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The MTEK-1000 unit is to be used to measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity.

The MTEK-1000 unit is a pulse oximeter. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-1000-US oximeters are equipped to monitor ECG waveforms.

This is a submission for a 510(k) premarket notification for the MTEK-1000 Pulse Oximeter, which was cleared by the FDA in 1998. The document provided does not contain the detailed study information typically required to answer your questions about acceptance criteria and device performance in the format you've requested.

The document primarily states that the MTEK-1000 is substantially equivalent to legally marketed predicate devices. For 510(k) submissions, manufacturers typically compare their device to existing devices rather than conducting extensive clinical trials with detailed acceptance criteria and standalone performance studies as might be done for a PMA (Premarket Approval).

Therefore, based solely on the provided text, I cannot provide the specific details regarding:

• 1. A table of acceptance criteria and the reported device performance: This information is not present in the letter. A 510(k) summary (which is a separate document) or the full 510(k) submission would contain performance data used to demonstrate substantial equivalence, but it's not in this clearance letter.
• 2. Sample size used for the test set and the data provenance: Not available in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
• 4. Adjudication method for the test set: Not available.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: MRMC studies are generally not required for 510(k) clearances, especially for devices like pulse oximeters, and are not mentioned here.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a pulse oximeter in this context. While the device itself is a "standalone" measurement tool, the concept of "algorithm only" performance or "human-in-the-loop" is typically associated with AI/ML diagnostic software, which this device is not.
• 7. The type of ground truth used: Not available.
• 8. The sample size for the training set: Not applicable as this device is not an AI/ML algorithm that requires a "training set" in the modern sense.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does tell us:

• Device: MTEK-1000 Pulse Oximeter
• Indications for Use: To measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. Also, "MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity."
• Regulatory Class: II
• Product Code: 74 DQA (Pulse Oximeter)
• Regulatory Pathway: 510(k) Premarket Notification
• Outcome: Substantial Equivalence to legally marketed predicate devices, allowing the device to be marketed.

To get the specific data you're looking for, one would typically need to review the 510(k) Summary (often publicly available) or the full 510(k) submission itself, which would contain the performance data and comparisons to predicate devices that led to the FDA's substantial equivalence determination. This letter is the official notification of clearance, not the detailed technical review.

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