(181 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, recurrent glioblastomas, trigeminal neuralgia, medically refractory essential tremor, ocular tumors, optic nerve tumors, benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas). skull base tumors, head and neck tumors (such as unknown of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland), and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base 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.
Based on preoperative radiological examinations, the Leksell Gamma Knife Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.
Each unit contains 192 sealed sources of Cobalt 60.
Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.
- The medical side consists basically of the radiation unit with a patient positioning system. The system control and power units are placed inside the cover of the radiation unit.
- The office side consists of the operator console with control panel and office computer.
This document is a 510(k) premarket notification for the Leksell Gamma Knife Perfexion device. The primary purpose of this submission is not to establish new performance criteria for the device itself, but rather to expand the "Indications for Use" for an already cleared device (K133565). Therefore, the provided text explicitly states that clinical and non-clinical testing were NOT required to support substantial equivalence, and no new performance testing has been made. This means there is no study described in this document that proves the device meets specific acceptance criteria based on new performance data.
Instead, the submission argues that the expanded indications for use for the Leksell Gamma Knife Perfexion are substantially equivalent to its predicate devices because the new indications apply to conditions within the previously cleared treatment area (head and neck) and do not affect the safety or effectiveness of the device.
Given this, I cannot provide the requested information in its entirety because the document explicitly states that no new studies or performance tests were conducted for this 510(k) submission.
However, I can extract the relevant statements from the document regarding the lack of new testing and the rationale for claiming substantial equivalence without new performance data:
1. A table of acceptance criteria and the reported device performance
- No new acceptance criteria or reported device performance for new testing are provided in this document. The purpose of this submission (K151159) is to expand "Indications for Use" for an already cleared device, not to present new performance data. The document explicitly states: "The technical characteristics of the device has not changed compared to the previously cleared Leksell Gamma Knife® Perfexion K133565 and no new performance testing has been made."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No new clinical or non-clinical studies were conducted or presented in this submission. The claim of substantial equivalence is based on the device's prior clearance and the nature of the expanded indications.
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)
- Not applicable. No new clinical or non-clinical studies were conducted or presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new clinical or non-clinical studies were conducted or presented.
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 tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical device for radiation therapy, not a standalone algorithm. The device's performance is tied to its physical components and established treatment parameters, which are stated as unchanged from K133565.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No new performance studies requiring a ground truth were conducted for this particular submission. The substantial equivalence argument relies on prior clearance and a risk analysis review.
8. The sample size for the training set
- Not applicable. No algorithms requiring a training set are discussed in this submission.
9. How the ground truth for the training set was established
- Not applicable. No algorithms requiring a training set are discussed in this submission.
§ 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.