(292 days)
The GelPOINT Mini Advanced Access Platform is indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.
The proposed device is an iteration of Applied Medical's GelPort Blunt Tip Trocar System. The predicate GelPort system provides a single access port and must therefore be used in combination with additional ports. Three ports is common, each requiring a dedicated incision. The proposed device, in essence, combines three of the single port predicates into one compact construct that requires but a single incision. A fourth port is included in the package as an option.
The proposed device is a sterile, single-use instrument intended to access abdominal, thoracic and pelvic cavities in preparation for endoscopic surgical procedures. It features a sleeve type wound retractor and a detachable cap. The wound retractor consists of a flexible polyurethane cylindrical sheath that has a semi-rigid polyurethane inner ring attached at each end. The detachable Gel-cap is constructed of a semi-rigid polycarbonate ring and a flexible gel-like material. The Gel-cap is fastened to the wound retractor with a locking attachment lever. The Gel-cap can accommodate up to four access ports that are inserted through the gel in a formation preferred by the user. The ports accommodate laparoscopic tools ranging from 4.8 to 13.2mm and have sealing features that allow insufflation of the surgical space.
The provided text describes the regulatory clearance of a medical device (GelPOINT Mini Advanced Access Platform) and outlines the testing conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the specific information typically found in a study proving a device meets acceptance criteria for an AI/ML-driven medical device, such as performance metrics (accuracy, sensitivity, specificity), details on test set data (sample size, provenance), expert ground truth establishment, or multi-reader studies.
The document focuses on non-clinical performance testing for a physical medical device (an endoscopic access platform), not a software or AI-based device. Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device and study.
Below, I will extract the information that is present in the document relevant to non-clinical performance testing and note where the requested information is not applicable or not provided.
Study Proving Device Meets Acceptance Criteria for GelPOINT Mini Advanced Access Platform
This document describes the non-clinical performance testing used to demonstrate substantial equivalence of the GelPOINT Mini Advanced Access Platform to its predicate device, the GelPort Blunt Tip Trocar System. The testing primarily focused on the physical and functional aspects of the access platform.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Predicate and proposed devices met all testing acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results for each test. Instead, it describes the types of functional tests performed.
| Test Category | Acceptance Criteria (Descriptions from Document) | Reported Device Performance |
|---|---|---|
| Biocompatibility | In accordance with FDA guidance ISO 10993-1 for devices contacting tissue for less than 24 hours. Compatible in: Cytotoxicity, Intracutaneous reactivity, Sensitization. | "The proposed device ... was found compatible after being subjected to these tests." (Implies acceptance criteria were met for these tests). |
| Functional Performance | Implicit: Demonstrate substantial equivalence by performing comparably to the predicate device and maintaining functional integrity. Quantitative thresholds not specified. | "Predicate and proposed devices met all testing acceptance criteria." (Specific numerical results are not provided, but it's stated they passed). |
| Resistance to Detachment | (Not explicitly defined beyond "while operated as intended") | Met acceptance criteria. |
| System Leak Test | (Not explicitly defined beyond "with and without instruments") | Met acceptance criteria. |
| Seal Particulation | (Not explicitly defined beyond "during instrument exchanges") | Met acceptance criteria. |
| Seal Resealing Ability | (Not explicitly defined beyond "after removal instruments") | Met acceptance criteria. |
| Instrument Drag Force | (Not explicitly defined beyond "created by inserting and removing instruments") | Met acceptance criteria. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for "side-by-side bench testing" of the proposed and predicate devices.
- Data Provenance: This is not applicable in the context of clinical data for an AI/ML device. The testing was bench testing (laboratory-based, physical performance testing) rather than involving human subject data or retrospective/prospective patient data. The manufacturer is "Applied Medical Resources Corporation" based in California, USA, where the testing presumably took place.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable: This type of testing (functional performance of a physical surgical access device) does not involve medical image interpretation or clinical decision-making that would require expert-established ground truth. The ground truth refers to the physical functionality and safety parameters measured in the lab.
4. Adjudication Method for the Test Set
- Not Applicable: No adjudication of expert opinions was necessary as the study was non-clinical bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No: This was not an MRMC study. MRMC studies are typically performed for imaging diagnostics or AI-assisted interpretation, where human reader performance is evaluated. This document describes the testing of a physical surgical access device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The device functionality was tested standalone in a bench setting.
7. The Type of Ground Truth Used
- Bench Test Measurements/Physical Properties: The "ground truth" for this study was based on objective measurements of physical and functional properties during bench testing (e.g., resistance to detachment, leak rates, particulation, resealing ability, drag force) and biological compatibility.
8. The Sample Size for the Training Set
- Not Applicable: This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As above, no training set was involved.
§ 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.