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The non-invasive CerOx 3215FOP monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx3215FOP monitor is intended for monitoring of newborn - adult. The prospective clinical value of data from the CerOx 3215FOP monitor has not been demonstrated in disease states. The CerOx 3215FOP monitor should not be used as the sole basis for diagnosis or therapy.

The CerOx Model 3215FOP uses the well-established principles of near infrared spectroscopy (NIRS) and flowmetry to monitor blood flow in tissue. CerOx Model 3215FOP is identical to the CerOx Model 3210FO technically and operationally.

The provided text describes a 510(k) submission for the CerOx Model 3215FOP, which is a blood flowmeter. The submission asserts substantial equivalence to a predicate device, the CerOx 3210FO.

Crucially, the document explicitly states that no performance testing, animal testing, or clinical studies were included in this 510(k) submission. Instead, the argument for substantial equivalence relies on the fact that the CerOx Model 3215FOP is "identical to the CerOx Model 3210FO technically and operationally."

Therefore, based on the provided text, the device itself (CerOx 3215FOP) does not have its own acceptance criteria or a study provided to demonstrate it meets them. Its acceptance is predicated on the substantial equivalence to a previously cleared device.

Since there are no performance studies described for the CerOx Model 3215FOP in this document, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide details about sample sizes, data provenance, expert ground truth establishment, or clinical study methodologies.

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The non-invasive CerOx 3215FO monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx 3215FO monitor is intended for monitoring of adults. The prospective clinical value of data from the CerOx 3215FO monitor has not been demonstrated in disease states. The CerOx 3215FO monitor should not be used as the sole basis for diagnosis or therapy.

The CerOx Model 3215FO uses the well-established principles of near infrared spectroscopy (NIRS) and flowmetry to monitor blood flow in tissue.

The provided text describes the CerOx Model 3215FO as being identical to its predicate device, CerOx Model 3210F, technically and operationally. Therefore, there are no specific acceptance criteria or a dedicated study for the CerOx Model 3215FO described in this document. Instead, the submission relies on the established safety and effectiveness of the predicate device.

The "study" described is a comparison study demonstrating equivalence to the predicate device, not an independent assessment against performance criteria.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the traditional sense of patient data. The "tests performed" were laboratory-based comparisons of physical characteristics (optical output power, acoustic output power, amplitude of light signals) between the new device and the predicate device. Therefore, there's no information on a sample size of patient data or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" here is the performance of the predicate device, CerOx Model 3210F, as assessed through physical measurements, not clinical expert interpretation.

4. Adjudication method for the test set

Not applicable. The "tests performed" were technical comparisons, not clinical evaluations requiring adjudication.

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 blood flow monitor, not an AI-assisted diagnostic imaging device that involves human readers.

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

This refers to a device's standalone performance. While the device does generate data independently, the study described is a comparison of physical characteristics, not a standalone clinical performance study. The device's function is to "monitor blood flow in tissue," which implies generating readings for a human operator.

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

The "ground truth" used for this submission is the established performance and technical specifications of the predicate device, CerOx Model 3210F. The tests validated that the CerOx Model 3215FO matched these established metrics.

8. The sample size for the training set

Not applicable. This describes a medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. This describes a medical device, not an AI/ML algorithm that requires a training set.

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

The CerOx Model 3210F 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. In addition, it employs principles similar to those of Laser Doppler flowmetry to monitor the microcircular blood flow in tissue. CerOx Model 3210F is identical to the CerOx Model 3210. It utilizes the same technical and operational methods.

The provided text is a 510(k) summary for the CerOx Model 3210F device. It describes the device, its intended use, comparison to predicate devices, and FDA clearance. However, it does not contain specific details about clinical studies, acceptance criteria, ground truth establishment, sample sizes for test or training sets, expert qualifications, or adjudication methods in the way a detailed study report would.

The document states that the CerOx Model 3210F is identical to the CerOx Model 3210 in hardware and operation for tissue oximetry, and performs an additional analysis for microcirculatory blood flow. The conclusion of the 510(k) is based on substantial equivalence to predicate devices (CerOx 3210 for tissue oximetry and Laserflo Blood Perfusion Monitor BPM2 for microcirculation blood flow) rather than detailed clinical effectiveness studies with explicit acceptance criteria and performance metrics for the new device.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth data are not present in this 510(k) summary. I can only provide information that is explicitly stated or can be inferred from the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary concludes substantial equivalence based on the device being "as safe and effective as" and "substantially equivalent to" the predicate devices, rather than on specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) and direct reporting of the device's performance against those criteria.

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

This information is not provided in the document. The filing is based on substantial equivalence to existing devices.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

There is no indication of an MRMC comparative effectiveness study being performed, nor is there any mention of AI in the context of this device. The CerOx Model 3210F is an oximeter/flowmeter and does not appear to involve AI assistance for human readers/clinicians, according to this summary.

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

This information is not provided in the document. The device is described as a monitor intended for use by medical professionals ("adjunct monitor").

7. The Type of Ground Truth Used

This information is not explicitly stated in the document. Since the device monitors regional hemoglobin oxygen saturation and microcirculation blood flow, ground truth would typically come from a reference standard for these physiological measurements, but the summary does not specify how this was established or if such ground truth was used for a specific clinical trial (which is not described in detail). The basis for equivalence is the device's mechanism and performance being similar to the predicate devices.

8. The Sample Size for the Training Set

This information is not provided in the document. There is no mention of a training set, as the filing is for substantial equivalence and not a de novo clearance requiring extensive performance data derived from machine learning or similar algorithms that would involve training sets.

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

This information is not provided in the document, as no training set is mentioned or implied.

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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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