(358 days)
The FORE-SIGHT® Oximeter. Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain and skeletal muscle. It is intended for use in any individual at risk for reducedflow or no-flow ischemic states.
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. When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates ≤ 8 kg.
When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on skeletal muscle of infants, children and adolescents between 5 and 50 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 Oximeter, MC-2000 Series, measures brain and skeletal muscle tissue oxygen saturation.
The FORE-SIGHT Oximeter consists of an optical transducer containing a laser light source and photodiode detectors, and a graphic display with user interface. The noninvasive, reflection mode, optical transducer is placed on the forehead (brain) or skeletal muscle, via a disposable sensor to determine tissue oxygenation. The FORE-SIGHT Oximeter is safe to use because it is designed to operate as a class 1 laser product, the safest FDA laser classification. Additional safety features include a laser interlock system, designed to prevent laser operation in case the optical transducer is not securely attached to the subject.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criterion Category | Specific Criterion from Document | Reported Device Performance (FORE-SIGHT Oximeter) |
|---|---|---|
| Safety Standards | UL 60601-1 Safety testing | Tested to this standard |
| CAN/CSA C22.2 No. 601.1-M90 | Tested to this standard | |
| IEC 60601-1 Safety of Medical Electrical Equipment | Tested to this standard | |
| EN 60601-1 Safety of Medical Electrical Equipment | Tested to this standard | |
| IEC 60601-1-1 Safety of Medical Electrical Systems | Tested to this standard | |
| IEC 60601-1-2: 2001 EMC Emissions and Immunity | Tested to this standard | |
| IEC 60601-1-4 Programmable Electrical Medical Systems | Tested to this standard | |
| IEC 60601-1-8 Alarm Systems | Tested to this standard | |
| IEC 60825-1 Safety of Laser Products | Tested to this standard (Class 1 laser product) | |
| Performance (Skeletal Muscle) | Precision (1 Standard deviation) against CO-oximetry | ± 4.9 % |
| Comparability/Superiority to predicate devices' precision | Comparable or better than predicate devices when compared to CO-oximetry measurements |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Description: "Pediatric Subject Skeletal Muscle Validation: CO-oximetry data from invasive arterial and venous blood samples from sites representative of skeletal muscle were respectively compared to FORE-SIGHT Oximeter values. FORE-SIGHT sensors were placed over skeletal muscle of adolescents, children, and infants undergoing examination in a catheterization laboratory."
- Sample Size: The document does not explicitly state the exact number of subjects (sample size) used in this clinical validation. It mentions "adolescents, children, and infants."
- Data Provenance: The study was conducted in a "catheterization laboratory," implying an institutional setting. The country of origin is not specified, but the submission is from a US company (CAS Medical Systems, Inc., Branford, CT, USA) to the FDA, suggesting it was likely conducted in the US or a country with comparable medical standards. It is a prospective study because it involved placing sensors on subjects and collecting data during an ongoing medical examination.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The ground truth for the skeletal muscle validation was established using CO-oximetry data from invasive arterial and venous blood samples. This is an objective, direct measurement, not an expert-based ground truth. Therefore, the concept of "number of experts" or "qualifications" for establishing this specific ground truth does not apply in the same way it would for image interpretation tasks. The expertise would lie in the medical professionals performing the catheterization and CO-oximetry.
4. Adjudication Method for the Test Set:
- Since the ground truth was invasive CO-oximetry, there was no adjudication method (like 2+1 or 3+1 consensus) required for establishing the truth itself. The comparison was statistical: FORE-SIGHT Oximeter values versus CO-oximetry values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described in the provided text. The study focused on validating the device's accuracy against a gold standard (CO-oximetry), not on evaluating human reader performance with or without the device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
- Yes, the clinical testing described is essentially a standalone performance study of the FORE-SIGHT Oximeter. It compares the device's StO2 values directly to the CO-oximetry ground truth without involving human interpretation of the device's output as part of the primary outcome measure.
7. The Type of Ground Truth Used:
- The type of ground truth used for the skeletal muscle validation was invasive CO-oximetry measurements from arterial and venous blood samples. This is a highly objective and direct measure of oxygen saturation.
8. The Sample Size for the Training Set:
- The document does not provide information on the sample size used for the training set of the FORE-SIGHT Oximeter's algorithm. The provided information relates to the validation (testing) performed to demonstrate substantial equivalence for the 510(k) submission.
9. How the Ground Truth for the Training Set Was Established:
- The document does not provide information on how the ground truth for any potential training set was established. While it states "Slight modifications of algorithm" compared to a predicate, the details of the original algorithm development or any subsequent retraining are not included here.
§ 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).