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The VS3-Iridium System is intended to provide real-time visible and near infrared fluorescence imaging in both open and minimally invasive procedures.

Upon intravenous administration and use of an ICG consistent with its approved labeling, the VS3-Iridium System is used to perform fluorescence imaging visualization of vessels, blood flow and tissue perfusion before during and after general minimally invasive surgical procedures and plastic, micro-, reconstructive surgeries.

Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-Iridium System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved labeling, the VS3-Iridium 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The VS3-Iridium System is an advanced stereoscopic visualization system made up of a combination of hardware and software to provide high definition visible and near infrared (IR) fluorescent imaging. The visualization system can incorporate an endoscope for minimally invasive surgical procedures and a microscope positioned above the patient during open surgical procedures.

The VS3-Iridium System including the endoscope and the microscope is designed to work with an approved infrared dye (Indocyanine green (ICG) or pafolacianine sodium injection or pafolacianine). ICG may be excited at excitation at either 785 or 805 nm, and pafolacianine is excited only by the 785 nm wavelength. The principle of operation is the same for both infrared dyes. That is, the VS3-Iridium System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera, enabling qualitative and quantitative measurement of the IR intensity. Near IR fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow.

The VS3-Iridium System allows the capture of normal (white) light image in parallel with the fluorescence IR image and displays both to the surgeon to provide a view of the anatomy. In addition, the VS3-Iridium System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

This document describes a 510(k) premarket notification for the VS3-Iridium System (VS3-IR), an advanced stereoscopic visualization system. The filing seeks to re-frame the indications for use statement to align with the specific indications of legally marketed Indocyanine green (ICG) products and pafolacianine, and to eliminate the need for the VS3-Iridium Fluorescence ICG Kit.

Here's an analysis of the provided information about acceptance criteria and supporting studies:

1. Table of acceptance criteria and reported device performance:

   The document explicitly states: "No performance data are needed to support the modified indications for use. As noted above, there are no technological changes associated with the proposed labeling changes. Additionally, no new surgical procedures or tissue types are being referenced in the modified indications for use."

   Therefore, there is no table of acceptance criteria or reported device performance for this specific 510(k) submission, as the changes are purely administrative regarding the Indications for Use statement and the removal of an accessory, not a modification to the device's technological characteristics or its core performance. The FDA granted substantial equivalence based on the device being "the same or similar" to previously cleared versions.

2. Sample size used for the test set and the data provenance: Not applicable. No new performance data was required for this 510(k) submission as there were no technological changes to the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new performance data was required for this 510(k) submission.

4. Adjudication method for the test set: Not applicable. No new performance data was required for this 510(k) submission.

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 applicable. The VS3-Iridium System is described as a visualization system for real-time visible and near infrared fluorescence imaging, not an AI-assisted diagnostic or interpretative tool that would involve human readers improving with AI assistance. This submission specifically deals with changes to the Indications for Use, not a new AI component or performance evaluation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The VS3-Iridium System is a visualization system used by a surgeon, implying human-in-the-loop operation. This submission does not introduce or evaluate any new standalone algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No new performance data was required for this 510(k) submission.

8. The sample size for the training set: Not applicable. This submission concerns re-framing indications for use and removing an accessory, not a new algorithm development or training.

9. How the ground truth for the training set was established: Not applicable. As above, this submission concerns re-framing indications for use and removing an accessory, not a new algorithm development or training.

Summary of the Study and Rationale for No New Performance Data:

The core of this 510(k) submission (K223020) is a "special 510(k) premarket notification to re-frame the indications for use statement to be consistent with specific indications of legally marketed ICG products, eliminating the need for the VS3-Iridium Fluorescence ICG Kit."

The manufacturer, Visionsense, Ltd., argues that:

• There are no changes in the technological characteristics of the visualization system hardware, software, or accessories.
• The only change in the system configuration is to obsolete the VS3-IR ICG Kit.
• The proposed changes in the indications for use statement are to reflect the previous discontinuation of a 3D module and associated endoscopes, streamline ICG-related indications, and reflect that these indications are derived from approved ICG drug labeling.
• These changes are considered a "simple statement of product functionality that has always been present and does not represent any new use for the system."
• There are "no questions related to safety or effectiveness of the device when used as labeled," and the change is "not considered a critical change to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device."

