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The GLOW800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow and related tissue perfusion in the cerebral vascular region as well as blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG).

Similar to the predicate device (Leica FL800 most recently cleared under K141136 and previously in K061871 and K080612), the GLOW800 is an accessory to the Leica Microsystems (LMS) Class I 510(k) exempt surgical operating microscope (SOM).

The GLOW800, a non-contact, non-invasive device similar to its predicate, allows the surgical microscope to produce excitation light and resolve fluorescent emission from the fluorescent agent Indocyanine green (ICG). The generated fluorescence signal depicts the distribution of the infra-red dye in the patient's blood vessels during the surgical procedure (fluorescence video angiography). The ICG fluorescence peak is captured for display on the SOM screen. Using an additional camera to capture the visible light (VL) video stream and digitally combining with the Near Infra-red (NIR) video stream presents a high definition display of the surgical site as a pseudocoloured combined image of the same field of view (FOV), which includes anatomical information.

The GLOW800 utilizes the illumination light source, supplied as standard with the SOM to produce excitation light which is filtered using an illumination filter (also referred to as the excitation filter) within the 750 and 800 spectral wavelength range.

The provided text describes the regulatory clearance for the GLOW800 device, comparing it to a predicate device (Leica FL800 ULT). The crucial information regarding acceptance criteria and study results comes primarily from the "Substantial Equivalence Summary Table: Comparison to Predicate Device" and the "Non-Clinical, Bench, and Clinical Performance Testing" sections.

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

Key Takeaway: The GLOW800 device did not undergo a study with pre-defined quantitative acceptance criteria for its performance in the way one might expect for an AI/algorithm-driven device. Instead, the "acceptance criteria" were based on demonstrating functional equivalence to a predicate device through various non-clinical (bench) and preclinical (animal model) studies, and human factors testing. The primary "performance" metric was qualitative assessment (visualization ability) by experts.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bench Testing: Described as "one-arm study using only the subject device GLOW800 on microscope platform M530 OH6 and assessed vs. historical experience with predicate FL800 (historical control)." No specific sample size for the "test set" in terms of number of devices tested is explicitly stated, but it implies a single GLOW800 unit was extensively tested against pre-established criteria and historical data.
• Preclinical Study:
  • Sample Size: 8 pigs.
  • Data Provenance: Conducted at the University of Mainz, Germany Institute of Neurosurgical Pathology. This was a direct comparative test, not a retrospective assessment.
• Human Factors Testing:
  • Sample Size: 21 surgeons and 15 nurses/other allied health professionals.
  • Data Provenance: Conducted at the Mt. Sinai Medical Center Neurosurgery Simulation Core, Annenberg Building, New York. This was a prospective study in a simulated operating room environment.

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

• Preclinical Study (Porcine Model):
  • Ground truth was based on "independent scoring assessments predefined within the protocol."
  • Experts involved in the assessment were "cardiovascular surgeon, neurosurgeons and veterinarians." The number of each type of expert is not specified, nor is their specific experience level (e.g., "10 years of experience").
  • The results state "n=18 comparative reviews," implying 18 assessments of the image sets. It's unclear if this means 18 different experts, or 18 reviews conducted by a smaller group of experts. Given the "independent scoring assessments" and the stated types of experts, it suggests multiple experts.
• Human Factors Testing: The "ground truth" for human factors was based on the ability of users (surgeons, nurses/techs) to perform tasks correctly and intuitively, assessed via "observational analysis." The primary "experts" here were the observers assessing performance against the predefined tasks and acceptance criteria, but their specific qualifications are not detailed beyond "observers."

4. Adjudication Method for the Test Set

• Preclinical Study: "Independent scoring assessments predefined within the protocol." This suggests that multiple experts made assessments, but the specific adjudication method (e.g., majority vote, consensus meeting, 2+1, 3+1) is not specified beyond being "independent."
• Human Factors Testing: "Observational analysis" with "pre-defined test cases and objective pass/fail criteria." No specific adjudication method among observers is mentioned, but the outcomes (e.g., "100% of users... perform key functions") suggest clear-cut observations rather than needing complex adjudication.

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 study was done in the context of AI assistance.
• The GLOW800 is a hardware accessory (optical system, camera, and basic software for combining images), not an AI/algorithm. Its purpose is to visualize blood flow, not to interpret or provide diagnostic insights based on that visualization. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device submission.
• The "comparative effectiveness" was primarily demonstrated by showing functional equivalence between the new device and a predicate optical device, meaning the new device provides similar or better visual information.

