(108 days)
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
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic, non-irritant, non-sensitizing for skin contact materials | Tests demonstrated materials to be non-toxic, non-irritant, and non-sensitizing. |
| Electrical Safety: Compliance with EN 60601-1 and ASTM F1415-92 | Tested and found to comply with applicable clauses of EN 60601-1 (1990) and ASTM F1415-92. |
| Clinical Accuracy (SpO2): Expected range of 70-100% SaO2 | Demonstrated "scientific accuracy" by statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values. Data was analyzed to determine the ARMS (Accuracy Root Mean Square) for each probe, but specific ARMS values or numerical accuracy thresholds are not provided. |
| Substantial Equivalence: In intended use, design, principles of operation, materials, and performance to predicate devices | The device is stated to be "substantially equivalent in intended use, design, principles of operation, materials, and performance to commercially available oximetry sensors." |
| Labeled Accuracy: Equivalent to predicate devices | The labeled accuracy of the Dolphin 2000 sensors is stated to be "equivalent to those of the predicate devices." |
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).
§ 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).