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E.CAM Computer / e.soft Workstation is a Gamma Camera computer for nuclear medicine used to detect or image the distribution of radionuclides in the body or organ, using the following techniques:

• Planar Imaging
• Whole body imaging
• Tomographic imaging (SPECT) for non positron emitter
• Positron imaging by coincidence
• Positron imaging without coincidence up to 588 keV
• Display and process nuclear medicine, PET and CT images

E.CAM Computer / e.soft Workstation provides primary user interface for acquiring images from the Siemens E.CAM family of nuclear medicine Gamma cameras, as well as a collection of clinical applications for processing and review of images from any nuclear medicine and/or positron emission imaging systems. E.SOFT relies on standard networking and image transfer protocols (TCP/IP and DICOM) for connection to/from other devices, including NM, PET and CT imaging stations, image review/storage (PACS) stations, hardcopy devices, external archive devices and HIS/RIS (Hospital information/Radiological Information Systems).

This 510(k) summary for the E.CAM Computer/e.soft Workstation does not contain the detailed study information needed to fill out your request. It states that the device is being modified to include features like attenuation correction with CT images and improved reconstruction. However, it does not include:

• Acceptance criteria or reported device performance metrics for these new features.
• Details about a study conducted to prove the device meets specific performance criteria.
• Information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

The document focuses on demonstrating substantial equivalence to previously cleared devices based on similar indicated use, operating principle, and basic product design, rather than presenting a performance study for the new modifications. It mentions a "risk analysis method used to assess the impact of the modifications was based on a Failure Modes and Effects Analysis (FEMA)," but this is a design control activity, not a performance study that generates the data you're asking for.

Therefore, I cannot complete your request with the provided text.

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To detect or image the distribution of radionuclides in the body or organ, using the following techniques:

• Planar İmaging .
• . Whole body imaging
• Tomographic imaging (SPECT) for non positron emitter .
• . Positron imaging by coincidence
• . Positron imaging without coincidence up to 588 keV

Emission Computed Tomography System

The provided text (K992731) describes the Siemens E.CAM Computer, an Emission Computed Tomography System. However, it does not contain the acceptance criteria or a study proving the device meets specific performance metrics.

This document is a 510(k) premarket notification for a medical device. Its primary purpose is to demonstrate substantial equivalence to previously legally marketed predicate devices, not to present a detailed performance study with acceptance criteria.

Therefore, I cannot fulfill the request to provide the acceptance criteria and the study details because that information is not present in the provided text.

Here's a breakdown of why the requested information is absent based on the document:

• No Acceptance Criteria or Reported Performance Data: The document explicitly states "Performance Standard: None established under Section 514 of The Food. Drug and Cosmetic Act." This indicates that there are no specific, pre-defined performance thresholds for this type of device at the time of this submission that Siemens would need to meet and report against in this document. The submission focuses on demonstrating substantial equivalence.
• No Study Details: The document refers only to "Substantial Equivalence" to previously marketed devices (K952109, K903315B, K892358). It does not describe any new study conducted by Siemens to establish specific performance metrics for the E.CAM Computer. The statement "The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device" speaks to regulatory compliance and general safety rather than a specific performance study.

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