(30 days)
1688 4K Camera System with Advance Imaging Modality:
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural 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 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality:
Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLightTM Cable is used 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.
Upon interstitial administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLightTM Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using indocyanine green (ICG) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing near-infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible as well as near-infrared spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY AGENT™ GREEN (indocyanine green for injection, USP) used for fluorescence imaging.
The modified AIM System (subject device) and predicate device are the same, with the exception of the 1688 4K Pendulum Camera Head and the optional Defog feature. The 1688 4K Pendulum Camera Head was cleared under K200310 and works as intended with the L11 LED Light Source that was cleared under K182160, K191046 and K192292. The optional Defog feature reduces the likelihood of fogged images common to irrigated surgical procedures.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically found in a clinical study report for an AI/ML medical device. This document is an FDA 510(k) clearance letter and its associated summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance data for a novel algorithm's clinical efficacy.
The document discusses general "Performance Data" and "Image Quality Assessments" but states these were provided to demonstrate that the optional Defog feature works as intended and does not require clinical studies to support the determination of substantial equivalence. This implies that the performance evaluation was primarily technical and verification-based, not a multi-reader, multi-case clinical study to assess diagnostic accuracy or improvement in human performance.
Therefore, I cannot extract the level of detail requested for the acceptance criteria and the study that proves the device meets them (e.g., number of experts, adjudication method, effect size of human improvement with AI, ground truth specifics, training set size) because this information is not present in the provided 510(k) summary.
The only "acceptance criteria" explicitly mentioned are found under "Performance Data," suggesting successful completion of standard technical and quality assessments.
Here's what can be inferred from the text regarding acceptance criteria and performance, although it's very high-level:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Laser Output (Technical Performance) | Pass |
| System Temperature Verification | Pass |
| Image Quality Assessments | Pass (for the optional Defog feature) |
| Software Verification (IEC 62304:2015 compliant) | Pass |
2. Sample size used for the test set and the data provenance: Not specified. The document indicates these were "performance data" and "image quality assessments" for the "optional Defog feature," suggesting a technical evaluation rather than a clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. The nature of the evaluations (technical testing of a "Defog feature" and image quality) does not typically involve expert clinical ground truth establishment in the way an AI diagnostic algorithm would.
4. Adjudication method for the test set: Not specified.
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: No, the document explicitly states, "The AIM (Advanced Imaging Modality) System does not require clinical studies to support the determination of substantial equivalence." This type of MRMC study is not mentioned or implied. The device's primary function is as an imaging system, not an AI-driven diagnostic aid that would directly impact human reader performance in interpreting images. The AI element, if any, is more integrated into image enhancement (like the Defog feature) rather than a separate diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned as a distinct performance metric for a standalone AI algorithm. The "Performance Data" section lists technical tests. While the "Defog feature" is an algorithm, its performance seems to have been assessed technically (image quality) rather than as a standalone diagnostic tool.
7. The type of ground truth used: For the "Performance Testing" and "Software Verification," the ground truth would be based on engineering specifications, regulatory standards (like IEC 62304), and visual assessment for "Image Quality Assessments." For a "Defog feature," "ground truth" might refer to known conditions of fogging in test environments and the system's ability to mitigate them visually. It is not clinical ground truth established by expert consensus, pathology, or outcomes data.
8. The sample size for the training set: Not applicable and not specified. The document does not describe the development or training of a machine learning model in the context of a dataset for diagnostic performance.
9. How the ground truth for the training set was established: Not applicable and not specified.
§ 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.