(405 days)
The Nvision VLE 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 Nvision VLE Imaging System is a general imaging system comprised of the Nvision VLE Console, Nvision VLE Catheter and the Nvision VLE Inflation Accessory Kit.
This 510(k) summary for the NinePoint Medical Nvision VLE Imaging System describes general performance data but does not contain the specific information required to complete your request for acceptance criteria and a study proving quantitative device performance against those criteria.
Here's what the document states and what it lacks:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (General): The document lists voluntary standards the device will be tested against and comply with. These are primarily safety and regulatory standards, not quantitative performance metrics for image quality or diagnostic accuracy.
- IEC 60601-1, General Safety
- IEC 60601-1-2, Electromagnetic Compatibility
- IEC 60601-1-4, Programmable Electrical Medical Systems
- IEC 60601-2-18, Endoscope
- IEC 60601-2-22, Laser Safety
- IEC 60825-1, Laser Safety
- ISO 10993-1, Biological Evaluation of Medical Devices
- ISO 10993-7, Biological Evaluation of Medical Devices, Ethylene Oxide Sterilization residual testing
- ISO 11135-1, Sterilization of Health Care Products, Ethylene Oxide
- Reported Device Performance: The document states: "In-vitro and clinical testing have been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests." However, it does not provide any specific quantitative performance results (e.g., sensitivity, specificity, resolution, accuracy, etc.) against any performance-based acceptance criteria for its imaging capabilities. The FDA letter explicitly limits the device's use for diagnostic analysis, stating, "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 indicates that the device's diagnostic performance, which would typically be measured against specific criteria, was not part of this clearance.
Therefore, a table of quantitative acceptance criteria and reported device performance cannot be generated from the provided text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states "In-vitro and clinical testing have been performed," but it does not provide any details on the sample size of the test set, the provenance of the data (country of origin), or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Since no specific performance metrics or diagnostic claims are being made and evaluated, the document does not mention the use of experts to establish ground truth or their qualifications. The FDA explicitly noted that the device's effectiveness for diagnostic analysis has not been evaluated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Due to the lack of details on a diagnostic performance test set or expert evaluation, no adjudication method is described.
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:
- This document describes an Optical Coherence Tomography (OCT) imaging system, not an AI or CAD system. Therefore, no MRMC comparative effectiveness study involving human readers with or without AI assistance was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- As this is an imaging system and not an AI algorithm, no standalone algorithm performance study was discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Given the device's current indication as an imaging tool "in the evaluation of human tissue microstructure" and the FDA's explicit statement that its safety and effectiveness for diagnostic analysis "has not been evaluated," the document does not specify a type of ground truth established for diagnostic performance. The "clinical testing" mentioned likely refers to safety and basic image acquisition rather than diagnostic accuracy against a histological or expert-derived ground truth.
8. The sample size for the training set:
- This device is an imaging system, not a machine learning algorithm that requires a training set in the typical sense. Therefore, no training set sample size is mentioned.
9. How the ground truth for the training set was established:
- As there's no mention of a machine learning training set, this information is not applicable and not provided.
In summary, the provided submission focuses on the substantial equivalence of the Nvision VLE Imaging System to a predicate device based on technological characteristics and compliance with general safety and regulatory standards. It does not include a quantitative performance study measuring imaging or diagnostic accuracy against specific acceptance criteria, nor does it involve AI or machine learning components that would necessitate training and test set specifics as you've requested.
§ 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.