(263 days)
The NIRO-200NX is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation and relative level of oxygenated hemoglobin and deoxygenated hemoglobin of blood in brain or in other tissue beneath the probes in any individual. The clinical value of trend data has not been demonstrated in disease states. The NR0-200NX should not be used as the sole basis for diagnosis or therapy.
The NIRO-200NX is a reusable piece of equipment that uses near infrared light for non-invasive measurement of hemoglobin oxygen saturation and relative levels of oxygenated hemoglobin and deoxygenated hemoglobin of blood in brain or in other tissue beneath the probes. The patient probes are applied to the skin over the tissue of interest. The probes have a light source and 2 photodiodes, one closer to the light source and one further away from the light source. The 2 photodiodes detect the light transmitted through the patient's tissue. The detected light is analyzed with the known light absorption characteristics of oxyhemoglobin and deoxyhemoglobin. The amount of light detected by the photodiode closer to the light source is subtracted from the light detected by the farther photodiode. The result is then used to calculate the hemoglobin oxygen saturation. Also, by measuring the changes in light detected from one of the photodiodes, the relative levels of oxygenated hemoglobin and deoxygenated hemoglobin are calculated.
The provided document describes the Hamamatsu NIRO-200NX device, a near-infrared oximeter, and its clearance process. Here's a breakdown of the acceptance criteria and the studies that support it:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally framed as the device performing "equivalently" to predicate devices, rather than specific quantitative thresholds.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Regional Hemoglobin Oxygen Saturation (rSO2) | Substantially equivalent performance to INVOS 5100C in both phantom study and clinical setting. |
| Relative Levels of Oxygenated Hemoglobin and Deoxygenated Hemoglobin (ΔO2Hb, ΔHHb) | Substantially equivalent performance to Hitachi ETG-100 and ETG-4000 in phantom study. |
| Electrical Safety | Passed applicable safety testing per IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Passed applicable safety testing per IEC 60601-1-2. |
| Light Emitting LED Product Safety | Class 1 LED product per IEC 60825-1. |
| Software Verification and Validation | Verified and validated software with moderate level of concern, conforming to FDA guidance. |
| Clinical Safety Record | No reported adverse events over 4+ years of clinical use in Japan and Europe. |
2. Sample Size Used for the Test Set and Data Provenance
Phantom Study:
- Sample Size: Not explicitly stated as a number of "samples" but implied to be a comparative study using multiple phantom configurations.
- Data Provenance: Retrospective, conducted internally by Hamamatsu (manufacturer of NIRO-200NX).
Published Clinical Literature (Bickler et al.):
- Sample Size: 23 individuals for the comparison between NIRO-200NX and INVOS.
- 181 individual measurements for INVOS.
- 179 individual measurements for NIRO-200NX.
- Data Provenance: Prospective clinical study. The country of origin for the study is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for the phantom study.
For the clinical study (Bickler et al.), the ground truth for regional hemoglobin oxygen saturation was established through blood draw results, which is a direct, objective measurement, not based on expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for the clinical study was based on direct blood draw measurements, which does not require adjudication. For the phantom study, the ground truth was based on the controlled properties of the phantom, also not 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 an oximeter, which provides quantitative measurements, not images requiring human interpretation or AI assistance in reading. There are no "human readers" involved in interpreting the device's direct output in the context of an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the NIRO-200NX is a standalone device that provides measurements directly. Its performance as an algorithm-only device was evaluated both through the phantom study and the comparison to blood draws in the clinical study.
7. The Type of Ground Truth Used
- Phantom Study: Controlled and known properties of tissue phantoms (simulated models).
- Clinical Study (Bickler et al.): Direct blood draw results (for regional hemoglobin oxygen saturation).
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This is typical for devices using established biophysical principles and comparative equivalence to predicates, rather than machine learning models that require explicit training datasets. The device's underlying principles are based on known light absorption characteristics of oxyhemoglobin and deoxyhemoglobin.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no explicit machine learning training set is mentioned or implied. The device's operation is based on established optical spectroscopy principles rather than data-driven machine learning training.
§ 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).