Search Results

The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or turnor bed during intracavity and intraoperative radiotherapy treatments.

The INTRABEAM® Spherical Applicators used with the INTRABEAM System are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast irradiation, based upon the medical judgment of the physician. The safety and effectiveness of the INTRABEAM System as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

The INTRABEAM System is a miniature, high-dose rate, low energy X-ray source that emits Xray radiation intraoperatively for the treatment of cancer at the tumor cavity. The INTRABEAM Spherical applicators are accessories to the INTRABEAM System. The INTRABEAM Spherical Applicators received 510(k) clearance in K992577. There are eight sizes of applicators in a set ranging from 1.5 cm to 5.0 cm in diameter. The INTRABEAM Spherical Applicators have not changed in design or technological characteristics as described in K992577.

Here's an analysis of the provided text regarding the INTRABEAM® System with INTRABEAM® Spherical Applicators, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative "acceptance criteria" in the typical sense (e.g., target accuracy, sensitivity, specificity thresholds) for a diagnostic AI device. Instead, the "acceptance criteria" appear to be based on a non-inferiority finding from a clinical trial, comparing the device's outcome to standard treatment.

Therefore, the table below reflects the primary clinical outcome used to support the device's expanded indication, interpreted as the "performance" that met the "acceptance" for the new indication.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (TARGIT-A Trial): N=2,232
• Data Provenance: "international, prospective, randomized" study. This indicates data was collected from various countries and in a forward-looking manner, specifically for the trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications for establishing the "ground truth" (e.g., recurrence diagnosis) within the TARGIT-A trial. However, as a large, international Phase 3 non-inferiority clinical trial on cancer treatment, it can be reasonably inferred that:

• Diagnosis of recurrence would have been established by a multidisciplinary team of qualified medical professionals, including oncologists, pathologists, and radiologists, adhering to strict clinical trial protocols.
• The investigators themselves were "physicians around the world".

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). As a large-scale clinical trial studying recurrence rates, the "ground truth" for local control (recurrence) would typically be determined by clinical follow-up and confirmed diagnostic procedures as part of the trial's defined endpoints, rather than a separate expert review panel for each case. Any ambiguous cases would likely follow the trial's pre-defined adjudication process, often involving an independent endpoint committee, though this is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of this 510(k). The study described (TARGIT-A trial) is a clinical trial comparing treatment modalities (IORT vs. whole breast irradiation), not a study evaluating human readers' diagnostic performance with or without AI assistance. The INTRABEAM System is a device for delivering radiation therapy, not a diagnostic AI tool for image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Yes, in a sense, the TARGIT-A trial can be considered a standalone performance study of the treatment modality. The trial compared the clinical outcome (local recurrence rate) of patients receiving INTRABEAM IORT (in conjunction with whole breast irradiation) versus those receiving whole breast irradiation alone. The device's "performance" in this context is its ability to achieve comparable clinical outcomes regarding breast cancer recurrence. The "algorithm" here is the treatment protocol involving the INTRABEAM system.

7. Type of Ground Truth Used

The ground truth used in the TARGIT-A trial was clinical outcomes data, specifically:

• Local control of breast cancer (i.e., presence or absence of recurrence).

This would be determined through patient follow-up, physical examinations, imaging studies, and potentially biopsy/pathology to confirm recurrence.

8. Sample Size for the Training Set

This information is not applicable as the INTRABEAM System is a medical device for radiation therapy delivery, not an AI algorithm that requires a training set in the typical machine learning sense. The "training" for practitioners would involve learning how to operate the device and apply the treatment based on clinical guidelines and the evidence from trials like TARGIT-A.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8. The device's efficacy is established through clinical trials, not through training on labeled datasets.

Ask a specific question about this device

The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments. The INTRABEAM® Balloon Applicator together with the INTRABEAM® System is intended to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.

The safety and effectiveness of the INTRABEAM® System as a replacement for whole breast irradiation in the treatment of breast cancer has not yet been established.

Not Found

This document is a 510(k) clearance letter from the FDA for the Carl Zeiss INTRABEAM® System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic or clinical accuracy (like sensitivity, specificity, etc.) for a medical imaging or AI device.

Instead, this document focuses on:

• Regulatory clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Intended Use: Defining the radiotherapy treatments for which the device is indicated.
• Limitations and Warnings: Explicitly stating that the "safety and effectiveness of the Carl Zeiss INTRABEAM® System with Balloon Applicators for breast brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established," and requiring this warning to be in the labeling.

