(105 days)
Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors.
Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic irradiation of intra-cranial structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target. The system consists basically of the radiation unit with patient positioning system and the operator console (with control panel and system computer).
This document is a 510(k) summary for the Leksell Gamma Knife® PERFEXION™. It is a Traditional 510(k) submission.
Analysis of Acceptance Criteria and Study Details:
Based on the provided text, the submission is a Traditional 510(k) for a medical device (Radionuclide radiation therapy system), specifically the Leksell Gamma Knife® PERFEXION ™. The purpose of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish novel performance criteria or conduct studies proving the device meets new acceptance criteria in the same way an AI/ML device might.
Therefore, many of the requested details regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are typical for an AI/ML device study, are not applicable or not explicitly detailed in the provided 510(k) summary.
The primary "acceptance criterion" for a Traditional 510(k) is substantial equivalence to a predicate device in terms of safety and effectiveness. The "study" that proves this is the comparison to the predicate device itself.
Here's a breakdown based on your requested information, highlighting what is present and what is not applicable/detailed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Safety and Effectiveness equivalent to predicate device. | "The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device the Leksell Gamma Knife® PERFEXION ™ (K061941) in safety and effectiveness." |
| Fundamental Technical Characteristics similar to predicate device. | "The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 k submission." (Comparison charts are not provided in this extract). |
| Intended Use matching predicate or well-understood clinical application. | "Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeter e.g. metastatic tumors." (This matches the predicate's intended use and the general use of Gamma Knife systems). |
Note: For a medical device like a radiation therapy system, specific performance metrics (e.g., radiation dose accuracy, positional accuracy, treatment time) would be detailed in the underlying engineering and validation studies, but these are summarized by the claim of substantial equivalence in the 510(k) document.
2. Sample size used for the test set and the data provenance
- Not Applicable/Not detailed. This 510(k) submission does not describe a clinical performance study with a "test set" in the context of an AI/ML device performing diagnostic or prognostic tasks. The "test" for a Traditional 510(k) is the demonstration of substantial equivalence through comparison of design, materials, and intended use, often supported by engineering verification and validation (V&V) tests rather than clinical studies with "test sets" of patient data for algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No "ground truth" for a test set is discussed, as this is not an AI/ML diagnostic device submission.
4. Adjudication method for the test set
- Not Applicable. No clinical test set requiring adjudication 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 is a hardware/software system for radiation therapy delivery, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm-only device. It's a complete radiation therapy system. While it contains algorithms for dose calculation and positioning, the 510(k) focuses on the system as a whole and its equivalence to a predicate, not isolated algorithm performance.
7. The type of ground truth used
- Not Applicable. The concept of "ground truth" as typically applied to image analysis or diagnostic AI is not present in this 510(k) summary. The "truth" for a radiation therapy system relates to its ability to accurately deliver radiation as intended, which is verified through engineering tests, phantom studies, and quality assurance protocols (not detailed in this summary, but inherent to the device type).
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device where a "training set" is used to develop a model.
9. How the ground truth for the training set was established
- Not Applicable.
Summary Regarding the Study(ies) for K063512:
The "study" that proves the device meets (the implied) acceptance criteria for this Traditional 510(k) is the comparison to its predicate device, Leksell Gamma Knife® PERFEXION ™ (K061941). The manufacturer asserts that:
- "The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device... in safety and effectiveness."
- "The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 k submission."
The 510(k) process for this type of device does not typically require new clinical studies with patient test sets, expert ground truth, or training sets as would be seen for a novel diagnostic AI/ML algorithm. Instead, it relies on demonstrating that the new device is as safe and effective as a device already on the market through engineering specifications, design comparisons, and adherence to recognized standards. The provided text doesn't offer details on specific engineering verification/validation studies, such as phantom measurements or simulation results, which would underpin the claim of equivalent technical characteristics.
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.