(32 days)
The Cedars-Sinai Cardiac Suite of applications is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. Cedars-Sinai Cardiac Suite may be used in multiple settings including the hospital, clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.
The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. Cedars-Sinai Cardiac Suite (non-viewer) minimum system requirements include a computer with at least IGB RAM, 50MB hard disk space for software installation. a display resolution of at least 1024x768 with 16-bit color, a network adapter, a mouse (or other pointer device; trackpad, trackball, etc ... ) and one of the following operating systems: Windows XP, Windows Vista, Windows 7, Windows 8, Windows Server 2003. Windows Server 2008. Windows Server 2012. Mac OS X (10.6. 10.7 & 10.8). The viewer component of the Cedars-Sinai Cardiac Suite minimum system requirements is iPad 2, iPad (3rd generation), iPad (4th generation) and iPad Mini. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. CSMC Cardiac Suite will be marketed as a comprehensive application suite that includes QPS+QGS (Quantitative Perfusion SPECT + Quantitative Gated SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quanitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO), Automated Reconstruction (AutoRECON), Remote Viewer (Viewer) and OPET. OPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.
The provided 510(k) summary does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets them.
Here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
The provided document describes the device as substantially equivalent to a predicate device, and mentions "performance" in a general sense, stating:
"Support of the substantial equivalence of the CSMC Cardiac Suite was provided as a result of software validation, which confirms all features of the device were compliant with the software requirements."
This statement confirms software validation was performed to ensure compliance with software requirements, but it does not specify clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or provide a table of reported device performance against such criteria. The document focuses on demonstrating substantial equivalence based on intended use, technological characteristics, and design.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text.
Missing Information from the Study Description:
The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical performance study with the requested metrics. As such, the following information cannot be found in the provided text:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The document primarily discusses the software as a computational/display tool for existing imagery, not a system that assists human interpretation in a comparative study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states it is "stand-alone software solution for Cardiac SPECT and PET imaging processing and review" and "allows automatic processing and review of quantitative and qualitative information." While this indicates standalone processing, it doesn't describe an 'algorithm only' standalone performance study against a clinical endpoint or ground truth. The "results provided should be reviewed by qualified healthcare professionals," implying human-in-the-loop is part of its intended clinical use.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned. Since it's a software for processing and quantifying existing images derived from SPECT/PET, the concept of a "training set" for an AI model (as often understood in current AI contexts) is not explicitly discussed. The validation described is "software validation, which confirms all features of the device were compliant with the software requirements."
- How the ground truth for the training set was established: Not mentioned.
In conclusion, the provided 510(k) summary focuses on demonstrating that the Cedars-Sinai Cardiac Suite Nuclear Medicine Software is substantially equivalent to a previously cleared device (CSMC Cardiac Suite- Nuclear Medicine Software K112474) based on intended use, technological characteristics, and design, along with general software validation. It does not include the detailed clinical performance study design, acceptance criteria, or results that your request asks for.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.