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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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