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

• This question is largely irrelevant as the GLOW800 is a hardware device (an accessory to a surgical microscope) designed for human use, not a standalone algorithm. Its "performance" is inherently tied to its ability to present visual information to a human operator.
• The "bench testing" does cover aspects of the device's technical performance (e.g., optical specifications, software functionality) in a "standalone" or de-coupled manner, ensuring it correctly processes and displays information.

7. The Type of Ground Truth Used

• Bench Testing: Internal design specifications, historical performance data of the predicate device, and "experiential basis" from prior device marketing history.
• Preclinical Study: The "actual" blood flow and vessel architecture in the porcine model (as visualized by the predicate device and assessed by expert observation of both devices' outputs) served as the de facto ground truth. The goal was functional equivalence in visualization, not an independent "pathology" ground truth of true blood flow given the real-time nature of the imaging.
• Human Factors Testing: Pre-defined "objective pass/fail criteria" for task performance and qualitative assessment of usability.

8. The Sample Size for the Training Set

No "training set" (in the context of machine learning) is mentioned or implied, as this device does not appear to employ machine learning or AI algorithms requiring a training phase.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The Carl Zeiss Surgical INFRARED 800 with the FLOW 800 option is a surgical microscope accessory used in viewing and visual assessment of intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with the FLOW 800 option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastic and reconstructive procedures and coronary artery bypass graft surgery.

INFRARED 800 with the FLOW 800 option is an accessory to the OPMI Pentero surgical microscope for visualizing blood flow intraoperatively. INFRARED 800 allows the surgical microscope to produce light to illuminate the fluorescence properties of the Indocyanine Green (ICG) dye and to detect the emitted fluorescent signal to examine the human vascular system during surgery. FLOW 800 provides the surgeon with a processing mode that allows convenient handling and visualization of the INFRARED 800 video data.

The provided 510(k) summary for the INFRARED 800 with FLOW 800 option does not contain explicit acceptance criteria or a dedicated study section detailing the device's performance against such criteria.

Instead, it relies on a "Substantial Equivalence" claim based on comparison to predicate devices and a review of existing clinical literature. This type of submission generally does not include a specific "acceptance criteria" table or a detailed "device performance" study as you might find for novel devices or those with specific quantitative performance claims.

However, I can extract information related to the device's clinical evaluation and training data based on the provided text.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the document does not present a table of explicit acceptance criteria or a dedicated study with quantified device performance metrics against those criteria. The submission is a substantial equivalence claim, meaning the device is considered safe and effective because it is similar to already legally marketed devices.

The "performance" is implicitly demonstrated through:

• Technological Comparison: The device utilizes similar technology (surgical microscope, ICG dye, CCD cameras, real-time visualization of images) to the predicate devices (Leica FL800, Novadaq SPY Intra Operative Imaging System).
• Clinical Literature Review: The submission points to peer-reviewed medical literature demonstrating the use and effectiveness of the INFRARED 800 accessory with Indocyanine Green (ICG) angiography in hundreds of patients for various surgeries.

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

• Sample Size: The document states that the INFRARED 800 accessory with ICG angiography "has been used in hundreds of patients." This suggests the "test set" for the clinical literature review encompasses a large, but unspecified, number of patients.
• Data Provenance: The data comes from "clinical literature that discusses the relevant studies," which are described as "peer-reviewed medical literature." This indicates the data is retrospective, collected from previously published studies. The countries of origin are not specified, but peer-reviewed medical literature generally implies multinational sources.

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

The document does not specify a number of experts or their qualifications for establishing ground truth within the context of a dedicated "test set" for this submission. The "ground truth" implicitly comes from the diagnostic and surgical outcomes reported in the peer-reviewed clinical literature that informed the substantial equivalence claim. These outcomes would have been determined by the operating surgeons and medical professionals involved in those published studies (e.g., neurosurgeons, plastic surgeons, cardiac surgeons).

4. Adjudication Method for the Test Set

No explicit adjudication method is described, as there wasn't a specific, controlled "test set" created for this 510(k) submission. The clinical evidence is derived from existing published studies, where the outcomes and diagnoses within those studies would have been adjudicated according to the standard practices of the respective clinical research teams.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on the device's equivalence to existing technology and its utility as demonstrated in clinical literature, not on assessing the improvement of human readers with AI assistance (which is not relevant for this type of imaging device).

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

This device is not an algorithm, but rather a surgical microscope accessory that aids in viewing and visual assessment by a human surgeon. Therefore, a "standalone algorithm-only" performance study is not applicable and was not conducted. The "performance" is inherently human-in-the-loop.

