(23 days)
The Auto Suture* Soft Thoracoport* obturator and sleeve is indicated for use in establishing a port of entry for endoscopic instruments (straight and curved) in thoracic and other procedures, where insufflation is not required.
The Auto Suture* Soft Thoracoport** obturator and sleeve consists of a sterile, single-use, blunt-tipped obturator and a flexible threaded sleeve. The threaded sleeve has a shroud at its proximal end to protect against foreign materials entering the cavity and for instrument stabilization. The Auto Suture* Soft Thoracoport** obturator and sleeve is available in 5mm, 12mm and 15mm sizes.
The provided text describes the "Auto Suture* Soft Thoracoport** Obturator and Sleeve" device and its 510(k) summary, but it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for AI/ML performance evaluation.
The document states:
- "Pre-clinical laboratory evaluations were performed to ensure that the device could be used as designed."
- "The studies demonstrated substantial equivalence to the predicate device in creating a port of entry for endoscopic instruments (straight and curved) in thoracic and other procedures, where insufflation is not required."
This indicates that the evaluations were done to show substantial equivalence to a predicate device, which is a regulatory pathway for medical devices. This is a different type of evaluation than setting specific performance criteria (e.g., sensitivity, specificity, accuracy) for an AI/ML model and then conducting a study to demonstrate those criteria were met.
Therefore, I cannot fill out the requested table and answer the study-specific questions based on the provided text. The document focuses on regulatory approval based on pre-clinical evaluations and substantial equivalence to existing devices, not on the performance metrics typically associated with AI/ML systems.
Here's why I cannot provide the requested information from the given text:
- Nature of the Device: The device is a surgical instrument (obturator and sleeve), not an AI/ML diagnostic or predictive system. Therefore, the concept of "acceptance criteria" for a fixed performance metric (like accuracy for an AI system) doesn't directly apply in the same way. The "performance data" section refers to pre-clinical evaluations ensuring it can be used as designed and is substantially equivalent to predicate devices.
- Lack of Specific Performance Metrics: The text does not list any quantitative performance metrics (e.g., sensitivity, specificity, AUC, F1-score) that would constitute "acceptance criteria" for an AI model.
- No AI/ML Study Details: The document does not describe any study involving AI, machine learning, human readers, or ground truth establishment in the context of an algorithm's performance.
If this were an AI/ML device, the detailed information requested would typically be found in a dedicated "Clinical Study Report" or "Performance Study" section of the 510(k) submission, clearly defining the study design, endpoints, and results. The provided text is a summary of safety and effectiveness, focused on the regulatory pathway of substantial equivalence.
§ 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.