(30 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: 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.
| Acceptance Criteria (Demonstration of Substantial Equivalence and Safety/Performance) | Reported Device Performance |
|---|---|
| Intended Use: Same as the predicate device. | The modified GammaPod has the same intended use: noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment. |
| Operating Principle: Same as the predicate device. | Uses the same radioisotope (Cobalt 60) and applies the same operating principle (rotating, multi-source gamma-ray emitting sources for focal radiation delivery). |
| Technical Characteristics: Maintain similarity to predicate despite modification. | The modification involved reducing Cobalt 60 sources from 36 to 25. This change was based on dosimetric evaluation to deliver a nearly identical target volume dose while reducing incidental radiation to the heart. The modification impacts the Irradiation Unit and Treatment Planning System inputs, but not the control system software, imager loader, or breast immobilization systems. |
| Performance Specifications: Meet the same performance specifications. | No new or different issues of safety or effectiveness are raised. The device reportedly generates treatment plans of equivalent quality to the unmodified predicate. |
| Compliance with Regulations and Standards: Adherence to relevant standards. | The modified GammaPod meets the same sets of regulations and standards as the predicate device (e.g., IEC 60601-1, IEC 60601-2-11, IEC 62083, ISO 14971). |
| Treatment Planning System (TPS) Accuracy: Verified for new configuration. | Testing of the treatment planning system software was conducted to verify accuracy of treatment plans based on the 25-source configuration. |
| Radiation Safety and Dosimetric Accuracy: Compliance with safety requirements. | Radiation tests (including safety measures and dosimetric accuracy) were conducted to demonstrate compliance with NRC requirements and IEC 60601-2-11. The measured radiation leakage profile remains far below recommended levels of IEC 60601-2-11 and NCRP Report #102. |
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.
§ 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.