(156 days)
The OLG-2800A is a portable monitor that measures respiration status of patients at a medical facility setting. The device is used with commercially available sensors for intubated and nonintubated patients. The device displays waveforms and numeric data of monitored parameters, such as: CO2 , EtCO2, respiratory rate, and trendgraphs. The device may generate an audible and/or visual alarm when a measured parameter falls outside preset limits.
The device LED display shows ETCO2 value and respiration rate and the LCD display shows CO2 waveforms, and alarm settings. The device is AC and/or battery operated. This device will be available for use by medical personnel on all patient populations depending on the CO2 sensor kit.
The OLG-2800A is a portable monitor that monitors respiration status of patients at a medical facility setting. The device is used with commercially available sensors for intubated and non-intubated patients. The device is a monitor, which displays waveforms and numeric data, such as: , EtCO2, and respiratory rate, as well as trendgraphs. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. Alarms are indicated by sound, blinking LED (numeric display) and messages on the LCD.
The device LED displays EtCO2 value and respiration rate and the LCD indicates CO2 waveforms, and alarm settings and trendgraphs. The device is AC and/or battery operated.
The provided text describes a 510(k) premarket notification for the Nihon Kohden OLG-2800A, a breathing frequency monitor and carbon dioxide gas analyzer. However, the document does not contain specific acceptance criteria or an explicit study proving that the device meets those criteria, as one would expect for a detailed performance study.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Nihon Kohden BMS-5130A Series Bedside Monitor). The "Performance Testing" section states: "To date, no special controls or performance standards are known or established for this device." This indicates that the regulatory pathway for this device did not require the applicant to conduct and report a study with explicit performance targets and outcomes in the same way that a novel high-risk device or a device with established performance standards would.
Here's an breakdown of the information that is available based on your request, and where the requested information is not present in the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The submission focuses on substantial equivalence to a predicate device rather than meeting specific quantifiable performance criteria for accuracy, sensitivity, or specificity. | The device was subject to: Environmental testing (temperature/humidity stress)Electromagnetic interference / electromagnetic compatibility testingSafety standards testingPerformance testing procedures "Test criteria were established before testing based on product specifications and applicable standards. The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and recognized standards as applicable." |
| Compliance with voluntary industrial standards | Complies with: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03)IEC 60601-1-2 (2001)IEC 60601-1-1 (2000) |
| Software verification and validation | "Software verification and validation verified and confirmed the operation of the software and hardware functions of the device." |
Explanation: The document does not provide specific numerical acceptance criteria (e.g., target accuracy, precision) for parameters like EtCO2 or respiratory rate, nor does it present the direct numerical results from performance tests against such criteria. The "performance testing" described is general and confirms the device met its own product specifications and recognized standards, rather than a pre-defined set of regulatory acceptance criteria for clinical performance that would typically be described in detail in a study report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The performance testing appears to be primarily engineering and standards-based (environmental, EMC, safety) rather than clinical performance data from patient populations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable/Not specified.
- Qualifications of Experts: Not applicable/Not specified. The testing described is against engineering specifications and industry standards, not against "ground truth" established by clinical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not specified. There is no mention of clinical adjudication for performance evaluation.
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 monitor displaying physiological data (EtCO2, respiratory rate); it is not an AI-assisted diagnostic imaging device requiring a "reader" study. The concept of "human readers improve with AI" is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The described "performance testing" (environmental, EMC, safety, and software verification) is essentially standalone testing of the device's adherence to its specifications and applicable standards. However, it's not "standalone" in the context of an AI algorithm's diagnostic performance without human intervention. This device provides raw data and alarms, which humans then interpret and act upon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the traditional sense for clinical diagnostic performance. The "ground truth" for the device's described performance testing would be the engineering specifications for the device itself and the requirements of the voluntary industrial standards (IEC 60601 series). For example, a CO2 sensor's accuracy might be verified against a calibrated gas mixture, but the details of such verification are not in this summary.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a physiological monitor, not an AI/machine learning system that requires a "training set" in the context of developing its core functionality.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for this type of device.
Summary of Regulatory Approach:
The K062115 submission for the Nihon Kohden OLG-2800A relies on demonstrating substantial equivalence to an existing predicate device (Nihon Kohden BMS-5130A Series Bedside Monitor). The performance testing described is primarily focused on confirming the device's compliance with engineering specifications and recognized safety/EMC standards, and the proper functioning of its software/hardware. It explicitly states that no special controls or performance standards are known or established for this device, which means the FDA did not require a dedicated clinical performance study with specific acceptance criteria in this 510(k) submission.
§ 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).