(201 days)
The moorLDLS-BI laser Doppler burns imager assesses the blood flow in burn wounds of the skin, when cleaned of surface debris, to aid in the clinician's assessment of burn wound healing potential. It is intended to be used as an aid to burn wound management for patients with Total Body Surface Area burn of up to 30%.
The device is intended to be used as an aid to burn wound assessment, and not as a stand-alone prediction device.
The moor DLS-BI laser Doppler burns imager is an imaging device to aid the clinician to judge the healing potential of bums and the need for surgery.
It uses the laser Doppler imaging technique to quantify the blood flow in an area of skin damaged by a burn. The device uses a line of laser light projected onto the tissue and a linear detector arrav that sample from the line as it is swept across the tissue to rapidly build up a colour coded image of blood flow in the burn area and the surrounding normal skin for healing potential prediction. In addition, a CCD camera is integrated into the scanner unit for recording a colour photograph at the time of scanning, corresponding closely with the blood flow image in size and aspect.
The moorLDLS-BI laser Doppler burns imager is a substantial equivalent to the predicate device moorLDI2-B1 and assesses burn wound healing potential.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the clinical investigation's objectives and the comparative analysis against the predicate device. The primary performance metrics are accuracy in predicting healing potential and agreement with the predicate device.
| Acceptance Criteria / Performance Metric | Reported Device Performance (moorLDLS-BI) | Notes |
|---|---|---|
| Overall accuracy in predicting burn wound healing potential (compared to healing records) | 94.2% | This is a standalone performance metric for the moorLDLS-BI. |
| Agreement with predicate device (moorLDI2-BI) for HP14 (healing in 21 (healing in >21 days) | 98.5% | Demonstrates close correlation and substantial equivalence for predicting long healing times. |
| Non-inferiority to the predicate device (moorLDI2-BI) | Unlikely to perform more than 1.7% worse. (In fact, performed slightly better) | This indicates that the moorLDLS-BI is at least as effective as the predicate device, fulfilling a key aspect of substantial equivalence. |
| Electrical safety, laser radiation safety, electromagnetic compatibility, and programmable medical device standards conformity | Designed and tested for compliance with standards | Although specific compliance percentages or detailed results aren't provided, this statement confirms that regulatory safety criteria were met. |
| Good correlation for tissue blood flow measurement (bench testing) | Good correlation between moorLDLS-BI and predicate device in flow model and normal skin tissue scan results | This bench testing supports the foundational equivalence of the physiological measurement principle between the two devices before clinical application. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 596 burn cases for 204 burn patients.
- Data Provenance: Multi-center clinical investigation conducted in five burns centers across various countries: 2 in the UK, 1 in the USA, 1 in Belgium, and 1 in Australia. The study was prospective in nature, as it was a "Clinical Investigation" designed to assess the performance of a new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with X years of experience).
However, given the nature of "healing records" being the ground truth and the device's intended use as an aid to "clinician's assessment of burn wound healing potential" by "burn surgeons," it is highly probable that the ground truth was established by burn care clinicians/surgeons responsible for patient management and outcome tracking.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used for establishing the ground truth from "healing records."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a MRMC comparative effectiveness study was not explicitly done for human readers. The study focused on comparing the performance of the device (moorLDLS-BI) against the predicate device (moorLDI2-BI) and against healing records, not on comparing human reader performance with and without AI assistance.
- Effect size of human reader improvement: Not applicable, as this type of study was not conducted as described. The device is intended as an "aid to burn wound management," implying human oversight, but the study directly compares device performance, not human-AI synergy.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone performance assessment was done. The "overall accuracy of 94.2% was found for moorLDLS-Bl when compared with healing records" represents the device's standalone performance in predicting healing potential.
- It's important to note that while the device has standalone accuracy, its intended use statement explicitly says, "It is intended to be used as an aid to burn wound assessment, and not as a stand-alone prediction device," indicating that clinical interpretation by a human is still required.
7. The Type of Ground Truth Used
- Outcomes Data (Healing Records): The primary ground truth for the overall accuracy of the moorLDLS-BI was based on "healing records." This refers to the actual observed healing time of the burn wounds, which is a direct patient outcome.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size for a training set. The description mentions a "clinical investigation" and performance data, but does not distinguish between a training set and a testing set in the context of machine learning model development. This suggests the moorLDLS-BI, while a new device, might not be heavily reliant on a trainable "algorithm" in the modern AI sense, but rather on a refined physical measurement principle and associated processing algorithms for which the mentioned clinical investigation serves as a validation/test set.
9. How the Ground Truth for the Training Set Was Established
Since a distinct "training set" is not mentioned or detailed, the method for establishing its ground truth is also not described. If any internal development process involved a training phase, that information is not part of this 510(k) summary.
§ 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).