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The Keller Medical Specialties Model-KMS890+ Combined Pulse Oximeter and Non-invasive Blood Pressure Monitor is intended to monitor the arterial oxygen saturation (SaO2), pulse rate and measure the blood pressure parameters. All values are obtained by non-invasive methods. The blood pressure parameters measured are systolic and mean arterial pressure.

This device can be operated by the internal rechargeable battery. Alarm settings for the displayed parameters can be adjusted as required.

The Model KMS-890+ is a portable, battery operated, non-invasive monitor used to measure a patient's blood pressure and/or oxygen saturation level with the pulse rate

Here's an analysis of the provided text regarding the acceptance criteria and study for the Keller Medical Specialties Model KMS 890+ Combined Pulse Oximeter/BP Monitor:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it relies on a claim of "substantial equivalence" to predicate devices. The reported device performance is therefore described in qualitative terms relative to these existing devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "No clinical tests performed." Instead, "The Model KMS 890+ was bench tested using commercially available simulators to assure the reliability of the readings."

• Sample Size for Test Set: Not applicable, as no human clinical test set was used. Bench testing with simulators implies a testing methodology rather than a patient sample size.
• Data Provenance: Not applicable, as no human data was collected. The testing was conducted in a laboratory setting using "commercially available simulators."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. Since no human clinical tests were performed, there was no need for experts to establish ground truth from patient data. The "ground truth" for the bench testing would have been the known parameters produced by the commercially available simulators.

4. Adjudication Method for the Test Set:

Not applicable. No human clinical test set was used, so no adjudication method was employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states, "No clinical tests performed." Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, in essence. The "bench testing using commercially available simulators" can be considered a standalone performance evaluation of the device's measurement capabilities. The device (the "algorithm" in this context) was directly evaluated against known inputs from the simulators without human interpretation of its outputs for diagnosis or decision-making.

7. The Type of Ground Truth Used:

The ground truth used for the device's evaluation was established by the known parameters and outputs of the commercially available simulators used during bench testing.

8. The Sample Size for the Training Set:

Not applicable. This device is a vital signs monitor, not an AI/ML algorithm that would typically require a training set of data. Its functionality is based on established physiological measurement principles, not learned patterns from data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set was used for this device.

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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.

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.

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