(89 days)
The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.
A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repar, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement.
The users of the 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT/heurosurgeons and urologists.
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with Advanced Imaging Modality 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 Advanced Imaging Modality 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 LED Light Source with Advanced Imaging Modality 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 Advanced Imaging Modality 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 Advanced Imaging Modality 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 Advanced Imaging Modality and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The L12 LED Light Source with Advanced Imaging Modality is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Stryker's Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light, near-infrared illumination and transillumination, and cyan spectral imaging system. Near-infrared illumination is used for fluorescence imaging using SPY AGENT™ GREEN (indocyanine green for injection, USP) or CYTALUX™ (pafalocianine) 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. Cyan Spectral Imaging is intended as an alternative mode of visualization that uses narrow bands for illumination during endoscopic surgery to provide greater visualization of surface structures and fine capillary patterns of the mucosal membrane.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Stryker 1788 4K Camera System with Advanced Imaging Modality and L12 LED Light Source with AIM:
A table of acceptance criteria and the reported device performance cannot be fully constructed from the provided document. The document primarily lists regulatory standards and general performance categories, indicating that the device "passed" these tests. It does not provide specific quantitative acceptance criteria or detailed reported performance values for each criterion.
However, based on the Performance Data section (page 9), we can infer the types of tests conducted and their general outcome:
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Specific Standard/Test (if mentioned) |
|---|---|---|
| Safety Testing | ||
| Electromagnetic Compatibility | Pass | IEC 60601-1-2:2014, IEC 60601-4-2:2016 |
| Electrical Safety | Pass | ANSI AAMI ES 60601-1:2005 + A1:2012 + A2:2021, IEC 60601-1-6:2010 + A1:2013 + A2:2020, IEC 60601-2-18:2009 |
| Laser Safety | Pass | IEC 60825-1:2014, IEC 62471 / Comparative testing to legally marketed predicate device |
| System Functionality | ||
| Sterilization | Pass | ISO 17664-1:2021, ISO 17664-2:2021, ISO 14937:2009, AAMI TIR12:2020, AAMI TIR30:2011, AAMI ST58:2013/(R)2018 |
| Software Verification & Validation | Pass | IEC 62304:2015 |
| Usability | Pass | IEC 62366:2015 + A1:2020 |
| Imaging Performance | ||
| Bench Performance Testing | Pass (against device input specifications and predicate devices) | Spatial Uniformity, Minimum Detectable Fluorescence, Fluorescence Detection Depth, Clinically Meaningful Limits of Detection, Signal to Noise, Photobiological Safety (IEC 62417), Contrast |
| General Performance Testing | Pass (against user needs and intended uses) | (Not specified beyond general user needs and intended uses) |
Here's the requested information based on the provided document:
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A table of acceptance criteria and the reported device performance
- (See table above)
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document states: "NOTE: The Advanced Imaging Modality (AIM) System does not require clinical studies to support the determination of substantial equivalence." This implies that no clinical test set (patient data) was used in the assessment for substantial equivalence. The testing described appears to be primarily bench and laboratory-based. Therefore, sample size and data provenance in the context of clinical data are not applicable based on this document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Since no clinical studies were performed, there's no mention of experts establishing ground truth for a clinical test set. The "Pass" results are based on compliance with engineering standards and comparisons to predicate devices in bench testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set demanding adjudication was used.
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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 MRMC comparative effectiveness study was done. The document explicitly states: "The Advanced Imaging Modality (AIM) System does not require clinical studies to support the determination of substantial equivalence." There is also no mention of AI assistance in the context of human readers for this device. The "Advanced Imaging Modality" refers to specialized illumination and visualization techniques, not AI-powered image analysis for diagnosis.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an imaging system (camera and light source) that provides visual information to a surgeon. It is not an AI algorithm that operates standalone without human interpretation or intervention for diagnostic or therapeutic decisions.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the performance testing, the implied "ground truth" or reference was primarily device input specifications and the performance of currently legally marketed predicate devices. For regulatory compliance, the ground truth was adherence to FDA-recognized voluntary consensus standards (e.g., IEC standards for electrical safety, usability, software, etc.).
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The sample size for the training set
- Not applicable. This document describes a medical imaging hardware system, not a machine learning model that requires a training set.
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How the ground truth for the training set was established
- Not applicable. As there is no machine learning component requiring a training set, the establishment of ground truth for such a set is not mentioned.
§ 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.