(313 days)
The KSEA Fiberscope is indicated for use to provide visualization of the pericardium and cardiac chambers during endoscopic heart surgery procedures.
The KSEA Fiberscope is a manually operated surgical device. The KSEA Fiberscope is flexible fiberoptic telescope which utilizes fiber-optic technology.
The provided document is a 510(k) summary for the KSEA Fiberscope, a medical device for visualization during endoscopic heart surgery. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics as would be found in a clinical trial report for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth is not explicitly available in this type of regulatory submission.
Here's an analysis based on the available information, noting what cannot be extracted from this document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria or quantitative performance metrics in the way a study for an AI/ML device would. For 510(k) submissions, the acceptance criteria are generally met by demonstrating that the new device has "substantially equivalent" features, design, body contact material, and general intended uses to legally marketed predicate devices, and that it does not raise new safety or effectiveness issues.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Basic Features | Substantially equivalent to predicate devices |
| Design | Substantially equivalent to predicate devices |
| Body Contact Material | Substantially equivalent to predicate devices |
| General Intended Uses | Substantially equivalent to predicate devices |
| Safety Concerns | Does not incorporate any significant change that could affect safety or effectiveness; minor differences raise no new issues of safety and effectiveness; design differences have no affect on performance, function, or intended use. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) summary demonstrating substantial equivalence, not a study evaluating performance on a specific test set of data. It describes the device itself and its equivalence to others.
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" establishment in the context of a data-driven test set is described here. The evaluation is based on comparing device specifications and intended use against predicate devices.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication 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 applicable. This document is for a fiberscope, a manually operated surgical device, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The ground truth for this type of submission is the regulatory knowledge and performance history of the predicate devices. The device's "truth" is its ability to visualize as intended, which is assumed to be similar to its predicates.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product developed with a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML product requiring a training set with established ground truth.
§ 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.