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The Dolphin Medical 2150 Handheld Pulse Oximeter is indicated for use for spot checking and/or continuous noninvasive monitoring of fractional oxygen saturation of arterial hemoglobin, pulse rate, and patient temperature. The 2150 is for use with adult pediatric and neonatal patients in hospitals and hospital type facilities.

The Dolphin Medical 2150 Pulse Oximeter consists of the Dolphin ONE™ OEM 701 Module technology, and works with existing Dolphin ONE extension cables, and oximetry sensors to non-invasively calculate the functional saturation of arterial hemoglobin (SpO2) and pulse rate. It also includes a thermistor port which accepts off the shelf approved YSI 400 series patient temperature sensors for the reading of patient temperature. It features an easy-to-read display that presents patient data and status information: an LCD (liquid crystal display) display that shows the SpO2, pulse rate values, patient temperature, and other messages as appropriate. A Dolphin ONE Extension Cable connects the sensor to the 2150. The cable is available in two configurations, three foot or eight in length. The oximeter can be operated off either an internal rechargeable battery or with use of a medical grade AC power supply which is fumished with the unit. The Dolphin Medical Model 2150 Pulse Oximeter will be used for continuous noninvasive monitoring and spot checking of SpO2, pulse rate, and patient temperature for adult, pediatric, infant and neonatal patients in hospital-type facilities. Typical acute-care uses are the Operating Room, Recovery Room and the Adult and Neonatal Intensive Care Units. The Dolphin Medical Model 2150 Pulse Oximeter and accessories will be used for adult, pediatric and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The user responsible for the operation of the Dolphin Medical Model 2150 will normally be a licensed clinical professional such as a physician, nurse, or respiratory therapist.

Here's a summary of the acceptance criteria and the study that proves the Dolphin Medical 2150 Handheld Pulse Oximeter meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and the data provenance: The document states that the validation involved "Volunteers participated in the breathe-down protocol." However, the exact number of volunteers (sample size) for the test set is not explicitly mentioned in the provided text. The data provenance is stated as the "VA Hospital of Wisconsin - Milwaukee." The study design (breathe-down protocol) indicates it was a prospective study where participants' oxygen saturation was controlled.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The study was conducted by "Dr. Phillip Clifford, MD." It does not specify the number of additional experts used or their qualifications for establishing ground truth beyond Dr. Clifford's involvement and the medical facility where the study was conducted.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: The document does not mention any specific adjudication method for the test set. It primarily discusses comparing the device's SpO2 values to "functional SaO2 values."

4. 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 information is not applicable as the device is a pulse oximeter, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed in this context.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the clinical testing described is a standalone performance study of the Dolphin Medical 2150 Handheld Pulse Oximeter. It evaluates the device's ability to accurately measure SpO2 and pulse rate independently. Human users operate the device and interpret its display, but the accuracy assessment is of the device's output against a reference.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth used was "functional SaO2 values." In the context of pulse oximetry breathe-down studies, this typically refers to arterial blood gas (ABG) analysis performed by a CO-Oximeter, which is considered the gold standard for measuring arterial oxygen saturation (SaO2).

7. The sample size for the training set: The document does not provide any information regarding a separate training set or its sample size. The description of the device's internal technology (Dolphin ONE™ OEM 701 Module, patented Digital Signal Processing technology) suggests that algorithms were developed, but the details of their training are not disclosed in this summary.

8. How the ground truth for the training set was established: As no training set information is provided, how its ground truth was established is not discussed in this document.

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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 arterial hemoglobin (SpO2) and pulse rate for adult, pediatric and neonatal patients. The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpOz value, the high and low SpO2 and pulse rate 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 functional oxygen saturation of arterial hemoglobin (SpO-) 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) 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 lenath. 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 Dolphin Medical 2100 Pulse Oximeter and Accessories were evaluated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The information provided heavily emphasizes regulatory compliance and substantial equivalence to previously marketed devices, rather than a detailed standalone performance study.

