(86 days)
The noninvasive Or-Nim Pacifica Model 01 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 Pacifica monitor has not been demonstrated in disease states. The Pacifica monitor should not be used as the sole basis for diagnosis or therapy.
The Pacifica Model 01 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. The Pacifica Model 01 uses three low energy laser light sources for illuminating the tissue at three discrete wavelengths, and measures the optical attenuation of each light wavelength (mu, mu', mu'') as a function of depth, in the tissue. From the ratio of differences of the three optical attenuations, the oxygen saturation level is determined.
The Pacifica Model 01 comprises a display and processing unit and a probe that is coupled to the patient using a single use biocompatible adhesive. When the probe is attached to the patient, the system is operated to monitor the tissue blood oxygen saturation level. The probe is connected to the display and processing unit via optical fibers and electronic cables. The display and processing unit includes three separate units (a power unit, a transmitter-receiver unit and a processing unit) and a display.
The Pacifica Model 01 can be operated in two modes: Cerebral mode and Muscle mode. Muscle mode should only be used when the probe is attached to a muscle or soft tissue. Cerebral mode should be used when the probe is applied to the skull
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pacifica Model 01 device:
Important Note: The provided document is a 510(k) summary and the FDA's clearance letter. While it states that "clinical studies indicate the device is substantially equivalent to the predicates cited," it does not detail the specific acceptance criteria or the full study methodology, results, or sample sizes used to demonstrate this equivalence. It only generally states that safety and effectiveness evaluations were done. Therefore, much of the requested information cannot be definitively extracted from this document alone.
Acceptance Criteria and Device Performance (Based only on the provided text)
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied or stated) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device is as safe and effective as identified predicate devices. | The results of the evaluation support the conclusion that it is as safe and effective as, and is substantially equivalent to, the cited predicate devices. |
| Technical Parameters | Differences in technical parameters (compared to predicates) are minor and do not affect safety or effectiveness. | Some technical parameters differ between the Pacifica Model 01 and the predicate devices, but these differences are minor and do not affect safety or effectiveness. |
| Clinical Performance | Demonstrated clinical performance comparable to predicate devices in animal and human studies. | Safety and effectiveness evaluations based on animal and clinical studies indicate the device is substantially equivalent to the predicates cited. |
Study Details (Based only on the provided text)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The text only vaguely mentions "animal and clinical studies."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not provide details about how ground truth was established for any clinical evaluations.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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. The Pacifica Model 01 is an oximeter, not an AI-assisted diagnostic imaging device for human readers. Its primary output is a numerical oxygen saturation level.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself appears to be a standalone monitor providing a direct measurement (hemoglobin oxygen saturation). The study would likely evaluate its accuracy against a gold standard or predicate device. The document states it is "intended for use as an adjunct monitor," implying a human-in-the-loop for diagnosis and therapy, but the performance evaluation would be of the device's accuracy in producing a reading. However, the details of such a "standalone" performance study (its specific methodology, sample size, and results) are not provided in this summary.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. For an oximeter, "ground truth" would typically involve a co-oximetry reference method on arterial blood samples. The document does not specify what method was used for the "clinical studies."
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The sample size for the training set:
- Not applicable/Not specified. This device is a hardware oximeter, and the summary does not mention any "training set" in the context of an algorithm or machine learning model. If a calibration or internal algorithm development process was involved, details are not provided.
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How the ground truth for the training set was established:
- Not applicable/Not specified for the reasons above.
Summary of Limitations:
This 510(k) summary is a high-level overview. It confirms that "animal and clinical studies" were performed to demonstrate substantial equivalence to predicate devices, and that these studies "indicate the device is substantially equivalent." However, it does not provide the detailed scientific evidence, specific acceptance criteria, study methodologies, exact sample sizes (for either training or testing if applicable), ground truth establishment methods, or performance metrics that would typically be found in a full study report. To get that level of detail, one would need to review the complete 510(k) submission, which is not publicly available in this format.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).