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510(k) Data Aggregation
(312 days)
The BRDSS-C is indicated for use in the care of adult patients and adolescent patients 17 years of age or older who weigh 40kg (88lbs) or more with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for fluid recommendations. The BRDSS-C is intended to be initiated within 24 hours of the burn incident and completed by 72 hours post burn. The BRDSS-C is not indicated for use in patients who are less than 17 years of age.
The Burn Resuscitation Decision Support System – Clinical (BRDSS-C) is a burn decision support software application for assisting healthcare professionals in managing fluid resuscitation of burn patients during the initial 24 - 72 hours post burn. The system provides hourly (or half-hour) fluid calculations and recommendations for patients with 20% or greater Total Body Surface Area (TBSA) burn injuries, in addition to providing users with a graphical user interface to display volume status, Intake and Output (I/O) volumes, and other relevant fluid balance information.
The provided document is a 510(k) premarket notification for the Burn Resuscitation Decision Support System - Clinical (BRDSS-C), v. 1.0. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results and acceptance criteria as would be found in a clinical trial report.
Therefore, the information requested regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not fully available within the provided text.
However, I can extract the available information and point out what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. Instead, it demonstrates validation against software requirements and usability, and establishes substantial equivalence to a predicate device.
| Acceptance Criteria (based on software requirements & usability) | Reported Device Performance |
|---|---|
| Data intake validation | Passed |
| User warnings, alerts, and messages | Passed |
| User interface requirements | Passed |
| Functional requirements | Passed |
| Error handling requirements | Passed |
| Human factors usability requirements | Compliant with human factors usability requirements (demonstrated by a human factors study) |
| Software verification and validation | Passed (based on FDA's Quality System Regulation requirements under 21 CFR Part 820) |
| Clinical user validation | Passed (based on FDA's Quality System Regulation requirements under 21 CFR Part 820) |
| Intended Use & Technical Features Equivalence | Substantially equivalent to the predicate device (BRDSS - Burn Navigator) in terms of intended use and technical features; any differences do not raise new safety and effectiveness questions. |
Missing Information for this section: Specific quantitative thresholds for "passing" or "compliance" with software and usability requirements are not detailed. Performance metrics related to fluid calculation accuracy or clinical outcomes are also not provided.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "software verification and validation as well as clinical user validation" and a "human factors study." However, it does not specify the sample size for any test sets used in these validations or for the human factors study.
It also does not specify the data provenance (e.g., country of origin, retrospective/prospective) for any data used in these validation efforts.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not describe the establishment of a "ground truth" for a specific test set in the context of clinical performance, as it is a fluid resuscitation calculator and relies on an established algorithm.
For the "clinical user validation," it implies that burn care professionals were involved, but does not specify the number of experts or their qualifications used to evaluate the device. The device is "intended for use by healthcare professionals with burn care experience," suggesting that these individuals, or similar ones, would have been involved in the validation.
4. Adjudication Method for the Test Set:
Given that the document does not describe a clinical test set requiring ground truth, no adjudication method is mentioned or implied. The validation focuses on software functionality, usability, and equivalence to a predicate device running the same core algorithm.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The device is a "decision support system" providing fluid recommendations, not an imaging analysis tool typically associated with MRMC studies. The focus is on the algorithm's calculation and the software's usability and safety, not on how human readers' performance improves with or without AI assistance in interpretation.
6. Standalone Performance Study:
The document describes the BRDSS-C as a "fluid resuscitation calculator for fluid recommendations" and a "burn decision support software application." Its validation is described as: "The BRDSS-C has passed software verification and validation as well as clinical user validation based on the FDA's Quality System Regulation requirements under 21 CFR Part 820."
This indicates that its performance as a standalone algorithm (without human intervention in its core calculation logic) was indeed evaluated through software verification and validation testing. However, specific quantifiable metrics of this standalone performance (e.g., accuracy of fluid recommendations against a gold standard in a clinical dataset) are not provided in this summary. The evaluation focuses on whether the software correctly implements its algorithm and meets its functional and usability requirements.
7. Type of Ground Truth Used:
For the core function of the device (fluid calculations), the "ground truth" is inherently the mathematical output of the underlying burn decision support algorithm, which is the same as that used in the predicate device. The validation confirms that the software correctly implements this algorithm and provides accurate calculations based on the input.
For software validation, the "ground truth" would be the defined software requirements and specifications. For human factors validation, it would be usability standards and successful task completion by representative users. Clinical outcomes data are not mentioned as a ground truth for the device's validation in this document.
8. Sample Size for the Training Set:
The BRDSS-C uses the same burn decision support algorithm as the predicate device (BRDSS - Burn Navigator). This existing algorithm would have been developed and "trained" (in a broader sense, meaning its parameters and logic established) prior to the development of the BRDSS-C.
The document does not specify a sample size for a training set used to develop or re-train the algorithm for BRDSS-C, as it states the algorithm itself is the same.
