(255 days)
The noninvasive FORE-SIGHT ELITE Tissue Oximeter "Module" 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. The Module is also intended for use as an adjunct monitor of relative changes of oxygenated hemoglobin, deoxygenated hemoglobin, and their summation, total hemoglobin, of blood under the sensors. The Module is intended to allow for the display of StO2 and regional hemoglobin on a third party display/patient monitor and is indicated for use as follows:
When used with large sensors, the Module is indicated for use on adults and transitional adolescents ≥40 kg. When used with medium sensors, the Module is indicated for use on pediatric subjects ≥3 kg. When used with small sensors, the Module is indicated for cerebral use on pediatric subjects
The FORE-SIGHT ELITE Tissue Oximeter Module measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2). The Module additionally measures relative changes in oxygenated and deoxygenated hemoglobin concentrations for assessment of oxygenation changes as well as their sum, total hemoglobin concentration, under the sensor.
The Oximeter Module consists of a signal acquisition and processing unit, power isolation box, host power and communication cables, and sensor cables to connect with FDA cleared FORE-SIGHT ELITE 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 Module controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The Module provides simultaneous measurements on up to two Sensors.
The Module is a host-powered device. The host configures the Oximeter and provides applicable audible, on-screen, and dedicated visual alarm indicators. The host monitor also provides numeric and/or realtime graphical display for tissue blood oxygenation saturation and changes in hemoglobin concentrations. Measurement data is delivered to the host through various interfaces including USB and serial connections.
Here's a breakdown of the acceptance criteria and study information for the FORE-SIGHT ELITE Tissue Oximeter Module, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various validation studies demonstrating the device's accuracy against reference methods across different patient populations and measurement types. The core acceptance is based on demonstrating substantial equivalence to a predicate device (K180003) and a reference device (K143219), particularly for the new feature of measuring relative changes in hemoglobin concentrations.
However, the "Type Measurement" and "Reference" columns in Table 1: StO2 and Changes in Hemoglobin Concentration Validation Methodology implicitly define the performance metrics and the ranges over which the device was validated. The success of these validations, as stated in the "Conclusions Drawn from Clinical and Non-Clinical Testing," indicates that the device met the internal criteria used to establish substantial equivalence.
Here’s an interpretation of the performance and the implied criteria based on Table 1:
| Patient Population | Sensor | Parameter | Implied Acceptance Criteria (Range of Reference) | Reported Device Performance (Implied by "successfully undergone extensive clinical validation" and "high precision") |
|---|---|---|---|---|
| Adult | Large | StO2 | 48 to 88% (Cerebral), 50 to 90% (Non-Cerebral) | Demonstrated substantial equivalence to predicate for StO2 measurements. |
| ΔHHb, ΔO₂Hb | ±5 g/dL, ±19 μM (Cerebral/Non-Cerebral) | High precision to co-oximetry blood sample references. | ||
| Pediatric | Medium | StO2 | 48 to 92% (Cerebral), 53 to 88% (Non-Cerebral) | Demonstrated substantial equivalence to predicate for StO2 measurements. |
| ΔHHb, ΔO₂Hb | 0 to 2 g/dL, 7.4 uM (Co-oximetry), ±85 μM (Phantom) | Evaluated using convenience co-oximetry and frequency domain oximeter on phantom. | ||
| Pediatric | Small | StO2 | 50 to 90% (Cerebral), 66 to 96% (Non-Cerebral) | Demonstrated substantial equivalence to predicate for StO2 measurements. |
| ΔHHb, ΔO₂Hb | ±85 μM (Phantom) | Demonstrated equivalence to NIRO-200NX reference device and concurrent frequency domain oximetry. | ||
| Neonates | Small | StO2 | 50 to 90% (Cerebral, FORE-SIGHT MC3010), 66 to 96% (Non-Cerebral) | StO2 data averaged in two-minute windows for stability. |
| ΔHHb, ΔO₂Hb | ±85 μM (Phantom) | Demonstrated equivalence to NIRO-200NX reference device and concurrent frequency domain oximetry. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document provides specific sample sizes for some of the validation groups, particularly for the healthy adult volunteers and cardiac surgical patients. It also indicates the demographic breakdown of these subjects.
- Adult StO2 Validation (Healthy Adult Volunteers, Table 1 footnote 1):
- Sample Size: 25 healthy adult volunteers (12 Male, 13 Female)
- Data Provenance: Healthy adult volunteers, presumably within the US or a similar regulatory environment, prospective collection for the study.
