(184 days)
The EntriPort Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments. The Trocar may be used with or without visualization for primary and secondary insertions.
The EntriPort Mini Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments.
The EntriPort Surqical Trocar System is a broad range of surgical trocars and accessories intended for use as the means for providing surgical access for various instruments during endoscopic surgery.
The EntriPort Surgical Trocar System includes both full size and mini devices, which are available in disposable (single patient use) and reposable (at least one reusable, and one disposable component) configurations. Reusable components are limited to the Reusable Cannula and accessories of the Open Entry (Hasson) Trocar.
This document, a 510(k) Summary for the ConMed EntriPort Surgical Trocar System (K142464), details a premarket notification for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a standalone study with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information regarding AI device evaluation is not present in this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific, quantifiable acceptance criteria and reported device performance linked to those criteria for an AI device. Instead, it states that "Product performance testing demonstrates devices comply with design specifications and applicable sections of ISO 11607-1:2006, ISO 11135-1:2007, AAMI/ANSI ST67:2011, AAMI/ANSI ST81:2004(R)2010, ISO 10993-7:2008, ISO 14971:2007, ISO 594/1:1986, and ISO 594-2:1998." It also mentions "Performance testing, including blade insertion forces, entry wound defect size, instrument insertion and removal, maintenance of pneumoperitoneum, and trocar insufflation rate, demonstrates the device performance is substantially equivalent to the predicate devices."
This is general and focuses on compliance with existing standards and substantial equivalence to a predicate, not on novel performance metrics for an AI system.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes non-clinical bench and simulated use testing, but it does not specify sample sizes for these tests, nor does it refer to "test sets" or "data provenance" in the context of an AI study.
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)
This information is not provided. The document does not describe the establishment of a ground truth by experts, as it is not a study evaluating an AI algorithm's diagnostic or predictive capabilities.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Again, this is relevant for studies involving human interpretation or consensus, which is not described here for an AI device.
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 such study was done or reported. This document is for a surgical trocar system, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithmic performance study was done or reported, as the device is a physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No "ground truth" in the context of AI evaluation is mentioned or used. The evaluation focuses on the physical and functional aspects of the surgical trocar system against established engineering and medical device standards.
8. The sample size for the training set
This information is not provided. The concept of a "training set" is not applicable to a physical surgical device like a trocar.
9. How the ground truth for the training set was established
This information is not provided, as there is no "training set" or "ground truth" for an AI algorithm discussed in this document.
In summary:
This 510(k) document is for a surgical trocar system, which is a physical medical device. It is not an AI-powered device, and therefore, the information typically requested for evaluating the acceptance criteria and study data of an AI device (like test/training sets, ground truth establishment, expert adjudication, MRMC studies, etc.) is not present in this document. The document focuses on demonstrating substantial equivalence to an existing predicate device based on technical characteristics, materials, intended use, and compliance with general medical device standards.
§ 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.