(84 days)
The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing twodimensional, 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.
The provided 510(k) summary for the NinePoint Medical Nvision VLE Imaging System indicates that this device is an Optical Coherence Tomography (OCT) system, which is a general imaging system. While the document mentions compliance with several general safety and performance standards (like IEC and ISO), it does not contain details about specific acceptance criteria related to a clinical performance study for image interpretation, nor does it present the results of such a study.
The "Performance data" section (Section 7) primarily states that:
- The device will be tested against and comply with a list of voluntary standards (related to general safety, electromagnetic compatibility, biological evaluation, sterilization, etc.).
- "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."
This statement is very general and does not provide any specific quantitative acceptance criteria or detailed results of these tests that would be relevant to evaluating the device's diagnostic performance (e.g., accuracy, sensitivity, specificity for identifying specific tissue microstructures).
Therefore, based solely on the provided text, the extensive information requested in the prompt regarding acceptance criteria and a study proving those criteria cannot be extracted.
Here's a breakdown of why and what information is missing:
- Table of acceptance criteria and reported device performance: This information is not provided. The document lists general manufacturing and safety standards but not performance criteria for image quality or diagnostic accuracy.
- Sample size used for the test set and data provenance: No details about a specific test set, its size, or provenance are mentioned for clinical performance.
- Number of experts used to establish the ground truth for the test set and their qualifications: No information is provided about expert readers or ground truth establishment for a diagnostic performance study.
- Adjudication method for the test set: No adjudication method is described.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned, nor is an effect size for human readers improving with AI assistance (which is not relevant as this is an imaging device, not an AI diagnostic tool in the context of what's described).
- Standalone performance (algorithm only without human-in-the-loop performance): This is an imaging system, not an algorithm being evaluated without human interpretation. No separate algorithm-only performance is described.
- Type of ground truth used: No ground truth type is specified as there's no detailed diagnostic performance study described.
- Sample size for the training set: The product is an imaging system, not an AI/ML algorithm that typically requires a "training set" in the same way. The document doesn't mention an AI component that would have a training set.
- How the ground truth for the training set was established: Not applicable, as no AI model training is described.
In summary: The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices based on technological characteristics and compliance with general safety and voluntary standards. It does not contain the detailed clinical performance study data that would typically include specific acceptance criteria and detailed results related to diagnostic accuracy, which is what your questions are seeking.
§ 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.