(24 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.
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) 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.
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.
This document is a 510(k) Premarket Notification for the BRAVOS Afterloader Family. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device (K181903). The key takeaway relevant to acceptance criteria and performance studies is that this submission is for an updated version of an already cleared device, and the changes are primarily software-related with some minor hardware modifications. Crucially, the document states: "No animal studies or clinical tests have been included in this pre-market submission." Therefore, there is no direct study detailed here that "proves the device meets the acceptance criteria" in terms of clinical performance or human-in-the-loop improvements with AI, because this device is not an AI-assisted diagnostic tool but a brachytherapy afterloader.
The "acceptance criteria" discussed here are for demonstrating substantial equivalence to a predicate device, primarily through verification and validation of changes to an existing system, rather than proving novel clinical efficacy.
Given the information provided, I cannot fulfill all parts of your request as they pertain to AI-assisted diagnostic devices and clinical performance studies. However, I can extract the information relevant to this specific submission's approach to demonstrating device functionality and safety concerning its updates.
Here's a breakdown based on the provided text, focusing on how this submission addresses "acceptance criteria" in its context:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for an updated device, the "acceptance criteria" are implied to be that the updated system performs as intended, maintains safety, and remains substantially equivalent to the predicate. The "performance" reported is primarily that the updated system functions correctly and safely, particularly the software changes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| BRAVOS Afterloader System: | BRAVOS Afterloader System: |
| - Maintains same Intended Use and Indications for Use. | - "The subject device's indications for use and the intended use have not changed since the predicate submission." |
| - Similar Design and Technology. | - "Similar Design and Technology" |
| - Updated software (Jaguar v2.1) functions correctly. | - "Similar Jaguar Console Software (subject device updated to version 2.1)" |
- "Software verification and validation was conducted..."
- "Minor enhancements and bug fixes to improve loading large plans and dwell time values" |
| - Modified Emergency Drive Behavior functions safely. | - "Modified Emergency Drive Behavior" (No specific performance metric reported, but implies testing for safe operation). |
| - Firmware, Jaguar, and Service enhancements perform as intended. | - "Firmware: Minor enhancements and bug fixes for the connection to Service PC and loading Source Cable" - "Jaguar: ...Show patient picture on treatment reports"
- "Service: ...reduce parameters that are reset during source exchange and clarify names on sensor labels." |
| - Performance and functionality meet initial design input requirements. | - "Verification testing was performed to demonstrate that the performance and functionality of the updated BRAVOS Afterloader System meets the initial design input requirements." |
| - Integrity of changes verified. | - "Verification testing was performed to verify the integrity of any changes." |
| - Device functions correctly under clinically representative conditions. | - "Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel." |
| Overall: | Overall: |
| - Substantially equivalent to predicate (K181903). | - "Varian's BRAVOS Afterloader Family which consists of the updated BRAVOS Afterloader System is substantially equivalent to the predicate device (K181903)." - "Compared to the predicate device, the basic operation and technological characteristics are substantially the same."
- "The non-clinical data for the updated BRAVOS Afterloader System... supports the safety of the device and the software verification demonstrates that the subject device should perform as intended." |
| - Complies with relevant recognized standards (e.g., IEC 62304 for software). | - A list of 16 recognized standards (e.g., AAMI/ANSI 60601-1, IEC 62304) and one non-recognized standard (EN ISO 13485:2016) are listed with which the device conforms. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." Therefore, there isn't a "test set" in the sense of patient data for clinical performance evaluation. The "testing" refers to software verification and validation, as well as hardware verification of changes. The sample size for these engineering tests is not specified in the summary, and data provenance (country, retrospective/prospective) is not applicable as it's not a clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set with ground truth established by experts is mentioned, as the submission relies on engineering verification and validation for substantial equivalence with an existing device, not a new clinical claim requiring expert adjudication of data. Validation testing was performed by "qualified personnel," but their specific qualifications or number are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring ground truth adjudication is mentioned.
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 brachytherapy afterloader, not an AI-assisted diagnostic tool, and no clinical studies were performed for this particular submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The "algorithm" here is the control software for a physical device. Standalone performance would refer to whether the device's automated functions operate correctly, which is covered by the mentioned "software verification and validation" and "performance and functionality" testing. However, no specific metrics for "standalone performance" (e.g., source positioning accuracy, dose delivery precision) are detailed in this summary, beyond the general statement that it meets design input requirements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a software update to an existing medical device, the "ground truth" for the verification and validation involves confirming that the software's logic is correct, and the device performs according to its design specifications (e.g., source movement, safety interlocks, plan execution) which are derived from engineering requirements and previous clinical understanding of brachytherapy. It's not about clinical diagnostic ground truth.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device that requires a training set.
§ 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.