(55 days)
The Arthrex Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.
The Arthrex Synergy Vision Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision Endoscopic Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is 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 Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The Arthrex NanoNeedle Scope when used with the Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoNeedle Scope is indicated for laparoscopy and orthopedic procedures.
The Arthrex Synergy Vision Endoscopic Imaging System includes a camera control unit (CCU) console, camera heads, endoscopes, and a laser light source. The system provides real-time visible light and near-infrared (NIR) illumination and imaging.
The Arthrex Synergy Vision Endoscopic Imaging System uses an integrated LED light to provide visible light illumination and imaging of a surgical site. For NIR imaging, the system interacts with the laser light source to visualize the presence of a fluorescence contrast agent, indocyanine green (ICG) and pafolacianine. The contrast agent fluoresces when illuminated through the laparoscope with NIR excitation light from the laser light source and the fluorescent response is then imaged with the camera, processed, and displayed on a monitor.
The provided FDA 510(k) clearance letter and summary for the Arthrex Synergy Vision Endoscopic Imaging System (K250728) describes the device and its indications for use, but does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and a study that proves the device meets those criteria.
Specifically, the document states: "The Arthrex Synergy Endoscopic Imaging System did not require animal testing or human clinical studies to support the determination of substantial equivalence." This implies that performance data demonstrating device capabilities against specific acceptance criteria (beyond general functional testing and compliance with standards) were not generated through clinical studies or animal studies for this submission.
However, based on the information provided, here's what can be inferred and what is missing:
Acceptance Criteria and Device Performance (Inferred/Missing)
Since no human or animal clinical studies were performed, there appears to be no specific clinical performance acceptance criteria listed in this document. The "Performance Data" section primarily focuses on engineering and regulatory compliance testing.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Performance (General) | "The test results confirm the subject device met Arthrex product requirements and design specifications for the device." |
| Biocompatibility | "Leveraged from the biocompatibility testing... of the additional predicate devices, as there were no modifications made to the subject device... that would affect the biocompatibility..." |
| Sterility | "Leveraged from the... sterilization validation of the additional predicate devices, as there were no modifications made to the subject device... that would affect the... sterility of the device." |
| Electrical Safety (EMT) | "The test results confirm the subject device conforms with EMT safety... standards." |
| Electromagnetic Compatibility (EMC) | "The test results confirm the subject device conforms with... EMC standards." |
| Software Performance | "Software testing was conducted and documentation was provided in this submission. The test results confirm the Arthrex software updates met product requirements and design specifications established for the device." |
| Image Resolution | (Implicitly met by technical specifications matching predicate) 3840 x 2160, 400 x 400 (Nano), 720 x 720 (Nano) |
| Frame Rate | (Implicitly met by technical specifications matching predicate) 60 fps, 30 fps (Nano) |
| NIR Wavelengths/Detection | (Implicitly met by technical specifications matching predicate) Excitation Wavelength: 785 nm, Detection Bandwidth: 810 – 940 nm |
| Clinical Performance (e.g., Sensitivity, Specificity for specific disease/task) | NOT APPLICABLE / NOT PROVIDED. The document explicitly states no human or animal studies were required for substantial equivalence. Therefore, there are no reported clinical performance metrics like sensitivity or specificity. |
Study Details (Based on Provided Document and Inferences)
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Sample Size used for the test set and the data provenance:
- Test set sample size: Not applicable for clinical performance as the document explicitly states: "The Arthrex Synergy Endoscopic Imaging System did not require animal testing or human clinical studies to support the determination of substantial equivalence."
- Data provenance: Not applicable for clinical performance. The data provenance for engineering tests (e.g., EMT, EMC, software) would be internal Arthrex testing labs.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no human clinical studies establishing ground truth for clinical performance were conducted for this submission. Ground truth for engineering tests is established through technical specifications and industry standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for clinical performance.
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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 study was done. The device description does not indicate AI assistance features. The system is described as an endoscopic video camera and imaging system, not an AI-powered diagnostic aide.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is hardware (imaging system) with associated software, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering and regulatory compliance tests: Ground truth was established by adherence to design specifications, industry standards (e.g., for biocompatibility, sterility, EMT, EMC), and internal product requirements.
- For clinical performance (e.g., diagnostic accuracy for a specific disease): No such ground truth was established or presented as no clinical studies were performed.
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The sample size for the training set:
- Not applicable, as this device does not appear to utilize machine learning for clinical interpretation or outcome prediction in a way that requires a "training set" in the context of AI/ML models. "Software testing" refers to verification against technical requirements, not AI model training.
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How the ground truth for the training set was established:
- Not applicable for the same reasons as #7.
Summary of Key Takeaways from the Document:
The 510(k) clearance for the Arthrex Synergy Vision Endoscopic Imaging System (K250728) is based on substantial equivalence to existing predicate devices (K241361 and K243008). The justification for this clearance relies heavily on:
- Similar intended use and indications for use.
- Similar technological characteristics (e.g., components, imaging modes, specifications).
- Successful completion of engineering and regulatory compliance testing (e.g., functional testing, biocompatibility, sterility, EMT, EMC, software).
Crucially, the document explicitly states that no animal testing or human clinical studies were required or performed to demonstrate the device meets acceptance criteria related to clinical performance. This means the clearance is not based on a study proving diagnostic accuracy or clinical effectiveness in patients, but rather on the device's technological similarity and safety/performance in a non-clinical, engineering test environment compared to previously cleared devices.
§ 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.