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The noninvasive Or-Nim CerOx Model 3210 monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. It is also intended for use as an adjunct monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in adults. The prospective clinical value of data from the CerOx monitor has not been demonstrated in disease states. The CerOx monitor should not be used as the sole basis for diagnosis or therapy.

The CerOx Model 3210 uses the well-established principles of near infrared spectroscopy (NIRS) to monitor the concentration of oxygenated hemoglobin relative to the total concentration of hemoglobin in the blood. CerOx Model 3210 comprises a display and processing unit and probes that are coupled to the patient using a single-use biocompatible adhesive. When the probes are attached to the patient, the system is operated to monitor the tissue blood oxygen saturation level. The CerOx Model 3210 can be operated in two modes: Cerebral Mode and Muscle Mode.

The provided document, K093923, is a Special 510(k) Premarket Notification for the CerOx 3210 device. This type of submission is for modifications to a previously cleared device. Therefore, the focus of the submission is primarily on demonstrating that the modified device remains as safe and effective as, and substantially equivalent to, the predicate device, rather than proving the original device's performance from scratch or conducting extensive new clinical studies.

Based on the provided text, a detailed study proving the device meets specific acceptance criteria, with the requested information (sample sizes, expert qualifications, etc.), is not explicitly described in the provided sections. The summary focuses on comparing the modified device to its predicate and the design control processes.

Here's a breakdown of the available information and what is missing based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission states: "The results of the design control process and the tests performed on the modified device (CerOx Model 3210) support the conclusion that it remains as safe and effective as, and remains substantially equivalent to, the cleared predicate device (Pacifica 01)." This indicates that substantial equivalence to the predicate, which presumably met its own acceptance criteria, is the primary "acceptance criterion" for this special 510(k). No specific quantitative performance metrics or acceptance criteria for the device itself are listed.

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

This information is not provided. The document refers to "Hardware and software tests" but does not detail the sample sizes for these tests, nor the nature of the data (e.g., patient data, simulated data).

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

This information is not provided. Given that the submission focuses on modifications and substantial equivalence to a predicate, it's unlikely a new, extensive clinical validation with expert-established ground truth was conducted for this specific 510(k) modification.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not provided. An MRMC study is typically for evaluating the impact of AI assistance on human reader performance, which doesn't seem relevant for this device (a cerebral oximeter) as described. The device acts as an "adjunct monitor" for regional hemoglobin oxygen saturation and is not described as an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an oximeter, which inherently operates as a "standalone" sensor, providing measurements directly. The document states it "uses the well-established principles of near infrared spectroscopy (NIRS) to monitor the concentration of oxygenated hemoglobin relative to the total concentration of hemoglobin in the blood." Therefore, its performance is inherently standalone in terms of data acquisition and processing to produce a saturation value. However, the exact performance metrics and how they were tested beyond basic hardware/software validation are not detailed.

7. The Type of Ground Truth Used

This information is not explicitly stated for any performance evaluation. For oximeters, ground truth is typically established through co-oximetry measurements from arterial blood samples. However, this submission primarily relies on substantial equivalence to the predicate and compliance with voluntary consensus standards rather than a new clinical performance study.

8. The Sample Size for the Training Set

This information is not applicable/provided. The CerOx 3210 is a NIRS-based medical device, not an AI/ML algorithm that requires a training set in the conventional sense. It uses established physical principles, not machine learning, to derive its measurements.

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

This information is not applicable/provided for the same reasons as #8.

Summary of what can be inferred:

• Acceptance Criteria for THIS submission: The primary acceptance criterion for this Special 510(k) is demonstrating substantial equivalence to the predicate device (Pacifica 01, K073407) and adherence to recognized standards.
• Study: The "study" mentioned consists of design control processes, risk analysis (FMECA), and hardware/software tests to validate mitigations identified during the FMECA. This is not a clinical performance study with patient data and expert ground truth as typically understood for new device submissions.
• Ground Truth: The device relies on "well-established principles of near infrared spectroscopy (NIRS)." The performance is validated through testing against these principles and ensuring the modifications did not negatively impact the device's ability to operate safely and effectively, as compared to the predicate.
• AI/ML: The device description does not indicate the use of AI or machine learning; therefore, concepts like training sets, MRMC studies, or "algorithm only" performance (beyond its core function as a sensor) are not relevant to this submission.

In conclusion, the document focuses on demonstrating that modifications to an existing device (CerOx 3210 as a modification of Pacifica 01) did not alter its safety or effectiveness in a way that would preclude substantial equivalence to the original. It does not provide the detailed clinical study data often found in original 510(k) submissions, particularly concerning specific acceptance criteria with quantitative performance metrics, sample sizes, or expert adjudication.

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