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510(k) Data Aggregation
(62 days)
The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, and pyruvate levels and is intended as an adjunct monitor of trends in these parameters indicating the perfusion status of cerebral tissue local to catheter placement. Because the CMA System values are relative within an individual, these should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern.
The CMA Cerebral Tissue Monitoring System utilizes the principles of "microdialysis," to monitor biochemical markers of ischemia in the brain. The system consists of the following components: CMA 70 Brain Microdialysis Catheters, CMA 106 Pump and Syringe, Perfusion Fluid CNS, Microvials and Microvial Racks, ISCUS Clinical Microdialysis Analyzer or CMA 600 Microdialysis Analyzer and software, Reagents (lactate, pyruvate, glucose), Control Samples, Rinsing Fluid, Calibrator A. The CMA 70 Brain Microdialysis Catheter mimics the function of a blood capillary. Molecules in the interstitial fluid diffuse over the sterile, semi-permeable dialysis membrane of the catheter into the Perfusion Fluid, which is pumped by the CMA 106 Microdialysis Pump. The Perfusion Fluid equilibrates with the surrounding interstitial fluid and is collected in microvials at the outlet of the catheter. The microvials are changed regularly by the appropriate hospital staff and brought to the Microdialysis Analyzer (CMA 600 or ISCUS). The dialysate is analyzed for the concentrations of glucose, lactate and pyruvate, which are well-known markers of tissue ischemia. The data are displayed as trend curves on the screen of the analyzer showing the local changes in the hypoxic/ischemic state of the brain tissue.
The provided text is a 510(k) summary for the CMA Cerebral Tissue Monitoring System. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor details about training or test sets, ground truth establishment, or expert involvement.
The document states that the functionality for the CMA Cerebral Tissue Monitoring System with ISCUS is equivalent to its predicate device CMA 600 Cerebral Tissue Monitoring System (K020285) in safety and effectiveness. This implies that the current device is being cleared based on its substantial equivalence to a previously cleared device, rather than through a new clinical study demonstrating its performance against specific acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The information needed for those sections is not present in the 510(k) summary.
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(268 days)
The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, and pyruvate levels and is intended as an adjunct monitor of trends in these parameters indicating the perfusion status of cerebral tissue local to catheter placement. Because the CMA System values are relative within an individual, these should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern.
The CMA Cerebral Tissue Monitoring System utilizes the principles of "microdialysis," to monitor biochemical markers of ischemia in the brain. The system consists of the following components:
- CMA 70 Brain Microdialysis Catheters .
- CMA 106 Pump and Syringe .
- Perfusion Fluid CNS .
- Microvials and Microvial Racks .
- CMA 600 Microdialysis Analyser and software .
- Reagents (lactate, pyruvate, glucose) .
- Control Samples .
- Rinsing Fluid .
- . Calibrator A
The CMA 70 Brain Microdialysis Catheter mimics the function of a blood capillary. Molecules in the interstitial fluid diffuse over the sterile, semipermeable dialysis membrane of the catheter into the Perfusion Fluid, which is pumped by the CMA 106 Microdialysis Pump. The Perfusion Fluid equilibrates with the surrounding interstitial fluid and is collected in microvials at the outlet of the catheter. The microvials are changed regularly by the appropriate hospital staff and brought to the CMA 600 Microdialysis Analyser. The dialysate is analyzed for the concentrations of glucose, lactate and pyruvate, which are well-known markers of tissue ischemia. The data are displayed as trend curves on the screen of the CMA 600 showing the local changes in the hypoxic/ischemic state of the brain tissue.
The provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets these criteria, or a table of acceptance criteria and reported device performance. It is a 510(k) summary for the CMA Cerebral Tissue Monitoring System, primarily focusing on its intended use, device description, and substantial equivalence to predicate devices.
However, based on the nature of the device and the content provided, we can infer some general information and highlight what is not present in the document.
