(120 days)
The noninyasive FORE-SIGHT® 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 the brain of adults and children over 40 Kg.
When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of small adults and children between 4 and 80 Kg, and for use on skeletal muscle of infants, children and adolescents between 4 and 50 Kg.
When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates less than 8 Kg, and for use on the abdomen in neonates less than 4 Kg.
The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.
The FORE-SIGHT Absolute Tissue Oximeter measures a single parameter of oxygenated hemoglobin under the Sensor, allowing the clinican to continuously and accurately determine absolute levels of blood oxygenation in the tissue.
The Oximeter monitor features a LASER-SIGHT® Optical Technology generating 4 precise wavelenglis to optimize measurement of targeted hemoglobin states. COOL-LIGHT™ sensor technology ensures zero risk of patient burns. 3 sizes of sensors are available. The Oximeter is for continuous or spot checking use in a variety of hospital settings. A rechargeable battery pack permits the monitor to be used independently from an AC power source.
This request refers to the CASMED FORE-SIGHT Absolute Tissue Oximeter (K112820). However, the provided text does not contain acceptance criteria for the device, nor a study proving it meets such criteria.
The document discusses the device's intended use, comparison to predicate devices, and general statements about performance, safety, and clinical testing. It states that "The FORE-SIGHT Absolute Tissue Oximeter has successfully undergone extensive clinical study for the expanded indications for use especially for neonatal subjects." and cites a validation report: "Validation of the CASMED FORE-SIGHT® Tissue Oximeter for Skeletal Muscle and Abdominal Tissue Oxygen Saturation (StO2%) in Pediatric and Neonatal Subjects". However, the details of this study, including specific acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics, are not present.
Therefore, I cannot fulfill the request with the information provided. The missing information includes:
- A table of acceptance criteria and the reported device performance: This is entirely absent.
- Sample size used for the test set and the data provenance: Not specified for the cited clinical study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method for the test set: Not specified.
- 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, as this is an oximeter, not an AI diagnostic device for image analysis.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an oximeter, typically used for continuous monitoring by clinicians, so the concept of "standalone performance" in the AI sense might not directly apply here without further context on how "performance" is measured.
- The type of ground truth used: Not specified, although an oximeter's ground truth would typically be invasive blood gas analysis or other established direct oxygen measurement methods.
- The sample size for the training set: Not applicable, as this isn't an AI model with a distinct "training set" in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
To answer your request, you would need to provide the "Validation of the CASMED FORE-SIGHT® Tissue Oximeter for Skeletal Muscle and Abdominal Tissue Oxygen Saturation (StO2%) in Pediatric and Neonatal Subjects" report or similar detailed clinical study documentation.
§ 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).