(101 days)
The moorFLPI-2 Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.
The moorFLPI-2 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 coded images of the tissue blood perfusion in the microcirculation.
The provided text describes the moorFLPI-2 Full-Field Laser Perfusion Imager, a device intended for non-contact imaging of tissue blood perfusion in the microcirculation for clinical research use. It focuses on demonstrating substantial equivalence to a predicate device (moorFLPI Full-Field Laser Perfusion Imager, K063586).
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on a qualitative comparison to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalent technology and principle of operation to predicate | Uses the same technology and principle of operation as the predicate device |
| Performance equivalent to predicate device | Demonstrated performance equivalent to the predicate device |
| Safety equivalent to predicate device | Demonstrated safety equivalent to the predicate device |
| Effectiveness equivalent to predicate device | Demonstrated effectiveness equivalent to the predicate device |
| Same intended use as predicate device | Intended use is the same as the predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the "test set." It mentions "laboratory models and skin blood flow measurements on volunteers." The number of volunteers or specific lab models used is not provided.
- Data Provenance: The study was conducted by Moor Instruments Ltd, located in the United Kingdom. It appears to be a prospective comparison study as it describes testing the moorFLPI-2 directly against the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study focuses on direct device comparison rather than relying on expert-established ground truth for a diagnostic outcome.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a direct device comparison (measuring blood flow), a traditional expert adjudication method for a test set of cases is unlikely to be applicable in the same way as for diagnostic imaging.
5. 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, an MRMC comparative effectiveness study was not done. This device is a measurement instrument for blood flow, not an AI-powered diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The moorFLPI-2 is a standalone device ("Full-Field Laser Perfusion Imager") that performs measurements. The study described compares its performance to another standalone device (the predicate). Therefore, the study, by its nature of comparing two instruments, can be considered evaluating its standalone performance in relation to the predicate. However, it's not an "algorithm only" in the sense of a software-based AI system; it's a hardware device with integrated signal processing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" in the diagnostic sense (e.g., pathology for a tumor) is not directly applicable here. The study established "ground truth" through direct comparison to the predicate device's measurements on the same laboratory models and volunteers. The predicate device (moorFLPI) itself implicitly serves as the "reference standard" or "ground truth" for the new device's performance, as the goal was to demonstrate equivalence.
8. The Sample Size for the Training Set
This information is not applicable or not provided. The moorFLPI-2 is a measurement device that uses speckle contrast analysis, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its underlying physics and signal processing are based on established principles, rather than learning from a large dataset.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" for an AI algorithm.
§ 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).