(52 days)
The MammoSite device is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following · lumpectomy for breast cancer.
The MammoSite RTS is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
The MammoSite device is a radiation therapy system that includes the MammoSiteCatheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite Catheter Tray includes the MammoSite catheter and accessories to assist with the implantation of the catheter. The MammoSite is a catheter shaft with an inflatable balloon mounted on its distal end that positions the radiation source within the resected cavity for radiation delivery. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite.
The provided text focuses on the 510(k) summary for the Hologic MammoSite Radiation Therapy System (RTS). This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It does not describe a study that establishes acceptance criteria and then proves the device meets those criteria in the way typically seen for new AI/Diagnostic devices assessed through performance metrics.
Instead, the submission states that the modified MammoSite device has the same intended use, same technological characteristics, and the same materials/dimensions of the predicate MammoSite device. The assessment here is one of substantial equivalence to existing, cleared devices, rather than a novel performance study against specific acceptance criteria.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of regulatory submission. The "acceptance criteria" in this context are the FDA's criteria for determining substantial equivalence, not performance metrics of the device against a defined clinical outcome.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence claim, the "acceptance criteria" are based on a comparison to predicate devices, not specific performance metrics like sensitivity or specificity.
| Acceptance Criteria Category | Reported Device Performance (from submission) |
|---|---|
| Intended Use | Same as predicate MammoSite for brachytherapy delivery after lumpectomy for breast cancer. |
| Technological Characteristics | Same as predicate MammoSite (catheter shaft, inflatable balloon, positions radiation source, utilizes 192Ir seed or ribbon). |
| Materials/Dimensions | Same as predicate MammoSite. |
| Dosimetric Properties | Similar to predicate MammoSite. |
| Safety and Effectiveness | Hologic believes the modified device is substantially equivalent, raising no new issues of safety or effectiveness. (FDA adds a warning that safety and effectiveness as a replacement for whole breast irradiation has not been established). |
2. Sample size used for the test set and the data provenance
- Not applicable. This submission does not include a test set from a clinical performance study. The assessment is based on comparison to predicate device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No test set or ground truth in this context.
4. Adjudication method for the test set
- Not applicable. No test set.
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 device is a medical instrument (applicator system for brachytherapy), not an AI algorithm for diagnostic reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for this submission is the established safety and effectiveness profile and technological characteristics of the predicate devices, which act as the benchmark for substantial equivalence.
8. The sample size for the training set
- Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. Not an AI algorithm.
In summary: The provided document is a 510(k) submission for a modified medical device, the MammoSite Radiation Therapy System. The regulatory pathway chosen is substantial equivalence to existing predicate devices. Therefore, the "study" proving the device meets "acceptance criteria" is a comparison of the modified device's characteristics (intended use, technological characteristics, materials, dimensions, dosimetric properties) to those of the predicate devices, rather than a clinical performance study with specific metrics. The FDA's review confirms this determination, with an added labeling limitation regarding its use as a replacement for whole breast irradiation.
§ 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.