used to support and move a patient through the PET/CT scanner while CT and PET diagnostic image data are being acquired from the patient.

The ECAT PET/CT scanners are intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

The PET and the CT functions of these systems can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

The subject device is the patient handling system (PHS) or patient bed that is used with the currently marketed CPS ECAT PET/CT scanners. The ECAT PET/CT, ECAT LSO PET/CT and ECAT LSO PET/CT 16 systems are combined position tomography (PET) and X-ray computed tomography (CT) scanners. These three dual modality PET/CT tomographs all utilize the same basic patient handling system (PHS) to support and move the patient through the patient port in the scanner gantry. Currently, vertical positioning of the patient on the bed of these PET/CT scanners is only possible when the PHS bed is fully retracted out of the patient port.

The proposed modification for the PHS used on these three PET/CT scanners, which consists of two added footswitches and revised PHS controller firmware, will enable the system operator to raise or lower the PHS bed a limited distance when the bed and patient are in the scanner field of view (FOV), inside the patient port. This modification will allow the operator to more accurately position the patient in the FOV without having to first retract the bed and patient completely out of the patient port.

The provided document is a 510(k) summary for a PET/CT Patient Handling System (PHS) modification. It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not include detailed information about specific acceptance criteria or a dedicated study with the kind of quantitative performance data, ground truth establishment, or expert involvement typically associated with AI/algorithm-based medical devices.

The document states that "The modified PET/CT Patient Positioning System has been tested by CPS and found to meet its predetermined safety and performance requirements." However, it does not provide the specific acceptance criteria or the results of these tests in a detailed manner.

Given the nature of the device (a patient handling system modification, not an AI or image analysis algorithm), many of the requested elements for an AI device study (like sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, training set details) are not applicable or not provided in this regulatory submission.

Here's an attempt to answer the questions based only on the provided text, while acknowledging the limitations for an AI-focused request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, AUC) are NOT explicitly stated in the 510(k) summary.

The summary broadly states: "The modified PET/CT Patient Positioning System has been tested by CPS and found to meet its predetermined safety and performance requirements."

The "performance" described relates to the functionality of the modification rather than diagnostic accuracy: "The proposed modification... will enable the system operator to raise or lower the PHS bed a limited distance when the bed and patient are in the scanner field of view (FOV), inside the patient port. This modification will allow the operator to more accurately position the patient in the FOV without having to first retract the bed and patient completely out of the patient port."

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

Not applicable/Not provided. This is a hardware modification to a patient handling system, not an algorithm that processes data. Therefore, there isn't a "test set" of images or data in the context of an AI device. The testing referenced would be engineering and functional testing of the hardware and firmware.

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

Not applicable. Ground truth for diagnostic performance is not relevant for this device type and modification. The "ground truth" for its functionality would be whether the footswitches successfully operate the bed in the specified manner, which is typically verified through engineering tests.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic test set requiring adjudication is mentioned or relevant.

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

No, an MRMC comparative effectiveness study was not done, as it's not relevant for this type of device modification. The device is a direct patient handling system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a mechanical patient handling system with firmware. The concept of "standalone algorithm performance" does not apply. The performance is inherently linked to human operation.

7. The Type of Ground Truth Used

For the functionality of the device, the ground truth would be the direct observation of the PHS bed raising/lowering as intended with the new footswitch controls, and verification that it operates within specified mechanical and electrical tolerances and safety parameters. This is typically established through direct engineering measurement and functional testing. For safety, compliance with listed standards (IEC 60601-1, UL 187) would be the "ground truth" requirement.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that uses a "training set."

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

Not applicable.

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The ECAT LSO PET/CT 16 tomographic scanner system is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner. The ECAT LSO PET/CT 16 scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

The ECAT LSO PET/CT 16 is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner. This dual modality tomograph is a modified version of the ECAT LSO PET/CT (K013504) and will utilize the same PET component as the ECAT LSO PET/CT scanner. However, in place of the Siemens P10 SOMATOM EMOTION CT component that uses a single or dual row of X-Ray detectors, the ECAT LSO PET/CT 16 will be configured with the Siemens P30 SOMATOM SENSATION CT, utilizing 24 rows of X-Ray detectors and having the capability to acquire 16 slices of X-Ray data simultaneously. As with the unmodified system, 2D PET acquisition septa and the PET transmission sources are not incorporated in the modified ECAT LSO PET/CT. PET emission data is acquired only in 3D mode and PET attenuation correction map data are obtained from the CT. The PET and CT components are contained within a unified housing similar to the original ECAT LSO PET/CT to create an integrated, PET, CT, and combined PET/CT, tomographic imaging system.

