Search Results

The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

The Dolphin 2000™ Datex Compatible Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with major brands af pulse oximeter monitors. They represent a design change to the existing Dolphin Aristo Datex Compatible Sensors and the Dolphin 2000 Nellcor Compatible Sensors.

The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to predicate devices. The emitter and detector diodes are embedded in a laminate fo that is connected to the cable assembly. The sensors have an adhesive bandage backing that allows the sensor to be applied to the patient by wrapping it around a finger or toe (measurement site). Four sizes of disposable Dolphin 2000 Oximetry Sensors are available, which are indicated for use for adult, pediatric, infant and neonatal application sites. The Dolphin 2000 disposable sensors are provided non-sterile for single patient use. Disposable sensors are connected to the host oximeter through the use of an adapter cable.

The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespinstyle clip that is placed on the end of a finger clip sensor consistes of the emitter and detector components mounted in opposing clip halves, maintained in mild compression by a spring hinge. The molded outer components house the optoelectric components within contoured pads that maintain contact with the patient's fingeoloolear windows within these pads permit the optical energy to pass through the finge for the measurements.

The provided text describes the Dolphin 2000 Oximetry Sensors, a device for continuous monitoring of arterial oxygen saturation and pulse rate. The document focuses on regulatory submission (510(k) summary) rather than a detailed scientific study. Therefore, some of the requested information (like specific sample sizes for training sets, adjudication methods, or MRMC study details) is not explicitly present.

However, based on the provided text, here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for the Test Set: Not explicitly stated. The text mentions "volunteers participated in the breathe-down protocol." The exact number of volunteers is not provided.
• Data Provenance: The clinical testing was conducted at the VA Hospital of Wisconsin - Milwaukee. This indicates an origin within the United States. The nature of the study ("breathe-down protocols") implies a prospective design for the clinical accuracy evaluation.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: One expert is explicitly mentioned: "Dr. Phillip Clifford, MD." It is unclear if there were other experts involved in establishing the ground truth or overseeing the study.
• Qualifications: "Dr. Phillip Clifford, MD." implies a medical doctor, likely involved in patient care and clinical research, but specific specialization or years of experience are not provided.

4. Adjudication Method (Test Set)

• The text does not provide details on an adjudication method. For a clinical study measuring physiological parameters, expert adjudication in the typical sense (e.g., for image interpretation) is less common than adherence to standardized protocols and direct measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study is not described. The study focused on the standalone performance of the device against a "functional SaO2" ground truth.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was performed. The "breathe-down protocols" aimed to validate the device's accuracy by statistically comparing its SpO2 values to functional SaO2 values. This is a direct measurement of the device's performance.

7. Type of Ground Truth Used

• The ground truth for the clinical accuracy study was functional SaO2 values. These are typically obtained from a co-oximeter, considered a gold standard for blood oxygen saturation measurement, by drawing arterial blood samples during the breathe-down protocol.

8. Sample Size for the Training Set

• The document does not describe the development of an algorithm in the traditional sense that would require a "training set." This device is an oximeter sensor, where the underlying principle of operation (non-invasive optical assessment of tissue oxygenation) is well-established rather than a machine learning algorithm that is "trained" on data. Therefore, the concept of a "training set" as it applies to AI/ML devices is not relevant here.

9. How Ground Truth for the Training Set Was Established

• As explained above, the concept of a "training set" for this type of device (an oximetry sensor) is not applicable in the context of the provided document. The device's fundamental operating principles are based on known physics, and its performance is validated through clinical testing against a reference standard (functional SaO2).

Ask a specific question about this device

The Dolphin ONE Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

The Dolphin ONE Model 420 oximetry sensor is indicated for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate.

The Dolphin ONE Forehead Oximetry Sensor is a reusable sensor for use with approved Dolphin ONE pulse oximeter monitors.