Based on these justifications, the FDA determined that "No performance data are needed to support the modified indications for use." The device was deemed substantially equivalent to its own previously cleared versions (K150018, K152204, K183453, K191851, K210265) because the modifications were administrative and did not alter the technological characteristics or intended use in a way that would raise new questions of safety or effectiveness.

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The VS3 Iridium System is intended for viewing anatomical structures during invasive surgery and for viewing fluorescent images for the visual assessment of blood flow and lymphatic flow. The unit is indicated for viewing internal surgical sites during general surgical procedures. It provides an adjunctive method for the evaluation of tissue perfusion and related tissue transfer circulation in tissue and free flaps used in general, plastic, micro-and reconstructive surgical procedures. It also enables the identification of functional lymphatic vessel, and/or lymph nodes. The VS3 Iridium System is also intended to visualize tissues that have taken up the pafolacianine during procedures that are consistent with the approved labeling of that dye.

Upon intravenous administration and use of an ICG consistent with its approved labeling, the Iridium Module of the VS3-IR System is used to perform intraoperative fluorescence angiography.

Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-IR System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine in accordance with its approved labeling, the VS3-IR 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The VS3 Iridium System is an advanced stereoscopic visualization system made up of a combination of hardware and software to provide high definition visible and near infrared (IR) fluorescent imaging. The visualization system can incorporate an endoscope for minimally invasive surgical procedures and a microscope positioned above the patient during open surgical procedures.

The VS3 Iridium System including the endoscope and the microscope is designed to work with an approved infrared dye (Indocyanine green (ICG) or pafolacianine sodium injection or pafolacianine). ICG may be excited at excitation at either 785 or 805 nm, and pafolacianine is excited only by the 785 nm wavelength. The principle of operation is the same for both infrared dyes. That is, the VS3 Iridium System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera, enabling qualitative and quantitative measurement of the IR intensity. Near IR fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow.

The VS3 Iridium System allows the capture of normal (white) light image in parallel with the fluorescence IR image and displays both to the surgeon to provide a view of the anatomy. In addition, the VS3 Iridium System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

This Traditional 510(k) premarket notification is to expand the indication for use statement to include the additional cleared infrared dye, pafolacianine sodium injection, for use with infrared imaging.

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

Acceptance Criteria and Device Performance

The provided text focuses on expanding the indications for use of the VS3 Iridium System to include pafolacianine. The acceptance criteria are implicitly tied to demonstrating the safety and efficacy of the device when used with this new fluorescent dye, specifically its ability to detect target lesions.

Table of Acceptance Criteria and Reported Device Performance:

The study aimed to demonstrate the benefit of using the VS3 Iridium System with pafolacianine (OTL38) for detecting folate receptor positive (FR+) ovarian cancer that would otherwise be missed.

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: The imaging subgroup (those using the VS3 Iridium System) had a sample size of n=127.
   • Data Provenance: The study was a "phase 3, randomized, single dose, open-label study." While the specific country of origin is not explicitly stated for the data, the clinicaltrials.gov identifier (NCT03180307) indicates it was a registered clinical trial, which typically involves prospective data collection.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the text. The text mentions "confirmed FR+ ovarian cancer evaluable lesion," but it doesn't detail how this confirmation (ground truth) was established or who established it.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not provided in the text.

4. 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 was not a MRMC comparative effectiveness study in the typical sense of evaluating human readers with and without AI assistance for interpretation.
   • It was a study evaluating a device (VS3 Iridium System) used with a fluorescent dye (pafolacianine) to detect lesions not visible with normal light or palpation. The "effect size" is the proportion of patients where these additional lesions were found (33%).

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, this was not a standalone (algorithm only) study. The device is a "visualization system" used by surgeons/clinicians for intraoperative imaging. The detection of lesions relies on the combination of the OTL38 (pafolacianine) and NIR fluorescent light observed by humans.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The text frequently mentions "confirmed FR+ ovarian cancer evaluable lesion." This strongly implies that the ground truth for the presence of these lesions was based on pathology or other definitive clinical confirmation methods (e.g., biopsy). However, the exact method and who confirmed it are not detailed.

