(30 days)
The MolecuLightDX is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to
- (i) View and digitally record images of a wound,
- (ii) Measure and digitally record the size of a wound, and
- (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.
The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLightDX device should not be used to rule-out the presence of bacteria in a wound.
The MolecuLightDX does not diagnose or treat skin wounds.
The MolecuLightDX Imaging Device is a handheld medical imaging device comprised of a high-resolution color AMOLED display and touch-sensitive screen with integrated optical and microelectronic components. MolecuLightDX uses its patented technology to enable real-time standard digital imaging and fluorescence imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.
This document is a 510(k) summary for the MolecuLightDX device. It describes non-clinical testing performed on the device but does not contain information about clinical studies or acceptance criteria for identifying bacterial loads >10^4 CFU per gram. The summary focuses on established equivalence to a predicate device (MolecuLight i:X K191371) based on similar technological characteristics and compliance with electrical safety and software validation standards, rather than direct performance metrics against clinical acceptance criteria for bacterial load detection.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the identification of bacterial loads, cannot be fully provided from the given text.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily discusses compliance with safety and technical standards rather than specific clinical performance acceptance criteria for bacterial load detection. The key performance claim related to its indication for use is: "The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per gram as compared to examination of clinical signs and symptoms alone."
While this is an indication of efficacy, the document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, or AUC thresholds) for this "increased likelihood" or present a study showing the MolecuLightDX device itself met such criteria. Instead, it refers to its predecessor's demonstrated capability.
2. Sample size used for the test set and the data provenance:
Not provided in this document for the MolecuLightDX's bacterial load identification capability. The non-clinical testing mentioned includes:
- Standards Compliance Testing
- Software Verification and Validation
- System Verification and Validation
- Accuracy and Inter/Intra Reader Variability Testing of Wound Measurement Function
- Packaging and Transport validation
These tests do not involve clinical test sets for bacterial load identification. The effectiveness claim for bacterial load identification references earlier work/evidence from the predicate device, implicitly assuming the newer device maintains this capability due to similar technology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not provided in this document.
4. Adjudication method for the test set:
Not provided in this document.
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:
Not provided in this document. The device is a "handheld imaging tool" and not an AI-driven diagnostic algorithm in the typical sense that would necessitate an MRMC comparative effectiveness study for "AI vs without AI assistance". Its primary function is to enable visualization of fluorescence which clinicians then interpret.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is explicitly described as a "handheld imaging tool that allows clinicians... to view and digitally record images... The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds..." This indicates a human-in-the-loop system.
7. The type of ground truth used:
Not explicitly stated for the MolecuLightDX in this document regarding bacterial load. However, the indication for use refers to "bacterial loads >10^4 CFU per gram," which implies quantitative microbiology (CFU per gram) as the ground truth method in the referenced studies from which the claim of "increased likelihood" originated (likely from the predicate device's clearance).
8. The sample size for the training set:
Not applicable, as this document does not describe a machine learning algorithm requiring a training set for the bacterial load identification claim. The device is an imaging tool.
9. How the ground truth for the training set was established:
Not applicable.
Summary based on available information:
The provided document (a 510(k) summary) focuses on demonstrating substantial equivalence to a predicate device (MolecuLight i:X K191371) through non-clinical testing, regulatory compliance, and comparison of technological characteristics. It does not detail a specific clinical study for MolecuLightDX to establish performance against acceptance criteria for identifying bacterial loads. Instead, it leverages the known efficacy claim from its predicate device for its indication of use, implying that the MolecuLightDX, being technologically similar, shares this established capability. The "increased likelihood" claim for identifying bacterial loads >10^4 CFU per gram is presented as a previously established benefit from the predicate device's performance.
§ 878.4550 Autofluorescence detection device for general surgery and dermatological use.
(a)
Identification. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Performance testing must demonstrate the sterility of patient-contacting components of the device.
(6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin.
(8) Labeling must include the following:
(i) Instructions for use;
(ii) The detection performance characteristics of the device when used as intended; and
(iii) A shelf life for any sterile components.