(25 days)
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with AIM and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L12 Light Source with AIM 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.
Additionally, the L12 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with AIM and SafeLight Cable are 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 label, the L12 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The L12 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
The L12 LED Light Source with AIM is part of the Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The L12 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.
This document describes the Stryker L12 LED Light Source with AIM, which is an endoscopic imaging system used to provide real-time visible and near-infrared fluorescence imaging during various surgical procedures. The device received 510(k) clearance (K230754) based on substantial equivalence to predicate devices, primarily the 780 nm L11 LED Light Source with AIM (K221611).
The provided text does not contain details about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-enabled devices involving diagnostic accuracy or similar performance metrics. This is because the L12 LED Light Source with AIM is a hardware component (a light source) that enables certain imaging modalities, rather than a diagnostic algorithm itself. As such, its performance evaluation focuses on functional aspects and safety rather than diagnostic accuracy or human reader improvement.
Here's an analysis based on the information provided, specifically highlighting why certain requested sections are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are fundamental engineering and safety standards, and the reported performance is a simple "PASS" for these tests. There are no specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) provided as would be expected for an AI/ML-driven diagnostic device.
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance |
|---|---|---|
| Software Performance | Light Source Software Functional Test | PASS |
| Light Source Communication | PASS | |
| Bench Performance | Light Source Light Output | PASS |
| Light Source Power Draw | PASS | |
| Light Source Cable Compatibility | PASS | |
| Light Source Timing | PASS | |
| Safety Standards Adherence | IEC 60601-1 | Adheres |
| IEC 60601-2-18 | Adheres | |
| IEC 60601-1-2 | Adheres | |
| IEC 60601-1-6 | Adheres | |
| IEC 60825-1 | Adheres |
2. Sample size used for the test set and the data provenance
Not applicable. The device is a hardware component (light source). Performance testing was conducted in a bench setting on the device itself, not on a dataset of patient images or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This information is relevant for studies evaluating human perceptual or cognitive performance, typically in conjunction with AI/ML algorithms. The provided document describes safety and functional testing for a light source.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to establish ground truth in image datasets, often by resolving discrepancies among expert readers. This device underwent bench and software functional testing.
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 device is not an AI/ML algorithm designed to assist human readers in image interpretation. It is a light source that enables certain imaging modalities. The document explicitly states: "The L12 LED Light Source does not require clinical studies to support the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware component, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the conventional sense for AI/ML evaluation. The "ground truth" for the tests performed was defined by engineering specifications and expected functional outputs of the light source (e.g., specific light output, proper communication, correct timing).
8. The sample size for the training set
Not applicable. This device does not use a training set as it's not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this device.
§ 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.