(55 days)
The moorFLPI Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.
The moorFLPI is a device to perform non-contact imaging of tissue blood perfusion in the microcirculation, for example skin, using speckle contrast analysis. The tissue surface is illuminated with a diverging infra-red laser beam resulting in a laser speckle pattern. The pattern is imaged by a CCD camera and image processing of the speckle contrast is used to generate colour code images of the tissue blood perfusion in the microcirculation.
This 510(k) summary does not contain sufficient information to fully address all the requested points about acceptance criteria and a definitive study to prove the device meets them. The document describes the device, its intended use, and technological characteristics, and makes a general claim of substantial equivalence to a predicate device. However, it lacks specific details on formal acceptance criteria and the comprehensive study methodology typically found in detailed performance studies.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria or a direct comparison table are provided in this 510(k) summary. The document states that the moorFLPI has "substantially the same performance as the predicate device for measurements of superficial blood flow." This suggests that the acceptance criterion was likely general equivalence to the predicate, moorLDI2-IR, rather than specific numerical targets for metrics like accuracy, precision, sensitivity, or specificity.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantially equivalent performance to predicate device (moorLDI2-IR) for superficial blood flow measurements. | The results show that the moorFLPI, "within its specified range for flow measurements and area of tissue that can be imaged, has substantially the same performance as the predicate device for measurements of superficial blood flow." |
| Compliance with electrical safety standards. | "The moorFLPI Full-Field Laser Perfusion Imager has been designed and tested for compliance with the standards for electrical safety..." |
| Compliance with laser radiation safety standards. | "...laser radiation safety..." |
| Compliance with electromagnetic compatibility (EMC) standards. | "...electromagnetic compatibility..." |
| Compliance with programmable medical device standards. | "...and programmable medical device." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "a set of comparison tests has been carried out. These include measurements from a simple flow model and single point and image scans from blood flow in skin, using both devices."
- Sample Size: Not specified. The exact number of measurements, flow models, or human/animal subjects (if any for skin blood flow) is not provided.
- Data Provenance: The tests were conducted internally by Moor Instruments Ltd. (UK-based company). It's a retrospective analysis of test data conducted for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The document does not describe the involvement of human experts for establishing ground truth, as the performance evaluation primarily focuses on the device's ability to measure physiological parameters and demonstrate equivalence to a physical gold standard (simple flow model) and another device (predicate).
4. Adjudication Method for the Test Set
Not applicable. No mention of expert adjudication as the study is not based on diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed. The device is a measurement tool, and the comparison was made against a predicate device and a physical flow model, not human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was done. The described "comparison tests" of the moorFLPI's measurements against a simple flow model and against the predicate device represent the standalone performance of the device itself.
7. Type of Ground Truth Used
- Physical Model Data: "measurements from a simple flow model." This serves as a controlled, known ground truth for flow.
- Comparative Device Measurements: "single point and image scans from blood flow in skin, using both devices." The predicate device (moorLDI2-IR) essentially served as a reference or a comparative 'ground truth' for real-world superficial blood flow measurements. The statement implies that the moorFLPI's measurements were expected to align with those of the predicate.
8. Sample Size for the Training Set
Not applicable. This device is a measurement instrument, not an AI/machine learning algorithm requiring a "training set" in the typical sense. The "image processing software" uses established physics and signal processing principles (speckle contrast analysis) rather than being trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As implied above, there is no training set in the AI/ML context. The device relies on physical principles for its operation.
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).