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The Low-Profile Optical Probe, as part of the Nvision VLE Imaging System, is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal and pancreatico-biliary system tissue microstructures, by providing two-dimensional, cross-sectional, real-time depth visualization.

The NvisionVLE Imaging System is intended to provide an image of 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 subject to this 510(k) is a general imaging system comprised of the NvisionVLE® Console and NvisionVLE® Optical Probe.

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 or organ 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 highresolution, cross-sectional, 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 touch-screen 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: and (iv) a Probe Lock Accessory to prevent longitudinal motion of the Probe within the endoscope.

The provided document is a 510(k) Premarket Notification from the FDA for the NinePoint Medical NvisionVLE Low-profile Optical Probe. It concludes that the device is substantially equivalent to a legally marketed predicate device (NvisionVLE® Imaging System, K182261) and permits its marketing.

Important Note: The document explicitly states: "The NvisionVLE Imaging System is intended to provide an image of 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." This means the device is cleared for imaging, not for diagnostic claims or AI-based diagnostic analysis. Therefore, the questions related to AI performance metrics (acceptance criteria for diagnostic accuracy, standalone algorithm performance, MRMC studies, ground truth for training/test sets for diagnostic purposes) are not applicable in this context. The provided information relates to the device's ability to image tissue microstructure and its safety/effectiveness for that purpose.

Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets them, focusing on the device's clearance for imaging and not diagnostic capabilities.

Acceptance Criteria and Study for NvisionVLE Low-profile Optical Probe (K191117)

The NvisionVLE Low-profile Optical Probe, as part of the NvisionVLE Imaging System, is cleared as an imaging tool to evaluate human tissue microstructure. The regulatory finding of substantial equivalence (K191117) is based on the device having the same intended use, principles of operation, and technological characteristics as its predicate device (NvisionVLE Imaging System, K182261). The current submission (K191117) specifically sought to add additional specific anatomical locations (pancreatico-biliary tract) to its cleared indications for use, specifically for the Low-profile Optical Probe.

The core "acceptance criteria" here is substantial equivalence to the predicate device for its defined imaging purpose, specifically demonstrating that the expanded anatomical locations do not introduce new questions of safety or effectiveness.

1. Table of Acceptance Criteria (for Imaging Device) and Reported Device Performance

2. Sample Sizes and Data Provenance for the Clinical Literature Review (Test Set)

• Corral (2018) Study (Ex vivo):

  • Sample Size: 25 surgical specimens (biliary and pancreatic ducts).
  • Data Provenance: Not explicitly stated, but typically ex vivo studies are done in a controlled environment, likely retrospectively collected surgical samples from a local institution. The country of origin is not specified.
  • Retrospective/Prospective: Ex vivo studies on surgical specimens are inherently retrospective for the tissue acquisition, though the imaging and analysis are prospective.

• Tyberg (2018) Study (In vivo):

  • Sample Size: 10 patients (biliary and pancreatic ducts).
  • Data Provenance: Not explicitly stated. The country of origin is not specified.
  • Retrospective/Prospective: This was an "in vivo" feasibility study, which implies a prospective collection of patient data during ERCP procedures.

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

• The document describes studies that evaluated the feasibility of OCT imaging and the correlation of OCT images with tissue microstructure. The "ground truth" here refers to the actual tissue microstructure.
• Corral (2018): "Histology correlation to image: Yes." This indicates that a pathologist or similar expert was involved in interpreting the tissue histology to correlate with the OCT images. The specific number and qualifications of experts are not provided.
• Tyberg (2018): "Histology correlation to image: No." For this in vivo study, the focus was on the feasibility of obtaining images and identifying image features, not on a direct histological correlation. Therefore, no pathology-based ground truth establishment is mentioned for this study.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the interpretation of images or establishment of ground truth within these summarized studies. The studies appear to be descriptive and feasibility-focused rather than comparative diagnostic performance studies requiring such methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done to evaluate how human readers improve with AI vs. without AI assistance.
• The device is cleared as an imaging tool, and its safety and effectiveness for diagnostic analysis or differentiating normal vs. abnormal tissue "has not been evaluated." Therefore, there is no AI component or diagnostic claim in this submission that would necessitate an MRMC study comparing human performance with and without AI assistance.

6. Standalone (Algorithm-Only) Performance Study

• No, a standalone (algorithm-only) performance study was not done.
• As explained above, no AI algorithm for diagnostic analysis is part of this device's regulatory submission or its stated claims. The device provides images, and interpretation is left to the clinician.

7. Type of Ground Truth Used

• For the Corral (2018) study, the ground truth for tissue microstructure was based on histology/pathology correlation from surgical specimens.
• For the Tyberg (2018) study, the "ground truth" was the successful acquisition of in vivo images and the ability to identify image features, without direct histological correlation at the time of the study. The study focused on feasibility and safety.

8. Sample Size for the Training Set

• This device is an imaging system, not an AI/ML algorithm that requires a "training set" in the computational sense.
• The 510(k) submission describes the device itself and its performance based on traditional medical device evaluation principles (same intended use, same technology, existing performance data, clinical literature review for expanded use). Therefore, the concept of a "training set" for an AI model is not applicable here.

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

• As there is no AI/ML algorithm requiring a training set mentioned in this submission, this question is not applicable.

