(106 days)
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.
| Acceptance Criteria (Inferred from regulatory and predicate comparison) | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Radiation safety within recommended levels | Measured radiation leakage profile “far below the recommended levels of IEC 60601-2-11 and NCRP Report #102.” |
| Radiation dosimetric accuracy | "Radiation dosimetric accuracy tests were conducted to meet the requirements of the NRC and IEC 60601-2-11." (While specific values like "within X% of prescribed dose" aren't given, the statement implies successful meeting of these standards). |
| Mechanical safety and accuracy | "Tests for mechanical safety and mechanical accuracy were also conducted in house." (Results are not quantified but the conclusion is that the device met specifications). |
| Electrical safety (IEC 60601-1) | A certified laboratory certified compliance with IEC 60601-1:2012 Edition 3.1. |
| Electromagnetic compatibility (IEC 60601-1-2) | A certified laboratory showed that the GammaPod meets IEC 60601-1-2:2007 Edition 3.0. |
| Software Validation (V&V) | Verification and validation of the control system software and treatment planning system software were conducted in house in accordance with established V&V protocols within FDA Software Validation guidance. |
| Biocompatibility (ISO 10993) | Biocompatibility verified to the requirements of ISO 10993 for the breast cup and silicone flange by a certified laboratory. |
| Functional specifications | "Device performance was tested against a set of functional specifications in an environment that simulated...the actual operating environment." "Validation testing demonstrated that the device is as safe and effective as the predicate device." |
| Clinical feasibility, safety, and dosimetric accuracy | For 17 enrolled patients: "feasibility of using the GammaPod to deliver a focal dose of radiation to a partial volume of the breast while keeping the dose to other surrounding tissues and organs within specified limits was evaluated." And "the safety and dosimetric accuracy were also evaluated and the results demonstrated that the GammaPod system can safely deliver the prescribed doses as intended." |
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.
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.