7. The Type of Ground Truth Used

The ground truth is based on expert clinical observation and surgical outcomes reported in peer-reviewed medical literature. This includes:

• Assessment of closure/remnants of cerebral aneurysms
• Patency of vessels (including small perforating vessels)
• Real-time visualization of blood flow and vessel types in AVMs
• Assessment of patency in anastomosed vessels during bypass or free flap surgery

This is essentially "outcomes data" and "expert clinical consensus/observation" derived from actual surgical procedures.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or algorithm training. Since this is a hardware accessory for visualization, and not an AI/ML algorithm that requires training, the concept of a "training set" as typically understood in AI is not applicable. The device's design and functionality would be based on general engineering principles and medical knowledge related to fluorescence imaging.

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

As there is no mention of a "training set" in the context of algorithm development, there is no description of how ground truth for such a set was established.

In summary: The 510(k) submission for the INFRARED 800 with FLOW 800 option relies on a substantial equivalence pathway. It demonstrates this by comparing its technological features to legally marketed predicate devices and by referencing a body of existing clinical literature that documents the use and effectiveness of the INFRARED 800 accessory in "hundreds of patients." It does not present novel performance data against specific acceptance criteria, nor does it involve AI algorithms with distinct training and test sets in the modern sense.

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The Leica FL800 is a surgical microscope accessory used in viewing bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.

The Leica FL800 device is an accessory to the Leica surgical microscopes. It allows the surgical microscope to produce excitation light and resolve fluorescence light from the fluorescent agent ICG. The generated fluorescence signal depicts the distribution of the infrared doct in the patient's blood vessels during the operation (fluorescence video angiography).

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) summary for the Leica FL800, focusing on establishing substantial equivalence to existing devices for an extension of use into coronary vascular and bypass surgery, as well as plastic and reconstructive surgery. It clearly states:

"The Leica FL800 is an existing device which was granted market clearance by the FDA following the submission of a 510(k) pre-market notification (K061871). Leica Microsystems seeks only an extension of use into coronary vascular and bypass surgery, as well as plastic and reconstructive surgery. There will be no change to the device design, function or technical characteristics."

This means that the device's original performance and safety were established in a prior submission (K061871), and this current submission (K080612) is about expanding its indicated uses without altering the device itself. Therefore, a new study to prove specific performance metrics for this particular submission is not described because the device's fundamental performance is assumed to be established.

As a result, I cannot provide the requested information about acceptance criteria and a study proving they are met from the given text.

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The SPY® Fluorescent Imaging System is intended to intra-operatively enable surgeons to visually assess blood flow and related tissue perfusion during organ transplant procedures.

The Novadag® Technologies SPY® Fluorescent Imaging System used in plastic, micro, and reconstructive surgery indication consists of 2 components:

• · the SP2001 Imaging Device
• · the SPY Paq®

The SPY Pags are available in 2 configurations dependent on the intended indication for use. Each SPY Paq contains sufficient number of ICG, custom sterile drapes called Novadrape®, and diluent for 6 imaging procedures. Each configuration of SPY Pag has a unique part number assigned to it, and different Instructions for Use exist for the two types of SPY Pags. The different Instructions for Use also have unique part numbers for ease of assembly of the Pags and quidance for the end user.

The SP2000 Imaging Device consists of an imaging head containing a charge coupled device (CCD) camera, a laser light source, motion sensor, and distance sensor attached via an articulating arm to a mobile cart. The mobile cart contains a flat panel display, a computer with keyboard and optical mouse, an electronics enclosure, and a printer.

The SPY® System provides the surgeon with the capability to view, record, and replay fluorescent images of blood flow in vessels and organs. A laser light source is used to illuminate the area of interest. In order to obtain the images, ICG is injected intravenously through the central or peripheral venous line, bypass pump, cardioplegia line, or down a coronary graft. While the ICG is passing through the vessels, the absorption of laser light causes excitation of the ICG dye, followed by the emission of infrared energy. A CCD camera of the SP2000 Imaging Device captures the infrared emission, resulting in a fluorescent image of blood flow and related tissue perfusion. These images are used to evaluate the integrity of native and grafted vasculature and blood flow in the organs.

The SP2001 Imaging Device represents a modification of the SP2000 Imaging Device in the following ways:

• The maximum recording time for image sequences captured has been extended to 60 seconds from the 34 seconds of the SP2000 Imaging Device.
• An ability to move the SP2001 camera head in horizontal plane during image sequence acquisition has been implemented.
• A variable Laser Power Attenuator has been added to the device to permit laser illumination at power levels lower or equal to the laser power level of the SP2000 Imaging Device.
• New HELIOS 10 software has been developed to support the SPY System in its organ transplant surgery indication.

