(56 days)
The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.
The Pajunk TrocaSys consists of disposable trocar sleeves, disposable trocars and obturators and disposable valves (i.e. TrocaTec, TrocaPort, Hasson system for example for insufflation). The system is based on Pajunks reusable Trocars, Trokar sleeves and Accessories already cleared in K012771. The technical description remains unchanged. The systems and its accessories are manually operated surgical devices used by physicians for making incisions into the patient's body to allow insertion of endoscopes and end propio accessories during general endoscopic and laparoscopic procedures. The devices follow the FDA Draft Guidance for the Content of Premarket Notifications for Endoscopes used in Gastroenterology and Urology, dated 3/17/95. The trocars and obturators are used together with the trocar sleeves for puncture of the patient's body. After having made the incision, the trocar is removed to allow insertion of end scope and endoscopic accessories. The Disposable Hasson Cone, Disposable obturators/ trocars, Disposable Trocar valve, Disposable TrocaTec and Disposable TrocaPort are available seperately.
This document is a 510(k) Premarket Notification Submission for a medical device called "TrocaSys disposable Trocar System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria for device performance. Therefore, the information you've requested regarding acceptance criteria and performance studies in the way one might evaluate AI/ML-based devices or other novel technologies is not applicable within this document.
Here's why and what information can be extracted:
- 510(k) Submissions: These submissions establish that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or has different technological characteristics but does not raise new questions of safety and effectiveness.
- Focus on Equivalence: The primary "proof" in a 510(k) is the comparison to the predicate device, showing that the new device performs as safely and effectively as the predicate. This typically involves engineering tests, material compatibility, sterilization validation, and often a functional comparison, but not necessarily a clinical study with detailed performance metrics against specific acceptance criteria.
Therefore, your direct questions regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in terms of clinical performance metrics are not directly addressed in this type of submission.
However, I can extract information related to the device and its regulatory context:
1. A table of acceptance criteria and the reported device performance
As explained above, this 510(k) submission does not present acceptance criteria and reported device performance in the typical manner of a novel device proving its efficacy or diagnostic accuracy. The "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence to a predicate device.
The document states: "The system is based on Pajunks reusable Trokars, Trokar sleeves and Accessories already cleared in K012771. The technical description remains unchanged." This implies that the performance characteristics should be equivalent to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission doesn't detail a clinical study with a "test set" in the sense of patient data for performance evaluation. The "data provenance" would relate to the technical specifications and testing against standards for the device itself (e.g., material testing, sterilization validation), not patient 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. There is no mention of a "test set" requiring expert ground truth establishment for clinical performance in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No such adjudication method is mentioned as there is no clinical test set for performance evaluation described.
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 device is a manual surgical tool (trocar system), not an AI-assisted diagnostic or therapeutic system. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical performance evaluation. The "ground truth" for this device would be its ability to physically perform its function safely and effectively as a surgical tool, which is assessed through engineering principles, material science, and comparison to the predicate.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of machine learning or AI described for this manual surgical device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a new manual surgical device to a predicate device, rather than a report on a clinical study with specific performance acceptance criteria for a novel technology.
§ 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.