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This device is viewed as a component of a system. The APEX Oximeter adds modularity to Marquette's CD Telemetry System product line. The Apex Oximeter is intended for portable patient monitoring of an ambulating patient's oxygen saturation and pulse rate. This device is intended to be used by personnel trained in the use of the equipment. It is intended to be used within the hospital/facility environment.

This device is viewed as a component of a system. The APEX OXIMETER adds modularity to Marquette's telemetry product line. It is intended for portable patient monitoring of an ambulating patient's oxygen saturation and pulse rate. The oxygen saturation calculations for the Apex Oximeter is performed identically to the method used in the Nonin 8500 series hand held pulse oximeter. The oximeter generates serial communications with a custom protocol to communicate with the CD Telemetry System.

Here's a breakdown of the acceptance criteria and study information for the KC180299 APEX OXIMETER, based on the provided text:

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, not a detailed study report. As such, it does not contain the granular level of detail typically found in a comprehensive clinical or performance study. The information below is extracted directly from the text; many common elements of a detailed study will be marked as "Not provided" because the document does not include them.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it relies on substantial equivalence to predicate devices (Nonin Model 8500 and 9500 pulse oximeters) and general statements about meeting requirements. The "reported device performance" is a high-level conclusion rather than specific metrics.

Study Details

1. 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 provided. The document mentions "Various reliability and software testing" but does not specify sample sizes for these tests or for any patient data.
   • Data Provenance: Not provided. Country of origin or whether the data was retrospective or prospective is not mentioned.

2. 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 provided. The document does not describe the establishment of a ground truth in the context of expert review for a test set. The primary method of demonstrating performance is substantial equivalence to predicate devices.

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

   • Not applicable/Not provided. No expert-based adjudication method is described.

4. 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. This is a pulse oximeter, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

   • Yes, implicitly. The "various reliability and software testing" would assess the device's (algorithm's) performance in a standalone context to ensure it met its functional requirements and performed identically to the predicate device in its oxygen saturation calculations. The device itself is a standalone measurement tool, although it communicates with a telemetry system.

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

   • The "ground truth" for the oxygen saturation calculation is based on the identical method used by the predicate device, the Nonin 8500 series pulse oximeter. For other functional aspects (reliability, software performance), the ground truth would be defined by the technical specifications and requirements the device was designed to meet. No independent expert consensus, pathology, or outcomes data is explicitly mentioned as being used to establish ground truth for this device's performance validation beyond its equivalence to the predicate.

7. The sample size for the training set

   • Not applicable/Not provided. This device is a pulse oximeter, and its core function is based on established biophysical principles and algorithms, not machine learning that requires a "training set" in the modern sense of AI/ML development.

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

   • Not applicable/Not provided, as there is no "training set" in the context of AI/ML. The device's foundational "ground truth" for oxygen saturation measurement is essentially derived from the established and validated performance of its predicate devices, whose methods it duplicates.

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