(92 days)
The Uroplasty Rigid Endoscopic Needles are accessories to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needles may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.
The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 4 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The Rigid Endoscopic Needle is comprised of a stainless steel cannula 300 - 500 mm in length with an 18-23 gauge tip (10 - 15 mm in length) and a copolyester Luer lock hub.
This document is a 510(k) summary for the Uroplasty Rigid Endoscopic Needles. It describes the device, its intended use, and compares it to a predicate device. The document also mentions functional and biocompatibility testing conducted to support substantial equivalence.
Here's an analysis of the provided text in relation to your questions, noting that this is for a medical device cleared via 510(k) for substantial equivalence, not a standalone AI/software as a medical device (SaMD) study, so many of your detailed questions regarding AI performance and ground truth establishment are not directly applicable.
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A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format typically used for performance studies of AI/SaMD. Instead, it refers to "functional tests to demonstrate forces experienced by the needle during use and to demonstrate mechanical strength" and "biocompatibility." The reported performance is a general statement that these tests were conducted to support substantial equivalence.
Acceptance Criteria (Implied) Reported Device Performance Demonstrate forces experienced by the needle during use Functional testing conducted (specific results not detailed) Demonstrate mechanical strength Functional testing conducted (specific results not detailed) Meet biocompatibility standards Biocompatibility testing conducted (specific results not detailed) Substantial equivalence to predicate device (K091391) Determined to be substantially equivalent by FDA, based on conducted tests -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes physical device testing. It does not refer to "test sets" or "data provenance" in the context of clinical data or AI model evaluation. The tests are functional and biocompatibility tests on the physical needles. The sample sizes for these types of engineering tests are typically determined by standards and internal protocols, but are not specified here. The location of testing is Uroplasty, Inc. (Minnetonka, MN, USA), which implies the data provenance is also within the US. The tests would be prospective in nature, conducted on new or prototype devices.
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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)
This question is not applicable to the type of device and study described. This is not a study requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" for functional and biocompatibility tests is based on established engineering and biological standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations where there can be disagreement among experts. Here, the tests are objective, physical, and chemical evaluations.
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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
This question is not applicable. The Uroplasty Rigid Endoscopic Needles are a physical accessory, not an AI or imaging device, and therefore, an MRMC study related to AI assistance for human readers was not performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical endoscopic needle, not an algorithm or standalone software.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is based on engineering standards for mechanical strength and functionality, and biocompatibility standards (e.g., ISO 10993 series) for biological safety. There is no clinical or diagnostic "ground truth" as would be found in an imaging or diagnostic device study.
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The sample size for the training set
This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established
This question is not applicable. There is no "training set."
Summary of Findings:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of a physical medical device (endoscopic needles) to a previously cleared predicate device. The evaluation involved functional and biocompatibility testing of the physical product, rather than clinical studies with human subjects or performance evaluations of AI algorithms. Therefore, many of your questions regarding AI-specific criteria (sample size for test/training sets, data provenance for AI, number/qualifications of experts for AI ground truth, adjudication methods, MRMC studies, standalone AI performance) are not applicable to this particular 510(k) submission.
§ 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.