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The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes.

Xeleris 3, as a modification of its predicate device - Xeleris 2 (K051673), is a Nuclear Medicine, PET, NM/CT, and PET/CT workstation. Xeleris 3, as a medical device, is computer workstation software used for the display, processing, archiving, printing, reporting and networking of NM, PET, NM/CT, and PET/CT studies. Xeleris 3 runs on Microsoft Windows XP based PC workstation (color monitor, keyboard, mouse, and CD-RW for archiving), an Ethernet network connection and system software. Optional DVD device is also available. Xeleris 3 also operates in client-server configurations. Xeleris 3 is classified as class II medical device, complies with voluntary Digital Imaging and Communication in Medicine (DICOM) standard.

The provided 510(k) summary does not contain specific acceptance criteria or a study that proves the device meets such criteria in the way typically expected for a new medical device claiming a specific performance metric. Instead, the document describes a modification of an existing device (Xeleris 3 as a modification of Xeleris 2) and asserts substantial equivalence to the predicate device.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

None provided in the document. The submission focuses on device modifications and substantial equivalence to a predicate device. Therefore, a table comparing specific performance metrics against pre-defined acceptance criteria is not included.

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

No specific test set or clinical data is cited for validating performance against acceptance criteria. The document states: "The XELERIS 3 PROCESSING AND REVIEW WORKSTATION did not require clinical studies to support substantial equivalence." This implies that clinical performance was not evaluated with a separate test set to establish new performance metrics. The validation activities mentioned are:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Final acceptance testing (Validation)
• Performance testing (Verification)
• Safety testing (Verification)

These activities are focused on software development and verification rather than clinical performance evaluation against a patient dataset.

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

Not applicable. No ground truth establishment by experts for a clinical test set is mentioned, as clinical studies were not deemed necessary for substantial equivalence.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication is described.

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 such study was conducted or reported. This device is a "Nuclear Medicine Workstation" for display, processing, archiving, etc., and not an AI-assisted diagnostic tool that would typically undergo MRMC studies to assess reader improvement. The device employs "the same fundamental scientific technology as its predicate devices."

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

Not applicable. The device is a "workstation" intended for use by "Nuclear Medicine (NM) or Radiology practitioners," indicating a human-in-the-loop system. Its function is to provide tools for practitioners, not to perform diagnoses independently.

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

Not applicable, as no clinical performance study requiring ground truth is detailed.

8. The sample size for the training set

Not applicable. The document does not describe the development of an algorithm that would require a "training set" in the context of machine learning or AI. The device is a modification of existing software.

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

Not applicable.

Summary of Acceptance Criteria and Study Approach in the Provided Document:

The acceptance criteria for the XELERIS 3 PROCESSING AND REVIEW WORKSTATION, as implied by this 510(k) summary, are primarily centered around functional equivalence, safety, and effectiveness compared to its predicate device (XELERIS 2). The study that "proves the device meets the acceptance criteria" is, in essence, the documentation of software development, verification, and validation activities (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing), asserting that these activities ensure the modified device retains the same fundamental scientific technology and performs comparably to the predicate. The key phrase "The XELERIS 3 PROCESSING AND REVIEW WORKSTATION did not require clinical studies to support substantial equivalence" indicates that formal clinical performance studies with specific acceptance criteria and patient data were not conducted for this submission.

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