(137 days)
The MD300K1 Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.
The Pulse Oximeter MD300K1 can display %SpO2, pulse rate value and vertical bar graph pulse amplitude. It suits for adult and pediatric patients. The device has physiological alarm which includes PR high/low alarm and SpO2 high/low alarm. At the same time, the device has a buzzer which is used for sensor off indication, pulse.indication, low voltage indication and PR & SpO2 alarm. The pulse oximeter adapts 8-segment digital LED as indication. The applicant device has low battery voltage alarm function and automatically power of function. The device supplies a sensor as the accessory and uses 2 * AA batteries. The MD300K1 Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
Here's an analysis of the provided text regarding the KCAV399 Pulse Oximeter MD300K1, focusing on acceptance criteria and study details.
Based on the provided 510(k) summary, the document states that the MD300K1 Pulse Oximeter is substantially equivalent to the predicate device PM-60 Pulse Oximeter (K072581) based on having the "same classification information, same intended use, same design principle, same specifications, same product materials and performance effectiveness."
However, this document does not include a detailed study report with specific acceptance criteria, performance metrics, sample sizes, ground truth establishment, or multi-reader studies. It largely relies on a statement of equivalence to a predicate device.
Therefore, many of the requested fields cannot be filled directly from the provided text. I will explicitly state where the information is not available in the document.
Acceptance Criteria and Device Performance (Not Available in this Summary)
The document states that the device has "same specifications" and "performance effectiveness" as the predicate device (PM-60 Pulse Oximeter, K072581). However, the specific acceptance criteria for SpO2 and Pulse Rate accuracy, and the data demonstrating the MD300K1's performance against these criteria, are not detailed in this 510(k) summary provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available | Not Available |
| (Specific SpO2 accuracy requirements, e.g., ±2% for 70-100%) | (Actual measured SpO2 accuracy from a clinical study) |
| (Specific Pulse Rate accuracy requirements, e.g., ±1 bpm or ±2%) | (Actual measured Pulse Rate accuracy from a clinical study) |
1. A table of acceptance criteria and the reported device performance
- Not Available in this document. The document claims the device has "same specifications" and "same performance effectiveness" as the predicate device (PM-60, K072581). To fully answer this, a copy of the PM-60's performance specifications or the actual clinical study report for KCAV399 would be needed.
2. Sample size Used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available in this document. The summary does not provide details about a specific clinical test set, its sample size, or data provenance.
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 / Not Available. For pulse oximeters, the ground truth for oxygen saturation is typically established through co-oximetry (blood gas analysis, a direct measurement) rather than expert consensus on images. The document does not describe the methodology for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available / Not Applicable. As no expert review or consensus method is described for "ground truth," adjudication methods are not discussed.
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 pulse oximeter, not an AI-assisted diagnostic imaging device. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this device type and were not conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. A pulse oximeter is a standalone device that provides a measurement directly. The clinical performance of such a device is inherently standalone, as there is no "human-in-the-loop" interaction with an algorithm to interpret its output in the context of diagnostic decision-making beyond reading the numerical display. However, the study details demonstrating this standalone performance are not available in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in this document, but for pulse oximeters, the accepted ground truth for oxygen saturation (SpO2) is typically arterial blood gas analysis with a co-oximeter (a gold standard laboratory measurement). The document references "functional pulse oxygen saturation" but does not detail how the accuracy of the device against a ground truth was established within a study.
8. The sample size for the training set
- Not Applicable / Not Available. Pulse oximeters are typically based on optical principles and signal processing, not machine learning or AI that requires a "training set" in the conventional sense. If there were internal algorithm development or calibration, the details are not provided.
9. How the ground truth for the training set was established
- Not Applicable / Not Available. As above, a "training set" for AI/ML is not relevant to this type of device.
§ 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).