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The AC-1 Adapter Cable with Masimo sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO₂ sensor) for use with adult, pediatic, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The AC-1 Adapter Cable is fully conpatible oximetry cable that allows the use of Masimo LNOP Sensors with Nellow and Nellcor compatible pulse oximeter monitors. The cable represents a design change to the Masino patient cables. The AC-1 Adapter Cable is similar in construction to the predicate device enabling the Masimo LNOP Sensors to be comected to Nelleor and Nellcor compatible pulse oximeter monitors.

This Masimo AC-1 Adapter Cable is a cable that connects Masimo LNOP sensors to Nellcor and Nellcor-compatible pulse oximeter monitors. The 510(k) summary doesn't outline acceptance criteria directly for the adapter cable itself but rather refers to the accuracy of the Masimo LNOP sensors when used with the AC-1 adapter cable. The study mentioned supports the substantial equivalence of this combination.

Here's a breakdown of the information requested based on the provided text:

1. A table of acceptance criteria and the reported device performance

Note: The acceptance criteria are "implied" because the document states the accuracy is "equivalent to those of the predicate devices" and then provides the accuracy values achieved. It doesn't explicitly state "Our acceptance criterion is an accuracy of X%."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated. The document mentions "adult oximetry sensors on human volunteers under induced hypoxic conditions." It does not specify the number of volunteers.
• Data Provenance: Prospective. The study involved "human volunteers under progressive induced hypoxia." Country of origin is not specified, but Masimo Corporation is based in Irvine, CA, USA.

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)

Not applicable. The ground truth was established by a CO-Oximeter, not human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Ground truth was established by a CO-Oximeter.

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

Not applicable. This device is a cable for a pulse oximeter, not an AI-assisted diagnostic tool.

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

Yes, the performance listed directly reflects the accuracy of the Masimo LNOP sensors when used with the AC-1 Adapter Cable, measured against a CO-Oximeter. This is a standalone performance assessment of the device (or the device in combination with its intended sensor).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth was established by a CO-Oximeter measuring arterial hemoglobin oxygen from arterial blood samples. This is considered a gold standard for blood oxygen saturation measurement.

8. The sample size for the training set

Not applicable. This device is a passive cable and does not involve machine learning or training sets in the conventional sense.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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