(204 days)
The GeniCon trocar is available in 5, 7/8, 10 and 12mm diameter with either a pyramidal or conical tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.
This device incorporates several design features which facilitate the surgeons use both during insertion and while instrumentation is being inserted and manipulated.
Trocar Tip:
- A modified pyramidal tip to provide easier insertion for the surgeon by enabling the tip to . minimally incise the tissue while providing a lower profile transition from the stainless tip to the cannula.
Trocar Handle: - Enlarged to provide a more positive fit in the surgeon's palm during insertion, and provides a . groove to provide a more positive fit for the thumb during removal or re-insertion.
Cannula: - Clear casing for visualization of instrument and tissue passage. .
- Reverse trapezoidal fascia threads, they provide an easier insertion while a positive anchoring . during instrument use.
- . Extended CO2 port with male luer cap provides a "finger grip" during device insertion while the male luer cap is easier to remove and replace than the Apple silicone cap.
- . Double wall valve lock, assists in maintaining the valve position and to alleviate the premature release sometimes experienced by the Apple product.
Valve: - . A tapered membrane assembly provides a more positive seal around the instrument, while the silicon membrane was designed to reduce friction during instrument use.
- . A pull-tab was added to facilitate removal of the valve during specimen retrieval.
The provided text is a 510(k) summary for the GeniCon Trocar/Cannula System, which describes the device, its intended use, and a comparison to predicate devices. However, it does not contain the detailed information needed to answer the questions about acceptance criteria and a study proving those criteria are met.
Here's a breakdown of why this information is missing from the provided document:
- Acceptance Criteria Table: The document states that "Engineering testing has demonstrated that the valve assembly performs better than that of the Apple and Core trocar valve assembly," and that it "performed equal to if not superior in pressure testing, ease of use and insertion." However, specific numerical acceptance criteria (e.g., "pressure testing must maintain X pressure for Y duration") and the corresponding reported device performance values are not provided.
- Sample Size and Data Provenance (Test Set): The document mentions "Engineering testing," but does not specify the sample size of devices tested or the data provenance (e.g., where the testing was conducted, if retrospective or prospective data was used, etc.).
- Number and Qualifications of Experts (Ground Truth): This type of device (trocar/cannula) is used for surgical access. Its performance is assessed through engineering tests and usability, rather than through interpretation of complex data by experts to establish a "ground truth" in the way, for example, a diagnostic AI would. Therefore, the concept of a "ground truth" established by experts in the context of radiology or pathology, and their number/qualifications, does not apply here.
- Adjudication Method: Since there isn't a "ground truth" established by multiple experts in a diagnostic context, there's no adjudication method described.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is relevant for diagnostic devices where human readers interpret medical images or data. It is not applicable to a surgical instrument like a trocar/cannula system. Therefore, no information on an MRMC study or effect size is present.
- Standalone (Algorithm Only) Performance: A trocar/cannula system is a physical surgical instrument, not a software algorithm. Therefore, "standalone performance" in the context of an algorithm does not apply.
- Type of Ground Truth Used: As explained above, the "ground truth" for a surgical instrument's performance is typically established through objective engineering tests (e.g., pressure, friction, insertion force) and usability assessments rather than expert consensus on diagnostic interpretations or pathology.
- Sample Size for Training Set: Since this is a physical device and not an AI/ML algorithm, there is no "training set."
- How Ground Truth for Training Set was Established: Not applicable due to the nature of the device.
In summary, the provided document describes a traditional medical device (surgical instrument) and its performance relative to predicate devices through engineering tests and mentions of ease of use. It does not present information as would be expected for a diagnostic AI/ML device.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.