7. The sample size for the training set:

   • The provided text describes a Phase 3 clinical study designed to test the performance of the device, not to train it. The VS3 Iridium System is primarily an imaging and visualization system, not an AI-driven diagnostic algorithm that would typically require a separate "training set" in the context of machine learning. Therefore, information about a training set is not applicable/provided for this type of device and study.

8. How the ground truth for the training set was established:

   • As mentioned above, information about a training set is not applicable/provided for this device and study.

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Intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon. Use of device is limited to non-sterile procedures where non-sterile laparoscopes are used.

Not Found

The provided document is an FDA 510(k) clearance letter for a medical device called "Trans-anal Introducer." It states that the device is "substantially equivalent" to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance testing, study design (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment.

The letter is a regulatory document confirming clearance based on substantial equivalence, and it references the device's indications for use. It does not provide the detailed technical and clinical study data that would demonstrate how the device meets specific performance acceptance criteria.

Therefore, I cannot fulfill your request using the provided text. The information you are asking for (acceptance criteria table, study details, expert qualifications, etc.) would be found in the manufacturer's 510(k) submission, specifically the sections detailing the performance testing and clinical evaluations, which are not part of this public clearance letter.

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The Endoscope Module of the VS3-IR-MMS System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The Iridium Module of the VS3-IR-MMS System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

The VS3-IR-MMS System consists of the cleared base system and the Iridium Module that is the subject of this submission. The currently marketed VS3 system with endoscope functionality was cleared under the following product codes: GCJ (General Surgery Endoscope), GWG (Neurological Endoscope), and HRX (Orthopedic Arthroscope). The cleared base system consists of the following components and accessories: High Definition 3D Endoscope, High Definition 3D Camera with 3 control buttons and a focus adjustment knob, 2D Coupler, CCU, Light Source, and Display Monitor. The VS3-IR-MMS System that is the subject of this submission contains the previously cleared components of the cleared base system listed above, as well as a High Definition IR Fluorescence Scope (MMS), a Laser Light Source (LLS), associated software and VS, Iridium IR Fluorescence Kit. The new Iridium Module, which uses the newly added High Definition IR Fluorescence Scope (MMS) and a Laser Light Source (LLS), as well as the cleared High Definition 3D Camera, Camera Control Unit (CCU), and Display Monitor, is used to generate florescence excitation illumination for external use in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

The document describes the VS3-IR-MMS System and its Iridium Module, which is intended for capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method. The submission focuses on demonstrating substantial equivalence to a predicate device, the Novadaq Technologies SPY Imaging System (K063345), rather than setting specific performance acceptance criteria for the new module.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the Iridium Module's performance in terms of metrics like sensitivity, specificity, or accuracy. Instead, it relies on demonstrating that the device "functions as intended" and "met all performance acceptance criteria" based on bench testing and limited human subject evaluations. The primary "acceptance criteria" presented are related to regulatory standards compliance and functional equivalence to the predicate.

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

• Bench Testing:
  • ICG in sterile water: A single sample of 10mg ICG diluted to 2 ug/ml.
  • ICG through chicken skin: A single sample of ICG in sterile water covered with chicken skin.
• Human Simulation: A human hand was used. (Sample size: 1)
• Human Subjects: "Several human subjects" were evaluated in free flaps. (Exact sample size not specified, but implied to be small).
• Data Provenance: The human hand simulation and human subject evaluations were conducted "outside of the United States." The context suggests these were prospective evaluations, albeit limited.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test sets. The interpretations of "good quality imaging" during bench testing and "functions as intended" or "no adverse events" during human evaluations were likely made by the researchers or clinical personnel involved in the studies, but their specific expert qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not mention any formal adjudication method (e.g., 2+1, 3+1) for evaluating the test results. The assessment appears to be based on direct observation and qualitative judgment by the study personnel.

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 MRMC comparative effectiveness study was done. This device is not described as an AI-powered diagnostic or assistive tool for human readers in the traditional sense. It's an imaging system for visualizing blood flow.

