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The Glo-Tip® Spray Catheter (subject device) is a sterile, single use device compatible with the accessory channel of an endoscope. The device consists of a long, thin polytetrafluoroethylene (PTFE) tube (catheter) with a stylet (metal wire) that together are introduced into the ductal area or elsewhere in the GI tract. Fluid (e.g., water or saline) can be injected through the catheter to spray the tissue that needs cleaning. The Glo-Tip® Spray Catheter can also be used in chromoendoscopy (to apply a dye to the mucosa of the gastrointestinal tract through an endoscope to aid in disease detection).

AI/ML Overview

The provided text describes the Glo-Tip® Spray Catheter and its performance data, but it does not detail a study involving AI or human readers. The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, many of the requested categories related to AI performance, human reader studies, and ground truth establishment in that context are not applicable.

Here's the information that can be extracted and a note on the unavailable information:

Table of acceptance criteria and the reported device performance:

Requirement	Acceptance Criteria (summary)	Reported Device Performance
Packaging shall maintain functional integrity of the device following EO sterilization and shipping.	Meet user requirements and have acceptable visual appearance following two sterilization cycles and simulated shipping conditions.	Packages met acceptance criteria.
Product must perform intended use over labeled shelf life.	Same requirements as above, except following two sterilization cycles and aging.	Product performed as intended over labeled shelf life.
Sterile product must be adequately packaged to maintain sterile barrier during expected shipping conditions.	Non-opened sterile packaging shall not show any signs of functional damage, such as holes in the pouch and/or voids in the seal area after simulated shipping conditions.	No signs of functional damage.
Package maintains sterile barrier over labeled shelf life.	Same requirements as above previous, except following aging.	Package has acceptable sterile barrier.
Device must be a Glo-tip device.	Distal tip of device must be fluoroscopically visible.	Tip is fluoroscopically visible.
The product label shall contain accurate dimensional/compatibility information (Catheter outer diameter and length).	Catheter outer diameter: 6.9 Fr with acceptable tolerance. Working length: 235 with acceptable tolerance.	Device dimensions are in accordance with labeling.
In accordance with ISO 8600-1:2013, Clause 4.3: The maximum insertion portion width shall not be larger than that stated in the instruction manual.	Maximum insertion portion width < 2.6 mm when measured in accordance with ISO 8600-4:2014, using a measuring instrument with a minimum accuracy of 0.05 mm.	Device dimensions are in accordance with labeling (implied by previous result).
Biocompatibility Testing:
ISO 1X MEM Elution Method	(Implied: Non-cytotoxic)	Test article considered not cytotoxic.
ISO Intracutaneous Irritation Study in Rabbits: two extracts	(Implied: Non-irritant)	Test article considered a non-irritant.
ISO Guinea Pig Maximization: two extracts	(Implied: Not a sensitizer)	Test article considered not a sensitizer.
Sterilization:	Sterility assurance level of 10⁻⁶ with acceptable sterilization residuals.	Sterilization validation demonstrates device meets this.

Sample size used for the test set and the data provenance:
The document refers to "Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing." It does not specify sample sizes for these tests, nor the exact provenance of any data used (e.g., country of origin, retrospective/prospective). These are typically internal lab tests conducted by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The performance testing described is for a physical medical device (catheter), not an AI/diagnostic device that would require expert-established ground truth.
Adjudication method for the test set:
Not applicable, as this is for a physical medical device and not an AI/diagnostic device involving expert review.
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 not an AI/diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a physical device like this, "ground truth" would correspond to objective physical, chemical, and biological measurements or observations made during bench, sterilization, biocompatibility, and shelf-life testing, conforming to established standards (e.g., ISO for biocompatibility). There is no "expert consensus" or "pathology" in the diagnostic sense.
The sample size for the training set:
Not applicable. This is not an AI/diagnostic device requiring a training set.
How the ground truth for the training set was established:
Not applicable. This is not an AI/diagnostic device requiring a training set.

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