1. A table of acceptance criteria and the reported device performance

Based on the provided text, specific numerical acceptance criteria and direct reported performance metrics (e.g., accuracy +/- X%) are not explicitly stated. However, the document refers to compliance with several standards, including FDA Guidance Document for Pulse Oximeters: 9/7/1992 and EN 865:1997. These standards typically define accuracy requirements for pulse oximeters. Without access to the specific content of these standards and the detailed testing reports, precise numerical acceptance criteria cannot be extracted.

Implicit Acceptance Criteria (based on standards listed):

• Accuracy for SpO2: Based on the FDA Guidance Document for Pulse Oximeters, this would typically involve a root mean square (Arms) difference between the pulse oximeter reading and a co-oximeter reference within a specified range (e.g., ±2% or ±3% for 70-100% SpO2 in adults, and potentially different for neonates).
• Accuracy for Pulse Rate: Typically defined as a range of difference (e.g., ±3 bpm or ±2% of reading) compared to an ECG reference.
• Performance in Motion and Low Perfusion: Testing would ensure the device maintains accuracy under these challenging conditions, again with specified accuracy limits.
• Safety and EMC Standards Compliance: As indicated by compliance with a long list of IEC, CSA, UL, and other standards.

Reported Device Performance:
The document states: "Additional performance validation testing has been performed for the 560 neonatal disposable sensor and has been included in this submission." However, the results of this testing, including specific accuracy figures or performance data, are not provided in this summary. The document primarily asserts "substantial equivalence" to predicate devices, implying that its performance meets the level demonstrated by those devices, which would have adhered to the same general performance standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature) for the performance validation testing mentioned for the neonatal sensor.

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)

Given that this is a pulse oximeter, ground truth for performance testing is typically established using a co-oximeter for SpO2 and an ECG device for pulse rate, rather than human experts interpreting data. The document does not mention human experts being used to establish ground truth for performance testing. If studies involved human subjects, medical professionals would be involved in monitoring, but not typically in "establishing ground truth" in the way an expert panel would for image interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as ground truth is established by objective measurement devices (co-oximeter, ECG) rather than human interpretation requiring adjudication.

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

Not applicable. This device is a standalone medical device (pulse oximeter) for direct measurement, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the device is intrinsically standalone. A pulse oximeter provides direct measurements (SpO2 and pulse rate) without requiring human interpretation of complex outputs in the way an AI-driven image analysis system would. The performance validation testing would be on the algorithm's ability to accurately calculate these parameters based on the sensor's optical signals. The document implicitly supports this by stating it "receives and calculates the signals from the LEDs within the sensor to determine the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate".

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For pulse oximeters, the accepted gold standard (ground truth) for SpO2 accuracy is typically:

• Co-oximetry: Direct measurement of arterial oxygen saturation (SaO2) from arterial blood samples using a laboratory co-oximeter. This is usually performed during a "hypoxia study" where subjects' oxygen levels are carefully lowered.
• Electrocardiogram (ECG): For pulse rate, an ECG device is the gold standard.

The document refers to "performance validation testing" and compliance with standards like the "FDA Guidance Document for Pulse Oximeters: 9/7/1992" and "EN 865: 1997", both of which mandate the use of co-oximetry and ECG for establishing ground truth during such studies.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. Given this is a 510(k) submission for a traditional medical device (pulse oximeter), the concept of a "training set" in the context of machine learning algorithms is likely not directly applicable in the way it would be for AI/ML-driven devices. While the device contains electronic hardware and software, the development process might involve calibration and optimization using engineering data rather than a distinct "training set" as defined for AI models.

9. How the ground truth for the training set was established

As there is no mention of a distinct "training set" in the context of AI/ML, this information is not provided. For traditional medical device development, internal validation and calibration would occur using established measurement methods, but the document does not elaborate on these details.

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