(155 days)
The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of (SpO2) and pulse rate for adult, pediatric and neonatal patients. arterial hemoqlobin
The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate alarm limits, alarms, trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the function of arterial hemoglobin (SpQz) and pulse rate, and provide for the connection to the connecting cable.
The Dolphin Medical Pulse Oximeter Model 2100 is available in one configuration as a portable standalone oximeter that is 10 cm / 3.94 inches high, 27.5 cm / 10.83 inches wide, 25 cm / 9.84 inches deep and weighs about 4 kg / 8.8 lbs. The unit is powered either with a voltage input of 100-240 Vac, 50-60 Hz or with a sealed lead-acid battery with an operating time of approximately 4 hours based upon 2 Ampere hour battery (200mA OEM Module, 300mA System Module) and a charge time of about 4.5 hours to 80% capacity.
The extension cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration drive to the oximetry sensor from the monitor receives the detector signal from the oximetry sensor.
The extension cable is available in one configuration and is approximately 8 feet / 2.44m in length, and the sensor(s) are approximately 18 inches / 45.72 cm in length.
The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.
The oximetry sensor is available in either a disposable configuration, and with one configuration for the extension cable (8 feet).
The provided text describes a 510(k) premarket notification for the Dolphin Medical 2100 Pulse Oximeter. It mentions compliance with several standards and refers to "clinical data" but does not contain explicit acceptance criteria or a detailed study description with performance metrics in the format requested.
The document largely focuses on device description, predicate device comparison, and regulatory compliance rather than presenting specific performance data from a clinical study against predefined acceptance criteria.
Therefore, many of the requested fields cannot be accurately populated from the provided text.
Here's what can be extracted or inferred, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Present in Document | Not Present in Document |
| (e.g., Accuracy of SpO2 within ±2% in specified range) | (e.g., SpO2 accuracy: Mean difference ± SD = 0.5% ± 1.2%) |
| (e.g., Pulse Rate Accuracy within ±3 bpm) | (e.g., Pulse Rate accuracy: Mean difference ± SD = 1 bpm ± 2 bpm) |
| (e.g., Bias and precision values for SpO2 and pulse rate) | (e.g., A statistical analysis of "clinical data" was provided to the FDA, but the specific metrics are not detailed in this summary.) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided text. The document refers to "clinical data" being provided to the FDA, but the number of subjects or data points is not mentioned in this 510(k) summary.
- Data Provenance: Not specified in the provided text. It's unclear if the data was collected retrospectively or prospectively, or its country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Provided. For pulse oximeters, the "ground truth" for SpO2 is typically established through co-oximetry measurements from arterial blood samples, not by expert consensus on visual assessment. The document does not describe the methodology for ground truth establishment.
4. Adjudication method for the test set
- Not Applicable/Not Provided. As ground truth for pulse oximeters is usually instrumental (co-oximetry), an adjudication method by human experts is not typically used for this type of device 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
- No. This is a pulse oximeter, a medical device for measuring physiological parameters (SpO2 and pulse rate). MRMC studies are typically relevant for diagnostic imaging AI devices where human readers interpret images. This device does not involve human interpretation with or without AI assistance in the way an MRMC study would measure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, by nature of the device. A pulse oximeter inherently performs "standalone" measurement. The device calculates SpO2 and pulse rate from sensor signals. The performance evaluation would assess the accuracy of these algorithmic measurements against a reference standard (e.g., co-oximetry). The document states, "the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the function of arterial hemoglobin (SpQz) and pulse rate". The software update mentioned is in "the Dolphin ONE OEM-601 Module, the component that functions as the oximetry engine," which implies algorithmic performance.
7. The type of ground truth used
- Not explicitly stated, but likely co-oximetry. For pulse oximeters, the gold standard for measuring arterial oxygen saturation (SaO2) is ex vivo co-oximetry performed on arterial blood samples. This is implicitly the required ground truth for pulse oximeter accuracy studies, as per FDA guidance for pulse oximeters, which the device claims to comply with ("FDA Guidance Document for Pulse Oximeters: 9/7/1992").
8. The sample size for the training set
- Not applicable/Not provided. This document describes a medical device, not a machine learning model that would typically have a distinct "training set" in the sense of AI. While the device contains software ("internal software validation of the OEM-601 Module"), the development process for such software historically would involve engineering validation and potentially calibration data, but not a "training set" for an AI algorithm as understood in modern AI development.
9. How the ground truth for the training set was established
- Not applicable/Not provided. (See point 8).
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).