(76 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, realtine depth visualization, and may be used to mark areas of tissue.
The NvisionVLE Imaging System is intended to provide an image of the tissue microstructure. 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.
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, cross-sectional, real-time imagery of tissue called Volumetric Laser Endomicroscopy (VLE).
In addition to the imaging capability, the device provides a means of marking areas of tissue with an additionally integrated 1470nm laser. The ability to create temporary laser marks directly on tissue enables a clinician to place visual reference marks on tissue regions of clinical interest immediately following their identification via VLE.
The device consists of the following five main components and accessories: (i) a mobile NvisionVLE Console with an integrated computer and two touch-screen interfaces; (ii) proprietary NvisionVLE Software used to acquire, process, and visualize VLE images; (iii) a single-use, sterile NvisionVLE Marking 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 Marking Probe's balloon to facilitate placement; and (v) a Probe Lock Accessory to prevent longitudinal motion of the Marking Probe within the endoscope. The first four components provide the previously-cleared (K143678) VLE imaging functionality of the NvisionVLE Imaging System. The device consists of a Laser Marking Unit and a Hand Controller as part of the NvisionVLE Console, and updated NvisionVLE Software for the laser marking functionality. A Probe Lock Accessory is also provided to the user as a convenience to help stabilize the Marking Probe during laser marking.
The provided document is a 510(k) premarket notification letter and summary for the Nvision VLE Imaging System. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on the addition of a laser marking functionality.
However, the document does not contain specific acceptance criteria, study results quantifying device performance (e.g., accuracy, sensitivity, specificity), sample sizes for test sets, details about ground truth establishment for test or training sets, or information regarding multi-reader multi-case (MRMC) studies.
The "Performance Data" section (Page 6) states that bench and animal tests were conducted to assess performance and safety, confirming the feasibility of the laser marking and finding optimum parameter settings. It also mentions that clinical testing "evaluated the safety and efficacy of this technology, confirming the use of the laser marking functionality for aiding a physician to further evaluate tissue regions of interest as identified on the VLE image." However, these statements are general and do not provide the detailed quantitative results required to fill out the table and answer the specific questions about acceptance criteria and how they were met.
Therefore, I cannot extract the requested information from the provided text.
Based on the provided document, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: The document mentions that performance data demonstrates safety and effectiveness, and that "all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests," but it does not specify what those acceptance criteria or performance metrics were, nor does it provide quantitative results.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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: Not mentioned. The device described is an imaging system with a marking function, not explicitly an "AI" device for diagnostic analysis.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The device is for clinical use by a physician.
- The type of ground truth used: Not explicitly stated for specific studies. "Feasibility" and "safety" were evaluated.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
§ 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.