(141 days)
The D-SPECT™ Cardiac Scanner System is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The D-SPECTTM Cardiac Scanner System includes display equipment, patient and equipment supports, component parts, and accessories.
D-SPECT™ Cardiac Scanner System is primarily intended, but not limited to, cardiac applications.
D-SPECT™ Cardiac Scanner System supports radionuclides within the energy range of 40-170 keV.
The D-SPECT™ Cardiac Scanner System supports acquisition and imaging modes such as, but not limited to, SPECT (Single Photon Emission Computed Tomography), Multi-Gated SPECT and features low count rate (low dose) acquisition, with no lose in image quality.
D-SPECT™ Cardiac Scanner System is intended for Processing, Reporting, Archiving, Display, Communication and analysis of SPECT data, using tools for imaging and fully automated review and quantification of Cardiac SPECT data including Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS).
Spectrum Dynamics' D-SPECT™ Cardiac Scanner System is a SPECT device, which is designed to perform myocardial perfusion imaging. The device is comprised of a detector head, gantry, and patient chair. Device operation is controlled from an acquisition station console. The system is supported by use of data-transfer accessories (RFID tags), which are attached to the patient's wrist, for patient and radiopharmaceutical agent positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector modules rotate within the closed detector head. The special scanning geometry and detector technology enable shorter scan times. Additionally, a new revision of software was developed, adding Archiving, Display and Communication capabilities (NEMA standard DICOM protocol) with external processing stations PACS systems. The new software package also features correction of insignificant bugs discovered since last release. The modified D-SPECT™ Cardiac Scanner System include a Processing workstation. The Processing Workstation, which is part of the imaging system, is equipped with software package for Processing, Archiving, Display, Communication and analysis of emission computerized tomography data using tools for imaging and fully automated review and quantification of Cardiac SPECT data including the Cedars Sinai Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS) software.
The provided text is a 510(k) summary for the D-SPECT™ Cardiac Scanner System. Its primary focus is on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in a quantitative sense.
Therefore, many of the requested sections (e.g., specific acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth for training) cannot be extracted from this document as such detailed performance study information is not included. The document emphasizes that the intended use, indications, and technological features are similar to predicate devices, implying that the risks and benefits are comparable.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document does not provide a table of acceptance criteria or specific quantitative performance metrics beyond stating that "low count rate (low dose) acquisition, with no lose in image quality" is a feature. The core argument is substantial equivalence to predicates, not meeting new, specific quantitative performance thresholds.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. No studies or test sets are described in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be extracted. No studies or test sets are described in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. No studies or test sets are described in the document.
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
- Cannot be extracted. The document describes a SPECT cardiac scanner system and its associated software for processing and analysis. It does not describe an AI-assisted interpretation system or an MRMC comparative effectiveness study. The software features "fully automated review and quantification," but an MRMC study comparing human performance with and without this automation is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be extracted. While the software includes "fully automated review and quantification," the document does not describe a standalone performance study for these automated features. The focus is on the device as a whole system being substantially equivalent.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be extracted. No studies (and thus no ground truth definition) are described in the document.
8. The sample size for the training set
- Cannot be extracted. No training sets are mentioned.
9. How the ground truth for the training set was established
- Cannot be extracted. No training sets are mentioned.
Summary of what the document does convey regarding "acceptance criteria" and "study":
The "study" or evidence provided is the Rational for Substantial Equivalency. The "acceptance criteria" for this 510(k) submission are implicitly demonstrating that the modified D-SPECT™ Cardiac Scanner System is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness.
Key points from the document regarding "acceptance criteria" through substantial equivalence:
- Intended Use & Indications: The modified device's intended use and indications are "identical to the legally marked devices" (K072468, K003264, K980715, K080784). The "widened indications" for the modified D-SPECT™ (K110507) compared to the older D-SPECT™ (K072468) are aligned with the indications of the other predicate devices (PACS, automated review/quantification).
- Technological Features & Performance: "The technology, performance and most of the specifications of the proposed modified D-SPECT™ Cardiac Scanner System are similar to the legally marketed predicate devices."
- Risks & Benefits: Because of the similarity in intended use, indications, and technological features, the document asserts that "the risks and benefits are comparable to the predicate devices."
- No New Questions of Safety or Effectiveness: The ultimate "acceptance criterion" for a 510(k) is that "there are no new questions of safety or effectiveness raised by the introduction of modified D-SPECT™ Cardiac Scanner System."
In essence, this 510(k) relies on the regulatory pathway of substantial equivalence, where the "proof" is the detailed comparison to legally marketed predicate devices, rather than a de novo performance study against pre-defined quantitative acceptance criteria.
§ 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.