(232 days)
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.
| Acceptance Criteria (Not explicitly stated, inferred from general statements) | Reported Device Performance (Qualitative) |
|---|---|
| Effective visualization of superficial, subcutaneous vascular structures | - Effectively provided and enhanced visualization of superficial, subcutaneous vascular structures when compared to the naked eye. |
| Safety | - Found to be safe. |
| Meet established user and design requirements | - Demonstrated that the VTS1000 met design requirements. |
- 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.
§ 880.6970 Liquid crystal vein locator.
(a)
Identification. A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.