Search Results

The MSI is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds to:
· View and digitally record images of a wound.
· Measure and digitally record the size of a wound.

• · View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.
  · View and digitally record thermal images of a wound.
  The MSI does not diagnose or treat skin wounds.

The MSI Kit includes the following: the MSI, a Universal Serial Bus (USB-C) cable, a wall adapter, and a carrying case.
The MSI captures and processes optical data of an imaged wound. The MSI consists of three imaging modalities: white light, autofluorescence and thermal. The MSI has 395nm excitation LEDs for autofluorescence imaging, a sensor for measuring distance to the wound, and a thermal sensor for capturing temperature gradients.
The MSI is powered by an onboard rechargeable battery and has a USB-C connection for uploading images to a computer. The manual provides users of the MSI with detailed instructions for proper use, maintenance, and storage.

The provided text outlines the general safety and performance testing conducted for the Multispectral Imager Kit (MSI Kit) to establish its substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria or detailed results of a study demonstrating the device meets those criteria.

However, based on the information provided, here's a breakdown of what can be inferred and what is missing:

Acceptance Criteria and Reported Device Performance:

The document lists various performance tests, implying certain acceptance criteria for each, but the specific numerical targets or thresholds are not provided. The conclusion statement indicates that the clinical and non-clinical data "indicate that the MSI Kit is as safe and effective as the predicate devices," which serves as a general statement of meeting underlying acceptance criteria for equivalence.

Missing information: The actual acceptance criteria (e.g., minimum accuracy for wound measurement, specific signal-to-noise ratio requirements for fluorescence imaging) and the quantitative results from the study demonstrating the device's performance against these criteria are not detailed in the provided text.

Detailed Information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific acceptance criteria and detailed quantitative results are not provided in the document. The document lists the types of tests performed and generally states that the device's performance was evaluated, leading to a conclusion of safety and effectiveness comparable to predicate devices.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document does not specify the sample size for any of the performance tests, including the clinical study.
• Data Provenance:
  • Clinical Study: "A clinical study was conducted under anticipated conditions with anticipated users." The location (country of origin) is not specified, nor is whether it was retrospective or prospective. Given the phrasing "conducted," it implies a prospective study.
  • Bench Studies: Performed to verify various performance aspects. No information on data provenance other than being "bench studies."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that the MSI is "a handheld imaging tool that allows clinicians diagnosing and treating skin wounds to: ... View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light," and that it "does not diagnose or treat skin wounds." The clinical study evaluated the "ability of the MSI to detect autofluorescence signals from tissues or structures consistent with the indications for use."

This implies that the assessment of autofluorescence signals in wounds would typically require clinical experts. However, the document does not specify the number of experts or their qualifications used to establish ground truth for any test set.

4. Adjudication method for the test set

The document does not specify any adjudication method for establishing ground truth in the clinical study or any other performance testing.

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

The document does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study, nor does it refer to AI assistance or human reader improvement with AI. The device is described as an "imaging tool" for clinicians, not as an AI-powered diagnostic aid that assists in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device description focuses on its imaging capabilities and the output of images (white light, fluorescence, thermal) for clinician evaluation. None of the performance data sections suggest a standalone algorithm-only performance assessment where the device makes interpretations without human involvement. The indications for use specifically state it "does not diagnose or treat skin wounds" and provides images for clinicians.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used in the clinical study. For "autofluorescence signals from tissues or structures consistent with the indications for use," the ground truth would likely involve a clinical assessment by wound care specialists or potentially correlated with wound characteristics that are known to exhibit certain autofluorescence, but this is not specified.

8. The sample size for the training set

The document does not mention a training set or its sample size. This suggests that the device's functionality does not rely on a machine learning model that requires a labeled training dataset in the way a diagnostic AI would. The device's operation, as described, appears to be based on capturing and processing optical and thermal data rather than learning from data.

9. How the ground truth for the training set was established

Since no training set is mentioned, there is no information on how ground truth for a training set was established.

Ask a specific question about this device