(204 days)
Siemens INFINITY etCO2 is indicated for use in the adult, pediatric and neonatal populations, in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode is not intended for use in the neonatal patient population). In conjunction with the SC 7000 / SC 9000XL monitors, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.
The INFINITY etCO2 Pod is an addition to Siemens SC8000/SC7000/SC9000XL INFINITY modular bedside monitoring series. When connected to an INFINITY modular bedside monitor the etCO2 pod will measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate.
Here's the breakdown of the acceptance criteria and the study information based on the provided text, recognizing that this is a 510(k) summary for a medical device (Siemens INFINITY etCO2 Pod), and its primary intent is to demonstrate substantial equivalence to predicate devices rather than providing a detailed clinical study report. Therefore, some information expected in a full clinical study might be limited or inferred.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state "acceptance criteria" in a quantified, pass/fail manner. It focuses on demonstrating equivalence to predicate devices and lists the device's measuring capabilities and range. The "reported device performance" is essentially the device's specifications, which are presented as similar to or improved upon the predicate devices.
| Metric/Parameter | Acceptance Criteria (Inferred from Similarities/Improvements) | Reported Device Performance |
|---|---|---|
| Intended Use | To measure EtCO2, iCO2, and respiration rate in mainstream & side-stream modes (side-stream not for neonatal). Alarms for out-of-limit parameters, timed/alarm recordings. (Must match predicate's core function) | Measures EtCO2, iCO2, and respiration rate in mainstream & side-stream modes (side-stream not for neonatal). Alarms for out-of-limit parameters, timed/alarm recordings. |
| Intended Population | Adult/Pediatric/Neonatal | Adult/Pediatric/Neonatal |
| Intended Environment | Healthcare environment by healthcare professionals | Healthcare environment by healthcare professionals |
| Displayed Parameters | EtCO2, iCO2, Respiration rate (RRc). (Must be at least functional equivalent to predicate without spirometry/pulse oximetry) | EtCO2, iCO2, Respiration rate (RRc) |
| Display Scales | Comparable to predicate (0-40, 0-80 mmHg) with potential for improvement/flexibility | 0-40, 0-60, 0-80, 0-100 mmHg (More display flexibility than Siemens predicate) |
| Measuring Method | Dual-wavelength, non-dispersive infrared (Must be identical to predicate) | Dual-wavelength, non-dispersive infrared |
| Measuring Capabilities | Mainstream and Sidestream | Mainstream and Sidestream |
| Measuring Range | 0 to 99 mmHg CO2 partial pressure (Siemens predicate) or 0 to 100 mmHg partial pressure (Novametrix predicate). A CO2 ≥ 100 is out of range. | 0 to 100 mmHg CO2 partial pressure |
| Averaging | Breath, 10s, 20s (Siemens predicate) or Breath, 10s, 20s, Instantaneous (Novametrix predicate). Must be at least equivalent. | Breath, 10s, 20s, Instantaneous (Improvement over Siemens predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Assessment of non-clinical performance data for equivalence: Section T" and "Assessment of clinical performance data for equivalence: Section V." However, it does not provide details on the specific sample size, data provenance, or whether the data was retrospective or prospective for any test set. The 510(k) summary focuses on demonstrating substantial equivalence, and often, extensive clinical trials with detailed data are not explicitly summarized in this front-end document if equivalence can be shown through other means (e.g., bench testing, comparison to predicate specifications).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The nature of the device (etCO2 measurement) suggests that "ground truth" would likely be established through validated reference devices or methods, rather than expert interpretation of images or other subjective data.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the type of measurement, adjudication by expert consensus is unlikely to be the primary method for ground truth, which is typically based on objective measurements.
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
This document is for a basic medical device (etCO2 monitor) from 1999, which is not an AI-powered diagnostic tool. Therefore, an MRMC study or any assessment of human performance improvement with AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is a device that directly measures physiological parameters (CO2 concentration and respiration rate). Its performance is inherently standalone in the sense that the device itself produces the measurement. There is no separate "algorithm only" performance reported in the context of interpretation that would require human-in-the-loop comparison. Its performance would be assessed against a reference standard to demonstrate accuracy. The document implies that "non-clinical performance data" and "clinical performance data" were reviewed for equivalence, but without details.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. However, for a device measuring end-tidal carbon dioxide and respiration rate, the ground truth would typically be established using:
- Reference Standard Devices: Highly accurate and calibrated gas analyzers or capnographs known to be reliable.
- Controlled Gas Mixtures: Precisely known concentrations of CO2 to test accuracy across the measuring range.
- Physiological Reference: For respiration rate, potentially a spirometer or other validated method.
It is highly unlikely to involve expert consensus or pathology in the way it would for imaging diagnostics.
8. The Sample Size for the Training Set
This information is not provided in the document. This is not an AI/machine learning device that typically involves a distinct "training set." The development of such a device relies on engineering principles, sensor calibration, and physiological modeling, not data-driven model training in the modern AI sense.
9. How the Ground Truth for the Training Set was Established
As this is not an AI/machine learning device, the concept of a "training set" and establishing ground truth for it in that context is not applicable. The device's underlying principles are based on established physics (dual-wavelength, non-dispersive infrared measurement) and engineering, likely validated through bench testing and, potentially, in-vivo testing against standard methods, but not through a "training set" of patient data for algorithm learning.
§ 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).