- Adult ΔHHb, ΔO₂Hb Validation (Healthy Volunteers, Table 1 footnote 2):
- Sample Size: 43 healthy volunteer subjects (22 Male, 21 Female)
- Data Provenance: Healthy adult volunteers, presumably within the US or a similar regulatory environment, prospective collection for the study.
- Adult ΔHHb, ΔO₂Hb Validation (Cardiac Surgical Patients, Table 1 footnote 2):
- Sample Size: 5 cardiac surgical patients (3 Male, 2 Female)
- Data Provenance: Convenience sample measurements from cardiac surgical patients undergoing cardiopulmonary bypass procedures, retrospective or prospective (convenience sample often implies retrospective use of available data, but could be prospective for the study).
- Pediatric ΔHHb, ΔO₂Hb Validation (Cardiac Surgical Patients, Table 1 footnote 3):
- Sample Size: No specific number for cardiac surgical patients for ΔHHb, ΔO₂Hb.
- Data Provenance: Evaluated using convenience samples.
- Pediatric StO2 Validation (Interventional Catheterization, Table 1 footnote 3):
- Sample Size: 5 pediatric patients (4 Male, 1 Female)
- Data Provenance: Pediatric patients undergoing interventional catheterization procedures, prospective collection for the study.
- Neonatal StO2 Validation (No specific number mentioned, Table 1 footnote 5):
- Sample Size: Not explicitly stated but refers to "term, premature low birth weight (LBW), and very low birth weight (VLBW) neonates."
- Data Provenance: Clinical study, possibly prospective.
- Liquid Optical Phantom Validation:
- Sample Size: Not applicable, involves optical phantoms rather than human subjects.
- Data Provenance: Laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the "number of experts" or their "qualifications" involved in establishing the ground truth. However, the ground truth itself (co-oximetry blood samples) is considered a gold standard, and its analysis would typically be performed by trained clinical laboratory personnel according to established protocols, rather than requiring an "expert panel" for interpretation in the same way an imaging study would.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for this device (StO2 and hemoglobin concentrations) is established directly through co-oximetry blood samples and optical phantom measurements, which are objective and quantitative measurements, not subject to subjective interpretation and thus do not require an adjudication method among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an imaging device that would typically involve human readers interpreting cases. It is a physiological monitoring device with quantitative output. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance Study
Yes, in essence. The clinical validation studies described represent the standalone performance of the device's algorithm in measuring StO2 and changes in hemoglobin concentrations against a physical ground truth (co-oximetry and optical phantoms). The "Module controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification. The FORE-SIGHT algorithm determines the StO2 values...". This directly describes standalone algorithm performance.
7. Type of Ground Truth Used
The primary ground truth used is:
- Co-oximetry of blood samples: Considered the gold standard for measuring oxygen saturation and hemoglobin concentrations in blood. This was used for both cerebral and non-cerebral measurements across adult and pediatric populations.
- Frequency domain oximeter on liquid optical phantom: Used as a reference to validate the differential changes in hemoglobin concentrations (ΔHHb, ΔO₂Hb), particularly for the smaller sensors and pediatric/neonatal populations where invasive blood sampling might be more challenging.
- FORE-SIGHT MC3010: Used as a reference for StO2 measurements in neonates, indicating a comparison to an established device.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" or its sample size. The description of the device as "identical to the primary predicate device K180003 with the singular addition of software enhancement for the processing and display for relative changes in hemoglobin concentrations" suggests that the core algorithm for StO2 was already established and validated in previous submissions (K180003 and "earlier CASMED Premarket Notifications"). The focus here is on the validation of the enhanced software and the new parameters (ΔHHb, ΔO₂Hb).
For new algorithms, particularly those using machine learning, a training set would be explicitly detailed. The method described here is more akin to traditional medical device validation, where the algorithm is developed based on known physiological principles and validated against ground truth. If there was an implicit "training" or "development" dataset, it is not described in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Since an explicit "training set" and its establishment are not detailed, this question cannot be answered directly from the provided text. The device's algorithm appears to be based on established spectroscopic principles for measuring tissue oxygenation rather than a data-driven machine learning approach that would typically involve a distinct training set. The "validation studies" mentioned are for testing the performance of the already developed algorithm.
§ 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).