(250 days)
The Medley™ EtCO2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired. The Medley™ EtCO2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.
The EtCO2 Module is the newest module to the currently marketed Medley™ Medication Safety System (Medley™ System). ALARIS Medical will incorporate currently marketed Oridion capnograph technology and accessories into the Medley™ EtCO2 Module. The Medley™ EtCO2 Module will be used to measure inspired and expired carbon dioxide (FiCO2 and EtCO2 respectively) and Respiration Rate (RR) on patients in the operating room, ICU, NICU, transport and emergency treatment. This capnograph technology originates from the MediCap/NPB-75 (K964239).
The provided text describes the Alaris Medical Systems Medley EtCO2 Module, a capnograph designed to continuously monitor end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The document is a 510(k) premarket notification summary.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, does not explicitly state specific numerical acceptance criteria or performance metrics (like accuracy, precision, or bias) for EtCO2, FiCO2, or RR measurements. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (typically quantitative thresholds for accuracy, precision, etc.) | "The performance data included in this submission indicate that the Medley™ EtCO2 Module meets specified requirements, and is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The evaluation appears to be based on demonstrating "substantial equivalence" to a predicate device and relies on the predicate's established performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not available in the provided text. No ground truth establishment by experts for a test set is described.
4. Adjudication Method for the Test Set
This is not applicable/not provided as no test set requiring expert adjudication for ground truth is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned in the document. The device is a monitor, not an AI diagnostic tool requiring human reader interpretation or assistance.
6. Standalone Performance Study (Algorithm Only)
The document does not describe a standalone performance study in the context of an algorithm's performance. The Medley EtCO2 Module is a hardware device that incorporates "currently marketed Oridion capnograph technology." Its performance is evaluated against (or shown to be equivalent to) an existing predicate device rather than undergoing a separate standalone algorithm performance study. The statement "The performance data included in this submission indicate that the Medley" EtCO2 Module meets specified requirements" suggests internal testing was done, but no details of such a study are provided.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any performance evaluation. Given it's a capnograph, ground truth would typically come from a gold-standard CO2 measurement method, but this is not detailed. The primary basis for approval appears to be substantial equivalence to a predicate device.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. As a hardware medical device based on existing technology, the concept of a training set for an algorithm is not directly applicable in the information provided.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as no training set is described.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Oridion MicroCap/NPB-75, K964239) rather than detailing specific standalone performance studies with quantitative acceptance criteria, test sets, or ground truth establishment relevant to AI/algorithm performance. The approval hinges on the assertion that the "technological characteristics" and "performance data" show the device is "substantially equivalent" to the predicate.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).