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The SPY System is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures.

The SPY System consists of two components: the SP2001 Imaging Device and the SPY Pag. The SPY System utilizes the fluorescent imaging agent ICG. The SP2001 Imaging Device consists of an imaging head containing a camera, a laser light source, and a distance sensor attached to a mobile cart via an articulating arm. The mobile cart contains a flat panel monitor, a computer with keyboard and mouse, an electronics enclosure, and a printer. While ICG distributes through the vessels or tissues, absorption of laser light at 808 nm causes excitation of the ICG followed by emission of infrared energy at a wavelength of 830 nm. This results in a fluorescent image of the blood vessels and related tissue perfusion. A CCD camera with an 830 nm optical band-pass filter captures the images, Image sequences. up to 60 seconds in duration, are displayed on the monitor and recorded on the computer hard drive. The image sequences can be exported to a CD, DVD, memory stick or lpod. The camera head can be moved in the in horizontal plane during image sequence acquisition. Once the image is captured, the laser automatically shuts off.

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:

Acceptance Criteria and Device Performance Table:

It's important to note that this 510(k) summary does not explicitly state specific pass/fail acceptance criteria with numerical targets for the device's performance related to the proposed expanded indication (GI surgical procedures). Instead, it relies on demonstrating comparable performance to previously cleared indications and safety profiles. The performance reported is qualitative based on clinical utility and image quality.

Study Details:

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

   • Test Set Sample Size: Not explicitly stated as a numerical sample size for the current 510(k) submission's GI surgical procedures. The text refers to "All cases were conducted under the attending surgeons' medical judgment as part of the reconstructive clearance for the device. The examples are not meant to be all encompassing... but illustrate the safety and effectiveness of SPY imaging in this system throughout the GI tract from the esophagus to the anus." This suggests a collection of cases, but no specific number is provided.
   • Data Provenance: The studies were conducted on humans in various countries where the SPY System is commercially available (United States of America, Japan, Europe, Canada, Israel, and Russia). It's a combination of prospective and retrospective human experience since it refers to "over 10,000 surgical procedures in humans" and "This current 510(k) submission contains clinical performance data that support the use of the SPY System during GI surgical procedures. All cases were conducted under the attending surgeons' medical judgment as part of the reconstructive clearance for the device." This implies clinical use data rather than a dedicated, controlled prospective study for this specific indication expansion.

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

   • This information is not provided in the summary. The qualitative assessment of "utility," "safety," and "high quality images" appears to be based on the general judgment of "attending surgeons" and the reported experience in clinical use, rather than a formal ground truth established by a panel of independent experts for a specific test set.

3. Adjudication method for the test set:

   • This information is not provided. Given the nature of the data ("clinical utility" and "attending surgeons' medical judgment"), a formal adjudication method (like 2+1 or 3+1 consensus) for a specific test set does not appear to have been performed or described for this submission.

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 described as an intra-operative imaging system that provides images for visual assessment by surgeons, not an AI-assisted diagnostic tool that interprets images or improves human reader performance in a quantifiable MRMC study setup.

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

   • No, a standalone algorithm-only performance study was not done. The device's utility is explicitly stated as providing "fluorescence images for the visual assessment of blood flow," implying human interpretation is integral, not merely a supplemental step to an automated algorithm. The system is a medical device for imaging, not an AI diagnostic algorithm in isolation.

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

   • For the current GI indication, the "ground truth" is largely observational clinical utility and safety data from real-world surgical procedures, assessed by the attending surgeons, and general lack of adverse events. It is not framed as a formal ground truth established against a gold standard like pathology or long-term outcomes data in the context of a controlled study. For the original 510(k) (K042961), pig studies were used to demonstrate image quality, lack of thermal/physiological effects, but not explicitly linked to a "ground truth" in the diagnostic sense.

7. The sample size for the training set:

   • This information is not applicable/not provided in the context of this 510(k) summary. The SPY System is an imaging device, not a machine learning model that requires a "training set" in the traditional AI sense. Its underlying technology is optical fluorescence imaging. Previous clearances and extensive clinical use (over 10,000 procedures) serve as a broad "experience base" rather than a dedicated training set for an algorithm.

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

   • This information is not applicable for the same reasons as #7. There is no training set for a machine learning algorithm described in this submission.

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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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