(57 days)
The Axxent Surface Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver surface brachytherapy, including Intraoperative Radiation Therapy (IORT) during the time the treatment site is exposed surgically.
The Axxent Surface Applicator is a component of the Axxent Electronic Brachytherapy System which utilizes a proprietary miniaturized x-ray source and does not require radioactive isotopes. The applicator allows the Axxent HDR Xray Source to deliver high-dose rate, low energy radiation treatment to skin and tissue surfaces. The Axxent HDR X-ray Source mimics the penetration and dose characteristics of Iridium-192 within the treatment target. The Axxent Surface Applicator is provided in multiple circular aperture sizes to accommodate a range of lesion sizes. The applicators are reusable and sterilizable. Single use disposable end caps are provided to help flatten the treatment surface.
The provided text is a 510(k) Summary for the Axxent® Surface Applicator. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing data from a study that establishes acceptance criteria and then proves the device meets those criteria.
Therefore, many of the requested sections about acceptance criteria, detailed study design, and performance metrics are not available in this specific document.
Here's a breakdown of what can be extracted and what is not present:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not describe specific numerical acceptance criteria or performance metrics for the Axxent Surface Applicator itself, beyond stating that its technological characteristics are "the same" as the predicate device. The focus is on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. No specific test set or clinical study data is presented to evaluate the Axxent Surface Applicator's performance against defined criteria. The substantial equivalence relies on comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available. Since no specific test set requiring ground truth establishment is described, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. As there's no described test set, there's no adjudication method 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/Not Available. The Axxent Surface Applicator is a physical medical device (brachytherapy applicator) and not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Available. This device is a physical applicator, not an algorithm, so this type of study is not relevant or described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Available. No ground truth data is discussed as there is no performance study presented for this device.
8. The sample size for the training set
- Not Applicable/Not Available. The device is a physical medical device, not an AI model, so there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable/Not Available. As above, no training set for an AI model is relevant to this device.
Summary of Device Comparison (from the document):
The core of the 510(k) submission is the claim of substantial equivalence to the predicate device.
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Predicate Device: Nucletron Valencia Skin Applicator Set (K073107)
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Claim of Equivalence: "The technological characteristics of the Axxent Surface Applicator are the same as the Nucletron Valencia Skin Applicator approved in K073107. The device is substantially equivalent in terms of design, materials, principles of operation, and product specification to the predicate device."
This document focuses on demonstrating that the new device is functionally identical or very similar to a device that has already been cleared by the FDA, rather than proving its performance against new, specific acceptance criteria through a clinical or performance study.
§ 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.