(161 days)
The Axxent® Electronic Brachytherapy System 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.
The Axxent Electronic Brachytherapy System (System) consists of three primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Source); and an Axxent-compatible applicator (Applicator). The System is designed to deliver doses of X-ray radiation to the tissue in proximity to the applicator using a disposable, miniature X-ray tube powered by the Controller.
The Axxent Electronic Brachytherapy Controller 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 disposable, miniature X-ray tube located at the end of a flexible cable. The Source is inserted into a lumen of the appropriate Applicator.
This document is a 510(k) summary for the Axxent® Electronic Brachytherapy System. 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria and extensive study data in the way a clinical trial for a new drug or novel high-risk device might.
Based on the provided information, the document does not contain the type of detailed acceptance criteria and study data requested in the prompt. Instead, it focuses on:
- Substantial Equivalence: The core of this 510(k) is to demonstrate that the Axxent Electronic Brachytherapy System is substantially equivalent to a previously cleared device (K050843) for technological characteristics and another (K061582) for indications for use.
- Technological Characteristics: The summary explicitly states, "The technological characteristics of the Axxent Electronic Brachytherapy System are the same as the Axxent Electronic Brachytherapy System cleared in K050843. These devices are equivalent in terms of design, materials, principles of operation and product specifications." This means that the device's performance is assumed to meet prior acceptance criteria because its core technology is identical to an already cleared device.
- Limitations: The FDA letter (K072683) adds a specific limitation to the device's labeling regarding its use for whole breast irradiation, indicating that its safety and effectiveness for this specific use have not been established. This is a post-submission requirement rather than a set of performance criteria the device had to meet for its general clearance.
Therefore, many of the requested detailed points about acceptance criteria and study design are not present in this type of regulatory document.
However, I can extract the available information and state which points are not covered:
Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly detailed as new acceptance criteria the device had to meet for this submission. The device is deemed substantially equivalent in "design, materials, principles of operation and product specifications" to a previously cleared device (K050843). | The Axxent Electronic Brachytherapy System delivers high dose rate X-ray radiation for brachytherapy using an X-ray source and applicator. Performance is assumed to be equivalent to the predicate device K050843. |
| Specific Limitation/Warning from FDA: Safety and effectiveness as a replacement for whole breast irradiation in the treatment of breast cancer. | Not Established: The FDA explicitly states that the safety and effectiveness for this specific application have not been established, and a warning label is required. |
Study Information (Based on available text):
- Sample size used for the test set and the data provenance: Not provided. The submission relies on substantial equivalence to predicate devices, not new clinical testing data described here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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 a radiation therapy delivery system, not an AI-based diagnostic or assistive device that would involve human readers or AI assistance in that context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided, as this submission relies on substantial equivalence.
- The sample size for the training set: Not provided. This type of device does not typically have a "training set" in the context of an algorithm.
- How the ground truth for the training set was established: Not applicable for this type of device and submission.
Summary of what is present:
- Identified Device: Axxent® Electronic Brachytherapy System
- Intended Use: To deliver high dose rate X-ray radiation for brachytherapy.
- Basis for Clearance: Substantial equivalence to predicate devices (K050843 and K061582) in terms of design, materials, principles of operation, and product specifications.
- Specific FDA Limitation: The safety and effectiveness of the device as a replacement for whole breast irradiation in the treatment of breast cancer has not been established, and a warning is required.
§ 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.