(115 days)
The Aïmago EasyLDI Microcirculation Camera is intended for blood flow measurements in the microcirculation. In particular, it can be used for measuring perfusion of healthy and injured skin including burn wounds, skin flaps (plastic and reconstructive surgery) and hand surgery.
EasyLDI Studio is intended to be used as offline viewer application for snapshots, videos and references recorded with the Aïmago EasyLDI Microcirculation Camera.
The Aïmago EasyLDI microcirculation camera is a device for imaging blood flow in the microcirculation. It is a medical diagnostic imaging device which serves to visualize the perfusion of cutaneous microcirculation in the form of arbitrary units in real-time. The EasyLDI uses the established laser Doppler technique performing a 2-dimensional area scan to build up a color coded image of the blood flow in the tissue. In the form of arbitrary units, this image allows the surgeon to quantify movement of blood cells beneath the skin surface.
The software changes implemented in the Aïmago EasyLDI microcirculation camera V2.X allow the user different modes of displaying the information on the built-in screen, thus facilitating the assessment of the microcirculation patterns for the specified applications.
EasyLD! Studio is a standalone software which runs on Windows systems. It is an optional accessory to the Aïmago EasyLDI microcirculation camera. It can be used to view LDI items (i.e. LDI snapshots, videos or references previously recorded with the Aïmago EasyLDI) on a commercially available desktop computer.
The provided text describes a 510(k) summary for the Aïmago EasyLDI Microcirculation Camera and its accessory, EasyLDI Studio. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial would.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. This submission primarily relies on comparing technological characteristics and demonstrating safety and effectiveness based on in-house and contract laboratory testing for regulatory compliance (e.g., FCC, IEC standards).
Here's a breakdown of what can be extracted and what is not available based on the provided text:
Acceptance Criteria and Device Performance
The document does not specify performance-based acceptance criteria in the typical sense of a clinical or functional study (e.g., sensitivity, specificity, accuracy for a particular clinical outcome). Instead, "acceptance criteria" here refer to regulatory compliance and equivalence:
| Acceptance Criteria (Regulatory/Equivalence) | Reported Device Performance (Compliance) |
|---|---|
| Substantial Equivalence to Predicate Device (K121449) | Cleared as substantially equivalent. Changes do not adversely affect safety and effectiveness. |
| FCC Rules for Digital Devices (Subpart B of Part 15 for Class A) | Fulfills the requirements. |
| ESD safety (IEC 60601-1-2) | Fulfills the requirements. |
| Electromagnetic immunity (IEC 60601-1-2) | Fulfills the requirements. |
| Electrical safety requirements (IEC 60601-1) | Fulfills all requirements. |
| Ability to display information in different modes (V2.X software) | Allows user different modes of displaying information, facilitating assessment of microcirculation. |
| EasyLDI Studio: Ability to view LDI items (snapshots, videos, references) | Intended to be used as offline viewer application for snapshots, videos, and references recorded with the Aïmago EasyLDI Microcirculation Camera. |
Study Details
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any performance testing related to clinical application. The testing mentioned refers to regulatory compliance tests (e.g., FCC, IEC), for which sample sizes for device hardware/software are typically small and not relevant to clinical data.
- Data Provenance: Not applicable in the context of clinical data. The testing mentioned ("performed in-house as well as at contract laboratories") is for regulatory compliance, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth for a test set in a clinical context is mentioned. Clinical assessments are explicitly stated to be "aid to healthcare professionals," and the device "do not provide specific clinical assessments such as burn depth assessments or potential healing times."
4. Adjudication method for the test set
- Not applicable. No clinical test set or adjudication process is described.
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 or reported. This device precedes the widespread use of clinical AI assistance in this context. The software changes are described as facilitating assessment, but no studies on reader improvement are mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device's core function is to visualize and measure blood flow, which is then interpreted by a human professional. The "new software applications are intended only as an aid to healthcare professionals in their clinical assessments." This implies a human-in-the-loop scenario. No standalone algorithm performance without human interpretation is described for clinical outcomes. The device itself is a standalone imaging device, but its utility for "assessment" relies on the human user.
7. The type of ground truth used
- Not applicable for clinical efficacy. The "ground truth" for the regulatory compliance testing would be established by the standards themselves (e.g., an ESD test either passes or fails according to IEC 60601-1-2 criteria). The device's output is "arbitrary units" of blood flow, which doesn't directly map to a "ground truth" in the sense of a definitive diagnosis or pathology.
8. The sample size for the training set
- Not applicable. This device is cleared based on predicate equivalence and compliance with engineering standards, not through machine learning or AI model development that would require a training set.
9. How the ground truth for the training set was established
- Not applicable, as no training set for a machine learning model is mentioned.
§ 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).