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

The device is an imaging system; it captures and displays images for human interpretation. The concept of "standalone algorithm only" performance, as it applies to AI/ML diagnostic tools, is not relevant here. The system's function is to provide the visual information.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Bench Testing: The ground truth was the known presence and concentration of ICG and the physical setup (ICG solution, ICG under chicken skin). Visual assessment of "good quality imaging" was the outcome.
• Human Simulation (Hand): The ground truth was the expected blood flow in a human hand after ICG administration. Visual assessment of corresponding dye fluorescence was the outcome.
• Human Subjects (Free Flaps): The ground truth was the actual tissue perfusion and related tissue-transfer circulation in free flaps. The assessment was that the device visualized blood flow and "functions as intended with no adverse events reported." This implies clinical observation of actual perfusion.

8. The Sample Size for the Training Set

No information is provided about a "training set" for the Iridium Module. The document describes a system with specific optical and imaging characteristics, not a machine learning model that requires a training set. The software modifications mentioned are likely for instrument control and image processing, not for AI model training.

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

As no training set is mentioned in the context of machine learning, this question is not applicable.

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The VS3-OT system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.

The VS3 Stereoscopic High Definition Vision System, Model VS3-OT consists of the following components:

• Endoscope
• Light source
• Camera Control Unit (CCU)
• Camera
• Display monitors
• 2D Endoscope coupler

The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-0T is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 Stereoscopic High Definition Vision System. Model VS3-OT allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-OT also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-OT to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way a typical performance study for AI/ML devices might. Instead, it focuses on general performance standards, substantial equivalence to predicate devices, and regulatory compliance.

However, based on the information provided, we can infer some "acceptance criteria" through the lens of comparison to predicate devices, particularly regarding technical specifications. The study described is a comparison of the subject device (VS3-OT) with legally marketed predicate devices, focusing on demonstrating substantial equivalence rather than a standalone performance study with a test set, ground truth, and human readers in the traditional sense.

Here's an attempt to structure the information according to your request, highlighting what is present and what is absent:

Acceptance Criteria and Study for Visionsense Ltd VS3 Stereoscopic High Definition Vision System, Model VS3-OT

The provided document describes the regulatory submission for the VS3 Stereoscopic High Definition Vision System, Model VS3-OT, focusing on demonstrating substantial equivalence to predicate devices rather than a standalone performance study with explicit acceptance criteria and corresponding performance metrics for a novel AI/ML algorithm.

The "acceptance criteria" can be inferred from the technical specifications of the predicate devices which the subject device aims to match or exceed to demonstrate substantial equivalence. The "study" refers to the comparison table provided in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like the VS3-OT (an endoscope), performance standards often relate to optical and physical characteristics. Since this is a substantial equivalence submission, the "acceptance criteria" are the performance characteristics of the predicate devices. The "reported device performance" is the VS3-OT's specifications.

Note: "Meets" indicates that the subject device's reported performance is comparable to or better than the predicate devices' specifications, supporting the claim of substantial equivalence for these technical characteristics.

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

This document does not describe a "test set" in the context of an AI/ML algorithm evaluation with a specific sample size of cases or images. The "study" relies on a direct technical comparison against the published specifications of predicate devices. There is no information about data provenance (e.g., country of origin, retrospective/prospective) for a test set, as such a test set is not explicitly detailed.

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

Not applicable. The document does not describe a test set that requires expert-established ground truth for an AI/ML algorithm. The comparison is based on objective technical specifications.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or expert review process described in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with or without AI assistance was not performed or described in this submission. The device is an imaging system (endoscope), not an AI diagnostic tool.

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

Not applicable. The device is a surgical vision system; it is not an AI algorithm performing standalone analysis.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the published technical specifications and performance characteristics of the legally marketed predicate devices, which serve as the benchmark for demonstrating substantial equivalence. There is no explicit mention of pathology, outcomes data, or expert consensus being used as ground truth for a novel AI algorithm's performance.

8. The Sample Size for the Training Set

Not applicable. This submission is for a conventional medical device (endoscope), not an AI/ML system developed with a training set of data.

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

Not applicable. As there's no training set for an AI/ML algorithm, the method of establishing its ground truth is not relevant here.

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