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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).

Study Details (as per the document):

1. 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.

2. 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.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. 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.

5. 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.

6. 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).

7. The sample size for the training set: Not applicable. This is not an AI/ML device.

8. 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.

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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 consists of three primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Source); and an Axxentcompatible 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.

Here's an analysis of the provided text regarding the Axxent Electronic Brachytherapy System, focusing on acceptance criteria and study details.

Important Note: The provided text is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to predicate devices and general safety/effectiveness. It does not contain the detailed information typically found in a clinical study report addressing specific performance metrics, sample sizes for ground truth, expert qualifications, or MRMC studies for AI devices. This device is a radiation therapy system, not an AI-powered diagnostic tool, so many of the requested categories (like MRMC, standalone AI performance, and AI-specific ground truth details) are not directly applicable or reported in this type of submission.

Acceptance Criteria and Reported Device Performance

Given that this is a radiation therapy system and the submission focuses on substantial equivalence, the "acceptance criteria" here refer more to the successful demonstration of the device meeting its performance, functional, and system requirements during verification and validation testing, rather than specific diagnostic accuracy metrics.

Study Details (Based on Available Information)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in the provided documents. The validation testing likely involved a series of engineering and functional tests on the device itself, rather than a "test set" of patient data in the way an AI diagnostic device would.
   • Data Provenance: Not applicable in the context of patient data for a performance study. The "data" here refers to the outcomes of the engineering and software validation tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not directly applicable to a hardware/software system validation in the way it would be for a diagnostic AI system requiring expert consensus on images. The "ground truth" for this device's performance would be established by engineering specifications and regulatory standards. Expert oversight would be from the development and testing engineers and regulatory affairs personnel within iCAD/Xoft.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy to resolve discrepancies between readers, particularly for ground truth establishment or comparative reader performance. This submission describes performance and functional testing of a radiation delivery system.

4. 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 MRMC study was done or reported. This device is a therapeutic device (radiation delivery system), not an AI-assisted diagnostic tool. Therefore, human reader (e.g., radiologist) improvement with AI assistance is not a relevant metric for this submission.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Standalone performance (algorithm only) is partially relevant in that the device's control system and dose delivery algorithm operate in a "standalone" fashion to execute a treatment plan. The "Assessment of Non-Clinical Performance Data" indicates "Validation testing was performed according to a Software System Test Plan. All performance, functional and system requirements were met." This implies the software and system were tested independently to ensure they meet their specifications. However, this is not an "AI algorithm only" performance as conceptualized for diagnostic AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the device's function and performance is its adherence to predefined engineering specifications, design requirements, and regulatory standards. This is assessed through various verification and validation tests (e.g., electrical safety, radiation output accuracy, software functionality, mechanical integrity). For safety, a risk analysis identifies potential hazards.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning system that requires a "training set" of data for model development. Its software and control algorithms are developed through traditional engineering and programming methods.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this type of medical device as described in the provided document.

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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:

Study Information (Based on available text):

1. 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.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
3. Adjudication method for the test set: Not provided.
4. 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.
5. 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.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided, as this submission relies on substantial equivalence.
7. 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.
8. 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.

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The Xoft Axxent Electronic Brachytherapy System is intended to provide brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.

The safety and effectiveness of the Axxent Electronic Brachytherapy System as a I he salely and chectryedies of the ristion in the treatment of breast cancer has not been established.

The three components of the Axxent Electronic Brachytherapy System include the Controller, Balloon Applicators-BR and X-ray Source.

The Controller is a mobile platform that is responsible for the overall operation of the device. The radiation is delivered by a disposable, microminiature X-ray source located at the end of a flexible cable. The X-ray source at the distal tip of the cable is inserted into the central lumen of the appropriately-sized Balloon Applicator. The System is designed to deliver doses of X-ray radiation directly to the excised tumor bed when the physician desires to deliver intracavitary or interstitial radiation to the surgical marqins following lumpectomy for breast cancer.

The Axxent Electronic Brachytherapy System does not utilize a radioactive isotope, or require an HDR isotope afterloader, and thus does not require the heavily-shielded treatment rooms necessary for the delivery of isotope-based HDR brachytherapy.

The provided text is a 510(k) Summary for the Axxent Electronic Brachytherapy System (K050843), focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The 510(k) summary primarily addresses:

• Device Name: Axxent™ Electronic Brachytherapy System
• Predicate Devices: Photoelectron Corporation Photon Radiosurgery System (PRS), Varian VariSource Remote Afterloader, Proxima Therapeutics MammoSite Radiation Therapy System (RTS).
• Device Description: Three components - Controller, Balloon Applicators-BR, and X-ray Source. It describes its function as delivering X-ray radiation directly to the excised tumor bed for intracavitary or interstitial radiation following lumpectomy for breast cancer, without using a radioactive isotope.
• Intended Use: To provide brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.
• Technological Characteristics: Claims similarity and equivalence to predicate devices in design, materials, principles of operation, product specifications, and sterilization.
• Summary of Equivalence: Argues substantial equivalence to predicate devices based on design, materials, function, and intended use.
• FDA Communication: Includes a letter from the FDA stating the determination of substantial equivalence and a critical warning that “The safety and effectiveness of the Axxent Electronic Brachytherapy System as a sole or adjunctive form of breast irradiation in the treatment of breast cancer has not been established.” This warning was required to be presented in a black box in the device's labeling.

In summary, this 510(k) submission is a regulatory document focused on demonstrating substantial equivalence to already cleared devices, not on providing a study with acceptance criteria and performance data as you've requested for an AI/ML device. The device described is a physical medical device (X-ray radiation therapy system), not an AI/ML system, which would require different types of performance evaluation.

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