(178 days)
The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery.
The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic surgery. There are two neoClose product codes, neoClose Hasson and neoClose Universal, each consisting of an AccuGuide and two AutoAnchors loaded onto two Drivers. The neoClose Hasson is designed to provide sealed anchoring of a laparoscopic trocar and suture placement for subsequent soft tissue approximation. The neoClose Universal is equivalent to the neoClose Hasson design in its method of soft tissue approximation but does not provide for sealed anchoring of a trocar. Soft tissue approximation is facilitated by delivering two AutoAnchors, through an AccuGuide with a Driver. The AutoAnchors and Drivers for both the neoClose Hasson and Universal are identical but the AccuGuides differ in construction. The Hasson AccuGuide features Suture Locks, a flexible Sleeve, and two Guide Channels while the Universal AccuGuide features a Thumb Grip and one Guide Channel.
The provided text describes a 510(k) summary for the neoClose device, which is a suture passer for endoscopic/laparoscopic surgery. However, the document does not contain the specific details required to answer your request about acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly refers to "at least as safe and effective as the predicate devices."
- Reported Device Performance: The document states that "Design Verification bench testing and an acute GLP Animal Study support the performance of the neoClose device and demonstrates that it is at least as safe and effective as the predicate devices." No specific quantitative performance metrics (e.g., tensile strength, closure time, success rate) are provided or compared against defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified, beyond mentioning "Design Verification bench testing and an acute GLP Animal Study." The country of origin for the animal study is not mentioned, nor is whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The studies mentioned (
Design Verification bench testingandGLP Animal Study) do not involve human expert interpretation in the way an AI diagnostic device study would. The performance appears to be assessed via scientific and clinical endpoints in animal models and bench tests.
4. Adjudication Method for the Test Set
- Not applicable. See point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs. Without AI Assistance
- No, an MRMC study was not done. This device is a surgical tool, not an AI-assisted diagnostic device. The documentation focuses on equivalence to a predicate device through bench and animal testing, not on human reader performance with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For bench testing: Likely engineering specifications, physical measurements, and possibly simulated clinical conditions.
- For the GLP Animal Study: Clinical and pathological observations in an animal model. The specific endpoints or "ground truth" (e.g., successful tissue approximation, absence of complications, healing outcomes) are not detailed.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning, so there is no training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
In summary: The provided 510(k) summary is for a physical surgical device and discusses its substantial equivalence to a predicate device through bench and animal testing. It does not provide the kind of information requested regarding AI performance, human reader studies, or detailed acceptance criteria with quantitative results, as would be expected for an AI/ML-based diagnostic device.
§ 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.