(112 days)
To establish a path of entry for minimally invasive instruments. The instrument is intended for creating secondary ports under direct visualization.
The (TRADE NAME) Non-shielded Surgical Trocar with Threaded Sleeve has application in thoracic, general, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments. The instrument is intended for insertion under direct visualization for secondary port locations.
The (TRADE NAME) Non-shielded Surgical Trocar consists of two main subassemblies: a non-shielded obturator sub-assembly and the sleeve sub-assembly.
The non-shielded obturator sub-assembly is designed with a protective sheath to cover the flat blade. This protective sheath protects the gaskets on the sleeve assembly when the obturator and sleeve are mated together for insertion into the operative cavity. When the sleeve and obturator are properly engaged, the protective sheath is retracted so that the blade is exposed when it extends from the trocar sleeve.
An inner and outer gasket seals to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through cannula during a surgical procedure. Integral threads along the outside diameter of the cannula portion of the sleeve provide a retention mechanism to stabilize the sleeve in tissue
The (TRADE NAME) Non-shielded Surgical Trocar shall be provided in a variety of sizes from 3mm to 12mm in diameter and 75mm to 150mm in length.
This device is designed to create secondary trocar sites and is labeled to be used only under direct visualization of the insertion site.
This document is a 510(k) Summary of Safety and Effectiveness for a surgical trocar, not a study evaluating an AI device or algorithm. Therefore, the requested information about acceptance criteria, study design for AI evaluation, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone performance of an AI is not available in the provided text.
The document describes a medical device (a non-shielded surgical trocar) and its equivalence to a predicate device, based on pre-clinical laboratory evaluations for its physical performance.
Here's a breakdown of what can be extracted from the provided text, recognizing it doesn't fit the AI/algorithm evaluation paradigm:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or detailed reported performance values. Instead, it states that "The studies demonstrated acceptable performance to the Predicate Device" for specific functionalities. This implies that the acceptance criteria were likely functional and comparative to the predicate device, although the numerical benchmarks are not listed.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Mating obturator with sleeve | Acceptable performance |
| Insertion into operative cavity | Acceptable performance |
| Removal of obturator from sleeve | Acceptable performance |
| Security of sleeve in tissue | Acceptable performance |
| Maintenance of pneumoperitoneum of the operative space | Acceptable performance |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "Pre-clinical laboratory evaluations were performed." The number of devices tested or the conditions under which they were tested are not detailed.
- Data Provenance: Not specified, but given it's pre-clinical laboratory evaluations, it would be internal testing.
- Retrospective or Prospective: These were likely prospective tests conducted on the newly designed device.
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 as the "ground truth" here pertains to physical device performance (e.g., maintaining seals, insertion functionality), not interpretation of medical data by experts. The "truth" would be determined by the objective success or failure of the device during the specified pre-clinical tests, as assessed by engineering or testing personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for expert review of medical data, not for the physical performance testing of a medical 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
Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be objective measurements and observations from the pre-clinical laboratory evaluations (e.g., successful insertion, no leakage, proper mating of components). It is not based on medical diagnoses or outcomes data in humans, as these are pre-clinical tests.
8. The sample size for the training set
Not applicable. This is not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI model.
In summary, the provided text describes a traditional medical device (surgical trocar) and its regulatory submission. It does not pertain to the evaluation of an AI-powered device or algorithm, and therefore the specific questions tailored to AI evaluation cannot be answered from this document.
§ 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.