(336 days)
The Model 512 Handheld Pulse Oximeter is intended to provide non-invasive spot checking of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport.
The Model 513 Handheld Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport.
The monitor and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgment of a licensed medical practitioner.
The Model 512/53 Pulse Oximeters are designed for non-invasive measurement of the functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as successories to the Model 510 monitor. The Model 510 displays digital values of SpO2 and pulse rate. The Model 512/513 consists of a microprocessor based data acquisition system that measures oxygen saturation data. The Model 513 also contains additional circuitry to support battery backed trend data storage and retrieval. Data is stored in a 16Kbyte serial Flash RAM, with time and date retrieved from a separate serial real time clock. The trend data may be transferred serially to a printer or PC via an IRDA compatible chipset.
Acceptance Criteria and Device Performance for Model 512/513 Pulse Oximeter
The provided document describes the predicate device equivalence of the Model 512/513 Pulse Oximeter, rather than a standalone study with defined acceptance criteria and performance metrics for the new device. The core of the submission relies on demonstrating that the Model 512/513 is substantially equivalent to the legally marketed Model 510 Pulse Oximeter and that its sensors meet the currently published accuracy specifications of the Model 510.
Therefore, the "acceptance criteria" for the Model 512/513 can be inferred as meeting or performing comparably to the Model 510's established accuracy specifications. The document does not explicitly state these numerical specifications for the Model 510, nor does it provide specific novel performance data for the Model 512/513 beyond stating that "inter-device comparison studies were conducted to establish the Model 512/513s accuracy and to ensure that the sensors meet their currently published accuracy specifications with the Model 510."
However, based on the information provided, we can structure the response by inferring the likely acceptance criteria based on standard pulse oximetry requirements and what is typically tested for equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Given the lack of explicit numerical acceptance criteria for the Model 512/513 in the provided text, and the reliance on demonstrating equivalence to the Model 510, the table below reflects this approach. The "Reported Device Performance" is derived from the statement that the device meets the predicate's specifications.
| Acceptance Criterion (Inferred from Predicate Equivalence) | Reported Device Performance (Model 512/513) |
|---|---|
| Functional arterial oxygen saturation (SpO2) accuracy comparable to Model 510's published specifications | Sensors meet currently published accuracy specifications of the Model 510. |
| Pulse rate accuracy comparable to Model 510's published specifications | Sensors meet currently published accuracy specifications of the Model 510. |
| Non-invasive measurement capability | Designed for non-invasive measurement. |
| Ability to operate in specified patient populations (neonatal, pediatric, adult) | Intended for neonatal, pediatric, and adult patients. |
| Ability to operate in specified environments (hospital, hospital-type facilities, intra-hospital transport) | Intended for hospital, hospital-type facilities, and intra-hospital transport. |
| Use of identical SpO2 and pulse rate software algorithm as predicate device (Model 510) | Uses identical SpO2 and pulse rate software algorithm as the predicate device, Model 510. |
Note: The FDA's Oximeter regulation (21 CFR 870.2700) typically requires accuracy testing against arterial blood gas (SaO2) measurements over a range of saturations (e.g., 70-100% SpO2), often using hypoxic challenge studies. The absence of these specific details indicates that the submission focuses on predicate equivalence through comparison studies, implying the Model 510 already met these regulatory standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "inter-device comparison studies were conducted," but details on the number of subjects, measurements, or data points are absent.
- Data Provenance: Not explicitly stated. The document does not mention the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of medical device testing for regulatory submission, it is highly probable these were prospective clinical studies, but this is not confirmed in the text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not stated in the context of expert review for ground truth in this submission. The ground truth for pulse oximetry accuracy studies is typically established through direct arterial blood gas (SaO2) measurements performed by trained medical personnel, not by a panel of experts reviewing images or other subjective data.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Pulse oximetry accuracy studies generally rely on direct physiological measurements (arterial blood gas analysis) as the gold standard, rather than expert adjudication of subjective assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is assessed. This device is a measurement device, not an interpretive one.
6. Standalone Performance Study (Algorithm only without human-in-the-loop)
- Standalone Study: Yes, in essence, the "inter-device comparison studies" to establish the Model 512/513's accuracy and ensure sensors meet published specifications of the Model 510 represent a standalone performance assessment of the device's measurement capabilities. While not using the explicit term "standalone study," the objective of these comparisons was to verify the device's inherent accuracy in measuring SpO2 and pulse rate, independent of a human interpreting its output.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for pulse oximetry accuracy is typically established by arterial blood gas (SaO2) measurements, which are considered the gold standard for arterial oxygen saturation. While not explicitly stated in the provided text, this is the standard methodology for validating pulse oximeter accuracy.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not stated. The document indicates that the Model 512/513 uses the "identical SpO2 and pulse rate software algorithm" as the predicate device, Model 510. This implies the algorithm was already developed and validated with the Model 510. There is no mention of a new algorithm requiring a separate training set for the Model 512/513, suggesting it leverages the existing, validated algorithm from the predicate device.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As the Model 512/513 uses the identical algorithm from the predicate device (Model 510), any "training" would have occurred during the development of the Model 510. The document does not provide details on the training set or ground truth establishment for the Model 510's algorithm development. It focuses solely on the equivalence of the 512/513 to the already-cleared 510.
§ 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).