The ECAT LSO PET/CT 16 gantry structure, patient handling system (PHS), advanced computational system (ACS 3), workstation and software will be similar to the ECAT LSO PET/CT with only minor modifications. The gantry's unified housing has been modified cosmetically and enlarged to accommodate the increased size of the SOMATOM P30 CT gantry. In addition, the patient handling system (PHS) has been modified to ensure adequate dual scan coverage for PET and CT patient scanning, with the increased axial depth of the new SOMATOM P30 CT gantry. The high performance Siemens P30 SOMATOM SENSATION CT with 16 slice capability provides for faster and higher quality CT acquisitions but does not otherwise affect performance of the ECAT LSO PET/CT 16.

The ECAT LSO PET/CT 16 scanner is intended for use primarily as a clinical, whole-body oncology machine with high-end spiral CT performance and fast patient-throughput clinical PET performance. As on the original system, the CT component will also enhance PET scans by allowing fast, essentially noise-free, attenuation correction for PET studies and by providing precise anatomical reference through fused PET and CT images. In addition, the ECAT LSO PET/CT 16 will retain mechanical isolation and independent functionality of the PET and CT scanning systems, thereby allowing for most standard CT and PET clinical diagnostic protocols to be available on the PET/CT system.

The purpose of introducing this modified ECAT LSO PET/CT 16 system is to offer a combined PET and CT tomograph having very high CT performance with the fast throughput of the ECAT ACCEL PET, as a higher performance alternative to the presently distributed ECAT LSO PET/CT system.

This document is a 510(k) summary for a medical device (ECAT LSO PET/CT 16), which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed study information typically found in a clinical trial report or a performance validation study.

Therefore, many of the requested elements about acceptance criteria and study particulars cannot be fully extracted from the provided text. The document asserts that the combined PET/CT system "has been tested by CPS and found to meet its predetermined performance requirements" but does not detail what those requirements are or the specifics of the testing.

Here's an analysis of what can be inferred or explicitly stated:

Acceptance Criteria and Reported Device Performance

The document states that the device was found to meet "predetermined performance requirements." However, specific numerical acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, image resolution, signal-to-noise ratio, diagnostic accuracy improvements) are NOT provided in the text. The primary focus of this 510(k) is to demonstrate substantial equivalence based on technological similarity and safety/effectiveness, not detailed performance metrics against specific criteria.

• CT component meets 21CFR 1020.30 and 1020.33. |
  | - Functionality for whole-body oncology, fast patient-throughput PET, fast and high-quality CT acquisition, precise anatomical reference. | - Intended for clinical, whole-body oncology.
• High-end spiral CT performance and fast patient-throughput clinical PET performance are maintained/enhanced.
• Provides fast, noise-free attenuation correction and precise anatomical reference through fused images. |

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 specified. The document states "The combined PET/CT system has been tested by CPS," but gives no details about the test set (number of patients, number of images, type of data, provenance).

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 specified. The document makes no mention of expert review or ground truth establishment for a test set. This type of detail is typically part of a clinical performance study, which is not fully described here.

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

   • Not applicable/Not specified. The document does not describe a test set or an adjudication process for diagnostic performance.

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:

   • No, an MRMC study was NOT done. This document describes a hardware modification to an existing device (upgrading the CT component). It is not evaluating an AI algorithm or human-AI interaction.

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

   • Not applicable/Not specified. This pertains to a medical imaging device (a PET/CT scanner), not an algorithm that operates in a standalone mode. The device itself is the "standalone" imaging system.

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

   • Not specified. Given the nature of a 510(k) for a hardware upgrade, the "testing" likely focused on engineering performance, safety, and imaging characteristics rather than diagnostic accuracy against pathological ground truth for clinical cases.

7. The sample size for the training set:

   • Not applicable/Not specified. This device is a PET/CT scanner, not an AI or machine learning algorithm that typically requires a "training set."

