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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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The VTS1000 is a non-invasive electronic device to aid in the visualization of superficial vasculature. It is indicated for use during procedures requiring vascular or peripheral vessel access.

The VueTek Scientific™ VTS1000 is a near-infrared (NIR) emitter, video acquisition, and head mounted display (HMD) device that affords viewing of superficial, and its nead invanced and, by differentiating it with higher contrast from surrounding tissue. Visualization of vascular structures is provided by a portable headset display system which supplements normal line of sight viewing during vascular access procedures. The VTS1000 device does not replace the accepted conventional vascular identification and confirmation methods used by qualified professionals.

The provided text describes a pre-market notification (510(k) summary) for the VueTek Scientific™ VTS1000 device. While it mentions performance summary and clinical study results, it does not provide specific acceptance criteria or detailed study methodologies that would allow for a comprehensive table of acceptance criteria versus reported device performance as requested.

Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantifiable acceptance criteria (e.g., minimum sensitivity, specificity, or error rates). Instead, it provides qualitative statements about performance.

• Met the established user and design requirements and performs safely and effectively as designed, for its intended use. |
  | Conformance to international standards | - Conforms to IEC60601-01, IEC60601-1-2, CIE-S009/IEC-62471, ANSI IESNA RP 27.1, 27.2 and 27.3. |
  | Portability and flexibility | - Found to be portable, flexible. |
  | Normal line-of-sight viewing | - Provided normal line-of-sight viewing during use. |
  | Substantial Equivalence to predicate devices | - Determined to be substantially equivalent with similar devices currently legally commercially available. |

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

• Sample Size: The document states "Clinical study results involving subjects with ages from 65 years of age", but does not specify the number of subjects (sample size).
• Data Provenance: The document does not explicitly state the country of origin. It mentions "Clinical, non-clinical, and independent testing performance data were submitted," but it does not specify if the study was retrospective or prospective. Given the nature of a 510(k) submission for a new device, a prospective clinical study would be more likely, but this is not explicitly stated.

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

This information is not provided in the document. The VTS1000 is a vein locator that enhances visualization. The comparison is "compared to the naked eye," implying a direct visual assessment rather than requiring expert-established ground truth in the traditional sense of diagnostic interpretation.

4. Adjudication method for the test set:

This information is not provided in the 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:

• MRMC study: The document doesn't explicitly mention an MRMC study. It states the VTS1000 "supplements normal line of sight viewing" and "does not replace the accepted conventional vascular identification and confirmation methods." The comparison is "compared to the naked eye," suggesting an evaluation of the device as an aid, but not in the format of an MRMC study comparing human performance with and without AI.
• Effect size: Since an MRMC study is not described, the effect size is not provided. The device is an enhancement tool, not an AI for interpretation.

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

The VTS1000 is described as a "near-infrared (NIR) emitter, video acquisition, and head mounted display (HMD) device" that "affords viewing" and "supplements normal line of sight viewing." This indicates it's a visualization aid for human use, not a standalone algorithm that provides an output without human interpretation. Therefore, a standalone algorithm-only performance study would not be applicable or described.

7. The type of ground truth used:

Given the device's function (enhancing visualization of veins), the "ground truth" would likely be the actual presence and location of superficial veins, confirmed either visually by medical professionals (who would manually identify veins) or by the success of vascular access attempts. The document states it "effectively provided and enhanced visualization," implying that the enhanced view allowed for better or more accurate identification by the users. There is no mention of pathology or outcomes data being used for ground truth.

8. The sample size for the training set:

The VTS1000 is a hardware device with an optical system, not an AI or machine learning algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable.

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

As the concept of a training set is not applicable (see point 8), this information is not provided.

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The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures. The IR Viewer is indicated for use in procedures for inserting a needle or catheter in superficial, peripheral vessels.

The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures.

The provided document does not contain acceptance criteria or a study that proves the device meets acceptance criteria.

The document is a 510(k) premarket notification summary for the IR Viewer, a device for visualizing patient vasculature. It outlines the device description, intended use, predicate devices, and the FDA's substantial equivalence determination.

Here's a breakdown of what is and isn't in the document regarding your request:

What is present:

• Device Description: The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing for procedures involving needle or catheter insertion in superficial, peripheral vessels.
• Intended Use Statement: Clearly defined.
• Predicate Devices: ESP7 (Ironmaster) and Venoscope (Trinity Partners) are mentioned.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.

What is explicitly stated but lacks detail:

• "Performance Data: Performance data were submitted to characterize the device." This line is present, indicating that performance data exists and was submitted to the FDA, but the document does not elaborate on what that data entails, what the acceptance criteria were, or the results of any specific study.

Therefore, I cannot provide the requested information because it is not contained within the provided text. To answer your questions, details from the actual performance data submission would be required.

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The ESP7 Venous Imager is a non-invasive electronic visual aid device for the purpose of viewing of the human superficial venous vasculature. Indications for use: 1) viewing the superficial venous vasculature as a visual aid in taking blood or inserting an I.V.

The "ESP7 Venous Image" is designed for the same purpose, to locate veins which are otherwise not visible to the naked eye. It uses a similar technology in that it uses a standard Video Camera and television monitor mounted on a roll around height and angle adjustable metal stand. The ESP7 Venous Image, however, uses an Infrared filter placed between the camera lens and the CCD to eliminate visible light from entering the camera but allowing infrared and ultra violet light to pass through to the monitor. An on board light source broadcasts a low intensity light beam on the subject. The light source is a common household incandescent 50 watt light bulb that illuminates from a wave length of 350 to 900 nanometers. The ultra violet in the below 450 range is absorbed by the melanin in the epidermis forming a translucent window for the infra red to pass through the skin and differentiate the blue or carbon dioxide carrying venous vessels from the other objects in view.

I am sorry, but the provided text from K982612 contains a 510(k) summary and an FDA clearance letter for a device called the "ESP7 Venous Imager." However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary describes the device's technology and compares it to a predicate device ("E-Z-Jector"). The FDA letter details the clearance of the device based on substantial equivalence. Neither document includes:

• A table of acceptance criteria and reported device performance.
• Information on a test set (sample size, data provenance, ground truth experts, adjudication method).
• Details on MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used in any study.
• Training set sample size or how its ground truth was established.

Therefore, I cannot fulfill your request with the provided input.

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