(224 days)
The Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) 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 Extremity Compartment Monitor and Fluid Collection System (ECM-III) 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. The Introducer provides an access to the targeted muscle 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 Extremity Compartment Monitor and Fluid Collection System (ECM-III) provides a means of displaying the intracompartmental pressure.
The provided document is a 510(k) summary for the Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III). It describes the device, its intended use, and its substantial equivalence to a predicate device (Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)).
However, the document does not provide specific acceptance criteria in a quantitative format, nor does it detail a study that proves the device meets such criteria in terms of clinical performance or diagnostic accuracy. Instead, the performance data section focuses on verification and validation activities related to safety standards rather than clinical efficacy.
Therefore, many of the requested bullet points cannot be answered based on the information provided in this 510(k) summary.
Here's a breakdown of what can and cannot be extracted:
1. Table of acceptance criteria and the reported device performance:
The document states: "A risk assessment was conducted which covered (1) all aspects of the possible effects on the safety and effectiveness of the modified device, (b) described each device modification under consideration, (c) the verification and validation activities with acceptance criteria, (d) scientific justification for each activity and (e) acceptance criteria."
However, it then only lists the types of testing performed (ASTM 4169-09, electrical safety IEC 60601-1, EMC Emissions and Immunity IEC 60601-1-2) and concludes: "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."
It does not explicitly state the quantitative acceptance criteria for device performance (e.g., accuracy, precision) related to its intended use (measurement of intracompartmental pressures) or the reported numerical performance outcomes against those criteria. It only implies that the device conforms to safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not available in this document. The listed tests are engineering/safety compliance tests, not clinical performance studies with patient data.
3. 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. No clinical expert-driven ground truth establishment is mentioned for this type of device (a pressure monitor).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 measurement tool, not an AI-assisted diagnostic imaging system requiring reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device for direct measurement, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For device performance in terms of pressure measurement accuracy, the "ground truth" would typically come from calibrated reference instruments. The document implies such testing was part of the "verification and validation activities with acceptance criteria," but it does not detail the specifics of how this ground truth was established or what values were considered 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.
In summary:
This 510(k) document primarily addresses the safety and the claim of substantial equivalence to a predicate device based on similar technological characteristics and performance attributes (like "Monitoring Pressure Electrical Safety Vacuum Source Principles of operation"). It describes engineering and safety compliance testing, but it does not provide the kind of detailed clinical performance acceptance criteria, study data, or ground truth methodologies that would typically be found for diagnostic devices involving human interpretation or complex algorithms.
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