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The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 6 is intended to be utilized by appropriately trained health care professionals to:

• o 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
• Produce cross-sectional images of the body by computer reconstruction of o XRay transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

The Biograph 6 PET/CT provides registration and fusion of high-resolution metabolic and anatomic information. The PET component utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for fused PET and CT images. Additionally, the system maintains independent functionality of the PET and CT devices, allowing for single modality CT and / or PET diagnostic imaging.

The Biograph 6 TruePoint scanners are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology, and cardiology examinations. They provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system, the Siemens LSO PET scanner and the Siemens Somatom Emotion 6 CT.

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 component provides fast attenuation correction for PET studies as well as precise anatomical reference 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.

The Biograph 6 system which is the subject of this application is substantially equivalent to the commercially available Biograph 6 (K060060) and the commercially available Biograph 64 and Biograph 40 (K060631). The notable changes incorporated in this application consist of the addition of a water-cooled gantry option and an optional computer.

Here's a breakdown of the acceptance criteria and study information for the Biograph 6 TruePoint device, based on the provided text:

Important Note: The provided 510(k) summary focuses heavily on establishing substantial equivalence to previously cleared devices rather than detailing the direct performance testing of the Biograph 6 TruePoint against specific numerical acceptance criteria. The text explicitly states, "The Biograph 6 system which is the subject of this application is substantially equivalent to the commercially available Biograph 6 (K060060) and the commercially available Biograph 64 and Biograph 40 (K060631)." This implies that the performance of the Biograph 6 TruePoint is considered acceptable because it is demonstrably similar to devices already on the market and cleared by the FDA for the same intended use. Therefore, the "acceptance criteria" are intrinsically tied to the performance characteristics of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit numerical acceptance criteria for this specific device are not presented in the provided text. The "acceptance" is based on substantial equivalence to the predicate devices. However, we can infer the expected performance that formed the basis for this equivalence.

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

The provided text does not include information on a specific test set, its sample size, or data provenance for the Biograph 6 TruePoint itself. The submission relies on demonstrating substantial equivalence to pre-existing, cleared devices. Therefore, there's no mention of a separate test set used to independently validate the Biograph 6 TruePoint's performance in a clinical setting against acceptance criteria.

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

Since there is no mention of a specific test set or clinical study for the Biograph 6 TruePoint in the provided document, there is no information on the number or qualifications of experts used to establish ground truth.

4. Adjudication Method for the Test Set

As there is no mention of a test set, there is no information on an adjudication method.

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

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating substantial equivalence, not on comparing performance with or without AI assistance (as this is a medical imaging device, not an AI-driven interpretation tool in this context).

6. Standalone Performance Study

While the device operates "stand-alone" in the sense that it performs its imaging functions independently, the document does not describe a specific standalone performance study that rigorously evaluated its performance against predefined metrics, separate from the human-in-the-loop clinical use context. The substantial equivalence argument implicitly serves this purpose by referencing the proven performance of predicate devices.

7. Type of Ground Truth Used

Given the nature of a 510(k) submission focused on substantial equivalence for an imaging device, the "ground truth" for the predicate devices (and thus, implicitly for this device) would have been established through methodologies typical for medical imaging, likely involving:

• Clinical correlation: Comparing imaging findings with other diagnostic tests, patient outcomes, or surgical/biopsy results.
• Expert consensus: Interpretations by experienced radiologists or nuclear medicine physicians.
• Physical phantom studies: For technical performance metrics like resolution, signal-to-noise ratio, etc.

However, the provided document does not explicitly state the specific type of ground truth used for the original predicate device clearances, nor for any new studies conducted for the Biograph 6 TruePoint.

8. Sample Size for the Training Set

This document describes a medical imaging device (PET/CT scanner), not typically an AI/machine learning algorithm requiring a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable to this submission.

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

Since the concept of a "training set" as understood in AI/machine learning is not applicable here, this information is not present in the document.

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The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 64 and 40 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 (molecular) and physiologic functions within the human body; and
• Produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
  The Biograph 64 and 40 PET/CTs provide registration and fusion of highresolution metabolic and anatomic information. The PET component utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for fused PET and CT images. Additionally, the system maintains independent functionality of the PET and CT devices, allowing for single modality CT and / or PET diagnostic imaging.

The Biograph 64 and Biograph 40 are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology and cardiology examinations. The Biograph systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system, the Siemens LSO HiRez PET scanner and the Siemens Somatom Sensation 64 or 40 CT.
The combined PET/CT scanner is intended for use as a clinical, whole-body machine with high-end spiral CT and PET performance. The CT component provides attenuation correction for PET studies as well as precise anatomical reference 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.

The provided text is a 510(k) summary for the Biograph 64 and Biograph 40 PET/CT systems. It describes the devices, their indications for use, and claims substantial equivalence to previously cleared devices.

Based on the content, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert involvement, adjudication methods, or ground truth establishment. The document is primarily a regulatory submission for premarket notification, focusing on equivalence to existing devices rather than a detailed performance study against defined acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer the specific questions about standalone performance, MRMC studies, sample sizes, or ground truth establishment for a performance study. This type of information is typically found in detailed validation reports, not in a 510(k) summary.

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