Inferred Information:
The "acceptance criteria" for this type of device (a Class II intracranial pressure monitoring device) would typically relate to:
- Accuracy and Precision: The ability of the device to accurately measure glucose, lactate, and pyruvate levels in the microdialysate with a certain level of precision.
- Stability: The stability of the measurements over time.
- Repeatability: The consistency of measurements when repeated under the same conditions.
- Interference: The lack of significant interference from other substances that might be present in the microdialysate.
- Biocompatibility: The materials contacting the patient's tissue (catheter) must be biocompatible.
- Sterility: The device components intended for implantation or contact with sterile tissue must be sterile.
- Safety: The device must not pose undue risks to the patient.
- Functional Performance: The pump, analyzer, and software must function as intended for fluid delivery, analysis, and data display.
Information NOT present in the document which would be expected for a detailed study description:
- A table of specific acceptance criteria (e.g., "Glucose measurement accuracy within ±X%").
- Reported device performance values against these specific criteria.
- Details of a specific study designed to prove these criteria were met.
- Sample size used for a test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Information on standalone (algorithm-only) performance, as this device involves direct measurement rather than an interpretive algorithm in the AI sense.
- The type of ground truth used (e.g., a reference analytical method for biochemical levels).
- Sample size for a training set.
- How ground truth for a training set was established.
Summary based on the provided text:
| Information Category | Details from the Document |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | Acceptance Criteria (Inferred): The device's intended use is to measure trends in intracranial glucose, lactate, and pyruvate levels as an adjunct monitor. Therefore, acceptance criteria would implicitly involve the analytical performance (accuracy, precision, linearity, stability) of these measurements. The device is also "substantially equivalent" to predicate devices, implying its performance should be comparable in relevant aspects. Reported Performance: The document states, "numerous clinical studies have been conducted to demonstrate the correlations between these measures and their safety and effectiveness in a multimodal approach to monitoring brain injured patients." However, it does not provide specific performance metrics (e.g., accuracy, precision) for glucose, lactate, or pyruvate measurements by the CMA system itself, nor does it present a direct comparison table. The bulk of the justification for substantial equivalence relies on the types of parameters measured and their clinical relevance, rather than specific performance data against defined thresholds. |
| 2. Sample Size (Test Set) & Data Provenance | The document does not specify sample sizes for a test set or data provenance related to studies demonstrating the device's performance against specific acceptance criteria. The mentioned "numerous clinical studies" are general and don't provide these details for the CMA system itself. |
| 3. Number of Experts & Qualifications (Test Set) | Not applicable/Not provided. The device measures biochemical markers, not interprets images or complex clinical scenarios requiring expert consensus for ground truth on a 'test set.' |
| 4. Adjudication Method (Test Set) | Not applicable/Not provided. |
| 5. Multi-Reader Multi-Case (MRMC) study & Effect Size | Not applicable. This device is a measurement system for biochemical markers, not an AI-assisted diagnostic tool that would typically undergo MRMC studies with human readers. |
| 6. Standalone (Algorithm Only) Performance | Not applicable. The device's core function is direct biochemical measurement orchestrated by a system of hardware and chemical components, rather than solely an algorithm. |
| 7. Type of Ground Truth Used | For the biochemical measurements (glucose, lactate, pyruvate), the ground truth would typically be established by reference analytical methods (e.g., laboratory assays considered gold standards for measuring these specific analytes) when validating the analyzer's performance. The document does not specify which methods were used. |
| 8. Sample Size for Training Set | Not applicable. The device does not employ machine learning that would require a "training set" in the conventional sense. |
| 9. How Ground Truth for Training Set was Established | Not applicable. |
In essence, the provided 510(k) summary focuses on demonstrating "substantial equivalence" based on similar intended use and the general understanding of the clinical relevance of the parameters it measures, rather than presenting detailed experimental results against specific, quantitatively defined acceptance criteria for the new device.
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