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The Nvision VLETM Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, crosssectional, real-time depth visualization.

The NinePoint Medical Nvision VLE™ Imaging System is a general imaging system The Niler offit Wediod Nivision VLE TM Console, NVISion VLE™ Catheter and the Nvision VLE™ Inflation Accessory Kit.

The submission describes a labeling change for the Nvision VLE™ Imaging System, specifically an increase in the maximum recommended inflation pressure for the catheter balloon from 5 psi to 30 psi. The study conducted to support this change is a burst pressure test of the balloons.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Samples from two balloon manufacturing lots were characterized. The exact number of individual balloons tested is not specified beyond "samples from two lots."
• Data Provenance: The data is prospective, as the burst pressure testing was performed specifically to support this labeling change. The country of origin of the data is not explicitly stated, but given the submission is to the FDA in the US, it is likely that the testing was conducted either in the US or in a manner compliant with US regulatory standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This study does not involve human experts establishing ground truth for image interpretation or clinical outcomes. It is an engineering performance test assessing the physical integrity of a component.

4. Adjudication Method for the Test Set:

Not applicable. This is a direct measurement of physical properties (burst pressure) and does not involve adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. This is not an MRMC comparative effectiveness study. It is a performance test of a device component's physical characteristic.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is an imaging system, but the study described is a component-level performance test, not an evaluation of the imaging algorithm's standalone performance. The submission refers to a "labeling change only," implying the imaging algorithm itself was cleared in the predicate device (K112770).

7. The Type of Ground Truth Used:

The ground truth used is the measured burst pressure of the catheter balloons. This is a direct physical measurement.

8. The Sample Size for the Training Set:

Not applicable. There is no machine learning "training set" for this type of engineering performance test.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established in this context. The "ground truth" for the burst pressure test is the physical measurement itself.

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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:

1. 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.
2. 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.
3. 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.
4. Adjudication method for the test set: No adjudication method is described.
5. 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).
6. 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.
7. Type of ground truth used: No ground truth type is specified as there's no detailed diagnostic performance study described.
8. 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.
9. 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.

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