(324 days)
The Invivo Research Inc. Millennia 3500 Series Monitor with Anesthetic Agent monitoring is intended for general hospital or clinical use by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents whonitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide and Additionally, this more and to monitor these anesthetic agents is most commonly encountered in the operating room during administration of anesthesia. This device is available for sale only upon the order of a physician or other related licensed medical professional.
The Millennia 3500 Series Monitor with Anesthetic Agents Monitor is a patient monitor which draws a continuous flow of sample gas from the patient's anesthesia breathing circuit. The sample is then drawn through a measurement sample cell where the agent(s) and other patient gas concentrations are measured. Measured values are displayed as numbers and waveforms on the main display of the monitor. The monitor is operated by controls on the front panel of the monitor. The major functional subsystems of the device are the power supply, the pneumatic system, the measurement sample cell, the system electronics and product software. Power is supplied by an AC power cord, or an internal set of batteries. AC power is internally conditioned by the power supply subassembly, which powers the system and charges the internal batteries. The pneumatic system draws sample gas into the device through a moisture collection system. The sample then enters the sample cell, which is a cavity within the optical bench assembly. The sample is then exhausted out the rear of the unit. The sample cell cavity allows infrared light to be passed through the sample so a detector on the other side of the sample can measure the amount of infrared light absorption. The infrared light source consists of a resistive element which radiates a relatively wide spectrum of infrared light. The amount of transmitted infrared light is measured by an optical detector, and several optical filters are used to determine the identity and concentration of the anesthetic agents, nitrous oxide and carbon dioxide. The oxygen measurements are obtained using a polarographic oxygen cell which also receives sample gas from the sample cell. The electronic system consists of an analog circuit board, and a digital circuit board. These boards are added to the existing standard Millennia 3500 Series Patient Monitoring System. The analog board takes the electrical signals from the sample cell assembly and conditions them so that measurement calculations can be performed. The digital circuit board digitizes the conditioned analog signals and performs measurement calculations. Proprietary software algorithms are used to calculate measured concentrations of anesthetic agents and patient gases in the sample gas.
The provided text describes the Millennia 3500 Series Monitor with Anesthetic Agent Monitoring. However, it does not contain specific acceptance criteria or detailed study results that would allow for a comprehensive table of acceptance criteria and reported device performance, nor does it provide the detailed information requested regarding sample sizes, expert qualifications, or comparative effectiveness studies.
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing full study protocols and results. It states that "The Invivo Research Inc. Millennia 3500 Series Monitor with Anesthetic Agent monitor conforms with national and available international product safety standards for electrical, electromagnetic compatibility, and anesthetic agent monitoring." This is a general statement about compliance but not a detailed presentation of performance data against specific criteria.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an attempt to answer based on the available information and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Anesthetic Agent Monitoring | |
| Accuracy for Halothane Concentration | "Same performance specifications as predicate devices" (Datex AS/3, Datascope Multinex, Criticare Poet II) |
| Accuracy for Enflurane Concentration | "Same performance specifications as predicate devices" |
| Accuracy for Isoflurane Concentration | "Same performance specifications as predicate devices" |
| Accuracy for Sevoflurane Concentration | "Same performance specifications as predicate devices" |
| Accuracy for Desflurane Concentration | "Same performance specifications as predicate devices" |
| Other Gas Monitoring | |
| Accuracy for End-tidal CO2 Concentration | "Same performance specifications as predicate devices" |
| Accuracy for Nitrous Oxide Concentration | "Same performance specifications as predicate devices" |
| Accuracy for Oxygen Concentration | "Same performance specifications as predicate devices" |
| General Performance | |
| Conformance to national product safety standards for electrical, electromagnetic compatibility, and anesthetic agent monitoring | Stated as "conforms with national and available international product safety standards" |
Note: The actual numerical acceptance criteria for accuracy, drift, response time, etc., are not provided in this document. The stated "same performance specifications as predicate devices" is the primary performance claim.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. Performance testing is mentioned generally, but no details on the number of cases or samples are provided.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not specified. The document does not describe the establishment of a "ground truth" using human experts for performance testing. Performance is likely assessed against calibrated gas mixtures or reference devices, not human expert interpretation.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. This typically applies to studies involving human interpretation or clinical outcomes, which are not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not done, as this device measures gas concentrations and does not involve human readers interpreting images or data in the same way an AI diagnostic tool would.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device is a monitor that provides numerical readouts of gas concentrations. Its performance is inherent to the algorithm and sensors (standalone) without a human-in-the-loop directly influencing the measurement calculation itself. The "Proprietary software algorithms are used to calculate measured concentrations."
7. The Type of Ground Truth Used
- Inferred: Calibrated gas standards or reference measurement devices. For a gas analyzer, the ground truth for "concentration" would be established by preparing gas mixtures with known, precise concentrations and then measuring how accurately the device reports these known values. This is not explicitly stated but is the standard method for such devices.
8. The Sample Size for the Training Set
- Not applicable/Not specified. The document does not describe the development or training of AI/ML models in the modern sense that would require a "training set" of data labels. The device uses "Proprietary software algorithms" for calculations, but these are likely deterministic algorithms based on physical principles (infrared absorption) rather than statistical or neural network models trained on large datasets.
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not specified. As above, the concept of a training set ground truth, as used for AI/ML, does not appear relevant to the described device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).