(92 days)
LD-Oxi system is intended for use:
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.
To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement.
To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate variability.
The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.
The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes).
The device is intended use in licensed practitioner's office
This device is no intended to be used at home, in hospital or out-of-hospital transport
The device is not intended use in support life and not for continuously monitoring
The system will be use by practitioner.
The LD-Oxi System is a programmable electro medical system (PEMS) including:
2 USB plug and play Pulse oximeter device including an electronic circuit and reusable Adult SpO2 probe
2 Software installed on a computer
Description of the features
Displays SpO2%, pulse rate value and vertical bar graph pulse amplitude (photoplethysmography).
Mathematical analysis of the pulse waveform (photoelectrical Plethysmography feature).
Mathematical analysis of the Heart Rate Variability (HRV feature).
The provided document does not contain full details of a specific study proving the device meets acceptance criteria, specifically not in the format of a typical clinical validation study with detailed performance metrics, sample sizes, and expert ground truth establishment.
However, based on the information provided in the 510(k) Summary for the LD-Oxi System (K160956), here's what can be inferred and pieced together regarding acceptance criteria and performance, as well as the types of studies mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on establishing substantial equivalence to a predicate device (Electro Sensor Oxi K102442) rather than defining explicit acceptance criteria with numerical targets. For performance, it largely relies on the general equivalence to the predicate and standard compliance. The specifications table (page 4) compares the LD-Oxi with the predicate (ESO) for various parameters.
| Acceptance Criteria (Implied / Predicate's Performance) | Reported Device Performance (LD-Oxi System) |
|---|---|
| Intended Use | Same as predicate (spot check/monitor SpO2% & pulse rate, analyze PP and HRV, not for diagnosis) |
| Material in contact with patient | Reusable SpO2 probe PTU latex free |
| Scientific Background | Based on red and infrared light absorption characteristics of oxygenated and deoxygenated hemoglobins |
| Placement of the probe | Index finger |
| Power Supply | 5V (power supply by USB port) |
| Classification | Class II |
| Degree of protection against electric shocks | BF |
| Operating mode | Continuous use |
| IR Light Wavelength | 905 ±10 nm (Predicate) |
| IR Light Radiant Flux | 2.0mW (Predicate) |
| IR Light Spectral Bandwidth | 50nm |
| IR Light Forward Voltage | 1.7V |
| IR Light Reverse Voltage | 5V |
| RED Light Wavelength | 660nm ±2nm |
| RED Light Radiant Flux | 1.8mW (Predicate) |
| RED Light Spectral Bandwidth | 25nm |
| RED Light Forward Voltage | 2.4V |
| RED Light Reverse Voltage | 5V |
| Pulse Wave Resolution | 1% |
| Pulse Wave Signal Strength | 0-15 |
| Pulse Wave Bargraph | 0-15 |
| Plethysmogram | 0 - 100, auto-gained for highest resolution |
| Pulse Rate Measuring Range (No Alarm) | 30~235 bpm |
| Pulse Rate Resolution | 1bpm |
| Serial Communication Logic Levels | 3.3V CMOS voltage levels |
| Voltage | +3.3 ± 0.17 V DC |
| Average Current | 15mA |
| Module Oximeter Circuit Board | OEM from Beijing Choice Electronic Technology Co. Ltd. (MD300I K072825) (Predicate) |
| Circuit Board Size | 128 (L) x 143 (W) x 33 (H) mm (Predicate) |
| Circuit Board Weight | 1.2 Kg (Predicate) |
| Data Transmission Speed | 4800 Bauds (Predicate) |
| Probe Connection | LEMO (Predicate) |
| Mathematical analysis of heart rate | At rest (Predicate) |
| Standards Met | 60601-1 2nd Ed, 60601-1-2 2nd Ed, ISO 9919 (Predicate) |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly mention "test sets" or provide details on sample sizes for clinical performance evaluation. The "Performances and Effectiveness" section (page 7) lists general tests, but no specific human subject data or sample sizes for these tests are provided.
3. Number of Experts and Qualifications for Ground Truth
The document mentions "Peer reviews for the photoelectrical plethysmography mathematical analysis" and "Peer review reference for the heart rate variability mathematical analysis." However, it does not specify the number or qualifications of these experts.
4. Adjudication Method
No adjudication method is mentioned for any "test set" or peer review process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study comparing human readers with and without AI assistance is mentioned. The device's primary function is as a monitor and analyzer, not as an AI-assisted diagnostic tool for human readers. The mathematical analyses (PP and HRV) are explicitly stated "ARE NOT intended use for diagnosis."
6. Standalone Performance Study
The document refers to the following for performance and effectiveness:
- Calibration tests (simulator oximeter): This implies standalone testing of the oximeter's core functionality against known standards.
- Software verification (SRS/SDS/STD/STR/ Software algorithms tests with input data from the MIT-BIH database): This indicates standalone testing of the software algorithms (including PP and HRV analysis) using a recognized physiological database. This could be considered a form of standalone performance evaluation for the algorithmic components.
- Peer reviews: As mentioned above, these are qualitative assessments of the mathematical analysis.
7. Type of Ground Truth Used
- For the core oximeter function (SpO2% and pulse rate), the ground truth for calibration would likely come from simulator oximeter standards.
- For the software algorithms (PP and HRV), the mention of the MIT-BIH database suggests that the ground truth for these analyses would be derived from the expert-annotated physiological data contained within that database. (The MIT-BIH Arrhythmia Database, for example, is known for its expert annotations of ECG signals, which can be related to HR and HRV).
8. Sample Size for Training Set
The document does not specify a separate "training set" or its sample size. The description of the device and its validation focuses on direct measurement, software verification against existing databases, and established principles of oximetry and physiological analysis, rather than a machine learning model that requires a distinct training phase.
9. How Ground Truth for Training Set was Established
Since a "training set" as commonly understood in machine learning is not explicitly detailed, the method for establishing its ground truth is also not described. If the device uses algorithms developed using physiological databases like MIT-BIH, then the ground truth for those underlying algorithms would have been established by the experts who curated and annotated those databases.
In summary:
The LD-Oxi System's acceptance criteria and proven performance rely heavily on demonstrating substantial equivalence to a predicate device (ESO) and compliance with relevant medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-61). Performance claims are supported by calibration tests using simulators and software verification using data from established databases like MIT-BIH, implying a form of standalone algorithmic testing. Detailed clinical trial data with specific sample sizes, expert qualifications, or adjudication methods for new data collection are not provided in this 510(k) summary, as the nature of the modifications and the intended use (monitoring and analysis, not diagnosis from AI) did not necessitate such extensive studies for this particular submission.
§ 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).