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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 is a radiation therapy system that includes the MammoSite Catheter 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 describes a 510(k) summary for the MammoSite Radiation Therapy System (RTS) and outlines its intended use and substantial equivalence to previously cleared predicate devices. It also briefly mentions preclinical and clinical studies. However, the document does not contain specific acceptance criteria, reported device performance metrics in a quantitative manner, nor detailed information about a specific study that proves the device meets (or met) those criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Details of a standalone performance study.
7. Type of ground truth used for the test set.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document mentions "Extensive pre-clinical studies were performed to support the MammoSite" and that these studies "included in vitro laboratory studies to demonstrate that the MammoSite device, accessories, and packaging, performed as intended under simulated use and challenge conditions." It also states, "Biocompatibility testing was performed to demonstrate that the materials meet the biocompatibility requirements. The dosimetry of the MammoSite was characterized and is similar to the predicate MammoSite devices."

Regarding clinical data, it notes: "The multi-center phase clinical study initially done to evaluate the safety and effectiveness of the MammoSite supports the modified MammoSite. The clinical study included breast cancer patients who were undergoing tumor resection. Assessment methods used to evaluate safety and effectiveness included radiological and clinical measures. Brachytherapy was successfully delivered to the patients."

Crucially, none of these descriptions provide the specific quantitative data needed to answer your questions about acceptance criteria or study methodologies. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/effectiveness, rather than providing detailed study results and performance metrics against specific acceptance criteria.

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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:

1. Equivalent intended use: The device should be intended to provide brachytherapy to surgical margins following lumpectomy for breast cancer.
2. Similar technological characteristics: The device should function similarly to its predicates, utilizing the same principle of intracavitary radiation delivery.
3. 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:

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).

1. 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.

2. 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.

3. 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."

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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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.

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.

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The MammoSite Radiation Therapy System 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 catheter is a shaft with an inflatable balloon that positions the radiation source within the resected cavity for radiation delivery. The MammoSite is a variable 4 cm - 5 cm spherically inflated balloon. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite RTS.

Here's an analysis of the provided text regarding the MammoSite™ Radiation Therapy System (RTS) and its clinical study, organized according to your requested criteria:

Device: MammoSite™ Radiation Therapy System (RTS)
Intended Use: The MammoSite Radiation Therapy System is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (510(k) Summary) is for a substantial equivalence determination, not a post-market performance report. Therefore, it does not explicitly define quantitative "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy, or reduction in recurrence rates with specific thresholds) that the device must meet, nor does it provide a direct table of these criteria alongside reported device performance against those specific numbers.

Instead, the implied acceptance criterion for this 510(k) submission is to demonstrate safety and effectiveness equivalent to predicate devices for its intended use.

The device performance is reported qualitatively:

• Animal studies illustrated successful delivery of a clinical dose of brachytherapy.
• Clinical study evaluated safety; "Brachytherapy was successfully delivered to all patients."
• No new questions about safety identified.
• FDA added a warning regarding unestablished safety/effectiveness for replacement of whole breast irradiation in the treatment of breast cancer. |
  | Effectiveness (Clinical) | Equivalent clinical performance for delivering brachytherapy to surgical margins following lumpectomy for breast cancer, compared to predicate devices. | - "Brachytherapy was successfully delivered to all patients."
• "The clinical study demonstrated that 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."
• "Could deliver an equivalent radiation dose to current brachytherapy applicators" (based on dosimetry characterization). |
  | Technological Equivalence | Similar technological characteristics, materials, dimensions, and method of application to predicate devices. | - "MammoSite has the same intended use, similar technological characteristics, and similar materials/dimensions of the predicates."
• Compared implant duration, target sites, component materials and dimensions, radionuclide source, and clinical usage.
• "Utilize 1921 seed or ribbon as the radiation source with similar dosimetric properties."
• "Differences do not affect safety or effectiveness." |
  | Pre-clinical Performance | Catheter, accessories, and packaging perform as intended under simulated use and challenge conditions. | - "In vitro laboratory studies to demonstrate that the MammoSite catheter, its accessories and packaging performed as intended under simulated use and challenge conditions." |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states that a "multi-center phase II clinical study was conducted." It indicates that "all patients" (implied, the patients in this study) successfully received brachytherapy, and a "complete clinical summary including data analysis and individual patient data was provided to FDA." However, the exact number of patients (sample size) in this multi-center phase II clinical study is not explicitly stated in the provided 510(k) summary.
• Data Provenance: The study was a "multi-center phase II clinical study." Given the applicant's address (Alpharetta, GA, USA) and the FDA approval, it is highly probable the centers were primarily in the United States. The study was prospective as it "included breast cancer patients who were undergoing tumor resection" and evaluated safety and effectiveness based on radiological and clinical measures post-treatment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts used to establish a "ground truth" for the test set in the way one might for an imaging algorithm studying diagnostic accuracy.

For this device, the "ground truth" or primary outcome measures were related to the delivery of radiation therapy and patient outcomes (safety and effectiveness). These would typically be assessed by:

• Treating physicians (e.g., radiation oncologists, surgeons) at the clinical sites for successful delivery and clinical measures.
• Radiologists for radiological assessments.
• Pathologists for initial tumor resection confirmation (though not directly for device performance evaluation in the clinical study).

The document states, "Assessment methods used to evaluate safety and effectiveness included radiological and clinical measures." This implies a standard clinical evaluation by the attending medical staff, rather than a separate "ground truth panel" for retrospective assessment as might be seen for AI diagnostic devices.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for the test set outcomes (e.g., 2+1, 3+1 consensus). Clinical studies of this nature typically rely on individual site investigators' assessments and then aggregate data. If discrepancies arose in clinical data reporting, they would usually be handled by a clinical review committee (e.g., Data Safety Monitoring Board or study principal investigators), but this is not detailed in the summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done.

MRMC studies typically compare human reader performance (with or without AI assistance) in tasks like diagnosis or detection using a specific set of cases. The MammoSite RTS is an interventional device for delivering brachytherapy, not a diagnostic or screening tool. The clinical study evaluated the device's ability to safely and effectively deliver radiation, not how human readers interpret images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done.

The MammoSite RTS is a physical medical device (catheter and accessories) used to deliver radiation, not an algorithm or AI software intended to perform a task independently. Its "performance" inherently involves human-in-the-loop (physician-guided implantation and radiation delivery).

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the ultimate determination of safety and effectiveness as evaluated in the clinical trial. This would implicitly be based on:

• Clinical Outcomes/Measures: Direct observation of successful brachytherapy delivery, patient safety profiles (adverse events), and response to treatment as determined by treating physicians and follow-up.
• Radiological Measures: Imaging studies (e.g., mammograms, ultrasound, MRI) to assess the treated area, cavity size, and recurrence (or lack thereof) during follow-up.
• Dosimetry Characterization: For the pre-clinical phase, physical measurements and calculations confirmed the delivered radiation dose, which forms a basis for effectiveness.

It is not based on:

• Expert consensus (in the sense of a panel reviewing diagnostic images).
• Pathology (as in determining a diagnosis from tissue, though pathology of the initial lumpectomy would define the patient population).
• Outcomes data specific to a pre-defined "gold standard" for AI, but rather broad patient outcome data.

8. The Sample Size for the Training Set

Not applicable.

The MammoSite RTS is a physical medical device. It does not involve a "training set" in the context of machine learning algorithms. The preclinical and clinical studies were designed to validate the device's performance and safety, not to train an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

As there is no "training set" for an algorithm associated with this physical device, there is no ground truth established for it in that sense.

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