(105 days)
Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.
Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife". Leksell Gamma Plan® is intended to be used for planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy.
The provided text describes a 510(k) summary for the Elekta Instrument AB's Leksell GammaPlan® system. This document is a premarket notification for a medical device and primarily focuses on establishing "substantial equivalence" to a predicate device, rather than presenting a detailed clinical study with acceptance criteria and performance data in the way a diagnostic AI device submission might.
Therefore, many of the requested elements for acceptance criteria and study design are not present in this 510(k) summary because this type of submission typically demonstrates equivalence through technical specifications rather than extensive clinical performance studies.
Here's an analysis based on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance Study (as per the provided document)
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a specific table of acceptance criteria or reported device performance in the sense of accuracy, sensitivity, specificity, or other performance metrics for a diagnostic or AI-driven device.
Instead, the "acceptance criteria" for a 510(k) submission like this are generally satisfied by demonstrating substantial equivalence to predicate devices. This means showing that the new device has the same intended use, technological characteristics, and safety/effectiveness profiles as devices already legally marketed.
The key "performance" claimed in this document is:
| Acceptance Criterion (Implicit) | Reported Device Performance (Claim) |
|---|---|
| Substantial Equivalence | "The functionality for Leksell GammaPlan® is equivalent to its predicate devices Leksell GammaPlan® (K061540) and Leksell GammaPlan® (K051022) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate devices." |
| Intended Use | "Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®." |
| Device Classification | Radionuclide radiation therapy system (Class II, Product Code IWB, Regulation Number 892.5750) |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This submission does not describe a clinical performance study with a test set of patient data to evaluate the device's diagnostic or predictive performance. The assessment is based on technical equivalence to predicate devices, not on a new clinical data evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. There is no mention of experts or ground truth establishment because a clinical performance study on a test set is not detailed.
4. Adjudication method for the test set
Not applicable/Not provided. No test set or adjudication method is described.
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
Not applicable. This device is a dose planning system for radiation therapy, not a diagnostic AI system intended to assist human readers. Thus, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function or the information provided in this 510(k) summary.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable/Not explicitly detailed as a 'standalone performance study'. The Leksell GammaPlan is itself a computer-based dose planning system, used by human operators. Its performance is inherent in its functionality for dose planning, which is being compared for equivalence to existing versions of the same system (predicate devices). The submission focuses on its technical characteristics being similar, implying its standalone function is equivalent.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided in the context of a performance study. The "ground truth" for this 510(k) submission implicitly lies in the established safety and effectiveness of the predicate devices. The new device is deemed acceptable because it is substantially equivalent to these already-approved devices, whose 'ground truth' in terms of clinical utility and safety has already been accepted by the FDA.
8. The sample size for the training set
Not applicable/Not provided. This is not an AI/ML-driven device that underwent a distinct "training" phase with a dataset. It is a software system for dose planning.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there is no stated training set for an AI/ML model, the concept of establishing ground truth for it is not relevant to this document.
§ 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.