(73 days)
The Axxent® Electronic Brachytherapy System Model 110 XP 1200 is a high dose rate Brachytherapy device for use with Axxent Applicators to treat lesions, tumors and conditions in or on the body where radiation is indicated. Only Xoft Axxent Surface Applicators can be used with the Axxent Electronic Brachytherapy System Model 110 XP 1200.
The Axxent Electronic Brachytherapy System consists of two primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Catheter/Source). The System is designed to deliver doses of X-ray radiation to tissue in proximity to the applicator using a miniature X-ray tube powered by the Controller.
The Axxent Electronic Brachytherapy System is a mobile, computer-controlled platform that is responsible for the overall operation of the System. The Controller is designed to work with the Source, which is a miniature X-ray tube located at the end of a flexible catheter. The Catheter/Source is inserted into a lumen of an appropriate Applicator which are cleared separately under their 510(k). The Axxent Electronic Brachytherapy System Model 110 XP 1200 described in this 510(k) will only be used for surface applications using Xoft Axxent Surface Applicators.
The provided text describes a 510(k) premarket notification for the Axxent Electronic Brachytherapy System Model 110 XP 1200. This is a medical device for radiation therapy, not an AI/ML imaging device. Therefore, much of the requested information regarding AI-specific criteria (such as sample sizes for test and training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.
However, I can extract the acceptance criteria related to the device's performance and the nature of the study conducted to prove it meets those criteria.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are focused on demonstrating that technological changes do not negatively impact the device's fundamental functional, scientific, and performance characteristics, particularly concerning radiation dosage. The device seeks substantial equivalence to its predicate device (Axxent Electronic Brachytherapy System, K122951).
| Acceptance Criteria / Performance Aspect | Reported Device Performance (Model 110 XP 1200 vs. Predicate) |
|---|---|
| Spatial Parameters (Azimuthal and Polar Variation) | Equivalence with the current device. |
| Depth Dose | Equivalence with the current device. |
| First and Second Half Value Layers | Agreement between the current x-ray source/catheter and the proposed source/catheter measurement. |
| Consistency of Spatial Measurements, Depth Dose, and Source/Catheter Spectrum after Extended Use | Consistency demonstrated. |
| Source/Catheter Output Linearity and Reproducibility | Output is linear as a function of time and reproducible. |
| Proposed Source/Catheter Longevity | Functions for at least as long as the current source. |
| Usability in Simulated Clinical Setting | Able to be used in the same manner as the current x-ray source/catheter in a simulated clinical setting. |
| Clinical Dose Equivalence in Surface Applicator Indication | Clinical dose is identical when using either source/catheter design in the surface applicator indication. |
Study Details (as per the document):
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Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML study. The testing was non-clinical performance data (laboratory testing of the device's physical properties), not based on a "test set" of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this device's performance is based on physical measurements of radiation characteristics.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 an AI/ML imaging device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML imaging device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for performance was established through physical measurements and validation testing of the device's characteristics (e.g., spatial parameters, depth dose, half-value layers, output linearity, longevity).
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable.
Overall Study Description:
The study referenced is a non-clinical performance assessment conducted to support the substantial equivalence of the Axxent Electronic Brachytherapy System Model 110 XP 1200 to its predicate device. This involved a series of laboratory tests and validation activities focused on the physical and operational characteristics of the device, particularly the changes in the cooling system and anode target. The goal was to confirm that these changes did not alter the fundamental safety and effectiveness of the device, especially concerning radiation delivery. The conclusion from these non-clinical tests was that the clinical dose is identical regardless of whether the proposed or current source/catheter design is used in the surface applicator indication.
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.