(27 days)
The Diagnosoft, Inc. HARP 2.06 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.
The Diagnosoft, Inc. HARP 2.06 is intended for the quantification of regional and global cardiac function from magnetic resonance images. It includes a user friendly implementation of the HARP methods for fast and reproducible measuring of myocardial motion and strain in the heart. With a friendly graphic user interface, users are able to analyze tagged MR images in minutes and produce many measurements including strain, torsion, and regional wall thickening.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Diagnosoft, Inc. HARP 2.06 device:
It is important to note that the provided text is a 510(k) summary and FDA clearance letter, which often do not contain the detailed performance study results that would be found in a full study report or scientific publication. Therefore, some of the requested information, particularly specific performance metrics and sample sizes for the test set, adjudication methods, and detailed ground truth establishment, is not explicitly stated in this document.
Acceptance Criteria and Reported Device Performance
The document states that "Testing of the modified Diangosoft, Inc. HARP 2.06 has demonstrated that the device fulfills prospective defined performance criteria and that the modified device meets the user needs." However, the document does not provide specific quantitative acceptance criteria or a table of reported device performance values. It broadly states that the device's "performance specifications for the software characteristics performed by the HARP 2.06 are substantially equivalent to those of the HARP 1.1.0."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided document. The document states that the device fulfills "prospective defined performance criteria" and "meets the user needs." | Not explicitly stated in the provided document. The document indicates that the performance is "substantially equivalent to those of the HARP 1.1.0." |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. It does not mention the country of origin of the data or whether it was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided document.
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Adjudication method for the test set:
- Not specified in the provided document.
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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 MRMC comparative effectiveness study is mentioned in the provided document. The device is a "stand-alone software package" intended for "quantification of regional and global cardiac function," and the results "are interpreted by the physician." The study focuses on demonstrating substantial equivalence to its predicate device rather than human-AI collaboration.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance testing described is for the device as a "stand-alone software package." The document states, "Testing of the modified Diangosoft, Inc. HARP 2.06 has demonstrated that the device fulfills prospective defined performance criteria." This implies a standalone evaluation of the algorithm's performance in generating measurements.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. Given the context of "quantification of regional and global cardiac function," the ground truth for strain, displacement, and twist measurements would typically involve established, perhaps manually derived, measurements from the same tagged MR images, or potentially phantom studies with known motion. However, the document does not specify the exact method for establishing this ground truth.
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The sample size for the training set:
- Not specified in the provided document. Training set information is typically not included in a 510(k) summary for this type of device, especially when it's an upgrade that focuses on demonstrating equivalence.
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How the ground truth for the training set was established:
- Not specified in the provided document.
Summary of what is present and what is missing:
- The document clearly states that performance testing was conducted and that the device met pre-defined criteria and user needs, and is substantially equivalent to its predicate.
- It functions as a standalone software for quantification.
- Crucially, the document lacks specific quantitative details about the performance criteria, the results of the performance testing, the sample sizes of the test and training sets, the provenance of the data, the exact methodology for establishing ground truth, the number/qualifications of experts, or any MRMC studies. This level of detail is often summarized or omitted in the publicly available 510(k) summary but would be present in the full submission to the FDA.
§ 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.