(58 days)
Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals.
S-357 Video Imaging System
This 510(k) submission (K973798) for the SOPRO S-357 Video Imaging System does not contain a study that establishes acceptance criteria or device performance in the way typically expected for AI/ML devices or novel medical technologies.
Instead, the submission relies on the concept of substantial equivalence to predicate devices already on the market. This means the manufacturer argues their device is safe and effective because it is very similar to other legally marketed devices, rather than providing independent performance data against specific acceptance criteria.
Therefore, many of the requested elements for a study showing acceptance criteria and performance cannot be directly extracted from this document in the traditional sense.
Here's a breakdown based on the provided text, highlighting what is (and isn't) present:
1. Table of acceptance criteria and reported device performance:
This information is not provided in the document. The submission explicitly states: "SOPRO feels the S-357 Video Imaging System is substantially equivalent to the many marketed devices already in commercial distribution." and "Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the sames, SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device." This indicates that no specific performance metrics or acceptance criteria were established or measured for this device against a predefined standard.
2. Sample sized used for the test set and the data provenance:
Not applicable. There is no test set or study conducted to evaluate the S-357's performance against specific metrics. The substantial equivalence argument relies on the established safety and effectiveness of the existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth was established by experts for a test set, as no performance study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication method was used.
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, an MRMC study was not done. This device is a video imaging system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a video imaging system, not an algorithm, and its function inherently involves human operation and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No ground truth was used for a performance study. The "ground truth" in this context is the presumed safety and effectiveness of the predicate devices.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML algorithm and does not have a training set or associated ground truth.
In summary, this 510(k) submission is for a medical device (a video imaging system) that was cleared based on its substantial equivalence to existing devices, not on a performance study with defined acceptance criteria, ground truth, or expert evaluation. The information provided focuses on demonstrating the similarity in design, technology, specifications, and intended use to predicate devices from companies like Circon/ACMI, Storz, Stryker, Smith & Nephew, and Olympus.
§ 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.