(57 days)
HYPER Focus can be used to correct respiratory motion in PET images. Relative to non - corrected images, HYPER Focus can reduce respiratory motion effects and thus improve the measurement accuracy of SUV and lesion volume.
HYPER Focus is a software-only device. It is intended to be implemented on previously cleared PET/CT devices uMI 550 (K193241) and uMI 780 (K172143). HYPER Focus serves as an additional function for uMI 550 and uMI 780 to carry the respiratory correction. It uses the similar respiratory motion correction technique, non-rigid image registration, as the predicate device.
The provided text describes the regulatory clearance of a medical device called "HYPER Focus" (K210418), a software-only device designed to correct respiratory motion in PET images.
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state a table of quantifiable acceptance criteria with corresponding performance metrics like a typical clinical study report would. Instead, the acceptance criteria are implicitly tied to the device's ability to achieve "substantial equivalence" to a predicate device (GE Q.Freeze software, K113408) in terms of its ability to reduce respiratory motion effects and improve the accuracy of SUV and lesion volume.
The reported device performance is described qualitatively as:
| Acceptance Criterion (Implicit) | Reported Device Performance/Conclusion |
|---|---|
| Reduce respiratory motion effects in PET images. | "HYPER Focus can reduce respiratory motion effects..." |
| Improve the measurement accuracy of SUV. (Standardized Uptake Value) | "...and thus improve the measurement accuracy of SUV..." |
| Improve the measurement accuracy of lesion volume. | "...and lesion volume." |
| Technological characteristics equivalent to predicate device's respiratory motion correction function. | "HYPER Focus has the equivalent technological characteristic to the function of respiratory motion correction of predicate device." "Both devices are based on non-rigid image registration technique." "HYPER Focus also utilizes 100% of the acquired data counts, similar to the predicate device." |
| No new restrictions on use compared to predicate. | "...and does not introduce any new restrictions on use." |
| As safe and effective as the predicate. | "HYPER Focus is as safe and effective as the predicate." "HYPER Focus is substantially equivalent as safe as the legally marketed predicate device." "Design verification, along with bench testing demonstrates that HYPER Focus is substantially equivalent as effective as the legally marketed predicate device." |
| Software documentation and cybersecurity conformance. | "Software documentation for a Moderate Level of Concern software per FDA Guidance Document... is included as a part of this submission." "Cybersecurity information in accordance with guidance document... is included in this submission." |
| Risk analysis completed and risk control implemented. | "The risk analysis was completed and risk control was implemented to mitigate identified hazards." |
| All software specifications met acceptance criteria. | "The testing results show that all the software specifications have met the acceptance criteria." |
| Verification and validation testing acceptable to support substantial equivalence. | "Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a numerical sample size for the test set. It mentions "identical raw datasets obtained from UIH's uMI 780 (K172143) and uMI 550 (K193241)." This suggests that existing datasets were used, but the quantity of these datasets or individual patient cases is not provided.
- Data Provenance: The data was obtained from UIH's uMI 780 and uMI 550 devices. Given that the company, Shanghai United Imaging Healthcare Co., Ltd., is based in China, it is highly probable that the data originated from China. The document does not explicitly state whether the data was retrospective or prospective, but given they are "identical raw datasets obtained" and "existing data" for bench testing, it strongly implies retrospective use of previously acquired patient data.
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)
This information is not provided in the document. The document describes "engineering bench testing" and "performance verification" using "identical raw datasets," which suggests a technical analysis rather than an expert-read clinical study to establish ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. The study described appears to be a technical bench test comparing reconstructed images with and without motion correction, rather than a reader study requiring adjudication.
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
No, an MRMC comparative effectiveness study involving human readers is not described in this document. The study focuses on the device's quantitative performance (SUV and lesion volume accuracy) and its ability to reduce motion effects in comparison to non-corrected images, and on demonstrating substantial equivalence to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The "Performance Verification" section states: "Engineering bench testing was performed to support substantial equivalence and product performance claims. The evaluation and analysis used the identical raw datasets obtained from UIH's uMI 780 (K172143) and uMI 550 (K193241), and then respectively performed image reconstruction with/without HYPER Focus." This indicates that the algorithm's performance was assessed independently of human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document primarily refers to "bench testing" and "analysis" of quantitative metrics like SUV (Standardized Uptake Value) and sphere/lesion volume accuracy. The "ground truth" for this type of test is typically based on:
- Known physical properties of phantoms: For sphere volume and potentially SUV accuracy, phantom studies with known dimensions and activity concentrations are commonly used. While not explicitly stated, "bench test" often implies phantom studies.
- Comparison to "ideal" or "reference" motion-corrected images: The document states a comparison "in comparison with no motion correction." This implies an assessment against a baseline reference, where the ground truth is the improved accuracy obtained by the algorithm. For motion correction, perfect motion-free images are the ideal ground truth, which is often approximated or modeled.
- The document implies that the "ground truth" for proving efficacy is the demonstrated improvement in SUV and lesion volume accuracy and reduction of motion effects when HYPER Focus is applied, compared to images without motion correction.
The document does not suggest the use of expert consensus, pathology, or outcomes data as a ground truth for this particular submission, which is focused on validating the technical performance of motion correction software for PET images in the context of substantial equivalence.
8. The sample size for the training set
The document does not provide any information about the sample size used for the training set of the HYPER Focus algorithm.
9. How the ground truth for the training set was established
The document does not provide any information about how the ground truth for the training set was established. It focuses solely on the performance verification (testing) of the final algorithm.
§ 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.