(87 days)
The M70 fingertip pulse oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospital type facilities as well as in the home care environment. The oximeter is not suitable to monitor patient continuously for long term.
The M700 handheld pulse oximeter is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities as well as in the home care environment.
The subject device of M70 Fingertip Pulse Oximeter is a fingertip device, which can display %SpO2, pulse rate value, waveform pulse amplitude bar indication. The subject device consists of detector and emitter LED, OLED display module, CPU, driving circuit, power supply circuit and battery. The operational principle of subject device uses the method as mensurated optical density by spectrophotometer. It is base on the double wavelength Lambert Beer's Law and uses the specific absorbance of oxygenation hemoglobin and deoxyhemoglobin to calculate.
The subject device of M700 Handheld Pulse Oximeter is a handheld device, whose mainly function are display %SpO2, pulse rate value, pulse amplitude bar indication. The operational principle of subject device uses the method as mensurated optical density by spectrophotometer. It is base on the double wavelength Lambert Beer's law and uses the specific absorbance of oxygenation hemoglobin and deoxyhemoglobin to calculate. The subject device consists of detachable SpO2 sensor, Main Frame and Battery. The Main Frame consist two parts, which is Control Module and SpO2 Module.
The provided text is a 510(k) Summary Report for two pulse oximeters, the M70 Fingertip Pulse Oximeter and the M700 Handheld Pulse Oximeter. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving these devices meet those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
The report focuses on demonstrating "Substantial Equivalence" to predicate devices, which is a common pathway for medical device approval in the US. This means the manufacturer largely relies on the predicate devices' established safety and effectiveness.
Here's an analysis of the provided text in relation to your questions, highlighting what is not present:
1. A table of acceptance criteria and the reported device performance
- Not present. The document does not provide a table outlining specific acceptance criteria (e.g., accuracy range for SpO2, PR) or detailed performance data for the M70 or M700 that would directly compare to such criteria. The "Conclusion" sections for both devices state they have "same performance effectiveness, performance safety as the predicate device," but no specific metrics are given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. The document mentions "Laboratory testing" and "Clinical testing" were conducted for the M700, but it does not provide details on the sample size (number of subjects, number of data points), data provenance (country of origin), or whether the studies were retrospective or prospective.
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 present. As there's no detailed study description, there's no mention of experts used to establish ground truth or their qualifications. For pulse oximeters, ground truth is typically established by arterial blood gas analysis, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. No information regarding adjudication methods is provided.
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/Not present. Pulse oximeters are direct measurement devices; they do not involve human "readers" interpreting images or data where AI assistance would be relevant in an MRMC study. Therefore, this type of study would not be performed for this device, and no such information is present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The devices themselves are standalone in the sense that they directly measure and display SpO2 and pulse rate. However, the document doesn't explicitly describe a specific "standalone algorithm performance" study separate from the overall device testing. The focus is on the device as a whole.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Implicit, but not explicitly stated or detailed in the provided text. For pulse oximetry, the gold standard (ground truth) for oxygen saturation is typically arterial blood gas analysis (co-oximetry). While the document mentions "Laboratory and Clinical testing," it does not specify how ground truth was established for these tests.
8. The sample size for the training set
- Not applicable/Not present. These devices are not described as using machine learning or AI algorithms that would require a "training set" in the conventional sense. They operate based on established physical principles (Lambert Beer's Law and spectrophotometry) and fixed algorithms.
9. How the ground truth for the training set was established
- Not applicable/Not present. As these devices do not (as described) utilize machine learning requiring a training set, the establishment of ground truth for such a set is not relevant.
Summary of what is available regarding testing and equivalence:
- Device Tested: M70 Fingertip Pulse Oximeter and M700 Handheld Pulse Oximeter.
- Testing Conducted:
- M70: "Laboratory testing was conducted to validate and verify that M70 Fingertip Pulse Oximeter met all design specifications, including electrical safety, EMC, biocompatibility, specification."
- M700: "Laboratory and Clinical testing was conducted to validate and verify that M700 Handheld Pulse Oximeter met all design specifications, including electrical safety, EMC, biocompatibility, specific[ation]."
- Conclusion of Testing: "Results of these tests demonstrate compliance to the requirements of all consensus standards."
- Substantial Equivalence: Both devices were deemed "Substantially Equivalent (SE)" to their respective predicate devices (MD300C for M70, and PM-60 for M700, though the M700 section only lists the PM-60 without explicitly linking it as its predicate in the same way the M70 lists MD300C). This equivalence is based on "same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety."
- Differences from Predicate: Minor differences noted include Measurement Wavelengths, Working time, Operating temperature, PR Measuring range, Atmosphere pressure (M70); and Measurement Wavelengths, Display Unit, Power, Working time, Operating temperature, PR Measuring range, Relative humidity, Atmosphere pressure (M700). These differences were not deemed to affect safety or effectiveness.
§ 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).