(191 days)
The Bard® Intra-abdominal Pressure (IAP) Monitoring Device is intended for the monitoring of intra-abdominal pressure via a Foley urinary catheter. The measured pressures can be used as an aid in the diagnosis of intraabdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS).
The Bard® Intra-abdominal Pressure (IAP) Monitoring Device) is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which intra-abdominal pressure is measured.
The provided text is a 510(k) summary for the Bard® Intra-abdominal Pressure Monitoring Device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document states: "The results of bench and biocompatibility testing demonstrated that the functionality, integrity, and safety of the Bard IAP Device is adequate for its intended use and support a determination of substantial equivalence." However, it does not provide specific acceptance criteria values, reported performance metrics, or details about the studies themselves (e.g., sample size, data provenance, ground truth, expert qualifications, adjudication methods, or specific comparative effectiveness results).
Therefore, I can only partially fulfill your request based on the information provided.
Here's an analysis of the provided text in relation to your questions:
1. Table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria and reported device performance values are not explicitly stated. The general statement is given under "Summary of performance data":
| Acceptance Criteria (Explicitly stated) | Reported Device Performance (Explicitly stated) |
|---|---|
| Functionality is adequate for intended use | Functionality demonstrated to be adequate for intended use |
| Integrity is adequate for intended use | Integrity demonstrated to be adequate for intended use |
| Safety is adequate for intended use | Safety demonstrated to be adequate for intended use |
| Supports a determination of substantial equivalence | Supports a determination of substantial equivalence |
Note: This table reflects the general claims made in the summary. It does not provide quantitative metrics or specific pass/fail thresholds that would typically be found in detailed study reports.
2. Sample size used for the test set and the data provenance
Not specified in the provided text. The document only mentions "bench and biocompatibility testing" without detailing the sample sizes (e.g., number of devices tested, number of measurements taken) or the provenance of any data (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. The provided summary mentions "bench and biocompatibility testing." This type of testing typically involves engineering or laboratory measurements against established standards, not necessarily human expert-established ground truth in the way it might apply to diagnostic imaging or clinical assessment devices. No experts are mentioned in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not specified. As the testing described is "bench and biocompatibility," an adjudication method for a test set (presumably clinical or image-based) is not relevant or 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
No, an MRMC comparative effectiveness study was not done. This device is a measurement tool (an intra-abdominal pressure monitoring device), not an AI-powered diagnostic or interpretive system that would involve human readers or AI assistance in that context. The summary describes "bench and biocompatibility testing" for the device's physical and functional attributes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system. It is a physical medical device for measuring pressure. The performance evaluated would be the direct measurement capabilities of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For "bench testing," the ground truth would typically be established by controlled experimental conditions or calibrated reference standards. For example, pressure measurements would be compared against a known, precise pressure source. For "biocompatibility testing," the ground truth would be established by standardized laboratory assays and adherence to relevant ISO standards (e.g., ISO 10993 series) to assess material safety. The document does not provide details on these specific ground truths.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML device that requires a training set and established ground truth in that context.
In summary, the provided 510(k) pertains to a physical medical device for pressure monitoring and focuses on establishing substantial equivalence through bench and biocompatibility testing. It lacks the detailed quantitative performance metrics, study designs, and human-expert-related information that would be typical for AI/ML-based diagnostic devices.
N/A