(89 days)
The MammoSite 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 a radiation therapy system that includes the MammoSite RTS Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite RTS 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. Any device specifications that have changed as a result of the modifications to the device presented in this 510(k) have been documented in Proxima's product specifications for the MammoSite RTS.
The provided text describes the MammoSite Radiation Therapy System (RTS) and its substantial equivalence to a predicate device, rather than a study proving a device meets specific acceptance criteria with quantifiable metrics. The document details preclinical and clinical studies conducted to support the modifications to the device and its safety/effectiveness. However, it does not present a table of acceptance criteria with corresponding performance metrics in a format that lends itself to a direct comparison as requested.
Based on the information provided, here's a breakdown of the requested elements:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as quantifiable performance metrics with specific thresholds. Instead, it relies on demonstrating equivalence to a predicate device and successful delivery of brachytherapy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Preclinical: | |
| Performance as intended under simulated use and challenge conditions | Demonstrated through in vitro laboratory studies. |
| Biocompatibility requirements met | Demonstrated through biocompatibility testing. |
| Dosimetry characterized | The dosimetry of the MammoSite was characterized. |
| Equivalent radiation dose to commercially available brachytherapy applicators | Animal studies illustrated the performance of the device and demonstrated that a clinical dose of brachytherapy could be successfully delivered. It was concluded that the MammoSite RTS could deliver an equivalent radiation dose. |
| Clinical: | |
| Safety and effectiveness | Evaluated through a multi-center phase II clinical study, which assessed safety and effectiveness using radiological and clinical measures. Brachytherapy was successfully delivered to patients. The study demonstrated that the MammoSite RTS provides brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. The clinical study supported the changes to the device presented in the 510(k). A complete clinical summary including data analysis and individual patient data was provided to FDA. |
| Substantial equivalence to predicate device | The document repeatedly states that the device is "substantially equivalent to the predicate device" in terms of "intended use, similar technological characteristics, and similar materials/dimensions". Any differences were discussed and shown not to affect safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document only mentions a "multi-center phase II clinical study." It does not specify the number of patients included in this clinical study (the "test set").
- Data Provenance: The document does not specify the country of origin of the data. It mentions a "multi-center" study, implying data from multiple locations, but no specific countries. The clinical study was prospective, as it involved "breast cancer patients who were undergoing tumor resection" and where "brachytherapy was successfully delivered to the patients."
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)
The document refers to "radiological and clinical measures" for assessment in the clinical study. It does not provide information on:
- The number of experts involved in establishing ground truth.
- The specific qualifications of those experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for the 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
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. The device is a physical radiation therapy system, not an AI-powered diagnostic tool for human readers.
- Effect Size of AI Improvement: Not applicable, as this is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The MammoSite RTS is a physical medical device (a catheter and accessories) used to deliver brachytherapy, not a standalone algorithm. Its performance is always in conjunction with medical professionals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The clinical study assessed "safety and effectiveness" using "radiological and clinical measures." The successful delivery of brachytherapy and "a complete clinical summary including data analysis and individual patient data" formed the basis of the conclusions. This suggests that ground truth was established through a combination of:
- Clinical observation and assessment by physicians.
- Radiological evaluation (imaging data indicating proper placement and successful delivery).
- Patient outcomes data relating to the safety and successful delivery of the therapy.
8. The sample size for the training set
This information is not applicable in the context of this device and study description. The MammoSite RTS is a physical device, and its development and evaluation did not involve a "training set" in the sense of machine learning algorithms. The preclinical and clinical studies were for validation of the device's performance, not for training an algorithm.
9. How the ground truth for the training set was established
Not applicable. As mentioned above, there was no "training set" in the machine learning sense for this device.
§ 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.