(42 days)
The GelPOINT® Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.
GelPOINT Path is inserted into the anal canal to establish access to the rectum and lower sigmoid colon in preparation for transanal endoscopic surgery. The access channel lumen may be closed off with an airtight cap. The cap allows for insufflation of the surgical site. The cap is constructed of a gel material through which multiple sleeves may be placed. These sleeves establish ports that allow passage of a laparoscope and laparoscopic instruments without loss of insufflation. GelPOINT Path was previously cleared in access channel lengths ranging from 4.5cm to 15cm. The proposed clearance for the access channel length is 3.5cm to 15cm.
This document is a 510(k) summary for the GelPOINT® Path Transanal Access Platform, a medical device. It's a regulatory submission to the FDA, not a study report that details acceptance criteria and performance data in the typical sense of a clinical trial.
Therefore, many of the requested categories simply do not apply to this type of document because it describes a line extension of an already cleared device, not a new device requiring extensive de novo performance testing. The main argument for substantial equivalence is based on the lack of impact of the new feature (shorter access channel length) on already established safety and effectiveness.
Here's an attempt to answer the questions based on the provided text, with clear indications where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or reported device performance in terms of specific metrics like sensitivity, specificity, or accuracy. This is because the submission is for a line extension of an already cleared device (K110792 and K133393). The argument is that the proposed change (shorter access channel length) does not impact the performance specifications already established for the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission is for a line extension of a device. It refers to performance testing done for the predicate devices (K110792 and K133393) but does not provide details on their sample sizes or data provenance. No new testing of this nature was conducted or reported for this specific submission (K171701).
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. This type of information is not relevant to a 510(k) submission for a line extension of an existing mechanical device. There is no "ground truth" to establish through expert review in the context of diagnostic accuracy for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring adjudication in the context of this 510(k) submission.
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 device is a transanal access platform, not an AI-powered diagnostic tool. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a transanal access platform, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. There is no concept of "ground truth" in the context of diagnostic accuracy for this mechanical device's 510(k) submission. Safety and effectiveness would be established through performance testing related to its mechanical function, biocompatibility, sterility, etc. (as mentioned for the predicate devices), not through comparison to a diagnostic ground truth.
8. The sample size for the training set
Not applicable. This device is a transanal access platform; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this mechanical device, there is no ground truth to establish for it.
§ 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.