(90 days)
VariSeed 7.1 is a software application for planning and evaluating brachytherapy procedures for the treatment of prostate cancer that can be modeled according to AAPM TG-43. It facilitates pre-operative planning and post-operative evaluation as well as intra-operative planning and evaluation.
VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures. The application runs on standard Intel PCs under Microsoft Window® 32-bit operating systems. The application interfaces with video sources, printers, network sources, as well as DICOM and other image and data sources.
The provided text is a 510(k) Premarket Notification Summary for a medical device called VariSeed 7.1. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of acceptance criteria and device performance in the way a clinical trial or a performance study for a novel device would.
Therefore, the information required to fully answer your request (especially regarding detailed acceptance criteria, sample sizes, expert qualifications, and specific performance metrics like those in MRMC studies) is not present in the provided text. The document primarily describes the device, its intended use, and its technological characteristics compared to predicate devices.
However, I can extract the available information and point out what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable acceptance criteria with thresholds. The document relies on demonstrating "substantial equivalence" to predicate devices (VariSeed 7.0 and BrachyVision 6.0) by matching their functionality and adhering to specific industry standards.
- Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantitative error rates) are reported in the text. The device performance is implicitly considered acceptable if it matches the functionalities and adheres to the standards of the predicate devices.
| Feature/Characteristic | Acceptance Criteria (Implicit from Predicate Devices) | Reported Device Performance (VariSeed 7.1) |
|---|---|---|
| Intended Use | Planning and evaluation of brachytherapy procedures for prostate cancer. | Broadened to include HDR image acquisition. Substantially equivalent to predicate devices. |
| Work Flows | Offline, real-time, and nomogram planning with/without ultrasound images. | All matched with predicate devices. |
| HDR Image Acquisition | Utility for acquiring images and inputting pre-plan artifacts (present in BrachyVision). | Added; uses existing VariSeed 7.0 capabilities. Export to DICOM RT. |
| Dose Calculation Standard | AAPM TG-43 support for Anisotropy Constant and Factor. | All matched with predicate devices. |
| Anisotropy Function | Support for Anisotropy Function (present in BrachyVision). | Added; clinicians have option to represent dose distributions per TG-43 standard. |
| Real-time Isodose Calc. | Real-time calculation and display of isodoses over patient anatomy. | Matched with predicate devices. |
| Automatic Source Decay | Automatic source decay calculation. | Matched with predicate devices. |
| Industry Conformance | Conforms to AAPM TG-43 - Dosimetry of interstitial brachytherapy sources. | Matched with predicate devices. |
| DICOM Export | Image and structure data export to DICOM (VariSeed 7.0), Plan export (BrachyVision). | Image, structure, and plan data export to DICOM. |
| Level of Concern | Moderate (implicit from predicate devices' classification and function). | Moderate. Not intended for diagnostics or control of plan delivery. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not mentioned or applicable in this type of submission. Performance testing data relevant to specific sample sizes is not provided.
- Data Provenance: Not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not mentioned. This type of submission would typically involve verification and validation testing against known physics models or established clinical results, rather than expert adjudication of "ground truth" on a test set as might be done for diagnostic AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No, an MRMC study was not done or reported. This device is a treatment planning software, not a diagnostic AI system intended to assist human readers in interpreting medical images.
- Effect Size: Not applicable as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: The document does not describe standalone performance in the typical sense of an algorithm making decisions. The software is the algorithm, performing calculations (like dose distribution) based on user input. The "performance" is implicitly tied to its adherence to standards like AAPM TG-43 and its ability to replicate the functionality of predicate devices. There wouldn't be a separate "standalone" study from its core function. It's a tool for planning, not an autonomous agent.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's functionality would likely be based on:
- Physics Models/Standards: Conformance to AAPM TG-43 dosimetry standards for dose calculation.
- Predicate Device Functionality: The functions and outputs of the previously cleared VariSeed 7.0 and BrachyVision 6.0 are the primary "ground truth" for demonstrating substantial equivalence.
- User Requirements/Specifications: The software was developed to meet defined clinical needs for brachytherapy planning.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not a machine learning device that relies on a "training set" in the common sense. It's a rule-based software application for calculations and data management.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set in the machine learning context. The "ground truth" for its development would be the established physics principles and clinical requirements for brachytherapy planning.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.