(82 days)
The Vista StereoScope System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures.
The Vista StereoScope System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The system will be supplied as a Vista StereoScope Camera Head, Vista Stereo Endoscope and a 3D Camera Control Unit (CCU). The device is designed to work with commercially available light sources and video monitors or head mounted displays.
This 510(k) summary for the Vista StereoScope System focuses on its substantial equivalence to predicate devices based on intended use, method of operation, material, and design. It details the device's description and intended use and lists the safety standards it was designed to comply with. However, it does not contain a standalone study with acceptance criteria and reported device performance in the way a clinical performance study would.
Therefore, for the specific request, much of the information regarding a performance study, acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not present in the provided document.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance:
- Not provided. The document states "The Vista StereoScope System was designed and will be tested in compliance with the requirements of the following standards," and then lists several IEC, UL, and ISO standards. This indicates safety and general performance compliance but does not provide specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics from a study comparing it to a ground truth or a clinical outcome.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No performance study or test set is described.
3. 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):
- Not provided. No performance study and thus no ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. No performance study and thus no adjudication method is described.
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 provided. This device is a video endoscope system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not provided. This is a hardware device; a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. No performance study implies no ground truth establishment for a clinical or diagnostic outcome.
8. The sample size for the training set:
- Not applicable / Not provided. A training set is relevant for machine learning algorithms, which this device is not.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. A training set is relevant for machine learning algorithms, which this device is not.
Summary of what the document does state regarding performance/testing:
The document indicates that the Vista StereoScope System was designed and will be tested in compliance with the requirements of the following standards:
- IEC 601-1: General Safety Requirements for Medical Electronic Equipment
- IEC 601-1-2: Electromagnetic Compatibility Requirements and Tests
- IEC 601-2-18: Safety of Endoscopic Equipment
- UL 2601-1: Standard for Safety, Medical Electrical Equipment, Part 1: General Requirements for Safety
- ISO 10993: Biological Evaluation of Medical Devices
This means the device's acceptance is primarily based on meeting these fundamental safety and electrical standards, rather than a clinical performance study with specific quantitative metrics. The 510(k) process for this device relies on substantial equivalence to predicate devices, implying that if the predicates were deemed safe and effective, and the new device poses no new safety or effectiveness concerns, it also can be marketed.
§ 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.