(115 days)
The 3D SCOPE™ is designed to aid in visualization for general endoscopic and laparascopic procedures including general thoracic, and as an aid in visualization and examination of the evacuated cardiac chambers.
This 510(k) submission is for the addition of an indication for use of the currently marketed, cleared device 3D SCOPE™ Three Dimensional Medical Video System. 510(k) #: K923160. The primary application cleared for the AST 3D SCOPE™ is general endoscopic surgery and laproscopic procedures. This includes general thoracic procedures.
The provided text is a 510(k) summary for a medical device (3D SCOPE™) from 1996. It focuses on adding an indication for use ("examination of the evacuated cardiac chambers") to an already cleared device.
Crucially, the document explicitly states that "The device is not modified in any way except for the added indication for use." This implies that the device's performance, as proven by the original clearance (K923160), is considered sufficient for this new indication based on the device's established technological equivalency to its predicate.
Therefore, there is no new study described in this 510(k) summary demonstrating acceptance criteria for the new indication. The acceptance criteria and the study that proved them would have been part of the original 510(k) submission (K923160), which is not provided here.
Given the information provided, I cannot populate the requested table or answer most of the questions because the document does not describe a new study or new acceptance criteria for the device's performance related to its new indication. The clearance is based on the equivalency of the new indication to the previously cleared indications and the existing device's proven performance for those indications.
Here's what can be inferred or stated based on the provided text:
- Table of acceptance criteria and reported device performance: Not applicable. No new acceptance criteria or new performance data are presented for the added indication. The device's performance for general endoscopic and laparoscopic procedures was accepted in the original 510(k) (K923160).
- Sample size used for the test set and the data provenance: Not applicable. No new test set data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set data is presented.
- Adjudication method for the test set: Not applicable. No new test set data is presented.
- 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 is a 1996 device; AI assistance for visual medical devices in the context of MRMC studies was not a standard or relevant evaluation method at that time.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-only device; it's a visualization system for human use.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this 510(k) submission.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the modern sense.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The 510(k) submission is for an expanded indication for use of an already cleared and unmodified device. Therefore, no new performance studies, acceptance criteria, or ground truth establishment methods are described within this specific document. The justification for clearance relies on the established substantial equivalence and performance of the device under its original clearance (K923160).
§ 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.