(232 days)
The moorLDI2 Laser Doppler Imager is intended for blood flow measurements in the microcirculation. It is intended to be used for clinical research applications and pre-clinical research applications.
The moorLDI2 is a device to perform non-invasive blood flow measurements in the microcirculation, for example skin, using the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. The system scans a very low power laser beam across the tissue. Moving blood in the microvasculature causes a Doppler frequency shift of the laser light, which is photo detected and processed to generate a colour coded blood flow map, line by line. An in built CCD camera records a colour photograph to aid visualisation of the scan site.
The Moor Instruments Ltd moorLDI2 Laser Doppler Imager is a device intended for blood flow measurements in the microcirculation for clinical and pre-clinical research applications. The 510(k) summary provides information regarding its performance and comparison to a predicate device (moorLDI2-IR laser Doppler imager, K032841).
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a pass/fail sense for a clinical study comparing the new device against specific benchmarks. Instead, it focuses on demonstrating substantial equivalence to the predicate device. The performance characteristics of the device itself are given.
| Parameter | Acceptance Criteria (Equivalent to Predicate) | Reported Device Performance (moorLDI2) |
|---|---|---|
| Flux (Tissue perfusion) | Range: 0-5000 PU | Range: 0-5000 PU |
| Accuracy: ±10% relative to Moor Instruments 'standard' moorLDI; ±3% of measurement from temperature controlled (22 ±1°C) motility standard | Accuracy: ±10% relative to Moor Instruments 'standard' moorLDI; ±3% of measurement from temperature controlled (22 ±1°C) motility standard | |
| Conc (Concentration of blood flow) | Range: 0-5000 AU | Range: 0-5000 AU |
| Accuracy: ±10%; ±3% of measurement value | Accuracy: ±10%; ±3% of measurement value | |
| DC (Intensity) | Range: 0-5000 AU | Range: 0-5000 AU |
| Accuracy: ±10%; ±3% of measurement value | Accuracy: ±10%; ±3% of measurement value | |
| Maximum image resolution | 256 x 256 pixels | 256 x 256 pixels |
| Scan speed | 4ms/pixel, 10ms/pixel, 50ms/pixel | 4ms/pixel, 10ms/pixel, 50ms/pixel |
| Operating principle | Same as predicate device | Same as predicate device |
| Image resolution options | Same as predicate device | Same as predicate device |
| Laser classification | Same as predicate device (Class 3R) | Class 3R (per IEC 60825-1:2007) |
| Scan head external dimensions | Same as predicate device | Same as predicate device |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "The moorLDI2 laser Doppler imager was tested in direct comparison to the predicate device using laboratory models and skin blood flow measurements on volunteers."
- Sample Size: Not explicitly provided. The number of laboratory models or volunteers used is not specified.
- Data Provenance: The study involved "laboratory models" and "skin blood flow measurements on volunteers." The country of origin for the data is implicitly the United Kingdom, where Moor Instruments Ltd is based. The data would be considered prospective as it involves new testing for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The type of testing performed (laboratory models, skin blood flow measurements) suggests objective measurements rather than subjective expert consensus for ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable as the document describes direct comparison testing using objective measurements of performance characteristics rather than an expert-adjudicated test set in the traditional sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted or described. The device is a measurement instrument, and the study focused on technical performance comparison rather than human reader interpretation with and without AI assistance.
6. Standalone Performance:
Yes, a standalone performance evaluation was done. The document provides detailed specifications and performance parameters like "Accuracy" for Flux, Concentration, and DC (Intensity), stating these accuracies relative to a standard. The study also concludes that the device performs "as well as or better than the predicate device," which implies standalone performance evaluation of the new device and its comparison to the predicate.
7. Type of Ground Truth Used:
The ground truth appears to be based on objective physical measurements from "laboratory models" and "skin blood flow measurements on volunteers." For parameters like Flux, Conc, and DC, accuracy is given relative to "Moor Instruments 'standard' moorLDI" and a "temperature controlled (22 ±1°C) motility standard." This suggests a reliance on established measurement standards and controlled experimental conditions to define the true values.
8. Sample Size for the Training Set:
This information is not provided and is likely not applicable. The device is not described as an AI/ML algorithm that requires a training set in the conventional sense. It's a measurement instrument, and its development would involve engineering design and calibration rather than AI model training.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is not applicable, as there is no mention of an AI/ML component requiring a training set with established ground truth.
§ 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).