(205 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance (INTRABEAM + Whole Breast Irradiation) | Comparator Performance (Whole Breast Irradiation Alone) |
|---|---|---|
| Non-inferior local control rate of breast cancer when IORT is used in conjunction with whole breast irradiation. | 1.2% recurrence rate | 0.95% recurrence rate |
| Statistical Significance | p=0.41 (non-significant difference) | N/A |
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.
§ 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.