Here's an analysis of the provided 510(k) summary regarding the SPY® Fluorescent Imaging System (SP2001) for use in organ transplant procedures, focusing on acceptance criteria and supporting studies.

It's important to note that a 510(k) summary is a high-level overview. Detailed acceptance criteria and study designs are typically found in the full 510(k) submission, which is not provided here. Therefore, some information may be inferred or stated as "not specified" based on the available text.

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to predicate devices and expanding the Indications for Use, rather than explicitly stating quantitative performance acceptance criteria in the context of a new efficacy study. The "acceptance criteria" here are largely met by demonstrating safety, effectiveness, and equivalence to existing cleared devices, particularly for the expanded indication.

Based on the document, the de-facto acceptance criteria for this 510(k) submission revolve around:

1. Safety: No adverse acute or long-term cellular, renal, or hepatic effects from device use, and exposure levels below maximum permissible limits.
2. Effectiveness/Utility: Ability to acquire high-quality, reproducible fluorescent images of blood flow and tissue perfusion, enabling surgeons to visually assess these parameters.
3. Equivalence: The modified SP2001 device for organ transplant procedures is as safe and effective as the predicate SP2000 device and other legally marketed devices, with enhanced functionality.

Study Proving Device Meets Acceptance Criteria:

The current 510(k) relies on a combination of previous clearances, existing clinical experience, and minimal new data specifically for the organ transplant indication.

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

   • Test Set for Organ Transplant Indication: "31 cases in the United States and 18 reported in the literature from Japan" (total 49 cases) of human clinical experience. This data is retrospective from real-world use.
   • Previous Indications (CABG, etc.): "over 7000 vascular procedures in humans" (global, retrospective/real-world), and "six pig studies" (prospective, animal). Data provenance for the 7000 human procedures is unspecified beyond being "in the United States of America, Japan, Europe, and Canada."

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

   • Not explicitly specified for the 49 organ transplant cases. The assessment of blood flow and tissue perfusion appears to be a direct visual assessment by the attending surgeons during the procedures. The document refers to "surgeons" being able to assess blood flow, implying their intra-operative judgment serves as a form of ground truth.
   • For the CABG data, the ground truth of "lack of patency" was identified by the surgeon, leading to revision.

3. Adjudication method for the test set:

   • Not specified. Given the nature of intra-operative visual assessment by the operating surgeon, it's unlikely a formal adjudication process involving multiple independent experts was performed for each case in the real-world usage described. The surgeon's decision to revise a graft, for instance, implies their assessment/ground truth.

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:

   • No, an MRMC comparative effectiveness study was not done. The SPY System is an imaging device, and this submission is for an expanded indication for use, not for an AI/CAD product or an assessment of human reader performance improvement with AI assistance.

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

   • Not applicable. The SPY System is a device that provides visual information to the surgeon for assessment; it is not a standalone algorithm making diagnostic or decision-making outputs. The human (surgeon) is inherently "in-the-loop."

6. The type of ground truth used:

   • Surgeon's Intra-operative Visual Assessment/Clinical Judgment/Outcomes Data (for revisions): For the human cases, the ground truth is derived from the surgeon's observation and their subsequent actions (e.g., revising a graft). For the organ transplant cases, the ground truth is stated as the system enabling "surgeons to visually assess blood flow." In the CABG context, instances requiring "revision" clearly indicate identifying a clinical issue, which serves as a form of outcome-based ground truth related to the system's utility.
   • Physiological measurements in animal studies: For the pig studies, ground truth included the ability to acquire high-quality images, lack of detrimental effects on heart function/coronary flow, and no increase in myocardial tissue temperature.

7. The sample size for the training set:

   • Not applicable in the traditional sense. The 510(k) process for this device relies on prior clearances, general clinical experience (over 7000 procedures), and a smaller set of clinical experience for the new indication (49 organ transplant cases) for validation, not for training a new algorithm. The "HELIOS 10 software" mentioned as new was based on a "cleared DaqPac software" and focused on interface and reporting, not on a machine learning model that would require a dedicated training set.

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

   • Not applicable. As there isn't a "training set" in the context of a machine learning algorithm, the concept of establishing ground truth for it does not apply to this submission. The development of the device and its various software iterations would have relied on engineering verification and validation, as well as clinical feedback, but not a formally labeled "training set" for a learning algorithm.

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