(15 days)
The Endoscopy Video Camera System is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required.
The Endoscopy Video Camera System consists of a camera head and a camera controller. The system can be used with commercially available endoscopes and light sources and video monitors or head mounted displays.
The provided text describes a 510(k) summary for an Endoscopy Video Camera System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported device performance metrics in the way a clinical trial or algorithm validation study would.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available from the provided text, as the submission is centered on regulatory equivalence and bench testing, not clinical performance metrics against a defined acceptance criteria.
However, I can extract information related to the device description, intended use, and the basis for substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not available, as per the nature of this 510(k) submission. This 510(k) summary does not present specific quantitative performance metrics against predefined acceptance criteria for the device's diagnostic or surgical capabilities. The substantial equivalence is based on similar intended use, operating principles, and basic design, supported by testing that demonstrates the modifications do not adversely affect safety and effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document does not specify sample sizes for any test sets or details about data provenance. The "testing" mentioned is likely bench testing to confirm the modifications do not adversely affect safety and effectiveness, rather than a clinical study with a patient test set.
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 applicable / Not available. Ground truth establishment by experts is not described, as the submission focuses on device equivalence, not a diagnostic performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not available. Adjudication is not mentioned as part of this 510(k) summary.
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 comparative effectiveness study was not done. This device is an Endoscopy Video Camera System, which is a hardware component for visualizing endoscopic procedures. It does not incorporate AI, and therefore, an MRMC study assessing AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not available. This is a hardware device (camera system), not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not available. The concept of "ground truth" as used in diagnostic algorithm validation is not present in this submission. The "substantially equivalent" claim is based on comparison to a predicate device's design and intended use, supported by safety and effectiveness testing of system modifications (likely electrical, mechanical, and optical performance rather than clinical outcome).
8. The sample size for the training set
- Not applicable / Not available. There is no mention of a training set as this is a hardware device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable / Not available. As no training set is mentioned, its ground truth establishment is irrelevant.
To summarize, the provided document is a 510(k) summary for an Endoscopy Video Camera System, demonstrating substantial equivalence to a predicate device. It primarily addresses the device's design, intended use, and confirms that modifications do not adversely affect safety or effectiveness through unspecified "testing." It does not contain the kind of detailed performance study data with acceptance criteria, sample sizes, and ground truth methodologies that would be presented for a diagnostic algorithm or a clinical software.
§ 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.