(100 days)
The Spacelabs Healthcare Capnography Pod, Model 92516 (CapnoPod) is intended to provide a means of monitoring carbon dioxide and respiration rate and alert clinical personnel when the concentration moves outside of user-defined limits.
The CapnoPod is intended to be used with and controlled by a Spacelabs Healthcare monitors. The CapnoPod is intended to be used for monitoring adult, pediatric and neonate patients, under the direction of qualified medical personnel.
The Spacelabs Healthcare Capnography Pod (92516) (CapnoPod) is an easy-to-use modular unit in the Spacelabs Healthcare family of monitors). The CapnoPod is attached to the pod connection on the rear of a Qube Compact Monitor (91390) (Qube). The Qube is then used to control the CapnoPod, and provide the user interface for the CapnoPod.
The CapnoPod is a sidestream analyzer intended to provide a measurement of the following parameters: carbon dioxide (CO2); and respiratory rate.
The Qube displays information from the CapnoPod and is the user interface for the CapnoPod. The Qube provides a number display for CO2 and respiratory rate, and a capnograph waveform. The CapnoPod is intended to be used primarily in the operating room environment.
The provided text is a 510(k) Summary for the Spacelabs Healthcare Capnography Pod (92516). While it describes various tests conducted (electrical safety, EMC, software, and performance to standards), it does not contain the specific details required to fully address your request in the format you've outlined.
Specifically, the document primarily focuses on demonstrating compliance with recognized standards and internal documentation for safety and software development, rather than a clinical study with detailed acceptance criteria and reported device performance in terms of clinical accuracy or effectiveness.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate Device / Implied) | Reported Device Performance (from CapnoPod) |
|---|---|---|
| Carbon Dioxide (CO₂) | Yes (same as predicate) | Same |
| Respiratory Rate (RR) Range | 4 to 60 breaths per minute (bpm) (from predicate) | 1.5 to 150 bpm |
| RR Accuracy | ± 1 bpm (From predicate and stated as "Same") | ± 1 bpm |
| Electrical Safety | Compliance with IEC 60601-1, UL 60601-1 | Complies with the Standards |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Complies with the Standards |
| Software Testing | Compliance with FDA guidance, IEC 60601-1-4 | Complies with predetermined specification and Standards |
| Performance Testing (General) | Compliance with IEC 60601-1-8, ISO 21647 | Complies with predetermined specification and applicable Standards |
Missing Information for this table: Specific quantitative acceptance criteria for CO2 measurement accuracy, response time, or specific error margins. The document states "Same" for EtCO2 and FiCO2, implying the predicate's performance is met, but doesn't explicitly state what that predicate performance is beyond "Yes" (meaning it measures it).
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for any of the performance tests. The document mentions "test results indicated that the CapnoPod complies..." but doesn't detail the number of units tested, number of measurements, or patient data used.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). The tests referenced are primarily bench testing against standards ("internal documentation and the following Standards").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts and Qualifications: Not applicable or not stated. The performance tests seem to be against established physical standards and regulatory requirements, not clinical expert ground truth for interpretation.
4. Adjudication method for the test set
- Adjudication Method: Not applicable or not stated. This type of adjudication is typically for subjective assessments or discrepancy resolution in clinical image review, which is not the nature of the tests described for this device.
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
- MRMC Study: No. This device is a CO2 monitor, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The "Performance Testing" section and the detailed technology comparison describe the device's inherent measurement capabilities. While not explicitly termed "standalone algorithm performance," the testing against standards would represent the device's performance independent of operator interpretation beyond initial setup and monitoring. The software testing also validates the internal logic. However, it's not an "algorithm" in the sense of a complex AI model.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for the performance testing appears to be established industry standards and physical measurements (e.g., calibrated gas mixtures for CO2, known respiration rates for RR testing, specified electrical and EMC conditions). For software, it was compliance with "predetermined specification" and guidance documents.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable or not stated. This device is not described as using machine learning or AI that would require a "training set" in the conventional sense. Its functionality is based on established infrared sensor technology.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there's no mention of a training set for an AI/ML model, the establishment of ground truth for such a set is not relevant.
In summary: The 510(k) summary provided for the Capnography Pod primarily demonstrates compliance with electrical safety, EMC, software development processes, and general performance standards. It lacks the detailed clinical study information (like sample sizes for test sets, expert consensus, MRMC studies, or AI training set details) that would be common for more complex diagnostic AI/ML medical devices. The performance validation relies heavily on meeting established technical specifications and regulatory standards for medical device monitors.
§ 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).