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

   • Not applicable/Not specified. As there is no mentioned training set, there's no ground truth establishment for it.

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The CPS/Siemens ECAT Vision 3000 and Vision 5000 PET systems are positron emission tomography (PET) scanners that are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.

CPS ECAT Vision 3000 and ECAT Vision 5000 positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to detect the location and distribution of injected positron-emitting radionuclides in the body and produce cross- sectional images through computer reconstruction of the data.

The ECAT Vision 3000 and Vision 5000 are new positron emission tomography (PET) scanner systems. The ECAT Vision series PET scanners utilize rotating flat panel detector heads, LSO crystal detector technology and coincidence point source transmission scan capability. The ECAT Vision series scanners are produced and marketed under two distinct models, the ECAT Vision 3000 and the ECAT Vision 5000. The two models of the ECAT Vision are configured with either: 1) three detector heads in the ECAT Vision 3000, or 2) five detector heads in the ECAT Vision 5000.

A Patient Handling System (PHS) is provided with the Vision series scanners, which is a slightly modified version of the PHS included with the CPS ECAT EXACT series PET scanners (K962797). Vertical bed travel, horizontal scanning range and all other PHS operating characteristics are the same for the PHS provided with the Vision series scanners as those of the PHS provided with the ECAT EXACT series scanners. The maximum patient weight specification for the Vision series PHS, is 182 kg (400 lbs).

The acquisition computer system is an ACS III system, similar to that used for the ECAT PET/CT system (K002715). Image reconstruction for the ECAT Vision scanners is performed using a dedicated reconstruction computer. The reconstruction algorithm is FOREJ rebinning and 2D Attenuation Normalization Weighted OSEM (ANW-OSEM). The reconstruction system interfaces with the acquisition raid disk system for access to the basic acquired data.

The operating console computer is an updated version of the existing ECAT PET/CT operating console. The console runs Siemens Syngo software, with CPS ECAT PET acquisition and application software overlaying the Siemens software. This computer is based on an Intel Pentium system running Microsoft's Windows 2000, or later, operating system. Operating in a syngo-based, NT environment, the ECAT Vision operating software provides acquisition, display, diagnostic, application, system, archival, and retrieval support capabilities. Initially, whole-body oncology applications and visualization tools are being provided.

This is a 510(k) premarket notification for the ECAT Vision 3000 and ECAT Vision 5000 PET Scanners. It's a submission for a medical device and, as such, focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical efficacy studies with acceptance criteria in the typical sense for AI/software devices.

The document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9. This is because the submission is for a hardware device (a PET scanner) and emphasizes technological equivalence and device specifications rather than performance against a clinical ground truth for a diagnostic task.

Here's why the requested information is absent and what the document does provide:

• Acceptance Criteria & Reported Performance (Point 1): No specific acceptance criteria table or reported device performance against a clinical ground truth (e.g., sensitivity, specificity for disease detection) is provided. This is typical for a hardware scanner 510(k) where the focus is on physical specifications, image quality parameters (which are implicitly compared to predicate devices but not quantified in this way), and safety.

• Sample Size, Data Provenance (Point 2); Number of Experts (Point 3); Adjudication Method (Point 4); MRMC Study (Point 5); Standalone Study (Point 6); Type of Ground Truth (Point 7); Training Set Sample Size (Point 8); Training Set Ground Truth (Point 9): All these points are related to studies that would typically be performed for AI algorithms or diagnostic software where the output of the device is a diagnosis or a quantitative measurement requiring validation against a clinical gold standard. This PET scanner itself is an imaging modality, not a diagnostic algorithm. Its "performance" is more about image quality, resolution, acquisition speed, and patient throughput, which are assessed through engineering tests and phantom studies, and then compared to predicate devices' established performance.

What the document does describe and emphasize:

• Device Description: It details the hardware components (detector heads, LSO crystal technology, patient handling system, acquisition computer, reconstruction computer, operating console) and the imaging technique (positron emission tomography, FOREJ rebinning, 2D Attenuation Normalization Weighted OSEM).
• Predicate Devices: The submission clearly identifies previously cleared PET systems (ECAT EXACT, E.CAM LSO 311, ECAT PET/CT) as predicate devices and explains how the new ECAT Vision systems leverage or modify components from these proven technologies. This is the core of a 510(k) for a physical device – demonstrating substantial equivalence to a legally marketed device.
• Indications for Use: The intended purpose is to "image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body." This indicates the device is an imaging tool, not one that automates diagnosis.