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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 and may be used to mark areas of tissue. The software provides segmentation and display of common imaging features, including hyper-reflective surface, layering, and hypo-reflective structures.

The NvisionVLE® Imaging System is intended to provide an image of 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 sweptsource 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 purpose of this 510(k) submission is to add an artificial intelligence software tool referred to as Image and Visualization Enhancements (IVE) to the previously cleared, predicate NvisionVLE Imaging System (K153479). The IVE software module allows enhanced visualization (segmentation and colorized display) of the following commonly observed image features (also referred to as IVE features): (1) hyper-reflective surface, (2) layering and (3) hypo-reflective structures. The segmentation algorithm was developed using an artificial intelligence machine learning technique known as deep learning. Here, an artificial neural network was trained with manually labelled examples of each feature and then locked for realtime inference on new image data acquired by the device. Display of each feature can be toggled via the user interface, where a respective color overlay is presented. The default display of the IVE features is disabled and the standard VLE image data displayed per the cleared NvisionVLE Imaging System. Segmentation of these structures are based on existing image features, and IVE simply increases the conspicuity via the color overlays, thus aiding image review. It is a convenience tool and a resource for the clinician and as such, it does not alter the standard of care or the role of the physician in reviewing and assessing images generated by the system.

The provided text describes the acceptance criteria and a study proving the device meets those criteria. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "The target true positive and true negative detection fractions were prospectively set." However, the specific target values for these fractions are not explicitly listed in numerical form in the provided text. Instead, it states that the observed results *exceeded their target value with a significance level a

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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:

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.

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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:

1. 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.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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: Not mentioned. The device described is an imaging system with a marking function, not explicitly an "AI" device for diagnostic analysis.
6. 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.
7. The type of ground truth used: Not explicitly stated for specific studies. "Feasibility" and "safety" were evaluated.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

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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 NvisionVLE™ Imaging System is a general imaging system comprised of the NvisionVLETM Console, NvisionVLETM Optical Probe and the NvisionVLE™ Inflation Accessory Kit. The NvisionVLE™ Optical Probe is made up of an optical probe subassembly and a quide sheath. The optical probe subassembly is a fiber optic probe assembly secured inside a flexible, stainless steel torque shaft. The distal optics are housed in a stainless steel hypotube which is attached to the torque shaft. The proximal end of the optical fiber and torque shaft terminate in a standard fiber optic connector and catheter connector which interfaces with the system console. The optical probe subassembly transmits the optical signal and detects the reflected optical signal for image reconstruction of the targeted tissue. The guide sheath is a coaxially-designed balloon sheath. The sheath is composed of a PET balloon and a nylon shaft. The inner lumen of the sheath is sealed, enclosing the optical probe subassembly. The guide sheath is positioned within the organ structure of interest and allows the probe to rotate in a helical pattern while positioned in the inner lumen allowing for image reconstruction of the targeted tissue.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • Initial Engineering Test Samples: 5 K120800 Controls, 5 Proposed Enhancements (Total = 10 samples)
  • Manufacturing Build Samples: 10 K120800 Controls, 7 Proposed Enhancements (Total = 17 samples)
  • Overall Reported (summary): 15 control samples, 13 enhanced samples (This slightly differs from the sum of the detailed tables (15 controls vs 17 controls; 13 enhanced vs 12 enhanced). The summary likely refers to the effective number of control samples that experienced failure across the two tables combined, and the number of enhanced samples that successfully completed the most rigorous testing.)
• Data Provenance: The data appears to be retrospective in the sense that it evaluates modifications to an already cleared device and compares them against the previously cleared device. It's an internal engineering and manufacturing evaluation. The country of origin is not explicitly stated, but the company is based in Cambridge, Massachusetts, USA, suggesting the testing was likely conducted in the US.

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

Not applicable. This study is a performance test on device durability and mechanical integrity, not an evaluation of diagnostic accuracy requiring expert interpretation of images or patient outcomes. The "ground truth" for this test is the physical failure of the device (binding, fiber fracture, signal loss) under simulated tortuosity.

4. Adjudication Method for the Test Set

Not applicable. The outcome (pass/fail) is objectively determined by whether the device's optical fiber fractured or the torque coil bound, leading to a loss of signal. This is a direct physical outcome rather than an interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This study assesses the physical durability and mechanical performance of the device's components (optical probe and guide sheath), not its effectiveness in diagnostic tasks with human readers.

6. Standalone Performance Study (Algorithm Only)

Yes, in a sense. This is a standalone device performance study focusing on the mechanical durability of the device itself, rather than an algorithm. The "algorithm" aspect of imaging systems (image reconstruction, etc.) is not evaluated here, only the physical integrity of the probe.

7. Type of Ground Truth Used

The ground truth used is physical device failure (failure of the torque coil to bind, fracture of the optical fiber, and subsequent failure to transmit signal) under defined simulated conditions of tortuosity.

8. Sample Size for the Training Set

Not applicable. This study does not involve a "training set" in the context of machine learning. It's a physical engineering and manufacturing test of device durability.

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

Not applicable, as there is no training set for an algorithm. The "ground truth" for the test set (physical failure) was established by observing the operational state of the device under stress in a test fixture.

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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.

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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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