(130 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 Oximeter is indicated for use on adults and transitional adolescents ≥ 40 kg.
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 sensor. The sensor uses 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, RS-232 serial or wireless communications.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the FORE-SIGHT Elite™ Absolute Tissue Oximeter:
The provided text is a 510(k) summary for a medical device seeking substantial equivalence to existing devices. As such, it focuses on demonstrating that the new device performs similarly to predicate devices, rather than establishing novel absolute performance criteria with specific thresholds for accuracy, sensitivity, or specificity against a definitive ground truth.
Therefore, for many of your requested points, the answer will be "Not Applicable" or "Not Specified" because the nature of a 510(k) submission for this type of device does not typically require the same level of detailed performance metrics as, for example, an AI diagnostic algorithm. The primary "acceptance criterion" for a 510(k) is substantial equivalence to predicates.
Here's a breakdown based on your request:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for 510(k) of this device type) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Devices: | "The FORE-SIGHT Elite™ Absolute Tissue Oximeter has successfully undergone extensive performance, safety, electromagnetic, clinical, software and environmental testing to ensure it has been found to be substantially equivalent to the predicate devices." |
| - Optical Operating Principle: | "The FORE-SIGHT Elite Absolute Tissue Oximeter compares substantially to the cited predicate devices in that they use fundamentally the same optical operating principle, called multidistance diffuse reflectance spectroscopy." |
| - Hemoglobin Measurement: | "All cited monitors use light to examine a cross-section tissue microvasculature... The spectroscopic analysis determines concentrations of hemoglobin in its oxygenated and deoxygenated states. All cited monitors calculate oxygen saturation which reflects the percentage of oxygenated hemoglobin in the sampled tissue." |
| - Technical Capabilities: | "The FORE-SIGHT Elite Absolute Tissue Oximeter compares substantially to the predicates. All have 4-channel capability, an LED light source, similar user interface features and the benefits of portability." |
| Safety: | "Clinical evaluation, safety testing and software validation demonstrate the FORE-SIGHT Elite Absolute Tissue Oximeter is substantially equivalent to the predicate devices." (Implied to meet safety standards comparable to predicates) |
| Clinical Performance: | "The FORE-SIGHT Elite Absolute Tissue Oximeter has successfully undergone extensive clinical validation for the indicated use. The premarket notification cites a validation report: Validation of the CAS Medical System's FORE-SIGHT Elite™ Absolute Tissue Oximeter for Somatic Tissue Oxygen Saturation (StO2%) in Adult and Transitional Adolescent Subjects." |
| Software Validation: | "CAS has conducted a full program of individual hardware, software, systems verification and validation studies of the FORE-SIGHT monitor and sensors." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The document mentions "extensive clinical validation" and refers to a "validation report," but doesn't provide the sample size within this summary.
- Data Provenance: Not specified within the provided text (e.g., country of origin, retrospective/prospective). It just states "Clinical Testing to Show Substantial Equivalence."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable/Not specified. For a tissue oximeter, the ground truth would typically be established by comparing the device's readings against a reference method for oxygen saturation, not by expert consensus on images. The text does not describe this reference method or any "experts" involved in establishing ground truth for individual cases in a traditional sense.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image interpretation studies where there is subjective human assessment. This device measures a physiological parameter, and its validation would involve comparison to a direct (e.g., invasive blood gas analysis) or a highly accurate reference method, not an adjudication of human interpretations.
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
- MRMC Comparative Effectiveness Study: No. This device is a measurement device (oximeter), not an AI-assisted diagnostic tool that helps human readers interpret images or data. Therefore, an MRMC study and effect size in terms of human reader improvement with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in a sense. The device itself performs the measurement and algorithm calculation to derive StO2 values. The validation would assess the accuracy of these measurements compared to a reference method, which is inherently a "standalone" performance assessment of the device's measurement capabilities. However, it's not "standalone AI algorithm" in the context of recent AI-powered diagnostic devices. The summary states: "The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics." This implies standalone algorithmic processing for the measurement itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not explicitly stated in the provided text, but for an oximeter, the ground truth would typically be established through:
- Direct, invasive measurements: Such as arterial or venous blood gas analysis to determine oxygen saturation.
- Highly validated reference oximeters or spectrophotometers: Used in controlled experimental settings.
- The text only mentions "extensive clinical validation" for somatic tissue oxygen saturation (StO2%), implying a comparison against an accepted reference standard for StO2.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. The concept of a "training set" is primarily relevant for machine learning or AI models that learn from data. While the device uses a "FORE-SIGHT algorithm," it's described more as a pre-programmed computation based on physical principles (spectroscopy) rather than a continuously learning AI. Therefore, it may not have a "training set" in the modern AI sense. If the algorithm was developed empirically, the data used for that development is not mentioned.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/Not specified (as per point 8).
§ 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).