(40 days)
GammaPlan® is a computer-based system designed for Gamma Knife® treatment planning.
GammaPlan® is a computer-based dose planning system specifically designed for use with the Gamma Knife®. Gamma Plan® is intended to be used for planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy.
The provided text does not contain detailed information about acceptance criteria or specific studies to prove device performance. It primarily focuses on regulatory approval (510(k) summary) rather than scientific validation studies. Therefore, much of the requested information cannot be extracted from this document.
However, based on the provided text, here's what can be gathered and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided document. The document states that GammaPlan® is "substantially equivalent" to its predicate devices in safety and effectiveness, but it does not specify any quantitative acceptance criteria or report on specific performance metrics of the new device.
2. Sample size used for the test set and the data provenance:
This information is not present. The document doesn't describe any specific "test set" or data used for performance evaluation beyond asserting substantial equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present. No details about ground truth establishment or expert involvement are mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present. There is no description of an adjudication method, as no specific test set evaluation is detailed.
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:
This information is not present. The document does not describe an MRMC study or any assessment of human reader improvement with or without AI (though GammaPlan® itself is a dose planning system, not an AI for human readers in the traditional sense).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not present. While GammaPlan® is a computer-based system, the document does not detail specific standalone performance evaluations. It focuses on its role in "planning the dosimetry of treatments" and being "equivalent to its predicate device."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not present. No ground truth definition is provided.
8. The sample size for the training set:
This information is not present. There is no mention of a training set or the methodology for developing the device.
9. How the ground truth for the training set was established:
This information is not present. As there's no mention of a training set, the ground truth establishment for it is also not discussed.
Summary of what is available from the document:
- Device Name: GammaPlan®
- Intended Use: GammaPlan® is a computer-based system designed for Gamma Knife® treatment planning. It is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiotherapy.
- Regulatory Pathway: 510(k) Premarket Notification, based on substantial equivalence.
- Predicate Devices: Leksell GammaPlan® (K973441) and Leksell GammaPlan® 4C with MultiView (K042269).
- Claim of Performance: The functionality for the GammaPlan® is equivalent to its predicate device in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device.
To get the information requested, a more technical performance report or a validation study document would be necessary, which is typically separate from a 510(k) summary. The 510(k) summary mainly demonstrates that a new device is "substantially equivalent" to an existing legally marketed device, often by showing it performs as well or better than the predicate, but it doesn't always detail the full scientific validation studies with specific performance metrics and acceptance criteria for the new device as a standalone product.
§ 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.