Therefore, I cannot provide the requested information about acceptance criteria and a performance study based on the provided text. The traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically described for diagnostic AI/imaging devices (e.g., sensitivity, specificity, F1 score) are not present in this regulatory clearance letter. The "acceptance" here relates to regulatory clearance based on substantial equivalence, not a direct performance study like those for AI algorithms.

Ask a specific question about this device

The INTRABEAM® System is intended to be used for radiation therapy treatment. The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments.

The INTRABEAM® System described in this Special 510(k) is a modification and enhancement of the PRS400 System cleared under K980526 and K992577. The INTRABEAM® System consists of the PRS500 Control Console, the XRS 4, the Workstation Software, the User Terminal, the verification accessories, and the treatment accessories. The PRS500 Control Console provides all low-level operational control and safety functions of this System. The User Terminal with Workstation Software is the primary interface between the System and the user. The Software provides the high level control and display functions of the System. With the INTRABEAM® System, the radiologist, physicist, or technologist uses the Workstation Software on the User Terminal to set up the PRS500 Control Console (perform the pre-treatment verification and treatment planning), perform the treatment to completion, log all procedure variables and events, and after completion of the treatment, save and/or print treatment and performance data.

The provided document is a 510(k) summary for the Carl Zeiss Surgical GmbH INTRABEAM® System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics. The document focuses on regulatory compliance and technical equivalence rather than clinical performance data.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical performance study cannot be fully provided from the given text alone.

Here's an breakdown of what can be inferred from the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics in a clinical context. The document mentions "systematically tested to demonstrate that the modifications did not adversely affect safety and effectiveness." This implies internal engineering and regulatory compliance criteria were met, but these are not clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy).
• Reported Device Performance: No clinical performance data (like accuracy, sensitivity, specificity) is provided for the INTRABEAM® System or its comparison to the predicate in a clinical setting. The "performance" mentioned refers to engineering and safety performance.

2. Sample Size for the Test Set and Data Provenance:

• Sample Size: Not applicable in a clinical sense. The testing described (functionality, safety, electrical safety, EMC, environmental, mechanical stress, validation testing) refers to engineering and regulatory tests, not a patient-based test set for clinical performance evaluation.
• Data Provenance: Not applicable. The "testing" refers to internal company testing, not data generated from patient studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Number of Experts: Not applicable. Ground truth, in the context of clinical performance evaluation, would be established by medical experts reviewing patient data (e.g., imaging, pathology). This type of clinical expert review or ground truth establishment is not mentioned as part of the described testing.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. As there is no clinical test set with medical outcomes being evaluated, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was an MRMC study done? No, the document does not indicate that a MRMC comparative effectiveness study was performed. The focus is on the substantial equivalence of the modified device to the predicate device based on technological characteristics and safety/effectiveness testing.
• Effect size of improvement with AI vs. without AI assistance: Not applicable. This device is an X-ray radiation therapy control unit, not an AI-assisted diagnostic or interpretation tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Was a standalone study done? Not in the sense of an "algorithm only" performance study. The "systematic testing" includes "functionality (integration testing of hardware, firmware, and accessories), safety, electrical safety, electromagnetic compatibility, environmental testing, mechanical stress testing, and validation testing." This represents standalone engineering performance, but not standalone clinical performance in isolation from a human operator. The device itself is an integrated system with controls for a human user.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• Type of Ground Truth: Not applicable in a clinical performance sense. For the engineering and regulatory tests, "ground truth" would be established by design specifications and regulatory standards (e.g., electrical safety standards, electromagnetic compatibility limits, mechanical stress tolerances).

8. Sample Size for the Training Set:

• Sample Size: Not applicable. The INTRABEAM® System is a piece of medical hardware and software, not an AI/ML algorithm that requires a "training set" of data in the typical sense. Its functionality is based on programmed controls and physics principles, not learned patterns from a dataset.

9. How the Ground Truth for the Training Set Was Established:

• How Ground Truth Established: Not applicable. As there's no training set for an AI/ML algorithm, there's no ground truth established for it.

In summary, the provided 510(k) summary primarily addresses the regulatory approval process for a modified medical device, focusing on its substantial equivalence to a predicate device through engineering and safety testing. It does not contain information about clinical performance studies with acceptance criteria, human reader evaluations, or AI/ML algorithm training and validation common in submissions for diagnostic or AI-powered devices.

Ask a specific question about this device