The reusable forehead sensor is for use on the forehead and held in place with a disposable adhesive disc and headband. The emitter and detector are mounted in a sealed pouch (same materials as in the reusable Y sensor above) constructed in a flat cylindrical shape. The sensor is provided non-sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dolphin ONE Pulse Oximetry Forehead Sensor:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only explicitly states one clear acceptance criterion (accuracy) and its corresponding performance. Other tests (biocompatibility, environmental, pulse rate, skin temperature) are mentioned as having been "complied with" or having "no reports of biocompatibility issues," but specific quantitative acceptance criteria for those tests are not detailed in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "Volunteers participated in the breathe-down protocol," but does not provide the number of volunteers.
• Data Provenance: Prospective clinical testing. The study was conducted at the "VA Hospital of Wisconsin - Milwaukee," indicating data from the USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: One expert is explicitly named: "Dr. Phillip Clifford, MD." It is unclear if he was the sole expert establishing ground truth or if others were involved but not named.
• Qualifications of Expert(s): "Dr. Phillip Clifford, MD." His specific specialty (e.g., anesthesiologist, pulmonologist) or years of experience are not provided.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method. The ground truth seems to have been established by Dr. Clifford at the VA Hospital.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The document describes a standalone clinical validation study comparing the device's readings to functional SaO2 values. There is no mention of human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was done. The clinical validation describes directly comparing the device's SpO2 values to functional SaO2 values, indicating an assessment of the device's performance independent of human interpretation or AI assistance.

7. Type of Ground Truth Used

• Functional SaO2 values. The text states, "Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpO2 values to functional SaO2 values." This suggests a reference method (likely involving blood gas analysis) was used to determine the true arterial oxygen saturation.

8. Sample Size for the Training Set

• The document does not mention a training set. Pulse oximeters are typically hardware devices that implement established physiological principles; they do not usually involve machine learning models that require a "training set" in the conventional AI sense. The testing described is for validation of the device's accuracy.

9. How the Ground Truth for the Training Set Was Established

• As no training set is mentioned or implied for this type of device, this question is not applicable.

Ask a specific question about this device

The Dolphin 2000™ Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

The Dolphin 2000™ Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with major brands of pulse oximeter monitors. They are Nellcor and BCI Compatible Sensors.

The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to predicate devices. The emitter and detector diodes are embedded in a laminate of tapes and development an adhesive bandage that is connected to the cable assombly. "The consortient by wrapping it around a finger backing that allows the sensor to be upplied to the End (Colphin 2000 Oximetry Sensors are of toe (measurement site). Tour sizes of aloposes, infant and neonatal application available, which are indicated for doc for duall, positive, mon-sterile for single patient use.

The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespin-The re-usable Dolphil 2005 Finger Olip Oximony Consor consists of the style clip that is placed on the one on anyon one on anyon maintained in mild emitter and detector components mounted in opposing clip halves, mainter and consected emitter and delection components mounted in opposing only his house the optiolection in complession by a spring mings. The montain contact with the patient's finger. Clear components within contoured paids that the read to pass through the finger for the measurements.

The Re-usable Y sensor is for use on the ear, finger, hand, or neonatal foot and held in The Re-usable 1 Sensor is for use on the sensor can also be used on the adult ear with the place with a disposable bandage. The concer or enounted in a sealed pouch (same ear clip accessory." The emitter and other cructed in a Y shape. All Dolphin sensors are provided non-sterile.

Here's an analysis of the provided text regarding the Dolphin 2000™ Pulse Oximetry Y Sensor, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The given text does not explicitly state quantitative acceptance criteria for SpO2 accuracy that Dolphin Medical Inc. aims to meet. Instead, it states that "The labeled accuracy of the Dolphin 2000 sensors is equivalent to those of the predicate devices." For the purpose of this analysis, we will infer the de-facto acceptance criteria based on standard pulse oximeter testing practices and the reported performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The text mentions "Volunteers participated in breathing down protocols," indicating human subjects.
• Data Provenance:
  • Country of Origin: USA (VA Hospital of Wisconsin - Milwaukee).
  • Retrospective or Prospective: Prospective, as it involved "breathe-down protocols" with "volunteers" specifically for the validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not explicitly stated. The study was overseen by "Dr. Phillip Clifford, MD." It is common for a physician or a team of physicians to oversee such clinical studies and approve the ground truth, but the exact number establishing the ground truth is not specified.
• Qualifications of Experts: Dr. Phillip Clifford, MD. His specific specialization (e.g., pulmonologist, anesthesiologist) is not mentioned, but an MD degree suggests appropriate medical expertise for overseeing oxygen saturation studies.

