(64 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. The Indication/Intended Use and the fundamental scientific technology of the modified device has not been changed and the same as those described in the unmodified predicate device. CSMC Cardiac Suite will be marketed as a comprehensive application suite that includes QPS+QGS (Quantitative Perfusion SPECT + Ouantitative 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 Quantitative Blood Pool SPECT (QBS), ARG/QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO), Automated Reconstruction (AutoRECON), CSView (Cedars-Sinai Viewer) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them. Instead, it describes a 510(k) premarket notification for the "CSMC Cardiac Suite 2017" software, which asserts substantial equivalence to a previously cleared device (CSMC Cardiac Suite v2015- Nuclear Medicine Software, K141652).
While "software validation, which confirms all features of the device were compliant with the software requirements" is mentioned, it is a general statement and does not provide specifics that would allow for a comprehensive answer to your questions regarding acceptance criteria, study design, or performance metrics.
Therefore, many of your requested items cannot be extracted from the given text.
Here's an attempt to answer what can be inferred or directly stated from the provided document, with many sections marked as "Not provided in the text."
Acceptance Criteria and Device Performance
The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or agreement metrics) or report detailed device performance against such criteria. The "Performance Data" section merely states: "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."
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| Not provided in the text. | The device underwent "software validation, which confirms all features of the device were compliant with the software requirements." No specific performance metrics (e.g., accuracy, precision, recall) are reported. |
Study Details
- Sample size used for the test set and the data provenance: Not provided in the text.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the text.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in the text.
- 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: Not provided in the text. The document refers to the device as a "stand-alone software solution" and states "The results provided should be reviewed by qualified healthcare professionals." It does not describe a study involving human readers or their improvement with AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states, "The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review." However, it does not explicitly describe a standalone performance study with specific metrics that would compare its outputs to a ground truth, independent of human review. The "software validation" mentioned is very general.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in the text.
- The sample size for the training set: Not provided in the text.
- How the ground truth for the training set was established: Not provided in the text.
Summary of what is known:
- The submission is for the "CSMC Cardiac Suite 2017," a software for automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets.
- It is a "stand-alone software solution."
- The basis for substantial equivalence is primarily on its similarity in intended use, principle of operation, and technological characteristics to a previously cleared device (K141652).
- "Software validation" was performed to confirm compliance with software requirements. This is a general statement about software quality assurance, not a specific clinical performance study.
- The results from the device "should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians)." This indicates it's an aid, not a definitive diagnosis.
The document focuses on establishing substantial equivalence to a predicate device rather than detailing a specific clinical performance study with defined acceptance criteria and results.
§ 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.