Search Results

GammaPod™ is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.

The GammaPod™ is a teletherapy device that uses rotating, multi-source Cobalt-60 gamma-ray emitting sources to noninvasively deliver a focal dose of radiation to a partial volume of a human breast of a patient in the prone position while sparing the surrounding normal tissues and structures. The GammaPod system contains 4 main components: i. GammaPod irradiation unit, ii. Imager loader system, iii. Breast immobilization system, and iv. Treatment planning system.

The provided document is a 510(k) summary for the GammaPod™ - Model A, which is a teletherapy device. The submission focuses on a modification to an existing, previously cleared GammaPod device (K172706). The modification involves a change in the number of Cobalt 60 sources from 36 to 25.

Therefore, the acceptance criteria and study information provided pertains to the performance of this modified device compared to its predicate device, rather than a de novo establishment of performance for a completely new device. No clinical studies were conducted for this specific modification.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for a modification to a predicate device, the "acceptance criteria" are primarily based on demonstrating that the modified device is substantially equivalent to the predicate device and meets established safety and performance standards despite the change in source configuration. The reported performance focuses on showing that the modification maintains the existing performance characteristics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical testing was conducted for the current device modification." Therefore, there is no clinical test set, clinical sample size, or related data provenance information for this submission. The testing was non-clinical.

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)

Not applicable, as no clinical testing was conducted and no "ground truth" in the context of clinical expert review was established for this specific 510(k) modification. The evaluation was based on engineering and physics testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set was used requiring adjudication.

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 teletherapy system, not an AI-assisted diagnostic tool that would involve human readers interpreting images.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device's systems (e.g., the treatment planning system and the irradiation unit's dose delivery) in a controlled, non-clinical setting. The document indicates that such testing was done.

• Treatment Planning System Software Testing: "Testing of the treatment planning system software was conducted to verify accuracy of treatment plans based on the 25-source configuration."
• Radiation Tests: "Radiation tests including radiation safety measures and radiation dosimetric accuracy were conducted to demonstrate compliance with the requirements of the NRC and IEC 60601-2-11."
• Leakage Profile: "The measured radiation leakage profile of the modified GammaPod remains far below the recommended levels of IEC 60601-2-11 and NCRP Report #102."

These tests demonstrate standalone performance regarding the accuracy of dose planning and delivery, and radiation safety, for the modified 25-source configuration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" was based on:

• Established engineering principles and physics: For dosimetric accuracy and radiation safety.
• Design specifications and calculations: Expected dose distributions and leakage levels based on the new 25-source configuration.
• Regulatory standards: NRC requirements and international standards like IEC 60601-2-11 for radiation safety and performance.

8. The sample size for the training set

Not applicable. This 510(k) submission describes a physical hardware modification and associated software verification. It does not mention any machine learning or AI components that would require a "training set" in the conventional sense for a diagnostic device.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for machine learning or AI models. The verification and validation were based on engineering tests and compliance with established physical and regulatory standards.

Ask a specific question about this device

GammaPod™ is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.

The GammaPod™ is a teletherapy device that uses rotating, multi-source Cobalt-60 gamma-ray emitting sources to noninvasively deliver a focal dose of radiation to a partial volume of a human breast of a patient in the prone position while sparing the surrounding normal tissues and structures.

The GammaPod system contains 4 main components:

• GammaPod irradiation unit.
• Imager loader system.
• Breast immobilization system.
• Treatment planning system.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the GammaPod™ (K172706) primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing quantitative acceptance criteria and then directly reporting device performance against those criteria in a tabular format.

However, based on the non-clinical and clinical tests described, we can infer some "acceptance criteria" through the lens of safety and effectiveness as compared to regulatory standards and the predicate device.

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

• Sample Size for Clinical Test Set: 17 patients.
• Data Provenance: The study was a prospective Phase I clinical trial conducted under FDA-approved IDE No. G120054. The country of origin is not explicitly stated, but given the FDA approval and US company, it's highly likely to be within the United States.

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

The document does not provide details on the number or qualifications of experts used to establish "ground truth" for the clinical test set in terms of diagnosing or interpreting outcomes. The clinical study focused on the device's ability to safely and accurately deliver radiation doses as intended, presumably against a prescribed treatment plan developed by qualified medical professionals (e.g., radiation oncologists, medical physicists), but those roles are not detailed as "experts establishing ground truth" in the context of the study's primary outcomes.

For dosimetric accuracy, the "ground truth" would be established by physical measurements and calculations performed by medical physicists, verified against established standards (e.g., IEC 60601-2-11) and the device's treatment planning system.

4. Adjudication Method for the Test Set

The document makes no mention of an adjudication method (like 2+1, 3+1, or none) for the clinical test set. The clinical study, being a Phase I trial, focused on feasibility, safety, and dosimetric accuracy, which usually involves direct measurement and clinical assessment rather than consensus interpretation of diagnostic images.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this device. The GammaPod is a treatment delivery device, not an imaging device requiring human interpretation of output. Therefore, a study comparing human readers with and without AI assistance is not applicable here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The primary performance assessment for the GammaPod involves the overall system's ability to safely and accurately deliver radiation. This is inherently a "standalone" performance assessment for the device as a treatment delivery system. The treatment planning software component within the GammaPod system would have undergone standalone verification and validation (V&V) to ensure its algorithms calculate doses correctly, optimize trajectories, and perform image registration accurately without human intervention in the calculation itself. The document mentions:

• "Verification and validation of the control system software and treatment planning system software were conducted in house in accordance to the established Verification and Validation (V&V) Protocols within FDA Software Validation guidance."
• "Ensuring accurate dose calculation of the optimized plan and providing dosimetric indices for review."

These indicate a standalone assessment of the algorithmic components.

7. The Type of Ground Truth Used

For the clinical study:

• Feasibility: Likely determined by the ability to successfully plan and initiate treatment in each patient.
• Safety: Assessed through the monitoring of adverse events and the ability to keep radiation dose to surrounding tissues/organs within pre-defined limits.
• Dosimetric accuracy: This "ground truth" is derived from physical measurements (e.g., using dosimeters) and calculations against the prescribed treatment plan, ensuring the delivered dose matches the intended dose.

For non-clinical tests:

• Radiation safety/leakage: Ground truth established by regulatory standards (IEC 60601-2-11, NCRP Report #102) and direct measurement using calibrated equipment.
• Mechanical/Electrical Safety, EMC, Biocompatibility: Ground truth established by adherence to relevant international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993) and verified by accredited testing laboratories performing specific tests.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI algorithm development. The GammaPod is a radiation delivery device, and its design and performance verification follow engineering and physics principles, not typically a machine learning paradigm that relies on labeled training data in the same way. Software verification and validation (V&V) ensures the algorithms perform as expected, but this is distinct from "training" an AI model.

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

As no "training set" as understood in AI/ML contexts is relevant to this device's regulatory submission, the method for establishing its ground truth is not applicable or described. The accuracy of the treatment planning system's calculations would be verified against established physics models and experimentally validated dose distributions, rather than being "trained" on a dataset with pre-established ground truth.

Ask a specific question about this device