(226 days)
The GTK Trocars has an application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments.
The GTK Trocars has an application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments. The available model of the Trocar is model CT.
All the trocars have the similar structure. They are composed of cannula, stopcock, trocar cap, and obturator. The trocar cap has a universal seal which accommodates instruments of different diameters. The cannula has a valve which ensures the sealing performance.
The CT trocar consists of an obturator assembly and a cannula assembly. The obturator assembly can be assembled with the cannula assembly by indicator fitting. And Model CT includes CT bladeless trocar, CT optical trocar, and CT bladed trocar.
The provided document details the 510(k) premarket notification for the GTK Trocars, asserting its substantial equivalence to a predicate device. However, the document does not contain an "acceptance criteria" table with specific performance metrics and reported device performance for an AI/ML device. It describes testing for a physical medical device (trocars), focusing on biocompatibility, bench testing, and animal studies.
Therefore, I cannot provide the requested table of acceptance criteria and reported device performance for an AI/ML device, nor the specific details about test sets, ground truth establishment, expert qualifications, or MRMC studies that would be relevant to an AI/ML device's evaluation.
The document states:
- No clinical testing was done: "Substantial equivalence does not depend on clinical test data." This means there was no human clinical study performed to evaluate the device.
- Ground Truth for training set: Not applicable as there is no mention of a "training set" or "ground truth" in the context of an AI/ML model. The product is a physical medical device.
- Sample size for training set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. The device is a physical trocar, not an AI-assisted diagnostic tool.
Instead, the document describes the following types of studies:
Non-clinical Testing (Physical Device Testing):
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Biocompatibility Testing:
- Tests Conducted: Cytotoxicity, Sensitization & irritation, Acute systemic toxicity, Pyrogen test, Endotoxin Test.
- Standards Conformed: ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006.
- Ground Truth: These tests are based on established biological and chemical standards and reactions, not expert consensus on images or data.
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Bench Testing:
- Tests Conducted: Appearance, Dimensions, Endoscope visualization image quality, Obturator compatibility, Insertion & Cannula stability, Insertion force & Removal force, Penetration force, Leak rate.
- Ground Truth: These are engineering and performance validation tests against design specifications and industry standards for physical device functionality.
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Animal Study:
- Purpose: To demonstrate operational performance.
- Performance Criteria Assessed:
- Ability to access abdominal cavity
- Ability to maintain Pneumoperitoneum
- Ability to manipulate instruments for laparoscopic surgery
- Ground Truth: Based on observed functional performance in an animal model by trained professionals, adhering to veterinary and surgical best practices.
Summary of what is possible to provide based on the document:
- Type of Ground Truth Used: For biocompatibility, it's based on established ISO standards for biological evaluation. For bench testing, it's based on design specifications and engineering standards. For the animal study, it's based on observed functional performance in an animal model.
- Standalone Performance: The non-clinical tests (biocompatibility, bench, animal study) represent the standalone performance evaluation of the physical device. The document does not describe performance against a specific numerical acceptance criterion in the format of AI/ML metrics (e.g., sensitivity, specificity, AUC).
- Sample Size / Data Provenance / Experts / Adjudication: These details are not provided in the context of the physical device testing, as they are often more relevant for clinical trials or AI/ML evaluations. "Sample size" for physical device testing typically refers to the number of units tested, which is not specified but implied by the successful completion of the tests.
§ 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.