(28 days)
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.
The 1688 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.
This document, a 510(k) Summary for the Stryker 1688 4K Camera System with Advanced Imaging Modality (AIM), primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's diagnostic performance against specific clinical acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods is either not explicitly stated or not applicable in the context of this type of regulatory submission.
However, based on the provided text, I can infer and present some of the requested information related to the device's performance data that was provided in support of the substantial equivalence determination.
1. Table of Acceptance Criteria and Reported Device Performance
For regulatory purposes to demonstrate substantial equivalence, the "acceptance criteria" here relate to compliance with recognized standards and successful completion of specified tests.
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| Electrical Safety (ANSI/AAMI ES60601-1:2005 + A1:2012, IEC 60601-2-18:2009, IEC 60601-1-6:2010 + A1:2013) | Pass |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2014) | Pass |
| Performance - Bench (CCU Timing, Video Compatibility) | Pass |
| Software Verification (IEC 62304:2015) | Pass |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the traditional sense of a study evaluating diagnostic accuracy on patient data. The performance data provided are related to engineering and regulatory compliance testing. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission focuses on engineering and safety compliance, not clinical diagnostic accuracy assessed by experts against ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, there is no clinical test set requiring expert adjudication for ground truth.
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 such study is mentioned or implied in this document. The device description explicitly states it is an "endoscopic camera system that produces live video in the surgical field," which implies it is a viewing tool for human users, not an AI-assisted diagnostic device. The "Advanced Imaging Modality" refers to visible and near-infrared imaging for fluorescence and transillumination, not AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an imaging system intended for human-in-the-loop performance, providing visual information to a surgeon. There is no mention of a standalone algorithm for automated analysis.
7. The type of ground truth used
For the engineering and regulatory compliance tests:
- Electrical Safety, EMC, Software Verification: The "ground truth" is compliance with the specifications and requirements of the cited international standards (IEC, ANSI/AAMI).
- Performance - Bench: The "ground truth" is successful operation according to internal design specifications for CCU Timing and Video Compatibility.
There is no mention of clinical ground truth (e.g., pathology, clinical outcomes) as this submission does not present a clinical performance study.
8. The sample size for the training set
Not applicable. Since there is no mention of an algorithm based on machine learning or AI that would require a "training set," this information is not provided.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm 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.