(140 days)
The Quanta Pulse Oximeter , Model no. Pulse Link 1000 (or QH100) is a handheld pulse oximeter with alarm. It is intended to be used by trained healthcare professionals in hospital, hospital type facilities, as well as in the home care environment .
The Pulse Link 1000 Pulse Oximeter is indicated for non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate of patients on fingers (forefinger or middle finger).
The Pulse Link 1000 Pulse Oximeter is re-useable. It is indicated for adult patients under no-motion conditions.
The Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100) is a digital handheid pulse oximeter that displays numerical values for blood oxygen saturation (%SpO2) and pulse rate. It provide audible and visual alarms for both medium and high priority conditions.
The Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100) will typically operate for 24 hours continuously between alkaline battery replacements. The QH100 Oximeter requires no routine calibration or maintenance other than replacement of alkaline batteries and basic cleaning.
The Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100) determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Oxygen saturation and pulse rate values are displayed by LCM monitor. On each detected pulse, the LED indicates the health condition of the patient. If the health condition of the patient is bad ( under some specific criteria), the LED will blink red and beeps alarm from the speaker. A sensor disconnect is also indicated by the LED blinking yellow and beeps alarm from the speaker. The remaining energy of the battery is indicated by the marked scale of the battery indicator on the LCM monitor.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. The submission is a 510(k) summary for a pulse oximeter, and it focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred regarding performance and compliance:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical values for accuracy or other performance metrics. Instead, it states that the device conforms to applicable standards. The "performance" section mentions:
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|
| Operating specifications | Conforms to ISO 9919 |
| Safety requirements | Conforms to IEC 60601-1 |
| EMC requirements | Conforms to IEC 60601-1-2 |
It is inferred that the acceptance criteria are the requirements outlined in these standards. The device's reported performance is simply that it "conforms" to these standards, implying it meets their respective requirements. Specific accuracy ranges for SpO2 or pulse rate are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given 510(k) summary. The document states "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness," indicating that some testing was done, but details regarding sample size, data provenance, or study design (retrospective/prospective) are absent.
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)
This information is not provided. Given that this is a pulse oximeter and the claim is conformance to standards, the "ground truth" would typically come from reference instrumentation in a controlled environment, not expert human assessment in the way it might for imaging diagnostics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are not typically relevant for performance testing of a pulse oximeter where objective measurements against a reference are paramount.
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
An MRMC study is not applicable and was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that relies on human readers interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done, as detailed in the "bench testing" mentioned in the conclusions. The device's performance is determined by its ability to accurately measure SpO2 and pulse rate independently. The summary states: "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." This implies the device was tested to perform its intended function on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The direct ground truth used is not explicitly stated, but for a pulse oximeter conforming to ISO 9919, the ground truth for SpO2 accuracy would typically be established using invasive arterial blood gas analysis (CO-Oximetry) as a reference method in controlled desaturation studies on healthy volunteers. The ground truth for pulse rate would be a highly accurate heart rate monitor.
8. The sample size for the training set
This information is not provided. Pulse oximeters generally do not use "training sets" in the same way machine learning algorithms do. Their operation is based on established physical principles of light absorption by oxygenated and deoxygenated hemoglobin. If any calibration or algorithm tuning occurred, the data used for that is not disclosed here.
9. How the ground truth for the training set was established
This information is not provided and is likely not relevant in the context of a traditional pulse oximeter device design.
§ 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).