4. Adjudication Method for the Test Set

Not specified. The clinical testing involved comparing SpO2 values to functional SaO2 values, implying a direct comparison to a gold standard, rather than a consensus-based adjudication of the device's output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. This device is a sensor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. The study focused on the standalone accuracy of the sensor itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The "Clinical Testing" section describes a study where "Dolphin 2000 SpO2 values" were statistically compared to "functional SaO2 values," which is a direct measurement of the sensor's accuracy in a human clinical setting without human interpretation of the sensor's raw output.

7. The Type of Ground Truth Used

The ground truth used was functional SaO2 values. This is typically measured using arterial blood gas analysis (CO-oximetry), which is considered the gold standard for measuring arterial oxygen saturation.

8. The Sample Size for the Training Set

Not applicable. The Dolphin 2000 Oximetry Sensor is a hardware device (sensor) and not an AI/Machine Learning algorithm that requires a training set. Its "performance" is based on its physical design and electro-optical properties.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this device does not use a training set in the context of AI/ML. Its ground truth for performance validation (as described in point 7) was established through clinical measurements against a gold standard.

Ask a specific question about this device

The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

The Dolphin 2000 Y Oximetry Sensor is a fully compatible re-usable replacement sensor for use with Nellcor pulse oximeter monitors. The Re-usable Y sensor is for use on the ear, finger, hand, or neonatal foot and held in place with a disposable bandage. The sensor can also be used on the adult ear with the ear clip accessory. The emitter and detector are mounted in a sealed pouch (same material as in the re-usable clip sensor above) constructed in a Y shape. The sensor is provided non-sterile.

Here's a summary of the acceptance criteria and study details for the Dolphin 2000™ Pulse Oximetry Y Sensor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a number of volunteers. The document mentions "Volunteers participated in the breathe-down protocol."
• Data Provenance: Prospective clinical study conducted in the USA. (VA Hospital of Wisconsin - Milwaukee).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not explicitly stated. The study was conducted at the "VA Hospital of Wisconsin - Milwaukee, (Dr. Phillip Clifford, MD.)." Dr. Clifford, as an MD, would be considered an expert. It's unclear if other experts were involved in establishing the ground truth.
• Qualifications of Experts: Dr. Phillip Clifford, MD.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document refers to "statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values." This suggests a direct comparison method rather than an adjudication process involving multiple human interpretations of the ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? No, a MRMC comparative effectiveness study was not done. The study focuses on the device's accuracy against a physiological reference, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done? Yes, the clinical validation described focused on the direct performance of the Dolphin 2000 sensors (the "algorithm/device only") compared to functional SaO2 values. There's no mention of a human-in-the-loop component in this specific accuracy testing.

7. Type of Ground Truth Used

• Type of Ground Truth: Functional SaO2 values. This is a direct physiological measurement, likely obtained through co-oximetry, considered the gold standard for arterial oxygen saturation.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not stated. The document describes a medical device, not an AI/Machine Learning algorithm that would typically have a separate training set. The device's underlying principles are based on established oximetry technology, not on machine learning trained on large datasets.

9. How the Ground Truth for the Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable. As mentioned above, this is a hardware medical device using established photoplethysmography principles, not an AI system requiring a 'training set' with associated ground truth in the typical machine learning sense. The device's calibration and design would be based on fundamental scientific principles and existing validated technologies.

Ask a specific question about this device

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

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).

Ask a specific question about this device

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.

Ask a specific question about this device

The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

The Dolphin 2000 Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with Nellcor pulse oximeter monitors. They represent a design change to the Dolphin 2000 BCI Compatible Sensors.

The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to predicate devices. The emitter and detector diodes are embedded in a laminate of tapes that is connected to the cable assembly. The sensors have an adhesive bandage backing that allows the sensor to be applied to the patient by wrapping it around a finger or toe (measurement site). Four sizes of disposable Dolphin 2000 Oximetry Sensors are available, which are indicated for use for adult, pediatric, infant and neonatal application sites. The Dolphin 2000 disposable sensors are provided non-sterile for single patient use.

