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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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Upon intravenous administration and use of an ICG consistent with its approved label, 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 label, 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.

Clearance was originally given for the Visionsense Stereoscopic Vision System (VSII) in K073279, K081102, K082667, and K082355. Clearance was given for a 3D High Definition version of the VSII System called the VS3 Stereoscopic High Definition Vision System (VS3) in K123467, K131434, K141002. Clearance included the HD3D Camera, Laser Light Source (LLS), VS3 3D Endoscope, Camera Control Unit (CCU), Display Monitor, Xenon Light Source, and Endoscopic Light Cable.

Clearance was given for an iridium version of the VS3 system called the "VS3-IR System" in K150018 and K152204. This system introduced an iridium miniature microscope in K150018 and an iridium endoscope in K152204. The cleared system added a Light Integrator and an ICG Kit. The VS3-IR utilizes the VS3 system with a special Miniature Microscope (MMS) that is positioned 20cm to 45cm above the patient during the surgical procedure. The VS3-IR can also be used with an Iridium Endoscope to perform minimally invasive procedures. The VS3-IR is designed to work with Indocyanine Green (ICG) which is an IR fluorescence imaging agent and is supplied in the "VS3-IR Fluorescence ICG Kit". Each cleared "VS3-IR Fluorescence ICG Kit" contains six 25mg vials of sterile ICG imaging agent and six 10ml vials of sterile Water for Injection. ICG is a sterile, water soluble, tricarbocyanine dye with a peak spectral absorption at 785nm or 805nm in blood plasma or blood. ICG contains not more than 5.0% sodium iodide. ICG is to be administered intravenously. The sterile Water for Injection provided with the ICG, pH of 5.0 to 7.0, is used to dissolve the ICG. Before injection of ICG for each patient's imaging procedure, the ICG must be reconstituted using the sterile Water for Injection. ICG in blood has excitation at 785nm or 805nm. The VS3-IR system provides excitation light to the surgical field to excite the dye molecules, captures emission from the dye using an IR camera and measures the fluorescence signal intensity. The system enables high definition imaging for both fluorescence and visible light imaging, with real-time overlay of fluorescence and visible light images for display on the monitor. The system permits recording surgical procedures, storing them on removable storage devices, and playing the procedures back.

Clearance was given for adding three working channels to the VS3 in K153548 and the accessory "Trans-Anal Introducer" was cleared in K171208.

The VS3-IR system (805nm) was cleared for adding the excitation wavelength of 785nm in K183453.

The provided text describes a 510(k) premarket notification for the Medtronic VS3-IR device, seeking clearance to expand its indications for use. It details the device, its predicate, and performance data from various tests, but it does not contain a study explicitly proving the device meets specific acceptance criteria related to its clinical performance (e.g., sensitivity, specificity, accuracy) for fluorescence imaging and visualization of the lymphatic system.

The "Performance Data" section primarily focuses on:

• Biocompatibility: Confirmation that patient-contacting materials are the same as previously cleared devices and are biocompatible.
• Electrical Safety and EMC: Compliance with relevant IEC standards.
• Software Verification and Validation: Adherence to FDA guidance for "minor" level of concern software.
• Cybersecurity: Description of security features for a locked-down, stand-alone device.

The document discusses expanding the indications for use based on its substantial equivalence to a predicate device (PINPOINT Endoscopic Fluorescence Imaging System, K182606), particularly for visualizing the lymphatic system with interstitial administration of ICG. The substantial equivalence argument relies on technological characteristics being similar or having appropriate mitigations, rather than a direct clinical performance study with acceptance criteria for this expanded indication.

Therefore, I cannot fulfill all parts of your request because the provided document does not describe a study with clinical performance acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, or MRMC studies for the expanded indication.

However, I can extract information related to the device's technical characteristics and the types of performance data that were submitted.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted, the document does not present acceptance criteria for clinical performance (e.g., sensitivity, specificity, or accuracy for visualizing the lymphatic system) for the VS3-IR for its expanded indication, nor does it present device performance against such criteria. The reported "performance data" are related to safety, engineering, and software aspects.

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

No information is provided in this document regarding a test set sample size or clinical data provenance (e.g., country of origin, retrospective/prospective) for the expanded indication of lymphatic system visualization. The "Performance Data" section describes engineering and software tests, not clinical performance studies for this specific intended use.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable, as no clinical performance study with expert ground truth establishment for a test set is described in the provided text.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical performance study with adjudication is described.

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

No MRMC study is mentioned or its results (effect size of human reader improvement with AI vs. without AI assistance) reported in the document.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The document describes the VS3-IR system as an imaging device. While it performs "intraoperative fluorescence imaging and visualization," it is a tool for a surgeon, not an AI algorithm performing a diagnostic task autonomously. Therefore, a standalone algorithm performance study, in the typical sense of AI, is not applicable or described.

7. Type of Ground Truth Used:

For the expanded indication, the document relies on substantial equivalence to the predicate device (PINPOINT) which also has an indication for "intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes" using interstitial ICG. The basis for the predicate's clearance for this indication would have involved demonstrating its performance, but that information is not detailed here. No independent clinical ground truth (e.g., pathology, outcomes data, or expert consensus) is discussed for the VS3-IR in this document for this expanded indication.

