(132 days)
Simplicit90Y is a standalone software device that is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images.
Simplicit90Y supports the reading and display of a range of DICOM compliant imaging and related formats including but not limited to CT, PT, NM, SPECT, MR, SC, RTSS. Simplicit90Y enables the saving of sessions in a proprietary format as well as the export of formats including CSV and PDF files.
Simplicit90Y is indicated, as an accessory to TheraSphere®, to provide pre-treatment dosimetry planning support including Lung Shunt Fraction estimation (based on planar scintigraphy) and liver single-compartment MIRD schema dosimetry, in accordance with TheraSphere® labelling. Simplicit90Y provides tools to create, transform, and modify contours/Regions of Interest for calculation of Lung Shunt Fraction and Perfused Volume. Simplicit90Y includes features to aid in TheraSphere® dose vial selection, dose vial ordering and creation of customizable reports.
Simplicit90Y is indicated for post-treatment dosimetry and evaluation following Yttrium-90 (Y-90) microsphere treatment. Simplicit90Y provides tools to create, transform, and modify contours/Regions of Interest for the user to define objects in medical image volumes to support TheraSphere® post-Y-90 treatment calculation. The objects include, but are not limited to, tumors and normal tissues, and liver volumes.
Simplicit90Y is indicated for registration, fusion display and review of medical mages allowing medical professionals to incorporate images, such as CT, MRI, PET, CBCT and SPECT in TheraSphere® Yttrium-90 (Y-90) microspheres pretreatment planning and post-Y-90 treatment evaluation.
For post-Yttrium-90 (Y-90) treatment, Simplicit90Y should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for the case where there is a need for retreatment using Y-90 microspheres.
Simplicit®Y is a software device which provides features and tools for use in pre-treatment dosimetry planning of TheraSphere® Y-90 microspheres treatment and post-treatment evaluation of Y-90 microspheres treatment and operates on Windows computer systems.
Simplicit®Y pre-treatment dosimetry planning features include Lung Shunt Fraction estimation (based on planar scintigraphy) and liver single-compartment MIRD schema in accordance with TheraSphere® labelling. Simplicit®Y additionally provides tools to support TheraSphere® dose vial selection, dose vial ordering and includes the creation of customizable reports.
After administration of Y-90 microspheres, Simplicit®V provides post-treatment dosimetry evaluation with multi-compartment and voxel-wise MIRD techniques applying the Local Deposition Model with scaling for known injected activity to assist the clinician in performing assessment of treatment efficacy and quality assurance, including assessment of absorbed dose to structures such as liver, lung and tumors.
Simplicit®Y provides 2D and 3D image display and advanced dosimetry analysis tools including isodose contour line plan and dose volume histograms.
Simplicit®9Y provides tools for multi-modal image fusion using rigid and deformable registration capable of manual, semi-automated and fully automated operation. Simplicit90Y includes evaluation tools for assessment of registration quality.
Simplicit®9Y provides semi-automated and automated tools for segmentation of Region/Volume Of Interest on multi-modal images.
Simplicit®Y supports the reading, rendering and display of a range of DICOM compliant imaging and related formats including but not limited to CT, PT, NM, SC, RTSS. Simplicit90Y enables the saving of sessions in a proprietary format as well as the export of RTSS, CSV and PDF files.
Simplicit®Y should not be used to change a treatment plan after treatment has been delivered with Yttrium-90 (Y-90) microsphere implants.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets those criteria with numerical results. It focuses on regulatory approval based on substantial equivalence to a predicate device.
However, based on the information provided, here's a breakdown of what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The text states: "The results of performance, functional and algorithmic testing demonstrate that Simplicit®Y meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate device." This is a general statement of compliance, not a table of specific criteria and corresponding performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided. The document makes general statements about "performance, functional and algorithmic testing" but does not detail the size or nature of the test sets used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided. The document mentions general validation and verification but does not detail the process of establishing ground truth with experts.
4. Adjudication Method for the Test Set
This information is not explicitly provided.
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
This information is not explicitly provided. The document describes Simplicit90Y as a "standalone software device" and "a tool to aid in evaluation and information management of digital medical images," but it does not mention MRMC studies comparing human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device is described as a "standalone software device." The document implies that "performance, functional and algorithmic testing" was conducted for the device itself.
7. The Type of Ground Truth Used
This information is not explicitly provided. While the device aids in dosimetry planning and evaluation, the method for establishing "ground truth" for the testing mentioned generally is not detailed.
8. The Sample Size for the Training Set
This information is not explicitly provided. The document does not discuss the machine learning aspects of the software, and therefore, does not mention training sets.
9. How the Ground Truth for the Training Set was Established
This information is not explicitly provided.
Summary of what is present in the document:
The provided text is a 510(k) summary for the Simplicit90Y device. The core argument for its acceptance is substantial equivalence to an existing predicate device (MIM – Y90 Dosimetry, K172218) and several reference devices (Mirada RT, Mirada RTx, Mirada XD).
The study that proves the device meets (implicit) acceptance criteria is described as:
- Testing: "Simplicit®Y is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission. The results of performance, functional and algorithmic testing demonstrate that Simplicit®Y meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate device."
- Compliance: "Verification and Validation for Simplicit®Y has been carried out in compliance with the requirements of CFR 21 Part 820 and in adherence to the DICOM standard."
- Conclusion: "In conclusion, performance testing demonstrates that Simplicit®Y is substantially equivalent to, and performs at least as safely and effectively as the listed predicate device. Simplicit®0Y meets requirements for safety and effectiveness and does not introduce any new potential safety risks."
Essentially, the "study" is a set of "performance, functional and algorithmic testing" designed to show that Simplicit90Y performs similarly to its predicate device for its intended use, particularly for:
- Pre-treatment dosimetry planning (Lung Shunt Fraction, liver MIRD schema)
- Post-treatment dosimetry and evaluation (multi-compartment and voxel-wise MIRD techniques)
- Image registration, fusion, and review
- Contouring/Segmentation for regions of interest.
The document highlights that the proposed device has a narrower scope of indications compared to the predicate, focusing specifically on Y-90 dosimetry. This narrower scope, coupled with similar technology, is used to argue that it does not raise new safety or effectiveness issues.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).