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510(k) Data Aggregation
(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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