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The PortLand Trocars is very similar to all other trocar devices previously found to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976. Due to the increased demand for minimally invasive surgery, trocars have become an essential part of laparoscopic procedures. By providing the surgeon with a fully reusable instrument with replaceable tip such as the PortLand Trocars, SI have optimized the economy of a re-usable instrument, with the advantages of the disposable instrument, in the provision of the replaceable tip concept. The materials used in the construction of the PortLand Trocars are commonly found in other surgical instruments and are identical with that used in the product manufactured by Mikroland. Also, the means of sterilization (autoclaving) has long been used by hospitals for the sterilization of surgical instruments.
This document (K962193) is a 510(k) notification for the PortLand Trocars, a surgical device. The information provided is insufficient to answer the request about acceptance criteria and a study proving device performance against those criteria.
Here's why and what information is missing based on the prompt's requirements:
1. A table of acceptance criteria and the reported device performance:
- Missing. The document states "The PortLand Trocars is very similar to all other trocar devices previously found to be substantially equivalent..." and "this instrument is as effective as other competitive product and does not increase the risk to the patient." However, it does not provide specific, measurable acceptance criteria (e.g., force required for insertion, durability, sealing characteristics) nor any data on how the PortLand Trocars performed against such criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing. There is no mention of any specific test set, sample size, 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):
- Not applicable / Missing. This question is typically relevant for AI/ML-driven diagnostic devices where expert ground truth is established. For a mechanical surgical instrument like a trocar, "ground truth" would be performance specifications, and experts would be engineers or surgeons evaluating usability and safety. This document provides no such details.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Missing. Similar to point 3, this is relevant for diagnostic performance evaluation, not for the type of device 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 pertains to AI-assisted diagnostic tools and is not relevant for a surgical trocar.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This pertains to AI/ML algorithms and is not relevant for a surgical trocar.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Missing (and applies differently to this device type). For a trocar, "ground truth" would relate to its physical properties, safety, and functional performance. The document only mentions similarity to other devices and materials.
8. The sample size for the training set:
- Not applicable / Missing. This is typically for AI/ML and is not mentioned for this device.
9. How the ground truth for the training set was established:
- Not applicable / Missing. This is typically for AI/ML and is not mentioned for this device.
Summary of Document K962193 in relation to the prompt:
This 510(k) notification focuses on demonstrating substantial equivalence to predicate devices. It largely relies on:
- Similar intended use: Both the PortLand Trocars and existing trocars are for laparoscopic procedures.
- Similar technological characteristics: "very similar to all other trocar devices," "materials used... are commonly found in other surgical instruments and are identical with that used in the product manufactured by Mikroland."
- Similar principles of operation: Functionally, it's a trocar.
- Safety and Effectiveness claims: "as effective as other competitive product and does not increase the risk to the patient."
The document does NOT provide:
- Specific, quantified acceptance criteria.
- Results from a formal study (clinical or performance bench testing) with defined methodologies, sample sizes, or outcome measures to prove performance against those criteria.
- Any details related to AI/ML performance, ground truth, or expert evaluations in the context of diagnostic accuracy.
To answer your prompt fully, a different type of document, such as a detailed test report, clinical study protocol, or specific sections within a more comprehensive regulatory submission, would be required. The provided 510(k) summary is high-level and focused on equivalence rather than detailed performance data or AI/ML evaluation.
§ 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.