(67 days)
The Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II) is intended for the immediate or continuous measurement of intracompartmental pressures and/or the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome.
The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System (CMS-II) consists of four major components; an Introducer, a Pressure Monitoring and Fluid Collection (PMFC) Catheter, a Fluid Collection (FC) Catheter, and a Compartment Pressure Monitor. The Introducer consists of tear-away plastic sheath placed over a stainless steel trocar. compartment to facilitate the placement of the indwelling Pressure Monitoring Fluid Collection / Fluid Collection catheter. The indwelling Catheter is designed to monitor intramuscular compartment pressure as well as provide a means to sample interstitial fluid for laboratory analysis. The indwelling Catheter is designed for use up to 24 hours. The Twin Star Compartment Pressure Monitoring provides a means of displaying the intracompartmental pressure.
The provided text describes a 510(k) summary for the Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II). This document focuses on demonstrating substantial equivalence to predicate devices through performance testing rather than establishing acceptance criteria and detailed study results for a novel AI device.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text, as these are typically part of studies for novel devices or AI algorithms.
However, based on the text, I can infer the following:
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A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific reported device performance metrics like accuracy, sensitivity, or specificity. Instead, it indicates that "Bench testing was performed to support a determination of substantial equivalence and consisted of biocompatibility, electrical safety testing and design verification. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."The performance attributes considered for substantial equivalence are:
- Monitoring Pressure
- Fluid Collection
- Membrane Diameter
- Single Patient Use
- Pressure Sensor Location
- Electrical Safety
- Vacuum Source
- Principles of operation
While these are attributes, they are not presented as quantitative acceptance criteria with corresponding performance results.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not specified. The document only mentions "Bench testing" which implies laboratory-based tests rather than clinical data from a "test set" in the context of an AI study. -
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):
Not applicable. The device's performance was evaluated through bench testing and design verification, not against expert-established ground truth from a test set of patient data. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable (see point 3). -
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 study was not done. This device is a physical medical device (pressure monitor and catheter system), not an AI algorithm designed to assist human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device, not an algorithm. Its "standalone" performance would be its inherent accuracy and reliability as a physical instrument, which would have been assessed during the "bench testing" and "design verification." However, specific metrics are not provided. -
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable in the context of clinical "ground truth" as might be used for an AI algorithm. For this device, the "ground truth" would be established by validated measurement standards and known physical properties during bench testing (e.g., a known pressure applied to calibrate the monitor, known fluid volumes). -
The sample size for the training set:
Not applicable. This is not an AI algorithm with a training set. -
How the ground truth for the training set was established:
Not applicable. This is not an AI algorithm with a training set.
Summary of the study and its purpose:
The document describes a submission for 510(k) clearance for the Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II). The purpose of the study (bench testing, design verification, and risk analysis) was to demonstrate substantial equivalence to previously cleared predicate devices, thereby ensuring the safety and effectiveness of the new device for its intended use (immediate or continuous measurement of intracompartmental pressures and/or fluid withdrawal for analysis to aid in the diagnosis of compartment syndrome). The studies performed confirmed biocompatibility, electrical safety, and overall system operation, but specific performance metrics are not detailed in this summary.
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