(357 days)
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.
| Acceptance Criterion (Inferred from 510(k)) | Reported Device Performance (for GI surgical procedures) |
|---|---|
| Utility of SPY System in GI procedures | "The information contained in this 510(k) submission demonstrates the utility of the SPY System during GI surgical procedures in addition to the previously cleared indications." |
| Safety Profile (adverse events) | "To date, there have been no reports of adverse events associated with the SPY imaging procedure, including ICG injection." |
| Image Quality | "The SPY images obtained is comparable to those acquired with the SPY System for previously cleared applications." "The SPY System was able to acquire high quality images of the entire vascular bed on each area of interest." |
| ICG Dosing | "ICG was administered well below the 2 mg/kg limit and consistent with the previously cleared indications for ICG use as part of the SPY System." |
| Equivalence to Predicate Devices | "The testing demonstrates that the SPY System is equivalent to predicate devices..." |
| Electrical Safety | Successfully met all requirements of IEC 60601-1, IEC 60601-1-4, UL2601-1. |
| Electromagnetic Compatibility | Successfully met all requirements of IEC 60601-1-2. |
| Laser Product Safety | Successfully met all requirements of 21 CFR 1040, ANSI Z136.3, ANSI Z136.1. |
| Thermal Damage (tissue) | "Use of the SPY System does not cause any thermal damage to the area of interest, even after repeated imaging sequences." |
| Physiological Impact (cardiac) | "For the heart, there were no changes in electrocardiograms or arterial pressures during and/or following the use of SPY System." |
| Cellular Effects | "There were no acute or long-term cellular effects of using the SPY System." |
| Renal/Hepatic Effects | "There were no acute or long-term renal or hepatic effects of using the SPY System." |
| Ability to Image through Skin | "The SPY System is capable of imaging through the skin to provide a visual assessment of dermal and subdermal blood flow." |
Study Details:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.