(107 days)
The noninvasive FORE-SIGHT ELITE Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows:
When used with Large Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on adults and transitional adolescents ≥40 kg.
When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects ≥3 kg.
When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is indicated for cerebral use on pediatric subjects
The FORE-SIGHT ELITE Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2).
The Oximeter consists of a monitor unit, preamplifier assembly, and Small, Medium and Large Sensors. The Sensors use multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four Sensors with both numeric and real-time graphical display formats.
The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB and RS-232.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Bias & Precision) | Ranging from 0.05 ± 5.06% to 0.03 ± 5.69% compared to weighted co-oximetry reference. |
| Safety | No safety issues or adverse events related to the FORE-SIGHT ELITE Absolute Tissue Oximeter were encountered. |
| Compliance with Predetermined Specification | Test results demonstrated that the oximeter complies with its predetermined specification (System Functional and Performance Testing). |
| Electrical Safety | Met ANSI/AAMI ES60601-1: (2005), IEC 60601-1-8: (2006), IEC 60601-1-6: (2010), IEC 62366: (2007). |
| Electromagnetic Compatibility | Met IEC 60601-1-2: (2007). |
| Biological Safety (Materials) | Assured by biological testing under the standard ISO10993-1. |
Study Information
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): 136 subjects.
- Data Provenance: Not explicitly stated, but the study was conducted at "multiple institutions." Given the context of a 510(k) submission to the FDA in the US, it's highly probable the data is from the United States. The study involved a "demographically diverse population."
- Retrospective or Prospective: Not explicitly stated. However, the nature of "clinically validated" and "measurements... calibrated against a weighted co-oximetry reference of arterial and venous blood samples drawn simultaneously" suggests a prospective clinical study where measurements were taken for the purpose of validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth was established using a weighted co-oximetry reference of arterial and venous blood samples, not expert opinion.
4. Adjudication method for the test set:
- This information is not applicable/provided. The ground truth was based on objective blood sample analysis (co-oximetry), not expert consensus that would require 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:
- No, an MRMC comparative effectiveness study was not done. This device is an oximeter, which provides a direct physiological measurement, rather than an AI-driven image analysis tool that typically involves human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the clinical validation was for the standalone performance of the FORE-SIGHT ELITE Absolute Tissue Oximeter. The accuracy values provided (0.05 ± 5.06% to 0.03 ± 5.69%) reflect the device's performance against the gold standard without human interpretation as part of the measurement. It's intended as an "adjunct monitor," meaning it provides data for clinicians but its core function is autonomous measurement.
7. The type of ground truth used:
- Weighted co-oximetry reference of arterial and venous blood samples. These samples were drawn simultaneously from vascular locations appropriate to the tissue of interest (jugular bulb, central venous, umbilical venous) and weighted with a 30% arterial and 70% venous contribution.
8. The sample size for the training set:
- The document does not explicitly state a separate training set size. The device was "designed and developed in accordance with CASMED development processes" and "verified and validated," which would include internal development and testing. The 136 subjects mentioned are for the clinical validation (test set) for substantial equivalence, not necessarily the internal training data for algorithm development.
9. How the ground truth for the training set was established:
- This information is not explicitly provided for a training set. For the clinical validation (test set), as stated in point 7, the ground truth was established using weighted co-oximetry reference of arterial and venous blood samples. It's reasonable to infer that similar methods (or other physiological gold standards) would have been used during the device's internal development and refinement.
§ 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).