(71 days)
The Keller Medical Specialties Pulse Oximeter Model 850+ measures and monitors arterial oxygen saturation (SaO2) and pulse rate using standard dual wavelength pulse oximetry techniques.
This unit is portable with battery operation. The oximeter allows complete control of patient alarm limit settings.
This unit is not intended for use on neonates.
The Keller Model 850+ Pulse Oximeter is a portable, battery operated, patient pulse oximeter. It measures oxygen saturation and the pulse rate of the patient by means of an infrared sensor attached to the finger or ear.
The provided text describes the Keller Medical Specialties Model 850+ Pulse Oximeter, which measures and monitors arterial oxygen saturation (SaO2) and pulse rate. The information necessary to fully answer all parts of your request is limited, as the document focuses on regulatory submission (510(k)) and establishing substantial equivalence rather than detailing a comprehensive clinical study report with extensive statistical analysis.
However, based on the available text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria with numerical thresholds in the modern sense (e.g., "accuracy must be within ±X%"). Instead, the main "acceptance criterion" was demonstrating substantial equivalence to a predicate device and showing that there was no significant deviation in readings.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Keller Model 850) | "substantially equivalent to predicate device" |
| No significant deviation in readings compared to predicate device | "no significant deviation between the two devices" |
| Alarms tested and verified as accurate | "Alarms were tested and verified as accurate." |
| Equivalence to predicate device and a Biochem device (bench data) | "Bench data showed that the Model 850+ is equivalent to the Model 850 and a Biochem device." |
| Safe and effective on its own merits | "safe and effective on it's own merits" |
2. Sample size used for the test set and the data provenance
- Sample Size: 30 patients.
- Data Provenance: The study was a clinical comparison conducted on patients, comparing the Model 850+ to the predicate Model 850. The text does not specify the country of origin, but given the company location (Antioch, Illinois) and FDA submission, it's highly likely to be US-based. The study appears to be prospective in nature, as it involved actively "testing" the device on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts, their qualifications, or their role in establishing ground truth. The comparison was made against readings from a predicate device rather than an independent "ground truth" established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for a test set. This type of detail is usually associated with studies involving human interpretation (e.g., radiologists reading images), which is not the primary focus here. The comparison was device-to-device.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted human reading, which is not applicable to a pulse oximeter. The device measures physiological data directly.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The performance described refers to the standalone (device-only) performance of the Model 850+ compared to the predicate Model 850. The pulse oximeter is a diagnostic device that provides readings directly, without a human-in-the-loop component for interpretation in the same way an AI algorithm might augment a radiologist.
7. The type of ground truth used
The "ground truth" in this context was the readings obtained by the predicate device (Keller Model 850). The study aimed to show that the new device's readings were equivalent to or not significantly different from an already legally marketed and accepted device. There is no mention of pathology, outcomes data, or expert consensus being used as an independent ground truth for SaO2 or pulse rate measurements.
8. The sample size for the training set
The document does not mention a "training set" as this device is not an AI/ML algorithm. It's a hardware device measuring physiological parameters.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for 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).