8. Sample Size for the Training Set:

Not applicable. The document does not describe the development of an AI algorithm with a training set. The device is a fluorescence imaging system.

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

Not applicable, as no AI algorithm with a training set is described.

Summary of what the document does convey for the expanded indication:

The clearance for the expanded indication ("Upon interstitial administration and use of ICG consistent with its approved label, 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") is based on demonstrating substantial equivalence to a predicate device (PINPOINT Endoscopic Fluorescence Imaging System, K182606) which has a similar indication. This substantial equivalence is primarily supported by the similarity in intended use, technological characteristics (e.g., imaging agent, imaging head, light source type, spectral bandwidth, imaging distance ranges for endoscope configuration, scope dimensions, emission band, emission capture, and visible/IR image display), and comprehensive non-clinical performance data (biocompatibility, electrical safety, EMC, software, cybersecurity) proving the device itself is safe and effective for its stated functions. The document does not present a de novo clinical study with specific acceptance criteria for the VS3-IR's performance in visualizing the lymphatic system.

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The 3D Endoscope Module of the VS3-IR 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 MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing 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 Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the Medtronic Vs3-ir device. The document is an FDA 510(k) clearance letter confirming substantial equivalence to legally marketed predicates and outlining the device's indications for use. It does not include details on specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot generate the requested table and descriptions based on this input.

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The 3D Endoscope Module of the VS3-IR 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 and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.

The MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing 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 Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.

The VS3-IR System is made up of the following components:

• VS3 3D Endoscope (K123467, K141002, K131434)
• VS3-IR-MMS & ICG Kit (K150018)
• VS3-IR-Endoscope & ICG Kit (not yet assigned).

The VS3 3D endoscopes (cleared in K123467, K131434, and K141002) are based on the proximal camera concept with a stereoscopic camera block on the proximal side of the endoscope (the handle). The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block through an optical transmission system to PC workstations or external display monitors for enhanced viewing or capturing. VS3 includes reusable endoscopes which are cleaned and sterilized using the same methods and are indicated for the same lifecycle.

In addition to traditional endoscopic procedures, VS3-IR system includes support for Infrared (IR) Fluorescence visualization (hereafter referred to as Iridium utilizes the VS3 system with scopes that support IR fluorescence visualization. VS3 Iridium Miniature Microscope (VS3-IR-MMS) which was cleared in K150018 is positioned 20cm to 45cm above the patient during an open procedure. The proposed Iridium Endoscopes (VS3-R-Endoscope) is used during laparoscopic minimally invasive procedures. VS3 Iridium MMS and Endoscopes are designed to work with an approved IR fluorescence dve (Indocvanine Green or ICG), which has excitation at 805nm and emission band between 825nm and 850nm. VS3 Iridium (VS3-IR) provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera.

Both the Iridium MMS and Iridium Endoscope utilize the left channel of the VS3 imaging system (camera and image processor) for IR fluorescence imaging and the right channel for visible light imaging. This structure allows fluorescence imaging to use the same acquisition and processing pathways as the approved 3D endoscopes (cleared in K123467, K131434, and K141002).

The provided document describes the acceptance criteria and study for the Visionsense VS3-IR System, specifically focusing on the VS3-IR-Endoscope component.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative metrics alongside "reported device performance" in a separate column. Instead, it states that the device "met all performance acceptance criteria" during bench testing. The closest we can get to structured criteria are the functional requirements and the successful detection and visualization described.

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

The document describes bench testing, which typically does not involve a "test set" in the sense of clinical cases or data. The testing involved simulating a surgical field.

• Sample Size: Not applicable in the context of clinical data. The testing was conducted on the device itself and its ability to perform certain functions in a simulated environment.
• Data Provenance: Not applicable as it's bench testing, not clinical data. The testing was performed by Visionsense Ltd.

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

• Number of Experts: Not mentioned. Bench testing usually relies on engineering and scientific personnel to verify device function against specifications.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Bench testing for functional verification does not typically involve an adjudication process by human experts in the same way clinical data evaluation would.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document describes bench testing of the device's functional performance, not a study of human reader improvement with or without AI assistance. The device is for visualization, not an AI diagnostic tool that assists human readers.

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

• Standalone Performance: The study focuses on the standalone performance of the device's imaging capabilities. It verified that the device, without human interpretation for evaluation of its own core function, could detect and visualize fluorescence. However, the device itself is a "human-in-the-loop" tool, as it's an endoscope for surgeons to use for visualization. The bench testing verified the device's ability to produce the images that a human user would then interpret.

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

• Type of Ground Truth: For the bench testing, the "ground truth" was established by the physical and chemical principles of fluorescence (ICG excitation and emission) and the known properties of the simulated surgical field. The expectation was that the device would accurately capture and display this known phenomenon. It's a functional ground truth, verified by the correct operation of the system (laser excitation triggering fluorescence, detection by IR camera, and appropriate image fusion).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document describes the functional testing of a medical device (endoscope), not the development or training of an AI algorithm from a dataset.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable as no training set for an AI algorithm is mentioned or implied.

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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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