(106 days)
Leksell Gamma Knife® 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
- · Orbital tumors
- · Ocular tumors
- · Optic nerve tumors
· Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, chordomas, chordomas, glomus tumors, hemangiomas) - · Skull base tumors
· Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, - nasopharynx, sinonasal, salivary gland)
· Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, skull base tumors)
Leksell Gamma Knife® (available models Icon™, Perfexion™ and Elekta Esprit) is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
The provided text does not contain detailed information about specific acceptance criteria and a study that proves the device meets those criteria as it relates to a specific performance metric (like diagnostic accuracy). Instead, it focuses on the substantial equivalence of a new device model (Leksell Gamma Knife® - Elekta Esprit) to a predicate device (Leksell Gamma Knife® K173789) through non-clinical performance testing.
Here's an analysis based on the provided text, highlighting what is and isn't available:
Overall Conclusion from the Text: The document claims the new device is substantially equivalent to the predicate device because its fundamental technical characteristics are unchanged despite hardware and software updates to the user interface. Therefore, the performance is assumed to be equivalent, and no new clinical studies were conducted for this 510(k) submission.
Missing Information (per the request, but not available in the provided text):
- A table of acceptance criteria and reported device performance for a specific performance characteristic (e.g., diagnostic accuracy, sensitivity, specificity).
- Sample size used for a "test set" in the context of diagnostic performance.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts, their qualifications, and adjudication methods for establishing ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Specific type of ground truth used (pathology, outcomes data, etc.) for performance evaluation.
- Sample size for a "training set" for an algorithm.
- How ground truth for a "training set" was established.
Information Available from the Text (interpreted in the context of "acceptance criteria" as general device functionality and safety):
The "acceptance criteria" here are implicitly related to ensuring the device performs as intended and is as safe and effective as its predicate, primarily through non-clinical testing of hardware and software updates.
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical performance testing to ensure the new model functions as intended and meets requirements.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Conformance to technical requirement specification | "Results from verification and validation testing demonstrate that conformance to applicable technical requirement specification, user needs have been met..." (Page 5) |
| Functionality and Performance as intended | "Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new control system and the new hardware against requirement specification." (Page 5) |
| "Results from verification and validation testing demonstrate... that the device functions as intended." (Page 5) | |
| No undesirable effects from new/updated functionalities | "Regression test of unchanged functionalities in the developed system was done to ensure that new and updated functionalities did not introduce any undesirable effects." (Page 5) |
| Usability and design validation (meets intended use/user needs) | "Design and usability validation of the system have been performed by competent and professionally qualified personnel to ensure that the product fulfils the intended use and user needs." (Page 5) |
| Effectiveness of risk control measures related to safety (FRS) | "The design and usability validation was also made to ensure that the risk control measures associated with functions related to safety (FRS) for the affected functionality, mainly the user interface of the Control Panel were effective." (Page 5) |
| Biocompatibility | "Biocompatibility testing has been performed to ensure that all materials are biocompatible in relation to the use of the device." (Page 5) |
| Safety and Effectiveness Equivalence to Predicate | "The performance data demonstrate that the Leksell Gamma Knife - Elekta Esprit is as safe and effective and performs as well as the predicate devices Leksell Gamma Knife Icon and Leksell Gamma Knife Perfexion." (Page 5) |
| "The device safety and performance have been addressed by non-clinical testing in conformance with predetermined performance criteria, FDA guidance, and recognized consensus standards." (Page 5) | |
| "The results of verification and validation as well as conformance to relevant safety standards demonstrate that the Leksell Gamma Knife® – Elekta Esprit meets the established safety and performance criteria and is substantially equivalent to the predicate device." (Page 5) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of patient cases or images, as the testing was non-clinical and focused on system functionality. It refers to "module, integration and system level verification testing."
- Data Provenance: Not applicable in the context of patient data. The testing was conducted internally by Elekta Solutions AB (Sweden).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this 510(k) submission, as no clinical performance study involving diagnostic accuracy with expert-established ground truth was performed for substantial equivalence. "Design and usability validation... performed by competent and professionally qualified personnel" (Page 5) speaks to the expertise in verifying engineering and human factors aspects, not medical image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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. The submission explicitly states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." (Page 5). This device is a radiation therapy system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an algorithm's diagnostic performance. The device itself is a treatment system, and its standalone performance refers to its ability to deliver radiation as specified, validated through non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" was the device's technical specifications and intended functionality. Verification and validation ensured the device met these engineering and design requirements. There was no medical "ground truth" (e.g., pathology, clinical outcomes) established for diagnostic or treatment efficacy in a clinical setting in this submission.
8. The sample size for the training set:
- Not applicable, as this device is not an AI/ML algorithm trained on a dataset in the sense of image recognition or diagnostic prediction.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.