(11 days)
The Applied Medical Modular Trocar System is a sterile single use device, or may be used with a reusable stainless steel or reusable DuraGold® cannula and is intended for use in coniunction with Applied's currently marketed trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. If utilizing the Applied Medical Optical Separator Obturator with the Modular Trocar System it may be used with or without visualization for primary and secondary insertions.
The Modular Trocar System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system.
The Modular Trocar System will be available in sizes of 5mm, 11mm, 12 mm and 15mm diameter in lengths ranging from 55mm to 150mm.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. The document is a 510(k) summary for a medical device (Modular Trocar System) and primarily focuses on its substantial equivalence to predicate devices based on performance and functional testing.
Therefore, many of the requested fields cannot be directly extracted or inferred from the provided text.
However, based on the available information, here's what can be reported:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Inflation performance | Demonstrated comparable performance to predicate devices. |
| Leakage performance | Demonstrated comparable performance to predicate devices. |
| Substantial equivalence | Found substantially equivalent to predicate devices. |
| No new safety and effectiveness issues | No new safety and effectiveness issues identified. |
Note: The document states "The performance and functional testing of the Modular Trocar System included tests to verify the inflation and leakage as compared to its predicate devices." and "The performance and functional testing demonstrated that the Modular Trocar System is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed." This implies that the acceptance criteria for these aspects were met if the device performed comparably to its predicates and presented no new risks.
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 in the document. The text only mentions "performance and functional testing" without detailing the methodologies, sample sizes, or data provenance.
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 in the document. This type of detail is typically associated with studies involving human interpretation or clinical outcomes, which are not the focus of this 510(k) summary. The evaluation focuses on physical device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 to the device described. The Modular Trocar System is a physical surgical instrument, not an AI or imaging device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the device described. This refers to AI algorithm performance, not a physical medical device like a trocar system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in AI or diagnostic device studies relying on expert consensus or objective medical findings is not directly applicable here. For this device, the "ground truth" would be established by validated physical performance metrics and engineering standards related to inflation, leakage, and mechanical integrity, as compared to well-established predicate devices. The document implies that the device's performance was compared against the known and accepted performance characteristics of its predicate devices to demonstrate equivalence.
8. The sample size for the training set
This information is not provided in the document and is not applicable for this type of device where "training set" refers to data for machine learning. The device undergoes manufacturing and quality control, not algorithm training.
9. How the ground truth for the training set was established
This information is not provided in the document and is not applicable for this type of medical device as it's not an AI or data-driven system.
§ 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.