9. How the Ground Truth for the Training Set Was Established:
Since BRDSS-C utilizes an existing algorithm from its predicate, the document does not describe how a "ground truth" for a new "training set" was established for the BRDSS-C specifically.
The original algorithm (used by both BRDSS and BRDSS-C) would have been developed based on medical knowledge, clinical guidelines for burn fluid resuscitation (e.g., Parkland formula variations), and potentially validated against historical patient data or expert consensus in its initial inception. However, this information is not detailed in the provided 510(k) summary for BRDSS-C.
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(317 days)
The Burn Resuscitation Decision Support System (BRDSS) is indicated for use in the care of adult patients with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for hourly fluid recommendations. The BRDSS is intended to be initiated within 24 hours of the burn incident and ending by 72 hours post burn.
The BRDSS is a fluid calculator for use in the care of seriously burned patients. It is used to calculate the next dose of fluid for patients.
Device: Burn Resuscitation Decision Support System (BRDSS)
The provided documentation is a 510(k) summary for the Burn Resuscitation Decision Support System (BRDSS). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a dedicated study proving performance against those criteria, or the methodology for establishing ground truth or training a model.
Therefore, I can only extract limited information based on the available text.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria as a quantitative threshold or target. Instead, it states that the BRDSS "has passed product verification as well as clinical user validation." This implies that the device successfully met internal testing standards and was deemed acceptable by clinical users, but the specific metrics are not disclosed.
The "performance" described relates to its functionality and human factors, rather than a formal assessment of accuracy against a gold standard for fluid resuscitation recommendations.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from "Non-Clinical Data") |
|---|---|
| Hardware Requirements Met | Adheres to hardware requirements (e.g., form factor, power requirements). |
| Software Requirements Met | Adheres to software requirements (e.g., data input validation, user warnings, alerts and messages, user interface requirements, functional requirements, error handling requirements). Includes many human factors best practices for the software user interface. |
| Product Verification | Passed product verification. (Specific tests and metrics not detailed) |
| Clinical User Validation | Passed clinical user validation. (Specific methodology, number of users, and outcomes not detailed) |
| Warnings for Fluid Rate Deviation | Warnings are presented when the primary fluid rate recommendation is +/- 25% (and +/- 200mL/hr) from the current primary fluid rate dose. (This is a design feature, not an external acceptance criterion against a gold standard.) |
| Ability to Calculate Hourly Fluid Recommendations | The device is a "fluid resuscitation calculator for hourly fluid recommendations." (The accuracy of these recommendations against a medical gold standard is not explicitly detailed as part of the acceptance criteria beyond general "verification" and "validation.") |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide a specific sample size for a test set or details about data provenance (e.g., country of origin, retrospective/prospective). The statement "passed product verification as well as clinical user validation" suggests some form of testing, but the nature of this testing (clinical data-based evaluation vs. software testing) and its dataset characteristics are not described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a ground truth for a test set. The validation appears to be related to software functionality and user experience, rather than comparing the BRDSS's fluid recommendations against expert-determined optimal fluid recommendations for a cohort of patients.
4. Adjudication Method for the Test Set
Since no specific test set based on patient data for which a ground truth needed to be established is described, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention an MRMC comparative effectiveness study. The BRDSS is a "decision support system" or "calculator," which implies it provides recommendations based on predefined algorithms rather than interpreting complex medical images or data that typically require multiple human readers. Its primary predicate device is also a "next-dose calculator." Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable or relevant for this type of device based on the information provided.
6. Standalone (Algorithm Only) Performance Study
The document states, "The BRDSS has passed product verification as well as clinical user validation." This implies that the algorithm's performance (i.e., its ability to correctly calculate fluid recommendations based on its internal logic and inputs) was tested. However, the exact details of this standalone performance, such as accuracy metrics or comparison against a gold standard for fluid resuscitation outcomes, are not provided. The "Non-Clinical Data" section focuses on hardware, software, and human factors requirements, suggesting internal functional testing.
7. Type of Ground Truth Used
Given the nature of the device as a "fluid resuscitation calculator," the "ground truth" would ideally be expert consensus on optimal fluid calculations or actual patient outcomes related to fluid management. However, the document does not specify what type of ground truth was used during its "product verification" or "clinical user validation." It is most likely that the "ground truth" for verification involved comparing the BRDSS's calculated fluid recommendations against a pre-defined, accepted medical formula or protocol for burn resuscitation (e.g., Parkland formula variations), rather than actual patient outcomes or a panel of experts retrospectively determining the "correct" dose for each case.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. The BRDSS appears to be a rule-based calculator rather than a machine learning model that requires a distinct training phase. Its operation is based on established medical formulas for fluid resuscitation in burn patients.
9. How the Ground Truth for the Training Set Was Established
As the device appears to be a rule-based system and does not mention a training set, there is no information on how a ground truth for a training set was established.
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