(428 days)
Caremed Reusable & Disposable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40 kg and pediatric patients weighing 10 -50 kg at hospital facilities
Caremed Reusable & Disposable SPO2 Sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. The probe contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in sensor housing.
This document is a 510(k) premarket notification for the Caremed Reusable & Disposable SpO2 Sensors. It states that the device is substantially equivalent to a legally marketed predicate device. The information provided is primarily focused on demonstrating this substantial equivalence through comparisons of technical properties and adherence to standards, rather than providing a detailed clinical study report with specific acceptance criteria and detailed performance of the new device.
Here's an attempt to answer your questions based on the provided text, recognizing that some information is implicit or not fully detailed:
1. A table of acceptance criteria and the reported device performance
The document mentions that the subject device's SpO2 and Pulse Rate accuracy meet the requirements of ISO80601-2-61. However, it only provides the SpO2 Accuracy and Pulse Rate Accuracy of the predicate device (K100077 and K111888) as a comparison point in Table 1. It also states the subject device's accuracy has a "slight difference" from the predicate. Without the explicit values for the subject device's SpO2 and Pulse Rate accuracy and the specific ISO80601-2-61 requirements, a direct "acceptance criteria vs. reported performance" table cannot be fully constructed for the subject device.
However, based on the predicate device's performance as a proxy for expected accuracy and the statement that the subject device meets ISO80601-2-61 standards, we can infer some criteria.
| Acceptance Criteria (Inferred from Predicate & Standard) | Reported Device Performance (Implicit from "meets ISO80601-2-61") |
|---|---|
| SpO2 Accuracy (70-100%): | Meets ISO80601-2-61 requirements |
| - For systems with predicate K100077: ± 2% | |
| - For systems with predicate K111888: ± 3% | |
| Pulse Rate Accuracy (30-250bpm): | Meets ISO80601-2-61 requirements |
| - For systems with predicate K100077: ± 2 | |
| - For systems with predicate K111888: ± 3 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "human adult volunteers" but does not specify the number.
- Data Provenance: Not explicitly stated for the clinical trial. The company is based in Shenzhen, China.
- Retrospective or Prospective: "Clinical hypoxia test results were obtained in human adult volunteers" typically implies a prospective study.
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 or not mentioned. For SpO2 sensor accuracy testing, the ground truth (arterial oxygen saturation, SaO2) is typically established by laboratory methods such as co-oximetry of arterial blood samples, not by expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable or not mentioned. As the ground truth is established by co-oximetry, there's no need for an adjudication method involving human experts for the primary endpoints.
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 is a medical device for directly measuring physiological parameters (SpO2 and pulse rate), not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance test was done. The document states: "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Reusable & Disposable SPO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry." This is a direct measurement of the device's accuracy against a gold standard, which is a standalone performance assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry from arterial blood samples. This is considered a gold standard laboratory method.
8. The sample size for the training set
Not explicitly stated. For SpO2 sensors, "training data" often refers to data used to derive or refine the oximetry algorithm. If this refers to the data used for the algorithm, its size is not mentioned. If it refers to clinical data, the document mainly references the clinical performance study (test set).
9. How the ground truth for the training set was established
Not explicitly stated. Assuming a similar methodology to the test set, the ground truth for any algorithm development or training would likely have been established using co-oximetry from arterial blood samples.
§ 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).