(75 days)
Leksell Gamma Knife Perfexion™ with Extend™ Frame System is a teletherapy device intended for stereotactic irradiation of head structures.
The Extend™ system is an extension to Leksell Gamma Knife Perfexion™. It consists of a patient fixation system and new software functions in the system application. The patient fixation system is used to provide target localization and fixation of the patient's head at prescribed geometric coordinates.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Leksell Gamma Knife Perfexion™ with Extend™ Frame System, based on the requested information.
It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device. They typically do not contain detailed study designs and results as a full clinical trial report would. Therefore, much of the requested information, particularly quantitative performance metrics and detailed study methodology, is not present in the given text.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided K092083 510(k) summary, the device's acceptance criteria are implicitly rooted in demonstrating substantial equivalence to its predicate devices concerning safety and effectiveness. The summary does not provide specific numerical acceptance criteria for performance metrics (e.g., accuracy in mm, precision in degrees). Instead, it states that the functionality and fundamental technical characteristics are "the same" or "equivalent" to the predicate.
The document does not report specific quantitative device performance metrics that would typically be associated with acceptance criteria for a new device. It relies on the equivalence to previously cleared devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functionality equivalent to predicate devices (K063512, K030439) | "Functionality... is equivalent to its predicate device... in safety and effectiveness." |
| Fundamental technical characteristics equivalent to predicates | "The fundamental technical characteristics are the same to those of the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The 510(k) summary refers to "comparison charts" that were part of the full submission, but these are not included in the provided text. It is common for 510(k) submissions for devices like this to rely on engineering tests, phantom studies, and possibly limited clinical data or existing data from the predicate, without defining a "test set" in the sense of a clinical study with a specific patient cohort.
- Data Provenance: Not specified. It's likely that data would be from engineering tests, phantom measurements, and potentially historical performance data from the predicate devices. There is no mention of country of origin or whether it's retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. Given the nature of a radiation therapy system, ground truth might involve physical measurements (e.g., dose distribution, mechanical accuracy) rather than subjective expert assessment of images or clinical outcomes in the context of a 510(k) submission.
4. Adjudication method for the test set
- This information is not 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
- No, an MRMC comparative effectiveness study was not done (or at least, not described in this document). This device is a teletherapy system, not an AI-assisted diagnostic imaging tool. Therefore, the concept of "human readers improving with AI" is not applicable in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not directly applicable as this is a physical medical device (radiation therapy system), not a standalone algorithm. The "performance" would be its electromechanical and radiological accuracy and precision, which would be tested in a standalone manner (without patient or clinical staff interaction as part of the "performance" measurement itself, although operators are critical for its use). The document implies engineering and functional verification tests were performed to demonstrate mechanical and software performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document does not explicitly state the type of ground truth. For a device like the Leksell Gamma Knife, ground truth for performance validation typically involves:
- Physical measurements: Using phantoms (e.g., anthropomorphic head phantoms, dosimetry phantoms) and precise measurement equipment to verify radiation dose distribution, beam accuracy, mechanical and optical alignment, and targeting precision.
- Engineering specifications: Adherence to design tolerances and specifications for mechanical components and software.
- Comparison to predicate device performance: Demonstrating that the new device performs within the established parameters of the predicate device.
It is highly unlikely that expert consensus, pathology, or outcomes data would be used as "ground truth" for the technical performance validation of a 510(k) for this type of system; these are more relevant for clinical efficacy or diagnostic accuracy studies.
8. The sample size for the training set
- This information is not applicable/not provided. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its design and performance are based on engineering principles and physical laws, not on learning from a dataset.
9. How the ground truth for the training set was established
- This information is not applicable/not provided for the same reasons as point 8.
§ 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.