(175 days)
The Karl Storz VOICE1® SCB R-UI Speech Control Application is indicated for use in speech control of Karl Storz-approved devices and peripherals in conjunction with the Karl Storz SCB® R-UI software.
The Karl Storz VOICE1® SCB R-UI Speech Control Application is an independent application that works in the background of the SCB R-UI. VOICE1® recognizes commands spoken by the user and sends corresponding commands to the SCB R-UI system, enabling the user to control endoscopic and other ancillary surgical equipment and adjust device parameters entirely by speech control.
The provided documents for Karl Storz VOICE1® SCB R-UI Speech Control Application do not contain any information regarding acceptance criteria, device performance results, or details of a study that would prove the device meets specific criteria.
The documents primarily consist of:
- A 510(k) Summary (K083598, page 1) which describes the device, its intended use, technological characteristics, and claims substantial equivalence to a predicate device.
- A Substantial Equivalence Table (page 2) which compares the new device to the predicate device in terms of device type, user input, controlled devices, added functions, other software requirements, and intended use.
- An FDA letter (pages 3-5) confirming the substantial equivalence determination and outlining regulatory responsibilities.
- An Indications for Use statement (page 6).
Therefore, I cannot provide the requested table or answer questions 2 through 9, as no such study details are presented in the provided text.
Based on the information available:
1. Table of acceptance criteria and the reported device performance:
* No acceptance criteria or reported device performance metrics are mentioned in the provided text. The submission focuses on substantial equivalence to a predicate device, rather than presenting a performance study against predefined criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* No information provided.
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):
* No information provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* No information provided.
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 information provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No information provided. The device is a speech control application, inherently designed for human-in-the-loop interaction.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* No information provided.
8. The sample size for the training set:
* No information provided.
9. How the ground truth for the training set was established:
* No information provided.
§ 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.