(58 days)
VariSeed is indicated for use as a treatment planning software application used by medical professionals to plan, guide, optimize and document low-dose-rate brachytherapy procedures and for use as a biopsy procedure tracking software application used by medical professionals to plan, guide, and document biopsy procedures based on template guided needle insertion. VariSeed may be used on any patient considered suitable for this type of treatment and is intended to be used outside of the sterile field in an operating room environment or in a normal office environment.
VariSeed 9.0 is a free-standing PC based treatment planning software product designed for preoperative and intraoperative planning of LDR implants, intraoperative tracking of the implant procedure, and postoperative evaluation of completed implants. VariSeed also provides tools for supporting intraoperative template guided biopsy and using those results to guide future treatment.
The provided text is a 510(k) Premarket Notification for VariSeed 9.0, a treatment planning software. It describes the device, its intended use, and compares it to a predicate device (VariSeed 7.1). The document primarily focuses on establishing substantial equivalence to the predicate device and does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, expert qualifications, or ground truth details as requested.
The document indicates that "Verification and Validation were performed for all the new features and regression testing was performed against the existing features of VariSeed." It also states, "The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable." However, it does not provide the specific acceptance criteria, the reported device performance against those criteria, or the details of the studies conducted.
Therefore, many of the requested items cannot be extracted from the provided text.
Here's what can be gathered or inferred about the study and acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative or measurable format, nor does it provide reported device performance metrics against such criteria. Instead, it refers to a successful outcome of "conform[ing] to the defined user needs and intended uses" and the absence of high-priority discrepancy reports. The table below attempts to infer the nature of "acceptance criteria" from the document's content, primarily centered around functional correctness and safety.
| Acceptance Criterion (Inferred from Text) | Reported Device Performance (Inferred from Text) |
|---|---|
| Adherence to defined user needs and intended uses for new features | "The product conformed to the defined user needs and intended uses." |
| No "Safety Intolerable" Discrepancy Reports (DRs) | "No DRs remaining which had a priority of Safety Intolerable." |
| No "Customer Intolerable" Discrepancy Reports (DRs) | "No DRs remaining which had a priority of Customer Intolerable." |
| Functional correctness of all new features (e.g., Template Guided Biopsy) | "Verification and Validation were performed for all the new features... outcome was that the product conformed." |
| Functional correctness and non-degradation of existing features | "...regression testing was performed against the existing features of VariSeed... outcome was that the product conformed." |
| Compliance with applied standards (IEC 62366, 62083, 63204) | Implicitly met as part of successful verification and validation. |
| Device is as safe and effective as the predicate device | "The Verification and Validation demonstrates that the device is as safe and effective as the predicate." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "all the new features" and "existing features of VariSeed" were tested, but no number of test cases, patient data sets, or any other quantifiable sample size is provided.
- Data Provenance: Not specified. There is no mention of the origin (e.g., country) of any data used for testing, nor whether 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:
This information is not provided. The document describes "Verification and Validation" and mentions "System Requirements to Test Procedures Trace Matrix," implying internal testing by the manufacturer rather than a study involving external experts establishing ground truth in a clinical context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. The text implies internal testing and a process of addressing discrepancy reports until high-priority ones are resolved, but it doesn't describe an adjudication method for ground truth in a test set.
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 MRMC study is mentioned. This device is a treatment planning software, not an AI-assisted diagnostic device, so this type of study would not typically be applicable in the sense of "human readers improving with AI."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The software is an "application used by medical professionals to plan, guide, optimize and document," implying human-in-the-loop operation. The "Verification and Validation" appears to cover the software's functionality, which could be considered standalone testing of the algorithm's output (e.g., calculations, image processing, biopsy tracking) in a simulated environment, but this isn't explicitly detailed as a distinct "standalone" study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used for testing. Given the nature of the device (treatment planning software), the "ground truth" for verification and validation would likely involve:
- Engineering specifications and requirements: Ensuring the software's calculations, image manipulations, and data handling functions operate according to predefined algorithms and specifications.
- Physics-based models: For dose calculations (e.g., AAPM TG-43 support), the ground truth would be the expected output based on established physics models.
- Simulated data or known phantom data: To verify accuracy of measurements, contours, and planning processes.
8. The sample size for the training set:
The document does not mention a "training set." This type of software, focusing on treatment planning and biopsy tracking based on established physics and medical principles, typically does not use machine learning in a way that requires a distinct "training set" in the context of pattern recognition or predictive modeling like a diagnostic AI. Its functions are largely deterministic and rule-based.
9. How the ground truth for the training set was established:
As no training set is mentioned, this information is not provided.
§ 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.