In summary, this 510(k) is for a physical medical imaging device (PET scanner), not a software algorithm that performs a diagnostic task. Therefore, the requested information regarding acceptance criteria, study sizes, expert involvement, and ground truth establishment, which are typical for software-as-a-medical-device (SaMD) or AI product submissions, is not present in this document.

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The CPS/Siemens ECAT LSO PET/CT system is a combined positron emission tomography (PET) and Xray computed tomography (CT) scanner. The ECAT LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient. }

The ECAT LSO PET/CT is a combined position emission tomography (PET) and X-ray computed tomography (CT) scanner. This dual modality tomograph is a modified version of the ECAT PET/CT (K002715) and will utilize the same CT component from the Siemens SOMATOM EMOTION (CT) Scanner. However, in place of the PET component that uses 288 BGO crystal block detectors, the ECAT LSO PET/CT will be configured with the CPS ECAT ACCEL PET (K002584) using 144 LSO crystal block detectors, in combination with the Siemens Somatom EMOTION CT. As with the predicate system, 2D PET acquisition and the PET transmission sources are not included in the modified ECAT LSO PET/CT. PET acquisition data is acquired only in 3D and PET attenuation correction map data is obtained from the CT. The PET and CT components will be integrated as in the original ECAT PET/CT to create an integrated, PET, CT, and combined PET/CT, tomographic imaging system.

The ECAT LSO PET/CT gantry structure, patient handling system (PHS), advanced computational system (ACS 3), and workstations will remain essentially the same as the ECAT PET/CT system with only minor modifications to accommodate the different PET detectors. In addition, the ECAT LSO PET/CT as well as the HR+ based ECAT PET/CT will also be offered with either the Siemens single slice EMOTION CT (K991764) or the dual slice EMOTION MS CT (K003074), for the CT component of the system. The EMOTION MS CT with two rows of X-ray detectors does not otherwise affect performance of the ECAT LSO PET/CT.

This is a 510(k) premarket notification for the ECAT LSO PET/CT Scanner, a combined Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanner. This is a medical device, and the documentation provided describes its intended use and a comparison to a predicate device. However, it does not contain information about acceptance criteria or specific studies proving the device meets performance metrics.

The document is a US FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting detailed performance studies with acceptance criteria in the way a clinical trial or a robust standalone performance study would.

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about clinicians establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone performance study details.
• Type of ground truth used.
• Training set sample size or how its ground truth was established.

The provided text only includes:

1. Device Proprietary Name: ECAT LSO PET/CT Scanner
2. Common Name: Combination Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT)
3. Classification Name: Emission Computed Tomography System per 21 CFR 892.1200
4. Predicate Device: ECAT PET/CT from CTI PET Systems (CPS), 510(k) Number K002715
5. Device Description: It's a modified version of the ECAT PET/CT (K002715), utilizing the same CT component (Siemens SOMATOM EMOTION) from a predicate CT scanner (K002713, K991764, K003017 for single/dual slice versions) but replacing the 288 BGO PET crystal block detectors with 144 LSO crystal block detectors from the Siemens ECAT ACCEL PET (K002584). It integrates PET, CT, and combined PET/CT imaging.
6. Intended Use/Indications for Use:
   • To image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for determining metabolic and physiologic functions.
   • To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (from axial or spiral planes).
   • The PET and CT functions can be used in combination for high-resolution, noise-free CT attenuation correction maps for PET images, and to produce fused CT and PET images for detailed anatomic and metabolic function information.

Conclusion:

This document is a regulatory submission demonstrating substantial equivalence, not a performance study report. It states that "The ECAT LSO PET/CT gantry structure, patient handling system (PHS), advanced computational system (ACS 3), workstations will remain essentially the same as the ECAT PET/CT system (ACS 3), with only minor modifications to accommodate the different PET detectors." This implies that the performance characteristics are expected to be similar to the predicate device due to the nature of the modification (a change in detector type within the PET component, while other major systems remain the same or are sourced from predicate devices). However, specific performance criteria and studies demonstrating their fulfillment are not detailed in this 510(k) summary.

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