Search Results

The Axxent Balloon Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavity or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment.

The Axxent Balloon 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 intracavitary or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment. The Axxent HDR X-ray Source mimics the penetration and dose characteristics of Iridium-192 within the treatment target. The Axxent Balloon Applicator is provided in five sizes to ensure proper fit into treatment areas of varying shapes and sizes. The applicators are disposable and provided sterile.

The provided text is a 510(k) premarket notification for the Axxent® Balloon Applicator. It primarily focuses on the regulatory submission and approval process, stating that the device has "No device design changes" and that "The purpose of this submission is only to expand the indications for use of the Axxent Balloon Applicator to deliver intracavitary or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment."

Critically, the document does not describe any new study proving device performance or establishing acceptance criteria. Instead, it relies on the substantial equivalence to a previously approved predicate device (K050843) and its existing technological characteristics.

Therefore, I cannot provide the requested table and study information because the provided text does not contain any new acceptance criteria or details of a study conducted to prove the device meets new acceptance criteria. The submission is purely about expanding the indications for use based on the previous approval.

To answer your request, a new study would need to have been conducted, and the details of that study, including acceptance criteria and performance data, would need to be present in the document.

Ask a specific question about this device

To shape the beam from a low energy radiation therapy source up to 50kVp.

The Axxent FlexiShield Mini is intended to shape the beam from a low energy radiation therapy source up to 50kVp. It is a flexible pad placed over the surface requiring shielding that can be cut by the customer to shape the radiation therapy beam. It can be used on external patient surfaces, as well as internally during Intraoperative Radiation Therapy (IORT). The Axxent FlexiShield Mini is fabricated from a composite made from tungsten and silicone rubber. The pad is available in a circular shape with a diameter of 12.7 cm and a thickness of 1 cm. The Axxent FlexiShield Mini is provided non-sterile. The device is steam sterilizable.

The provided document, a 510(k) summary for the Axxent® FlexiShield Mini, is primarily an administrative submission to the FDA demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way one would typically find for a new diagnostic imaging AI algorithm.

The Axxent® FlexiShield Mini is a radiation therapy beam-shaping block, which is a physical medical device, not an AI algorithm or a diagnostic tool. Therefore, the questions regarding AI study design (sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of device and are not addressed in the document.

The "study" in this context is a demonstration of substantial equivalence to a legally marketed predicate device.

Here's the relevant information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance:

The document does not specify "acceptance criteria" in a quantitative, performance-based manner typically associated with clinical trials or AI algorithm validation. Instead, the primary "acceptance criterion" for 510(k) clearance is substantial equivalence to a predicate device.

2. Sample size(s) used for the test set and the data provenance:

Not applicable. This is a physical medical device, so there is no "test set" of data or "data provenance" in the context of an AI algorithm or diagnostic study.

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

Not applicable. There is no "ground truth established by experts" for this type of device's 510(k) submission.

4. Adjudication method 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:

Not applicable. This is not an AI-assisted diagnostic tool.

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

Not applicable.

7. The type of ground truth used:

Not applicable.

8. The sample size for the training set:

Not applicable.

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

Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device used in radiation therapy. It establishes equivalence to a predicate device based on design, materials, principles of operation, and product specifications. The questions posed in your request are primarily relevant to the evaluation of AI algorithms or diagnostic tools, which is not the nature of the Axxent® FlexiShield Mini.

Ask a specific question about this device

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.

• Predicate Device: Nucletron Valencia Skin Applicator Set (K073107)

• 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.

Ask a specific question about this device

The Axxent Electronic Brachytherapy System is intended to deliver high dose rate X-ray radiation for brachytherapy.
The Axxent Vaginal Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavitary brachytherapy in the vagina and rectum.

The Axxent Vaginal Applicator is a component of the Axxent Electronic Brachytherapy System which utilizes a proprietary miniature X-ray source and does not require radioactive isotopes. Each applicator provides a channel for the Axxent HDR X-ray Source-2.2 to deliver high-dose rate, low energy radiation treatment. The source mimics the penetration and dose characteristics of Iridium 192 within the target volume. The Axxent Vaginal Applicators are available in 4 different sizes. The applicators are reusable and sterilizable. An Applicator Clamp and Base Plate are provided as a required accessory to stabilize the Vaginal Applicator during radiation treatment.

The provided text describes a 510(k) premarket notification for the "Axxent® Vaginal Applicator Set" and does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document is primarily focused on establishing substantial equivalence to a predicate device, which is a regulatory pathway used when a new device is similar in intended use, technological characteristics, and safety and effectiveness to a legally marketed predicate device.

Therefore, I cannot provide the requested information as it is not present in the given text. The document confirms that the device is substantially equivalent in terms of design, materials, principles of operation, and product specification to the predicate device, but it does not detail specific performance studies with acceptance criteria, sample sizes, expert ground truth, adjudication methods, or comparative effectiveness studies.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device