(83 days)
The Protura Couch Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, Linac safeguard systems, and/or image guidance systems and the Protura Couch. The Protura Couch Software is also capable of operating the Protura Couch (6 Degree Axis Couch).
The proposed device, the Protura Couch Software 1.3.0 (Part No. MT6XSM1.3.0), is patient positioning software used in radiation treatments in conjunction with an Image Guided Radiation Therapy (IGRT) system. The Protura Couch Software interfaces with the Couch Hardware (K031866) and is intended to position the patient after diagnostic decisions have been made based on results from an IGRT system. The Protura Couch Software allows the user to control patient positioning with six degrees of freedom from outside of the treatment room. The Protura Couch Software also includes the ability to interface with record and verify systems, Linac software systems, Linac safeguard systems, and/or image guidance systems.
The provided document is a 510(k) summary for the Protura Couch Software 1.3.0, a patient positioning software used in radiation treatments. It states that non-clinical performance testing was conducted, but no clinical testing was performed. Therefore, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance based on a study, nor does it provide details about patient data, expert reviews, or comparative effectiveness studies.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists "Non-Clinical Performance Data" areas tested and states "All testing confirmed that the Protura Couch Software 1.3.0 is safe and effective for its intended use." However, it does not provide specific acceptance criteria (e.g., numerical thresholds, error limits) or quantitative results of the device's performance against such criteria.
| Acceptance Criterion (Inferred from testing areas) | Reported Device Performance (General Statement) |
|---|---|
| Movement of the Protura Couch | Confirmed safe and effective |
| Interfacing with External Systems | Confirmed safe and effective |
| Couch Pedestal and Isocenter Alignment | Confirmed safe and effective |
| Patient Record Handling | Confirmed safe and effective |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. No clinical testing with patient data was performed. The testing described is non-clinical performance testing of the software and hardware interfaces.
- Data Provenance: Not applicable, as no patient data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. No clinical testing or expert review of patient data was conducted.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No clinical testing or expert review requiring adjudication was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No. The document explicitly states: "No clinical testing was performed in the evaluation of this medical device." Therefore, no MRMC study, human reader improvement analysis, or AI assistance effect size was reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The non-clinical performance testing focused on the device's functionality, interfacing, and mechanical aspects. While this could be considered a form of "standalone" testing for the software's operational characteristics, it's not in the context of diagnostic or interpretive performance where "standalone" typically refers to an AI algorithm's accuracy in analysis without human input. The document describes testing of the software's technical operation (e.g., couch movement, interfacing), not its interpretation of data.
7. The Type of Ground Truth Used:
- Ground Truth: For the non-clinical performance tests, the "ground truth" would have been established by engineering specifications, calibration standards, and expected operational parameters for the couch movement, interface communication, and alignment accuracy. For example, for "Movement of the Protura Couch," the ground truth would be the programmed movement patterns and expected physical responses of the couch hardware. For "Couch Pedestal and Isocenter Alignment," it would be the precise physical alignment specifications.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. This device is software that controls a medical device (a radiation therapy couch). It is not an AI/ML algorithm that requires a training set in the typical sense (i.e., for learning from data to perform a diagnostic or predictive task). The software is programmed based on engineering principles and specifications, not trained on a dataset of patient cases.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device. The software functions based on its coded logic and interface protocols, not on learned patterns from a dataset.
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.