(267 days)
The Anchor™ Tissue Retrieval System™ by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and transvaginal removal of an organ or tissue during laparoscopic hysterectomy.
The Anchor™ Tissue Retrieval System™ by CONMED is a sterile, disposable, retrieval pouch for use with a dedicated introducer for the encapture and transvaginal removal of an organ or tissue during laparoscopic hysterectomy. The Anchor™ Tissue Retrieval System™ by CONMED consists of a rip stop nylon with polyurethane laminate pouch and two stainless steel arms attached to internal pusher rod, which is connected to a handle at the end distal to the patient. Around the internal pusher rod is the introducer with handle. The introducer handle incorporates a spring-loaded button and a stop mechanism is built into the pusher rod. There is a braided drawstring which enters the introducer with the pusher rod and loops through the rip stop nylon pouch with polyurethane laminate.
The provided text describes a 510(k) premarket notification for the Anchor™ Tissue Retrieval System™ by CONMED. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a new device's performance.
Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth methodologies) is not explicitly detailed in the provided text, as these are typically part of a full study report or design validation documentation, not a 510(k) summary.
However, I can extract the available information.
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "Design verification activities demonstrate the device meets design specifications" and lists the types of tests conducted. It does not provide specific numerical acceptance criteria or the reported performance values for each criterion. It only states that the results were "acceptable."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Bag volume meets specifications | Acceptable (Specific volume: 6000mL) |
| Drawstring length meets specifications | Acceptable |
| Puncture resistance meets specifications | Acceptable |
| Multiple deployments meet specifications | Acceptable |
| Insertion/removal force meets specifications | Acceptable |
| Bag burst pressure meets specifications | Acceptable |
| User performance during simulated use (insertion, multiple deployments, device/specimen removal, clarity of IFU, overall reliability and quality) | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Design validation activities consisted of simulated use in a cadaver model."
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: Cadaver model (simulated use). Country of origin is not specified, but the submission is to the U.S. FDA, implying U.S. standards or studies. It is a prospective simulation study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document mentions "Users performance including insertion, multiple assessed device deployments, device/specimen removal, clarity of instructions for use and overall reliability and quality of the device."
- Number of Experts: Not explicitly stated. The term "Users" suggests multiple individuals participated.
- Qualifications of Experts: Not explicitly stated. However, given the context of a surgical device and "user performance," it is highly probable these "users" were surgeons or other medical professionals with relevant experience in laparoscopic hysterectomy.
4. Adjudication Method for the Test Set
Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this type of study is not described. The device is a tissue retrieval system, not an AI diagnostic tool that would typically involve a multi-reader study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a medical device (a tissue retrieval system), not an algorithm or AI.
7. The Type of Ground Truth Used
For the simulated use in the cadaver model, the "ground truth" was likely subjective user assessment of performance, reliability, and clarity of instructions, potentially with objective measures of device functionality during the simulation (e.g., successful deployment, retrieval without tearing). It is based on expert assessment/observation in a simulated environment.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set. The "design verification activities" and "design validation activities" constitute the testing phases for the device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.