(60 days)
The Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor) is intended for the measurement and monitoring of intracompartmental pressures and the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The CMS Monitor is intended to be used in conjunction with the Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter (CMS Catheter).
The Twin Star Compartment Pressure Monitoring and Fluid Collection (CMS) Monitor displays and records pressure as measured by the Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter (CMS Catheter). The Twin Star CMS Catheter has been previously cleared by 510k notification. The multi-task CSM Monitor consists of a single housing unit that incorporates a vacuum pump, an infusion pump and a pressure monitor with visual display and user interface. The CMS Monitor provides the necessary functions required by the CMS Catheter. In addition to monitoring pressure, the CMS Monitor provides a very low volume fluid infusion to maintain the CMS Catheter's pressure lumen patency and a vacuum to the second lumen for fluid collection; both infusion and vacuum are required for the functional operation of the CMS Catheter.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document is a 510(k) summary for a medical device (Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor) seeking substantial equivalence to predicate devices. It does not explicitly state specific numerical acceptance criteria (e.g., within 5% accuracy of predicate). Instead, it relies on demonstrating "substantial equivalence" through performance testing against predicate devices.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Pressure Measurement | Substantially equivalent to Stryker Intracompartmental Syndrome Pressure Monitor System. | "Statistically proven that the performance of the Twin Star CMS Monitor was substantially equivalent to the performance of the predicate devices." |
| Infusion Capabilities | Substantially equivalent to Stryker Intracompartmental Syndrome Pressure Monitor System (for maintaining catheter patency). | "Statistically proven that the performance of the Twin Star CMS Monitor was substantially equivalent to the performance of the predicate devices." |
| Vacuum Capabilities | Substantially equivalent to Medela Median Vacuum Pump. | "Statistically proven that the performance of the Twin Star CMS Monitor was substantially equivalent to the performance of the predicate devices." |
2. Sample Size and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "Functional and performance testing."
3. Number of Experts and Qualifications:
The document does not mention the use of experts to establish ground truth or their qualifications. The performance testing described appears to be technical, comparing device against predicate devices, rather than clinical adjudication by experts.
4. Adjudication Method:
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for a test set. This type of adjudication is typically used in studies involving human interpretation of data, which is not the primary focus of this technical comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's technical performance compared to predicate devices, not on how human readers improve with or without AI assistance. The device in question is a monitoring device, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance:
The study described is a standalone performance test in the sense that the device's technical functions (pressure, infusion, vacuum) were evaluated directly against those of predicate devices. There is no mention of human-in-the-loop performance in this context, as it's a hardware monitoring device.
7. Type of Ground Truth Used:
The ground truth used in this submission appears to be the performance of the legally marketed predicate devices. The Twin Star CMS Monitor's performance in terms of pressure measurement, infusion, and vacuum capabilities was compared directly to that of the Stryker and Medela predicate devices.
8. Sample Size for the Training Set:
The concept of a "training set" is relevant for machine learning or AI-driven devices. Since this submission describes a hardware monitoring device without explicit AI involvement, there is no mention of a training set or its sample size.
9. How Ground Truth for Training Set Was Established:
As there is no mention of a training set, this information is not applicable and not provided.
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