(88 days)
Nonin's non-invasive Model 7600 4-Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.
The 8004CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8004CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.
The 8000CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8000CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.
Nonin's® Model 7600 4-Channel Regional Oximeter System with Equanox™ Technology and Bluetooth® Wireless Technology and compatible sensors (8004CA, 8000CA) continuously monitor and record the mixed arterial/venous blood oxygen levels through non-invasive near-infrared spectroscopy sensors. The system is comprised of three subsystems; sensor, patient oximetry device (pod) and 4-channel display unit.
The sensor allows light absorption measurements at various wavelengths in the near-infrared spectrum (approximately 700 to 900 nanometers). The sensor is approximately 1.5 by 3 inches.
The sensors plug into the patient oximetry device (pod) which controls the light emitted from the sensor LEDs and measures the light returning to the sensor photodiodes. From these measurements, the pod determines specific absorption values and calculates the mixed arterial/venous oxygen saturation values. The pods then communicate the regional oxygen saturation readings and other data to the display unit.
The 4-channel display unit displays absolute real-time regional hemoglobin oxygen saturation (rSO2) numeric data and trend lines. It is a battery-backed, mains powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module.
The Nonin Medical, Inc. K102715 submission for the Model 7600 4-Channel Regional Oximeter System does not contain specific acceptance criteria or a detailed study description with reported device performance metrics in the provided document sections.
The document states that the device "successfully undergone extensive performance, electromagnetic, safety, clinical, environmental, and software testing to ensure that it has appropriate functional features and is substantially equivalent to the predicate devices." (Section 2) However, it does not elaborate on what constituted "successful" in terms of specific performance metrics or acceptance criteria.
The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of novel performance studies with specific statistical acceptance criteria.
Therefore, I cannot populate the table or provide answers to most of the requested points as the specific information is not present in the provided text.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|
| Not provided in the document. | The document states the device "successfully undergone extensive performance... testing," but does not provide specific performance metrics (e.g., accuracy, precision, bias) or how "successful" was defined. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective). The document only mentions "clinical" testing was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided in the document.
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
- This information is not provided in the document. The device is a regional oximeter, not an AI-assisted diagnostic imaging device, so an MRMC study with human readers assisting AI would be out of scope for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The device is an oximeter, which inherently functions as a "standalone" measurement device that provides output for human interpretation. The clinical testing mentioned would implicitly evaluate the algorithm's performance in generating these measurements. However, no specific "standalone study" with detailed methodology or results (like those seen for AI algorithms) is described. The document states it "continuously monitor[s] and record the mixed arterial/venous blood oxygen levels through non-invasive near-infrared spectroscopy sensors," implying the device produces measurements independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. For oximeters, the "ground truth" for oxygen saturation is typically established through co-oximetry of arterial blood samples. However, this specific method is not detailed in the provided text.
8. The sample size for the training set
- This information is not provided in the document. Given that this is a 510(k) for a regional oximeter (a sensor and measurement device), rather than a machine learning algorithm that requires extensive training data, the concept of a "training set" in the context of AI/ML is likely not directly applicable here. The device's "training" would likely refer to the design and calibration process during manufacturing.
9. How the ground truth for the training set was established
- This information is not provided in the document. As noted above, the concept of a "training set" in the AI/ML sense is likely not applicable.
§ 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).