The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespinstyle clip that is placed on the end of a finger. The finger clip sensor consists of the emitter and detector components mounted in opposing clip halves, maintained in mild compression by a spring hinge. The molded outer components house the optoelectric components within contoured pads that maintain contact with the patient's finger. Clear windows within these pads permit the optical energy to pass through the finger for the measurements. The Dolphin 2000 re-usable sensors are provided non-sterile.

The Dolphin 2000 Oximetry Sensors were validated in clinical testing to demonstrate their accuracy in measuring arterial oxygen saturation (SpO2).

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly stated how many volunteers participated, but the study implies a group of "Volunteers."
• Data Provenance: Prospective (breathe-down protocol in a clinical setting), conducted at the VA Hospital of Wisconsin - Milwaukee, USA.

3. Number of Experts and Qualifications:

• Number of Experts: One expert is explicitly named: Dr. Phillip Clifford, MD.
• Qualifications: "Dr. Phillip Clifford, MD." implies a medical doctor, likely with expertise in physiology or critical care relevant to oximetry. Specific years of experience or specialization are not detailed.

4. Adjudication Method:

• Not applicable as the ground truth (functional SaO2) was established by direct measurement from arterial blood gas analysis, not expert consensus or review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone accuracy of the device against a physiological ground truth.

6. Standalone Performance:

• Yes, a standalone study was performed. The device's SpO2 values were statistically compared to functional SaO2 values obtained from volunteers during a breathe-down protocol.

7. Type of Ground Truth Used:

• Physiological Ground Truth: Functional SaO2 values, likely obtained through co-oximetry via arterial blood gas analysis, are implied as the comparison standard ("statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values").

8. Sample Size for the Training Set:

• The document does not explicitly mention a separate "training set" or its size. The described "Clinical Testing" focuses on validation. It is common for such medical devices to be developed and refined using internal data, but details of that process are not provided in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established:

• As a separate training set is not explicitly mentioned, the method for establishing its ground truth is not detailed in this document.

Ask a specific question about this device

The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) 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 document provided is a 510(k) summary for the Dolphin Medical 2100 Pulse Oximeter, which is a medical device regulation submission to the FDA. It outlines the product's intended use, predicate devices, and compliance with various standards. However, it does not contain the detailed study information required to answer many of your specific questions regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment.

A 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed clinical study report with specific performance metrics and study design details as might be found in a clinical trial publication.

Based on the provided text, here’s what can be extracted and what cannot:

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

• Cannot be created. The document mentions compliance with standards like ISO 9919:1992 and EN 865:1997, and the FDA Guidance Document for Pulse Oximeters: 9/7/1992. These standards and guidance documents define the acceptance criteria for pulse oximeters (e.g., accuracy against a co-oximeter in induced hypoxia studies). However, the actual acceptance criteria values (e.g., A_rms value) and the reported device performance values against these criteria are not present in this 510(k) summary. The summary only states that the device has been "designed to comply" and implies that "additional performance validation testing has been performed," but it does not present the results of that testing or the specific acceptance thresholds.

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

• Cannot be determined. The document mentions "additional performance validation testing" for certain sensor models but provides no details about the sample size, the nature of the test set (e.g., number of subjects, type of patients), or data provenance (e.g., country, retrospective/prospective).

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)

• Not applicable/Cannot be determined. For pulse oximeters, the "ground truth" for SpO2 accuracy is typically established by arterial blood gas analysis using a co-oximeter during controlled desaturation studies, not by human experts interpreting data. The document does not mention any role for human experts in establishing ground truth for performance testing.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers interpret medical images or data and their interpretations need to be reconciled to establish a consensus ground truth. This is not how pulse oximeter performance accuracy is determined.

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 pulse oximeter, not an AI-powered diagnostic tool that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

• Yes, implicitly. A pulse oximeter by nature is a standalone device that provides a measurement (SpO2 and pulse rate) without human interpretation in the loop to determine the primary output. The document states its intended use is for "continuous noninvasive monitoring." The performance validation mentioned would evaluate the accuracy of this standalone measurement against a reference standard.

