(73 days)
DIAGNOSOFT HARP is a stand-alone software package which provides the capability to review, analyze, and report on magnetic resonance (MR) images. HARP can import images from an MR system and display them in a viewing area on the computer screen. Images can be organized and displayed by study and series and organized into three-dimensional and temporal (multi-phase) collections. Temporal sequences can be displayed in a cine mode to facilitate visualization.
Tagged MR images can be imported, displayed, and analyzed. Available measurements include displacement, twist, and radial, circumferential, and principle strains. Tools are provided for display of regional motion properties of the heart.
A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out a complete clinical report of an imaging exam. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians in supporting the determination of a diagnosis.
DIAGNOSOFT HARP is a stand-alone software package, designed for the Microsoft Windows operating system, providing the capability to import, display, and analyze magnetic resonance images of the heart. HARP imports DICOM images containing anatomical MRI, tagged MRI, perfusion MRI, or delayed enhancement MRI and is independent of the MR scanner manufacturer. HARP is intended to support clinicians in the diagnosis of heart disease.
The provided 510(k) summary for KOL 1368, Diagnosoft HARP, is lacking sufficient detail to fully answer all aspects of your request regarding acceptance criteria and performance study specifics.
The document states: "A large body of literature exists describing the performance of HARP methods. Additional verification and validation tests were performed by Diagnosoft, Inc. to demonstrate that Diagnosoft HARP fulfills performance specifications." However, it does not provide the acceptance criteria used in these tests nor report the results of these specific tests.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document only states that "Additional verification and validation tests were performed by Diagnosoft, Inc. to demonstrate that Diagnosoft HARP fulfills performance specifications." However, the specific "performance specifications" (i.e., acceptance criteria) are not defined, nor are the quantitative results of these tests provided. | Not explicitly reported in a quantitative manner. The document asserts that the device fulfills performance specifications but does not provide specific metrics or results from the verification and validation tests performed by Diagnosoft. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. It is not mentioned whether the data was from a specific country, or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No, it was not done. The comparison provided (Table 2) is a side-by-side comparison of features between Diagnosoft HARP and the predicate device (Siemens Cardiac Tagging) rather than a comparative effectiveness study involving human readers. The document does not describe any study assessing the improvement of human readers with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Implied, but details are missing. The document states, "A large body of literature exists describing the performance of HARP methods. Additional verification and validation tests were performed by Diagnosoft, Inc. to demonstrate that Diagnosoft HARP fulfills performance specifications." This suggests standalone tests were performed, but the specific results, methodology, and acceptance criteria are not provided. The HARP device itself is described as "a stand-alone software package," meaning its core function is algorithm-driven analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified.
8. The sample size for the training set
- Sample Size for Training Set: Not specified. The document mentions "A large body of literature exists describing the performance of HARP methods," which might imply that the underlying algorithms were trained on data from this literature, but specific training set details are absent.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not specified.
Summary of Limitations in the Provided Document:
The provided 510(k) summary is designed to establish substantial equivalence based on intended use, indications for use, principles of operation, and technology, rather than a detailed performance study report. It relies on existing literature for the performance of the underlying methods ("HARP methods") and a general statement that "additional verification and validation tests were performed...to demonstrate that Diagnosoft HARP fulfills performance specifications."
For a comprehensive answer to your questions about acceptance criteria and study specifics, a more detailed performance study report would be required, which is not present in this 510(k) summary.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.