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The OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories and indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The OSI Medical Dolphin Pulse Oximeter and Accessories are indicated for use with adult, pediatric and neonatal patients in hospital, institutional, industrial and home environments.

The OSI Medical's sensor(s) are intended/indicated for use only with the OSI Medical Dolphin Stand-Alone Pulse Oximeter, and consist of the following:

Digital Dolphin Disposable Sensors
Digital Dolphin 210 Reusable Finger Clip intended for adults / pediatrics greater than 66.14 lbs. (30kg).
Digital Dolphin 110 Extension Cable

The OSI Medical extension cable is intended/indicated for use only with the OSI Medical sensor(s) and the OSI Medical Dolphin Stand-Alone Pulse Oximeter.

Device Description

The OSI Medical Dolphin Pulse Oximeter 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, 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 functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provide for the connection to the connecting cable.

The OSI Medical Dolphin Pulse Oximeter is available in one configuration as a portable stand-alone 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 a disposable or reusable configuration, and with one configuration for the extension cable (8 feet).

AI/ML Overview

The provided text does not contain specific acceptance criteria, detailed study information, or a table of acceptance criteria and reported device performance. It primarily focuses on the regulatory submission and approval of the OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100, and mentions compliance with various standards.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study details.
Standalone (algorithm only) performance study details.
Type of ground truth used.
Sample size for the training set.
How the ground truth for the training set was established.

The document states that "Additional testing has been performed for the disposable sensors including biocompatibility and performance validation which has been included in this submission," but it does not provide the results or methodologies of this performance validation. It lists various standards the device complies with (e.g., ISO 9919: 1992, EN 865: 1997, FDA Guidance Document for Pulse Oximeters: 9/7/1992, ASTM 1415:1992). These standards likely define performance criteria for pulse oximeters, but the specific acceptance criteria and the device's measured performance against them are not present in this summary.

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K Number

K012533

Device Name

MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES

Manufacturer

OSI MEDICAL, INC.

Date Cleared

2001-08-22

(16 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K002036

Intended Use

The OSI Medical Dolphin Stand-Alone Pulse Oximeter 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 OSI Medical Dolphin Pulse Oximeter and Accessories are intended for use with additional monitoring equipment in clinical facilities and home environments.

The OSI Medical's sensor(s) are intended/indicated for use only with the OSI Medical Dolphin Stand-Alone Pulse Oximeter, and consist of the following:

Digital Dolphin Disposable Sensors intended for adults / pediatrics greater than 66.14 Ibs. (30kg).
Digital Dolphin Reusable Sensors Intended for adults / pediatrics greater than 66.14 Ibs. (30kg).
Digital Dolphin 110 Extension Cable

The OSI Medical extension cable is intended/indicated for use only with the OSI Medical sensor(s) and the OS/ Medical Dolphin Stand-Alone Pulse Oximeter.

Device Description

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 functional oxygen saturation of arterial hemoglobin (SpQz) and pulse rate, and provide for the connection to the connecting cable.

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 oximetry sensor is available in a disposable or reusable configuration, and with one configuration for the extension cable (8 feet).

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details for the OSI Medical Dolphin Stand-Alone Pulse Oximeter:

This 510(k) submission primarily details the substantial equivalence of the OSI Medical Dolphin Disposable Optical Sensor, Model 510 by referring to an earlier 510(k) for the OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100 (K002036). The focus seems to be on demonstrating that the new disposable sensor works equivalently with the previously cleared oximeter. Therefore, the information regarding acceptance criteria and performance is largely indirect and based on the equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The main acceptance criteria for pulse oximeters are typically accuracy (SpO2 and pulse rate) and functionality, often assessed against a reference standard. Since this document is a 510(k) summary for a disposable sensor that relies on a previously cleared oximeter, explicit performance data for the entire system (oximeter + disposable sensor) is not detailed with specific accuracy numbers in the provided text. Instead, the document states that "Additional testing has been performed for the disposable sensors including biocompatibility and performance validation which has been included in this submission."

