(56 days)
The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.
The NinePoint Medical NvisionVLE® Imaging System is a high-resolution volumetric imaging system based on optical coherence tomography (OCT). In an analogous fashion to ultrasound imagery, OCT images are formed from the time delay and magnitude of the signal reflected from the tissue of interest. The NvisionVLE® Imaging System employs an advanced form of OCT known as swept-source OCT (SS-OCT), or Optical Frequency Domain Imaging (OFDI), in combination with a scanning optical probe to acquire high-resolution, crosssectional, real-time imagery of tissue called Volumetric Laser Endomicroscopy (VLE).
The device consists of the following main components and accessories: (i) a mobile NvisionVLE Console with an integrated computer and two touchscreen interfaces; (ii) proprietary NvisionVLE Software used to acquire, process, and visualize VLE images; (iii) a single-use, sterile NvisionVLE Optical Probe that is inserted through the working channel of an endoscope: (iv) a single-use, sterile NvisionVLE Inflation System that is used to inflate the balloon as required, to facilitate placement; and (v) a Probe Lock Accessory to prevent longitudinal motion of the Probe within the endoscope.
This document is an FDA 510(k) clearance letter for the NvisionVLE Imaging System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results for a new AI/ML-based device.
Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to AI/ML performance metrics like sensitivity, specificity, MRMC studies, or training/test set details for AI) are not present in this type of regulatory document.
However, I can extract information related to the device's functional and non-clinical performance, which serve as its "acceptance criteria" in the context of this 510(k) pathway.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Functional/Non-Clinical) | Reported Device Performance (as tested) |
|---|---|
| Image Quality: Confirmation of proper image on the Console | Met: Confirmed proper image on the Console. |
| Optical Performance: Acceptable probe lateral resolution, back reflection, and transmission rate | Met: Demonstrated acceptable probe lateral resolution, back reflection, and transmission rate. |
| Mechanical Integrity: Mechanical integrity of the probe/sheath tip, demonstrated through tensile testing | Met: Passed tensile testing, demonstrating mechanical integrity of the probe/sheath tip. |
| Functional Operation: Functional testing to ensure the probe loads and withdraws properly | Met: Performed functional testing, and the probe loads and withdraws properly. |
| (Compliance with Voluntary Standards) | (Complies with various IEC, ISO, ANSI/AAMI standards for biological evaluation, sterilization, electrical safety, EMC, software, and usability, as listed in Section 7 of the 510(k) summary.) |
Note on "Acceptance Criteria" for this specific 510(k): For this Special 510(k), the "acceptance criteria" are primarily focused on demonstrating that the modification (addition of balloon-less low-profile optical probes) does not adversely affect the fundamental safety and effectiveness of the device, and that it maintains the performance characteristics expected of the original cleared device. There are no clinical diagnostic performance metrics (e.g., sensitivity, specificity for disease detection) because the device's cleared indication for use explicitly states that its safety and effectiveness for diagnostic analysis (differentiating normal vs. specific abnormalities) has not been evaluated.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any specific functional or non-clinical test. The testing described is general "functional testing" and "tensile testing" which implies a sufficient number of samples were tested to ensure design verification, but specific numbers are not disclosed in this summary.
- Data Provenance: Not applicable in terms of patient data. The testing involves device components and systems (e.g., probes, consoles). This is non-clinical performance data, likely gathered at the manufacturer's testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This 510(k) describes non-clinical and functional testing of device characteristics, not clinical performance or diagnostic accuracy assessed by experts.
4. Adjudication method for the test set:
- Not applicable. This is not a clinical study involving human interpretation of results.
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. This is explicitly stated: "The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated." This device is an imaging tool to visualize microstructure, not a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The device is for human visualization of microstructure. It does not perform standalone diagnostic analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests described, the "ground truth" would be engineering specifications and established test methodologies (e.g., correct image display, specified resolution ranges, material strength limits, proper mechanical function). This is not a clinical ground truth like pathology.
8. The sample size for the training set:
- Not applicable. This document is for a medical imaging device, not an AI/ML product developed with a training set of data.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
Summary of what this document does tell us about "acceptance criteria":
For the NvisionVLE Imaging System, particularly concerning this Special 510(k) for new probe configurations, the acceptance criteria are entirely based on functional and non-clinical performance. The study "proving" the device meets these criteria involved a battery of engineering and bench tests, including:
- Image quality confirmation on the console.
- Quantitative measurements of optical performance (lateral resolution, back reflection, transmission rate) to ensure they meet specified levels.
- Mechanical integrity testing of components (e.g., tensile testing of probes).
- Verification of proper device operation (e.g., probe loading and withdrawal).
- Compliance with recognized voluntary consensus standards for quality, safety, and manufacturing.
The FDA's clearance indicates that these non-clinical tests demonstrate the modified device is "as safe and effective as the predicate device" and does "not raise any new or different questions of safety or effectiveness." It is crucial to reiterate that the device's cleared indication for use specifically states that its diagnostic capability for differentiating abnormalities has not been evaluated, meaning it's primarily a visualization tool.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.