(85 days)
The Bravos Afterloader System is indicated 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 of an unknown 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 brachytherapy. The system automatically moves a stainless-steel cable incorporating a small, high activity Iridium-192 pellet in a steel capsule (sealed source) into applicator(s) or catheter(s) inserted into the patient close by a malignant tumor or tumor bed.
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 for the BRAVOS Afterloader Family, specifically focusing on an updated BRAVOS Afterloader System. This submission claims substantial equivalence to a previously cleared predicate device (K191580).
Here's an analysis of the acceptance criteria and supporting study information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a quantitative table with reported device performance. Instead, it focuses on demonstrating that the updated device is "substantially equivalent" to its predicate and that verification and validation testing confirms it meets "initial design input requirements."
| Acceptance Criteria Category | Reported Device Performance Summary (from text) |
|---|---|
| Overall Equivalence | "The non-clinical data for the updated BRAVOS Afterloader System from the BRAVOS Afterloader Family supports the safety of the device and the software verification and validation demonstrate that the subject device should perform as intended in the specified use conditions." |
| Software Performance | "Software verification and validation was conducted according to QSR §820.30 and ISO 13485;2016 design control requirements." |
| "The software for BRAVOS Afterloader System was determined to be a 'major' level of concern." | |
| "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." | |
| Design Integrity | "Verification testing was performed to demonstrate that the performance and functionality of the updated BRAVOS Afterloader System meets the initial design input requirements." |
| Technological Characteristics | "At a high level, the subject and predicate devices are based on the following similar technological elements: Same Intended Use and Indications for Use as Predicate device, Similar Design and Technology as Predicate device, Similar Jaguar Console Software (subject device updated to version 2.1)." |
| Safety and Effectiveness | "Varian considers the updated BRAVOS Afterloader System from the BRAVOS Afterloader Family to be as safe and effective as the predicate device and substantially equivalent to the predicate device." |
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 does not provide specific details on the sample size used for any test set or the data provenance. It mentions "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." However, the number of "changes" or "production equivalent devices" is not specified, nor is the origin of the data (e.g., country).
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)
The document does not specify any experts used to establish ground truth. The testing described appears to be technical verification and validation, rather than clinical evaluation against expert-defined ground truth. It states "Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel," but does not detail the nature or qualifications of these "qualified personnel" beyond their role in conducting validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method for a test set.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." This device is a remote-controlled radionuclide applicator system, and the submission focuses on demonstrating substantial equivalence through non-clinical performance and software verification/validation, not a human-in-the-loop study with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of the algorithm itself (e.g., specific accuracy metrics for an AI component) is not explicitly described. The "BRAVOS Control Software" is mentioned as having "new and modified risks plus risk control measures" and being updated to version 2.1. The software is deemed a "major" level of concern. Performance data is mentioned as "Software verification and validation was conducted..." and "Verification testing was performed to demonstrate that the performance and functionality of the updated BRAVOS Afterloader System meets the initial design input requirements." This suggests functional testing of the software within the system context, rather than a standalone performance evaluation of a specific algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly describe the type of "ground truth" in a clinical sense. The "ground truth" for the verification and validation appears to be the initial design input requirements and the expected functionality as part of the system's operation. No clinical ground truth (e.g., pathology, outcomes) is referenced for performance evaluation.
8. The sample size for the training set
The document does not mention any 'training set' or provide a sample size for it. This typically pertains to machine learning or AI models, which are not the primary focus of this submission (which emphasizes electromechanical system updates and software verification/validation for an existing device type).
9. How the ground truth for the training set was established
Since no training set is mentioned, information on how its ground truth was established is not provided.
§ 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.