(76 days)
Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.
Leksell GammaPlan® is designed for use with the Leksell Gamma Knife and is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of health care professionals (e.g. neurosurgeons, radiation therapists, radiation physicists) such that the desired radiation dose is delivered by the Leksell Gamma Knife to a precisely defined volume.
The provided document is a 510(k) Summary for a medical device called Leksell GammaPlan®. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study supporting specific acceptance criteria for performance.
Therefore, the requested information pertaining to acceptance criteria and performance study details cannot be fully extracted from this document.
However, based on the available information, here's what can be provided and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from document) | Reported Device Performance |
|---|---|
| Conformance to applicable technical requirement specification | "Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification and user needs have been met" |
| Conformance to user needs | "Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification and user needs have been met" |
| Safety & Effectiveness | "safety & effectiveness have been achieved." |
| Functionality of new features (Stereotactic reference from CBCT, Mask fixation support with patient position correction from CBCT, Guided treatment delivery evaluation after CBCT) | "Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new and existing features against requirement specification." (No specific quantitative performance metrics reported) |
| No undesirable effects from new/updated functionalities | "Regression and re-test of unchanged functionalities in the developed system was done to ensure that the new and updated functionalities did not introduce any undesirable effects." (No specific results reported) |
| Product fulfills intended use and user needs | "Design and usability validation of the system has been performed by competent and professionally qualified personnel to ensure that the product fulfils the intended use and user needs." |
| Effectiveness of risk control measures related to safety (FRS) | "The design and usability validation was also made to ensure that the risk control measures associated with functions related to safety (FRS) for the new functionality was effective." |
Missing: The document does not provide specific, quantitative acceptance criteria (e.g., "accuracy must be within X%", "sensitivity Y%", etc.) or detailed quantitative performance metrics for the device. The reported performance is a general statement that criteria were met.
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 for Test Set: Not specified. The document mentions "module, integration and system level verification" and "regression and re-test," but does not provide details on the number of test cases, plans, or simulated data used.
- Data Provenance: Not specified. No information about country of origin or whether the data was retrospective or prospective. The summary explicitly states: "Clinical testing on patients was not required to demonstrate substantial equivalence or safety and effectiveness of the device." This implies the testing was likely done using simulated data or internal test scenarios.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: The document states that "Design and usability validation of the system has been performed by competent and professionally qualified personnel." No further details on their specific qualifications (e.g., neurosurgeons, radiation therapists, radiation physicists, experience levels) are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of the Leksell GammaPlan device itself (a treatment planning system) to a predicate device, rather than evaluating the impact of an AI component on human reader performance. The device is described as "a computer-based system designed for Leksell Gamma Knife® treatment planning," which processes inputs from healthcare professionals, not an AI intended to assist human readers in image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: The document describes "module, integration and system level verification" and "regression and re-test" to evaluate performance against requirements. This implicitly covers standalone algorithm performance as part of the overall system validation. However, it does not explicitly decouple an "algorithm only" performance metric from the system's intended use by healthcare professionals. The Leksell GammaPlan is a tool for treatment planning by professionals, not an autonomous diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated. Given that clinical testing was not required, the "ground truth" for the verification and validation testing would likely have involved adherence to expected computational models, dosimetry standards, and functional requirements, rather than clinical outcomes or pathology. It would be based on established physics principles and engineering validation criteria for medical device software.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. The document describes a "treatment planning system," not a machine learning or AI model that requires a separate training set. The system's functionality is based on predefined algorithms and physics models, not learned from a dataset in the way a deep learning model would be.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable/Not specified, as there is no mention of a "training set" in the context of this device.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.