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

• Implicitly, a reference standard for physiological measurement. For pulse oximeters, the ground truth for SpO2 accuracy is established by a reference method, typically an invasive co-oximetry measurement of arterial blood samples, often performed during controlled desaturation studies in human volunteers. The document does not explicitly state this, but it is the standard method for SpO2 accuracy testing as per relevant standards (e.g., ISO 9919, EN 865, FDA Guidance 1992 mentioned).

8. The sample size for the training set

• Not applicable/Cannot be determined. Traditional pulse oximeters use established optical principles and signal processing algorithms, not machine learning or AI that requires a "training set" in the common sense of the term. While algorithms are part of the device, they are typically developed using engineering principles and validated, not "trained" on a dataset in the way a neural network would be. The document does not mention any training set.

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

• Not applicable. As above, the concept of a "training set" and its associated ground truth establishment is not relevant to this type of traditional medical device, particularly as described in this 510(k) summary.

Ask a specific question about this device

The Dolphin Medical Voyager Pulse Oximeter and Accessories are indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an oximetry sensor). The oximeter is indicated for use with a Pocket PC (with Windows CE Operating System).

The Pocket PC based Dolphin Medical Voyager Pulse Oximeter and Accessories, is fully functional handheld device to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate through a Compact Flash (CF) Card. The Voyager consists of a CF card, and a connecting cable and is sold with the Dolphin ONE reusable and disposable sensors and the Dolphin Voyager Software as accessories. The user is required to load the Dolphin Voyager Software on a Pocket PC. The Voyager is intended for battery use only using the internal Pocket PC battery. The oximeter must not be used when connected to any other device, or when placed in the recharging cradle provided by the Pocket PC manufacturer. The Dolphin Voyager software will disable the oximetry function and display a message "Unit Charging - Do Not Use" when external power is detected. 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 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 (SpO2) and pulse rate, and provide for the connection to the connecting cable. The connecting cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration driver to the oximetry sensor from the the monitor receives the detector signal from the oximetry sensor. 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.

Here's a breakdown of the acceptance criteria and study information for the Dolphin Medical Voyager Pulse Oximeter, based on the provided text:

Acceptance Criteria and Device Performance

Note: ARMs (Accuracy, Root Mean Square) is a measure of the statistical accuracy of the pulse oximeter readings compared to reference values.

Study Details

1. Sample sized used for the test set and the data provenance:
* Sample Size: 14 volunteers.
* Data Provenance: Prospective, clinical data collected at the VA Hospital of Wisconsin - Milwaukee (USA).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not explicitly stated. However, the study was conducted under the direction of Dr. Philip Clifford, MD, implying medical expertise was involved in the clinical validation, including potentially obtaining functional SaO2 values.

3. Adjudication method for the test set:
* Not explicitly mentioned. The text states "Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpOz values to functional SaO2 values," suggesting direct comparison to a reference standard rather than multi-reader adjudication as typically seen in image-based diagnostics.

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:
* No. This type of study (MRMC) is not relevant for a pulse oximeter, which is a standalone device measuring physiological parameters, not interpreting images or clinical cases requiring human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes. The study assessed the accuracy of the Dolphin Medical Voyager Pulse Oximeter itself by comparing its readings (SpO2 values) to a reference standard (functional SaO2 values) during breathe-down protocols. This is a standalone performance evaluation.

6. The type of ground truth used:
* Physiological Ground Truth: Functional SaO2 values, likely obtained through co-oximetry, which is considered the gold standard for measuring arterial oxygen saturation. The breathe-down protocol specifically generated a range of SaO2 values for comparison.

7. The sample size for the training set:
* Not specified. The document describes the clinical validation study (test set) but does not provide details on any separate training set used for the device's development or internal calibration.

8. How the ground truth for the training set was established:
* Not specified, as details about a training set are not provided. However, generally, for pulse oximeters, initial calibration and development would also rely on comparisons to known physiological oxygen saturation levels, often from similar breathe-down studies or controlled laboratory settings.

Ask a specific question about this device

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.

Ask a specific question about this device