Given the information provided, we can infer the acceptance criteria and performance based on common pulse oximeter standards and the implicit claim of equivalence.

Acceptance Criteria Category	Specific Criteria (Inferred from standards and product type)	Reported Device Performance (Inferred/Stated)
Accuracy (SpO2)	SpO2 Accuracy (Arms) within generally accepted limits (e.g., +/- 2-3% in range 70-100% SpO2) per ISO 9919 / EN 865 and FDA guidance.	"Performance validation" has been performed, implying it meets the accuracy requirements of the predicate device and relevant standards. No specific SpO2 accuracy (e.g., Arms) is provided in this summary.
Accuracy (Pulse Rate)	Pulse Rate Accuracy (e.g., +/- 1-2 bpm)	"Performance validation" has been performed. No specific pulse rate accuracy is provided in this summary.
Biocompatibility	Compliance with ISO 10993 standards for patient contact.	Biocompatibility testing for the disposable sensors has been performed and included in the submission.
Electrical Safety	Compliance with IEC 60601-1 and CSA C22.2 No. 601.1	The device complies with IEC 601-1, CSA C22.2 No. 601.1, and UL2601-1.
Electromagnetic Compatibility (EMC)	Compliance with IEC 601-1-2	The device complies with IEC 601-1-2.
Functionality/Design	Meets design and operational specifications for a pulse oximeter.	"Substantially equivalent in design concepts, technologies and materials" to the predicate device.
Environmental/Packaging	Compliance with relevant environmental testing (e.g., IEC 6068-2 series, ISTA Procedure 2A).	Complies with IEC 6068-2-6, IEC 6068-2-27, IEC 6068-2-64, and ISTA Procedure 2A.

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

The summary does not explicitly state the sample size for the test set used for performance validation of the disposable sensors.

Data Provenance: The document does not specify the country of origin for the data. The study type (retrospective or prospective) is also not mentioned. However, "performance validation" for a new sensor usually implies a prospective study involving human subjects or controlled laboratory testing.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth. For pulse oximeter performance validation, ground truth (arterial oxygen saturation) is typically established through a co-oximeter analyzing arterial blood samples, not directly by expert consensus on visual assessment.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This is generally not applicable in the context of pulse oximeter accuracy studies, where comparison is made against a physiological reference standard rather than subjective expert interpretation.

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

No, an MRMC comparative effectiveness study was not done or described in this summary. This type of study is more relevant for diagnostic imaging devices where human interpretation is a key component. Pulse oximeters are typically evaluated for standalone accuracy.

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

Yes, implicitly. The "performance validation" for the disposable sensors, in conjunction with the oximeter, would be a standalone performance assessment. The device calculates SpO2 and pulse rate automatically, so the relevant performance is its accuracy in comparison to a reference standard, independent of human interpretation of the values.

7. The Type of Ground Truth Used

The ground truth for pulse oximeter accuracy studies is typically established by:

Co-oximetry of arterial blood samples: This is the gold standard for directly measuring functional arterial oxygen saturation (%HbO2) in blood.
Controlled hypoxia studies: For SpO2 accuracy, subjects are typically desaturated under controlled conditions, and simultaneous arterial blood samples are taken and analyzed by a co-oximeter.

While not explicitly stated in this summary, "performance validation" for a pulse oximeter sensor would undoubtedly rely on one of these methods, most likely co-oximetry.

8. The Sample Size for the Training Set

The document does not specify a training set size. Pulse oximeters, especially those from 2001, typically do not employ machine learning models in the same way modern AI-powered diagnostic devices do. Their algorithms are usually based on spectrophotometry and signal processing principles, which are designed rather than "trained" on large datasets. If any form of calibration or algorithm optimization was done using data, it's not described as a "training set" in the modern AI sense.

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

As explained in point 8, the concept of a "training set" and associated ground truth establishment for a pulse oximeter, as understood in contemporary AI/ML contexts, is not applicable or described in this 2001 510(k) summary. The device's underlying principles rely on known physiological properties of light absorption by blood, rather than statistical learning from a diverse training dataset.