(21 days)
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
The Stryker AIM LED Light Source (L10 & L11) is part of the Stryker Infrared Fluorescence (IRF) Imaging System, which is an endoscopic illumination and imaging system for real-time high definition (HD) visible light and near-infrared fluorescence imaging of indocyanine green (ICG) during minimally invasive surgery.
The Stryker Infrared Fluorescence Imaging System consists of the following main components:
- . A light source console and a light cable for outputting light within a visible light spectrum as well as near-infrared light spectrum;
- . A camera control unit for processing near-infrared and visible light images, and a coupler that is attached to the laparoscope and camera head (cleared separately);
- A laparoscope for visible light and near-infrared light illumination and imaging ● (cleared separately)
- An imaging agent kit containing ICG ●
The Stryker AIM LED Light Source uses an illuminator with a laser light source to illuminate the area of surgery. The device is used in conjunction with ICG to achieve its intended use in fluorescence angiography. The ICG is administered intravenously prior to image obtainment. A laser light is illuminated to the site of the surgery using a laparoscope. Absorption of laser light causes excitation of the ICG in the vessels resulting in emission of infrared light at a different wavelength. The camera system captures the infrared emission, processes the image and displays it on a surgical monitor.
This document describes a 510(k) premarket notification for the Stryker L10 and L11 LED Light Source with AIM (Advanced Imaging Modality). This notification primarily concerns a labeling modification allowing the use of the device with Stryker's SPY AGENT™ GREEN (Indocyanine green for injection, USP). As such, the study described focuses on demonstrating compatibility rather than proving a new performance characteristic of the device itself.
Therefore, the information typically requested regarding acceptance criteria for an AI/ML device, such as specific performance metrics, sample sizes for test/training sets, expert consensus, and MRMC studies, is not applicable to this submission. This is because the device being approved is a medical light source, not an AI/ML diagnostic or assistive device. The submission primarily relies on demonstrating substantial equivalence to previously cleared predicate devices and compatibility with a specific imaging agent.
However, I can extract the relevant information about the "study" that was conducted to support the labeling modification:
1. A table of acceptance criteria and the reported device performance:
Since this is not an AI/ML device, there are no acceptance criteria related to algorithmic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" here implicitly refer to the demonstration of visual equivalence/compatibility.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Visual equivalence of fluorescence with Stryker's SPY AGENT™ GREEN compared to a commercially available ICG imaging agent. | "Results from the imaging studies demonstrated that there was no visible difference observed in fluorescence between Stryker's SPY AGENT™ GREEN and another commercially available ICG imaging agent." This indicates that the device produces visually equivalent fluorescence imaging results with both ICG agents, implying compatibility and therefore meeting the implicit acceptance criterion for the labeling change. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document refers to "imaging studies" but does not quantify the number of images, cases, or subjects.
- Data provenance: Not specified, but given the nature of the device and testing, it would likely be laboratory-based bench testing rather than real-world clinical data. It is not indicated if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a visual comparison study to demonstrate compatibility, not a diagnostic accuracy study requiring expert-established ground truth. The assessment was based on "visible difference," likely by qualified personnel involved in the bench testing.
4. Adjudication method for the test set:
- Not applicable.
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. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (light source), not an algorithm.
7. The type of ground truth used:
- Implicitly, the "ground truth" was the expected fluorescence visualization when using a known, commercially available ICG imaging agent, against which the performance with SPY AGENT™ GREEN was compared. This is a technical (bench) demonstration of compatibility, not a clinical ground truth like pathology or outcome data.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document details a 510(k) submission for a medical light source that aims to modify its labeling to include compatibility with a new imaging agent. The "study" referenced is a bench test demonstrating visual equivalence of fluorescence with the new agent compared to an existing one. It is crucial to understand that the detailed criteria typically applied to AI/ML device approvals are not relevant here.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.