(42 days)
Leksell Gamma Knife® PERFEXION ™ is a teletherapy device intended for use in the stereotactic irradiation of intra-cranial structures.
Leksell Gamma Knife® PERFEXION ™ is a radiosurgery system for use in the stereotactic Lessen Gamilia Nime Fire - Fire Erivery 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™ and does not contain detailed information about acceptance criteria or specific study results to prove meeting those criteria.
The document primarily focuses on:
- Identifying the device and its manufacturer.
- Classifying the device and its regulation number.
- Identifying predicate devices for substantial equivalence.
- Stating the intended use of the device.
- Confirming its regulatory clearance by the FDA.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies from this document.
However, based on the provided text, here is what can be inferred and what is missing:
1. Table of acceptance criteria and the reported device performance:
- Missing. The document explicitly states: "The functionality for the Leksell Gamma Knife® PERFEXION ™ is equivalent to its predicate device... The fundamental technical characteristics are similar to those of its predicate device(s) and are listed on the comparison charts provided in this 510(k) submission." This implies that acceptance criteria and performance are likely demonstrated through a comparison to the predicate device's established performance, rather than a separate, detailed performance study with explicit acceptance criteria laid out in this summary. The actual comparison charts are not included in this extract.
2. Sample size used for the test set and the data provenance:
- Missing. No information on a specific "test set" or data provenance (country of origin, retrospective/prospective) is provided. The submission relies on demonstrating substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing. No information on "ground truth" establishment or expert involvement for a test set is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Missing. No information on an adjudication method is provided.
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:
- Missing. This device is a "Radionuclide radiation therapy system" (a hardware system for radiosurgery), not an AI-based diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Missing. This is a physical radiosurgery device, not an algorithm, so a standalone algorithm performance study is not applicable.
7. The type of ground truth used:
- Missing. As no specific performance study is detailed, no ground truth type is mentioned.
8. The sample size for the training set:
- Missing. As this is a hardware device submission, not a machine learning algorithm submission, there is no concept of a "training set" in the context of device performance as described here.
9. How the ground truth for the training set was established:
- Missing. Not applicable.
In summary, this 510(k) document is a regulatory submission for a physical medical device (Leksell Gamma Knife® PERFEXION™) seeking substantial equivalence to a predicate device. It confirms the device's classification, intended use, and substantial equivalence, but it does not include the detailed performance study data, acceptance criteria, or ground truth methodologies that would typically be found in a submission for, for example, a novel diagnostic AI algorithm.
§ 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.