(222 days)
The MammoSite RTS is an applicator 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MammoSite Radiation Therapy System (RTS) (K032067).
Summary of Acceptance Criteria and Device Performance:
The provided document (K032067) is a 510(k) summary for the Ellipsoid MammoSite RTS. It focuses on demonstrating substantial equivalence to previously cleared predicate devices (MammoSite K011690 and K030558, and Nucletron afterloaders) rather than establishing specific, quantitative performance metrics as "acceptance criteria" in the traditional sense of a new technology proving efficacy.
The "acceptance criteria" for this 510(k) are implicitly:
- Equivalent intended use: The device should be intended to provide brachytherapy to surgical margins following lumpectomy for breast cancer.
- Similar technological characteristics: The device should function similarly to its predicates, utilizing the same principle of intracavitary radiation delivery.
- Equivalent safety and effectiveness: The device, despite any minor differences, should be demonstrated to be as safe and effective as the predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated for substantial equivalence) |
|---|---|
| Intended Use: To provide brachytherapy to the surgical margins following lumpectomy for breast cancer. | The MammoSite RTS (Ellipsoid version) has the same intended use as the predicate MammoSite devices. "The MammoSite RTS is an applicator intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer." |
| Technological Characteristics: Similar to predicate devices (catheter, inflatable balloon, use of 192Ir seed/ribbon, dosimetric properties). | "The MammoSite has the same intended use, similar technological characteristics, and similar materials/dimensions of the predicate MammoSite devices." It positions the radiation source within the resected cavity for radiation delivery and utilizes 192Ir seed or ribbon with similar dosimetric properties. "Any differences that exist between the ellipsoid MammoSite RTS and the predicate devices were discussed and shown that these differences do not affect safety or effectiveness." |
| Safety and Effectiveness: Demonstration that any differences from predicates do not affect safety or effectiveness, and that the device performs as intended in simulated and clinical conditions, delivering an equivalent radiation dose. | Pre-clinical Studies: In vitro laboratory studies demonstrated the ellipsoid MammoSite devices, accessories, and packaging performed as intended under simulated use and challenge conditions. Biocompatibility testing confirmed material compliance. Dosimetry was characterized and found similar to predicate devices. Animal studies illustrated device performance and successful delivery of a clinical dose of brachytherapy. Clinical Studies: "The multi-center phase II clinical study initially done to evaluate the safety and effectiveness of the MammoSite RTS supports the ellipsoid devices presented in this 510(k)." Brachytherapy was successfully delivered to patients. The study "demonstrated that the MammoSite RTS provides brachytherapy..." |
Detailed Study Information:
The 510(k) relies on a combination of preclinical studies for the ellipsoid device and leveraging clinical data from previous MammoSite RTS approvals (specifically K011690).
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Sample size used for the test set and the data provenance:
- Clinical Test Set: The document refers to "The multi-center phase II clinical study initially done to evaluate the safety and effectiveness of the MammoSite RTS supports the ellipsoid devices presented in this 510(k)." This implies the clinical data for the original MammoSite (K011690) is used to support the ellipsoid variant.
- Sample Size: Not explicitly stated for the clinical study directly within this 510(k) summary, but says "The clinical study included breast cancer patients who were undergoing tumor resection." It notes "A complete clinical summary including data analysis and individual patient data was provided to FDA in K011690." Without access to K011690, the exact number of patients isn't known from this document.
- Data Provenance: "multi-center phase II clinical study." The country of origin is not specified, but typically for US-based 510(k)s, such studies would include US sites. It was a prospective study.
- Pre-clinical Test Set (for Ellipsoid device):
- Sample Size: Not specified (e.g., number of devices tested in vitro, number of animals in animal studies).
- Data Provenance: In vitro laboratory studies and animal studies. Specific geographic origins are not provided but are generally internal lab testing or contract research. Retrospective for analysis, but the testing itself would be prospective.
- Clinical Test Set: The document refers to "The multi-center phase II clinical study initially done to evaluate the safety and effectiveness of the MammoSite RTS supports the ellipsoid devices presented in this 510(k)." This implies the clinical data for the original MammoSite (K011690) is used to support the ellipsoid variant.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the clinical study, "Assessment methods used to evaluate safety and effectiveness included radiological and clinical measures." This implies clinical experts (physicians, radiologists) were involved in assessing outcomes. However, the exact number and their qualifications are not specified in this document.
- For preclinical work, experts in dosimetry, biocompatibility, and possibly animal research would have been involved, but their numbers and qualifications are not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify any adjudication method for the clinical or preclinical studies. It generally states that "Brachytherapy was successfully delivered to the patients."
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This application is for a medical device (applicator system for brachytherapy), not an imaging or diagnostic AI device which would typically involve such studies. The focus is on the safe and effective delivery of radiation, not interpretation of images by multiple readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not relevant or performed. This device is a physical applicator system for radiation therapy,
not a software algorithm.
- No, a standalone algorithm performance study was not relevant or performed. This device is a physical applicator system for radiation therapy,
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Study: "radiological and clinical measures" were used to assess safety and effectiveness. This implies a combination of:
- Clinical Outcomes/Events: Success of brachytherapy delivery, adverse events, patient outcomes (implied, not fully detailed here).
- Radiological images: Used for assessment (e.g., assessing balloon inflation, catheter placement, dose distribution, though not explicitly labelled as 'ground truth' for an AI).
- Preclinical Studies:
- In vitro: Performance metrics against simulated use conditions.
- Biocompatibility: Standardized test results against established benchmarks.
- Dosimetry: Measurement of radiation dose distribution compared to expected or predicate values.
- Animal studies: Observation of device performance and successful radiation delivery in an animal model.
- Clinical Study: "radiological and clinical measures" were used to assess safety and effectiveness. This implies a combination of:
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The sample size for the training set:
- Not applicable. This device is a hardware system, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for the device would be its engineering design, manufacturing processes, and preclinical testing, not data-driven machine learning.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" in the context of AI/ML for this device. The "ground truth" for its design and verification would be engineering specifications, material properties, and established medical physics principles.
§ 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.