(43 days)
The Reusable Trocar and Sleeve are manual surgical instruments used to support a cut down(lap approach) on secondary puncture placement. The trocar is used in Endoscopic Surgery(Abdominal and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve.
Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.
The device consists of Reusable Trocars and Sleeves, with available Single Use Disposable Caps. The Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.
The Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.
The Reusable Trocar, sizes 3mm -11mm. , is constructed with a stainless steel shaft and is available in pyramidal style.
The Sleeve, proportionally sized, is made of polymer and accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.
This document is a 510(k) summary for a medical device (Reusable Trocar and Sleeve). It focuses on establishing substantial equivalence to previously marketed devices rather than detailing a specific study to demonstrate performance against predefined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not provided in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria nor explicit reported device performance against such criteria. The entire purpose of this 510(k) submission is to demonstrate "substantial equivalence" to predicate devices, meaning the new device is as safe and effective as existing legally marketed ones. The "performance" is implicitly deemed acceptable if it's equivalent to the predicates.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
There is no mention of a "test set" or specific sample sizes for performance testing. The claim of equivalence is based on the device's design, materials, and intended use being similar to predicate devices. This type of submission relies on design comparisons rather than clinical trial data.
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. No "ground truth" establishment by experts for a test set is described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is mentioned.
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 document is about a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a manual surgical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe the establishment of a "ground truth" in the context of performance testing. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth establishment.
Summary based on the document:
The provided text from the 510(k) summary focuses entirely on demonstrating the "substantial equivalence" of the Pilling Weck Reusable Trocar and Sleeve to legally marketed predicate devices (Core Dynamics Entree II, Apple Medical Hunt Reich Secondary Trocar, and Access Surgical Access Single Use Trocar and Sleeve). This regulatory pathway typically relies on comparisons of technological characteristics, intended use, and materials rather than extensive de novo clinical performance studies with predefined acceptance criteria. Therefore, the document does not contain the detailed information requested about specific performance studies, sample sizes, expert involvement, or ground truth establishment as would be found for a novel device or an AI/ML product.
§ 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.