(169 days)
The Leksell® Gamma Knife Target System Model 24001 is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures
The Leksell® Gamma Knife Target System is an upgraded version of the currently available Leksell® Gamma Knife device. The device is intended for the stereotactic irradiation of intracranial structures and is composed of seven basic components. The Leksell® Gamma Knife Target System receives data from the Leksell Gamma Plan software. The Target System is composed of a Computerized Control System, Automatic Positioning System, Couch, Radiation Unit and Patient Surveillance System. The patient's head is fixated by the Leksell Stereotactic Coordinate Frame.
The provided text does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in the way typically expected for medical device performance studies (e.g., clinical trials with specific endpoints, statistical analyses, and a defined patient cohort).
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and general performance testing.
Here's an analysis of the provided information, addressing your points where possible:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative criteria (e.g., sensitivity, specificity, accuracy). | "The Leksell® Gamma Knife Target System has been demonstrated to perform as intended with accuracy and repeatability." |
| Implicitly: Performance matching or exceeding the predicate device in terms of "stereotactic irradiation of intracranial structures." | "The fundamental technical characteristics are similar to those of the predicate devices..." |
| Implicitly: Software and hardware functionality. | "Testing of the software and hardware components of the device have also been completed." |
| Implicitly: System integration. | "Integration testing and complete system testing have also been performed." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of patient data or clinical cases. The performance data mentioned relates to system-level technical testing rather than clinical study data. Therefore, there's no information on sample size, country of origin, or 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
Not applicable. As no clinical "test set" is described, there's no mention of experts establishing ground truth for such a set. The performance testing appears to be technical validation.
4. Adjudication method for the test set
Not applicable. No clinical test set or adjudication process 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 radiation therapy system, not an AI-assisted diagnostic or treatment planning tool that would involve human readers or AI assistance in that context. The "Target System" receives data from "Leksell Gamma Plan software," but the submission does not describe it as an AI system requiring an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm. The performance testing mentioned refers to the functionality and accuracy of the device's hardware and software components.
7. The type of ground truth used
For the technical performance testing, the "ground truth" would likely be based on engineering specifications, known physical properties (e.g., radiation dose distribution accuracy), and comparison to the predicate device's established performance. The document doesn't specify how this technical "ground truth" was established beyond "testing of the software and hardware components."
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary of the Study:
The "study" presented in this 510(k) summary is not a clinical trial or a performance study in the sense of evaluating diagnostic accuracy or treatment efficacy on patient data. Instead, it's a technical performance evaluation and a demonstration of substantial equivalence to a previously cleared device (Leksell® Gamma Unit Model 23004, Type B).
The 510(k) submission primarily relies on the following to demonstrate that the device performs as intended:
- Comparison of Technological Characteristics: The new device (Leksell® Gamma Knife Target System Model 24001) shares fundamental technical characteristics with its predicate, including the same radiation unit (Cobalt 60 through 201 collimator sources), receiving treatment planning data from Leksell® Gamma Plan software, and patient head fixation with the Leksell® Stereotactic Coordinate Frame.
- System-level Performance Testing: The document states that the device has undergone testing at the system and subsystem levels, including software and hardware components, integration testing, and complete system testing. The results of these tests are stated to have been included in other sections of the submission (Sections 13, 15, and 16), which are not provided here. The conclusion drawn from these tests is that the device "has been demonstrated to perform as intended with accuracy and repeatability."
This type of submission often focuses on demonstrating that changes introduced in a new model do not raise new questions of safety or effectiveness and that the device performs equivalently to an already-cleared device. Specific quantitative clinical performance metrics (like sensitivity, specificity, or survival rates) are typically not required for this type of substantial equivalence submission unless significant changes impacting clinical outcomes are introduced.
§ 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.