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The IV-eye is a hand-held, non-invasive imaging device that assists medical personnel, trained in vascular access procedure, to identify and locate suitable peripheral veins for the purposes of cannulation and venipuncture.

The IV-eye should only be used in conjunction with standard techniques of visualization and palpation in assessing and locating veins.

The IV-eye is intended only for skin contact via a disposable single use cover.

The IV-eye is a hand-held, battery powered electronic non-invasive imaging device that assists medical personnel, trained in vascular access procedure, to identify and locate suitable peripheral veins for the purposes of cannulation and venipuncture. The IV-eye transmits near infrared light into a patient's tissue at a wavelength of 850nm. As the light hits a vascular structure it is absorbed by the hemoglobin in the blood, whereas it passes through other tissue.

The camera in the device captures the light that has passed through the patient and, in identifying the blocked light and applying a number of algorithms, the IV-eye is able to produce an image on its LCD display of the patient's vascular structure directly underneath the device. This appears as a darker color to the contrasting tissue. The picture is updated in real-time and is close to actual size. Trained medical personnel can use the image of the patient's vascular structure to assist them in choosing a suitable vein for cannulation and venipuncture.

The IV-eye is intended to be used only by trained medical personnel to assist them in locating suitable veins for venipuncture and cannulation. It does not differentiate between arteries and veins and should therefore only be used in conjunction with standard techniques of locating veins. Other than regular cleaning and replacement of batteries, the IV-eye requires no routine or preventative maintenance.

The IV-eye includes a single-use cover which prevents the lower casing and wings of the device having direct contact with the patient, and is intended to reduce cross-contamination risk in using the device. The IV-eye is intended only for skin contact via this disposable single use cover.

The provided text describes a 510(k) premarket notification for the "IV-eye" device. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with specific performance metrics against pre-defined acceptance criteria as would be found in a full PMA submission or a comprehensive clinical trial publication.

However, based on the information provided, I can infer and extract some details regarding acceptance criteria and the study conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state quantitative acceptance criteria for device performance. Instead, the clinical study aims to "Demonstrating the ability of the IV-eye in identifying peripheral veins suitable for venipuncture and cannulation" and "Quantify the measurement depth capability of the IV-Eye in relation to the depth capability of the predicate VeinSite device from VueTek in order to establish equivalence."

The reported outcome is a qualitative statement of success: "Results of the clinical investigation support the indications for use of the IV-eye to identify and locate suitable peripheral veins for the purposes of cannulation and venipuncture and confirmed that the device can be considered equivalent to the Veinsite device from VuTek in terms of performance."

Without specific quantitative acceptance criteria, a table cannot be fully populated. However, if we interpret "equivalence in terms of performance" as the acceptance criterion, the device met this.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 30 healthy volunteers.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. It is a prospective clinical investigation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical study. It only mentions that the device "assists medical personnel, trained in vascular access procedure." It is implied that these "trained medical personnel" would assess the suitability of veins identified.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical performance assessment. The results statement is general, implying an overall assessment rather than a detailed adjudicated reading protocol.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not explicitly described. The study focused on demonstrating the IV-eye's ability to identify veins and its equivalence to a predicate device, not on quantifying improvement in human reader performance with the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The IV-eye device is described as "assists medical personnel" and "should only be used in conjunction with standard techniques of visualization and palpation." This indicates it is a human-in-the-loop device, not a standalone algorithm. Therefore, a standalone (algorithm only) performance study would not be applicable and was not described.

7. The Type of Ground Truth Used

The ground truth appears to be based on the assessment by "trained medical personnel" regarding the suitability of "peripheral veins for the purposes of cannulation and venipuncture." This suggests a form of expert assessment/clinical judgment as the ground truth. It is not explicitly stated if this was confirmed by subsequent successful cannulation/venipuncture or other objective measures (like pathology or imaging beyond the device itself).

8. The Sample Size for the Training Set

The document does not provide any information about a training set for the IV-eye. This is because the IV-eye is not described as an AI/ML device that requires a training set in the contemporary sense. It's an imaging device that uses "a number of algorithms" to produce an image, but it's not a learning algorithm that would have a separate training phase with a distinct training dataset.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.

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