(15 days)
The SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
The SenoRad applicator consists of a multi-lumen catheter connected to an inflatable spherical balloon that can be attached to commercially available High Dose Rate remote afterloader equipment for passage of the radiation source delivery wire. Five radiation source wire lumens are provided; one central lumen located along the long axis of the applicator and four curved lumens symmetrically offset from the central lumen. The balloon is inflated to a 4 or 5 cm spherical shape by a controlled volume injection of physiological saline to approximately 32 or 55 ml, respectively.
The provided text describes the SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy, but it is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices rather than a detailed study proving the device meets specific acceptance criteria in the way one might evaluate a diagnostic or AI-driven device.
Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance, and training set information is not applicable or not present in this type of regulatory submission. This document aims to show that the new device is as safe and effective as existing legally marketed devices, rather than establishing novel performance benchmarks.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission for a medical device rather than a performance study with explicit acceptance criteria for a diagnostic/AI tool, there isn't a table of statistical acceptance criteria (e.g., sensitivity, specificity, AUC) or corresponding reported performance metrics in the traditional sense.
Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance aspects evaluated were:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices) | Reported Device Performance (Summary of Preclinical Testing) |
|---|---|
| Intended Use | Same as predicate devices |
| Indications for Use | Same as predicate devices: To provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. |
| Intended Treatment Site | Same as predicate devices |
| Operating Principle | Same as predicate devices |
| Technological Characteristics | Same as predicate devices |
| Dosimetric Characteristics | Equivalent to current brachytherapy applicators. "Extensive preclinical testing was conducted to evaluate and characterize the performance... in vitro laboratory studies to demonstrate that the SenoRad applicator performed as intended under simulated use conditions. Biocompatibility testing was performed..." |
| Biocompatibility | Meets ISO 10993-1 requirements |
| Sterilization Method | Same as predicate devices |
| Materials of Construction | Materials vary but "have no impact on device safety." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of a diagnostic test set with images/data for analysis. The preclinical testing involved "in vitro laboratory studies" and "biocompatibility testing," but the number of units or tests performed is not quantified.
- Data Provenance: The studies were "preclinical testing" and "in vitro laboratory studies." No information is provided on specific countries of origin or whether data was retrospective or prospective, as this isn't relevant for this type of device's submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical medical device (an applicator for brachytherapy), not a diagnostic or AI algorithm that requires expert-established ground truth on a test set (e.g., image annotations, clinical diagnoses). Its performance is evaluated through engineering and biocompatibility testing.
4. Adjudication method for the test set
- Not applicable. See point 3.
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 a diagnostic device or an AI-assisted device. It is an applicator for radiation therapy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's evaluation is primarily based on engineering specifications, physical performance metrics (e.g., inflation to specific spherical shapes and volumes, source delivery wire passage), dosimetric characteristics (measured radiation dose profiles in a phantom, likely), and biocompatibility standards (ISO 10993-1). There is no "ground truth" from human expert consensus, pathology, or outcomes data in the context of this 510(k) submission.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm and does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.