(126 days)
To monitor relative blood flow changes distal to the occlusion of a brachial, ulnar, or femoral artery.
From the physician history and clinical findings, the person has pain, claudication, or changes in blood flow to the extremity.
The FloChec Plethysmograph Device (PPG) is similar to the PPG portion of the Hokanson EC-6 but does not include a strain gauge PPG function that is included in the EC-6. The FloChec Sensor is similar to that of the Parks' Mini-Lab which used a single wave length IR emitter in the sensor. The device is not sterile. Use of the FloChec device by a medical practitioner allows visualizing of the blood flow wave forms in the extremities. In viewing the effects on the wave forms as a result of events such as direct external pressure being applied proximal to the sensor.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria for the FloChec Photoplethysmography Device.
Instead, the document is a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to predicate devices rather than proving performance against pre-defined acceptance criteria through a specific study.
Here's what the document does state and what is missing:
The document states:
- Intended Use: To provide visualization and evaluation of the blood flow wave form in an extremity.
- Testing Conclusion: "It was concluded that the FloChec is equivalent to the predicate device."
- Indications for Use: To monitor relative blood flow changes distal to the occlusion of a brachial, ulnar, or femoral artery, for persons with pain, claudication, or changes in blood flow to the extremity, based on physician history and clinical findings.
- Device Type: Photoplethysmograph (PPG)
Missing Information (regarding acceptance criteria and performance study):
- Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document claims equivalence to a predicate device but does not provide specific performance metrics or thresholds for the FloChec device.
- Sample Size for Test Set and Data Provenance: Not mentioned.
- Number of Experts to Establish Ground Truth and Qualifications: Not mentioned.
- Adjudication Method: Not mentioned.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. There is no information about human readers or their improvement with or without AI assistance.
- Standalone (Algorithm Only) Performance Study: Not mentioned.
- Type of Ground Truth Used: Not explicitly stated, though the context implies comparison to the predicate device's output.
- Sample Size for Training Set: Not mentioned. This device is an analog measurement device, not an AI or deep learning model, so a "training set" in that sense would not apply.
- How Ground Truth for Training Set Was Established: Not applicable given the device type.
In summary, the provided text asserts that the FloChec device is "equivalent to the predicate device" in providing a visual representation of PPG waveforms, but it lacks the detailed study information (acceptance criteria, performance metrics, ground truth establishment, sample sizes, etc.) that would typically be found in a comprehensive clinical or performance study report. This document is focused on regulatory clearance through substantial equivalence.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).