(69 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, arteriovenous malformations, trigeminal neuralgia, meningiomas and vestibular schwannomas.
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. .
The provided text is a 510(k) summary for the Leksell Gamma Knife Perfexion. This document primarily focuses on establishing substantial equivalence to a predicate device and regulatory information. It does not contain a study that demonstrates the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would.
The "acceptance criteria" here would be the regulatory requirements for showing substantial equivalence for a medical device that performs radiation therapy, not a set of performance metrics for an AI algorithm.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth, and expert adjudication are not applicable to the information provided in this 510(k) submission.
Here's a breakdown of what can be extracted and what cannot, based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics in the context of a clinical study demonstrating AI/ML performance. The "acceptance criteria" for this 510(k) are implicitly the requirements for showing substantial equivalence (same intended use, similar technical characteristics, safety, and effectiveness) to the predicate device.
- Reported Device Performance: Not presented as a results table from a performance study. The document states that the device's functionality is "equivalent" to its predicate in safety and effectiveness.
2. Sample sized used for the test set and the data provenance
- Not Applicable: This document does not describe a clinical performance study with a test set. There is no information on sample size or data provenance in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: No test set or ground truth in the context of an AI/ML performance study is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No test set or adjudication method is mentioned.
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 not a study for an AI-assisted device, nor does it describe a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical radiation therapy device, not an algorithm, so the concept of standalone performance does not apply in the manner typically asked for AI/ML devices.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable: No ground truth in the context of an AI/ML performance study is mentioned.
8. The sample size for the training set
- Not Applicable: No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable: No training set or ground truth establishment is mentioned.
Summary of Relevant Information from the Provided Text:
- Device Name: Leksell Gamma Knife® Perfexion™
- Intended Use: Stereotactic irradiation of head structures (e.g., metastatic tumors, arteriovenous malformations, trigeminal neuralgia, meningiomas, vestibular schwannomas).
- Device Type: Teletherapy device (radiation therapy system)
- Predicate Device: Leksell Gamma Knife® Perfexion™ (K063512)
- Basis for Substantial Equivalence: "The functionality for the Leksell Gamma Knife Perfexion is equivalent to its predicate device K063512 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." (These comparison charts are not provided in the snippet.)
In conclusion, this 510(k) submission is for a physical radiation therapy device establishing substantial equivalence to a prior version, not an AI/ML device that would typically undergo a performance study with specific acceptance criteria, test sets, and ground truth as described in your prompt.
§ 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.