(79 days)
The BRAVOS Afterloader System is intended for use in the treatment of both benign and malignant disease or other conditions, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.
The Transfer Guide Tubes are intended to connect between the BRAVOS Remote Afterloader system and its range of Applicators. This connection creates a conduit for the source cable to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site.
The Length Assessment Device is intended to allow the user to establish an approximate length channel prior to the afterloader performing definitive length verification.
BRAVOS Afterloader System: The BRAVOS Afterloader System is a computer controlled remote electro/mechanical system used for automatically placing a cable incorporating an irradiated iridium pellet (sealed source) internally or close by a malignant tumor or tumor bed in a practice known as Brachytherapy.
Transfer Guide Tubes (TGT): Transfer Guide Tubes (TGT) are Brachytherapy applicator accessories. They are designed to provide a path for the dummy and source cable from the BRAVOS Afterloader System to the Applicator. The applicator end of a Transfer Guide Tube can vary in design to accommodate a range of Applicators.
Length Assessment Device (LAD): The Length Assessment Device (LAD) is a Brachytherapy applicator accessory and is used to determine the approximate length of the inner lumen of the Transfer Guide Tubes (TGT) and applicator assembly.
The provided document is a 510(k) Premarket Notification Summary for the Varian BRAVOS Afterloader Family. It focuses on establishing substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria in a detailed study.
Therefore, much of the requested information (like specific acceptance criteria values, reported performance, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for training) is not present in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document states that "Verification testing was performed to demonstrate that the performance and functionality of the new BRAVOS Afterloader Family met the initial design input requirements. Verification testing was performed to verify the integrity of any changes. Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel."
It also states, "The non-clinical data for BRAVOS Afterloader Family supports the safety of the devices and the software verification and validation demonstrate that the subject devices should perform as intended in the specified use conditions."
The document does not provide a specific table of acceptance criteria or quantitative performance metrics. Instead, it broadly states that the device met "initial design input requirements" and that "performance and functionality" were verified. The acceptance criteria for a device like this would likely be related to safety and functionality, such as:
| Acceptance Criterion (Inferred from documentation) | Reported Device Performance (Inferred from documentation) |
|---|---|
| Meets design input requirements | Performance and functionality met initial design input requirements. |
| Verification of changes integrity | Verification testing performed to verify integrity of changes. |
| Clinically representative validation | Validation testing performed on production equivalent devices under clinically representative conditions. |
| Safety of devices | Non-clinical data supports the safety of the devices. |
| Software performs as intended | Software verification and validation demonstrate anticipated performance. |
| Substantial Equivalence to Predicate | Concluded to be safe, effective, and substantially equivalent to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document only mentions "production equivalent devices" being used for validation testing.
- Data Provenance: Not specified. The document does not indicate the country of origin or whether the data was retrospective or prospective. It does state that "No animal studies or clinical tests have been included in this pre-market submission," implying that the testing was likely bench or lab-based.
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 specified. The document mentions "qualified personnel" performing validation testing, but does not provide details on their number or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified.
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 (BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device) is a standalone medical device used for brachytherapy, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the performance of the device itself (BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device) and its software. The testing performed ("Verification testing" and "Validation testing") is essentially assessing the standalone performance of the device without explicit human-in-the-loop as a variable in the performance assessment, beyond operators running the tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not explicitly stated. Given that the testing involved "initial design input requirements" and "clinically representative conditions," the "ground truth" for verification and validation would likely be defined by engineering specifications, physical measurements, and expected functional output as determined by design documents and industry standards for brachytherapy devices.
8. The sample size for the training set:
Not applicable / Not specified. This device is described as a "computer controlled remote electro/mechanical system" and related accessories. While it has "console software," the document does not suggest it is an AI/ML device that requires a distinct "training set" in the conventional sense of machine learning. The term "training set" is usually associated with AI models that are trained on data. This documentation describes typical software verification and validation for a medical device.
9. How the ground truth for the training set was established:
Not applicable. (See point 8)
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.