(38 days)
The Funnel Trocar™ is an access device for laparoscopic procedures. The new instrument creates and maintains a passageway for laparoscopic instruments during a variety of general, gynecologic, thoracic, and urological procedures.
The Funnel Trocar™ is a disposable single patient use device fabricated from surgical grade stainless steel, and biocompatible medical grade polymers. The device is available in a variety of diameters (5mm. 7/8mm. 12mm) and lengths (55mm. 70mm, and 100mm). The Funnel Trocar™ is supplied with either a shielded cutting obturator (trocar). The cannula is equipped with a luer fitting to provide access for insufflation of the operative area. The cannula is available with or without stability threads.
The provided text is a 510(k) summary for the Funnel Trocar™ and the FDA's clearance letter. This type of document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study with the elements you've requested for AI/software devices.
Therefore, most of the information regarding detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies will not be present in this document. The Funnel Trocar™ is a physical surgical device, not an AI or software-based medical device.
Here's a breakdown based on the information available and the nature of the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit in this document. The primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. This is typically achieved by comparing design, materials, intended use, and performance characteristics (e.g., mechanical strength, sterility, biocompatibility if applicable) to the predicate. | The FDA determined the Funnel Trocar™ is substantially equivalent to the predicate devices listed (Sabre Ultimate Shielded Trocar System K943976 and various Core Dynamics, Inc. Laparoscopic Trocars K901407, K911813, K950457, K953409, K953903). |
2. Sample sized 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 in the 510(k) summary. For physical devices, testing typically involves mechanical, material, and biocompatibility tests rather than clinical studies with "test sets" in the context of AI/software. If such tests were performed, the details would be in supporting documentation not included in this summary.
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 is not applicable and not provided. This concept relates to ground truth establishment for analytical or diagnostic software, which is not relevant to a physical surgical trocar.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable and not provided. Similarly, this is a concept used for human review in studies, especially for diagnostic accuracy, and is not relevant to the clearance of a physical surgical instrument like a trocar.
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
This is not applicable for this device. An MRMC study is designed for evaluating diagnostic algorithms, typically AI or software, and is not relevant to a physical surgical trocar.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable for this device. This refers to the performance of an AI algorithm independently, which is not what the Funnel Trocar™ is.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable and not provided. For physical devices, "ground truth" would relate to engineering specifications, material properties, and functionality testing, not a diagnostic outcome. The "truth" for substantial equivalence is met by demonstrating the device performs as intended and is as safe and effective as its predicates.
8. The sample size for the training set
This is not applicable and not provided. "Training set" refers to data used to train AI/machine learning models, which is not involved in the development or clearance of this physical medical device.
9. How the ground truth for the training set was established
This is not applicable and not provided for the same reasons as point 8.
In summary: The provided document is a 510(k) premarket notification for a physical medical device. The focus is on demonstrating substantial equivalence to already legally marketed devices, not on proving performance through clinical studies with the highly specific criteria you've outlined for AI/software devices. Therefore, most of your requested information is not relevant or present in this context.
§ 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.