(75 days)
The non-invasive Fore-Sight Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensor in individuals at risk for reduced-flow or no-flow ischemic states and is indicated for use as follows:
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When used with Large Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on adults and transitional adolescents ≥40 Kg.
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When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects ≥ 3 Kg.
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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 Fore-Sight Elite Monitor is used together with the preamplifier assembly (cable), and Small, Medium and Large Sensors.
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 pack. 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.
This document is a 510(k) summary for the FORE-SIGHT ELITE Absolute Tissue Oximeter. It states that the device is substantially equivalent to a previously cleared predicate device (K143675). The primary reason for this 510(k) submission is an algorithm update and other minor enhancements.
Based on the provided text, the device measures tissue oxygen saturation (StO2). The studies mentioned are primarily verification activities to demonstrate that the algorithm update did not adversely affect the safety and effectiveness of the device, rather than a clinical study establishing initial accuracy against a gold standard.
Here's the information extracted and organized based on your request:
Acceptance Criteria and Device Performance (as inferred from the document):
Since this is a 510(k) submission for an algorithm update to an already cleared device, the "acceptance criteria" are implied to be that the updated device (specifically, the updated algorithm) performs comparably to or better than the original device, and that its safety and effectiveness are not adversely affected. There aren't explicit numerical acceptance criteria for StO2 accuracy presented in this summary; rather, the focus is on the verification that the changes don't degrade performance.
| Criterion | Reported Device Performance |
|---|---|
| Algorithm Update Impact on Clinical Accuracy | "the algorithm update did not adversely affect the safety and effectiveness of the subject device." (Page 6) |
| "the subject device has the same clinical accuracy when compared to the secondary predicate." (Page 5) | |
| Robustness to Sensor Disruption Scenarios | "the algorithm has been made more robust to better handle sensor disruption scenarios caused by user or environmental factors." (Page 5) |
| Responsiveness for Pediatric Applications | "It has been made more dynamic for pediatric applications by increasing StO2 responsiveness." (Page 5) |
| Usability (Human Factors) | "The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm." (Page 6) |
| System Requirement Verification (Non-Clinical Performance) | "Completion of all verification and validation activities demonstrated that the subject device meets its predetermined design and performance specifications." (Page 6) |
| "Verification activities performed confirmed that the algorithm upgrade did not adversely affect the safety and effectiveness of the subject device. The measured StO2 parameter was tested using a bench simulation. Additionally, verification of each system requirement was tested after upgrading to the latest algorithm version to verify safety and effectiveness of the subject device. All tests passed." (Page 6-7) | |
| Software Verification | "Software verification was performed per FDA's Guidance for Industry and FDA Staff. 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'. Software was tested at a subsystem level to ensure the safety of the device. All tests passed." (Page 7) |
Detailed Study Information:
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A table of acceptance criteria and the reported device performance:
- See table above. The document focuses on verification that the changes did not negatively impact the device's performance or safety, rather than presenting accuracy metrics against a ground truth for a new device.
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Sample size used for the test set and the data provenance:
- The document mentions "bench simulation" and "verification of each system requirement" but does not specify the sample size for any test sets related to the algorithm performance or the origin of any data used for these tests (e.g., country of origin, retrospective/prospective).
- A "Usability Study" was conducted, but its sample size or data provenance is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the document does not describe a clinical study against a human-adjudicated ground truth. The tests performed are described as "bench simulation," "system requirement verification," and "software verification."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the document does not describe a clinical study with human readers requiring adjudication.
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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:
- No MRMC or human reader comparative effectiveness study is mentioned. This device is an oximeter, not an AI-assisted diagnostic imaging tool with human-in-the-loop analysis.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, "The measured StO2 parameter was tested using a bench simulation." (Page 7). Also, "Software was tested at a subsystem level to ensure the safety of the device. All tests passed." (Page 7). The results are qualitative (e.g., "All tests passed," "did not adversely affect").
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "bench simulation" of the StO2 parameter, the "ground truth" would likely be derived from the simulated conditions or established reference measurements in the lab, rather than expert consensus, pathology, or outcomes data, which are typically for clinical diagnostic AI. The document does not specify the method for establishing this "ground truth" in the bench simulation.
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The sample size for the training set:
- The document does not describe the training of a novel AI model. It discusses an "algorithm update" to an existing device. Therefore, a "training set" in the context of machine learning model development is not mentioned.
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How the ground truth for the training set was established:
- Not applicable, as no new training of a machine learning model is described in this submission summary. The "algorithm update" appears to be an enhancement to an existing, cleared 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).