(22 days)
The Anchor Tissue retrieval system by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.
The Anchor Tissue Retrieval System™ by CONMED is a sterile, disposable retrieval pouch for use with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. The Anchor Tissue Retrieval System™ by CONMED consists of a rip stop nylon pouch, two stainless steel arms attached to internal pusher rod connected to a handle at the distal end to the patient. Around the internal pusher rod is the introducer and handle. The introducer handle incorporates a spring loaded button and 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.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. | Meets criteria; same as predicate. |
| Where Used | Operating room | Meets criteria; same as predicate. |
| Prescription Only | Yes | Meets criteria; same as predicate. |
| Design | Specimen bag and a delivery system consisting of an introducer shaft deployment handle. | Meets criteria; same as predicate. |
| Materials | Nylon, stainless steel, polycarbonate | Meets criteria; same as predicate. |
| Mechanism to deploy bag | Automatic with compression of pusher rod | Meets criteria; same as predicate. |
| Mechanism to separate bag from introducer | Push button | Meets criteria; same as predicate. |
| Performance | Adequately tested through bench testing methodologies; no FDA performance standards. | Meets criteria; adequately tested, substantially equivalent to predicate. |
| Sterilization | Ethylene Oxide per ISO 11135:2014 | Meets criteria; same as predicate. |
| Biocompatibility | According to ISO 10993-1:2009 | Meets criteria; patient contacting materials compliant. |
| Redeployment Capability (New Feature) | Can be deployed more than once within a single patient procedure. | Meets criteria; redeployment verification testing performed. |
| Safety and Effectiveness (Overall) | No new issues of safety or effectiveness identified, and redeployment has no impact on current device safety and effectiveness. Benefits outweigh residual risks. | Meets criteria; concluded through risk management activities in accordance with ISO 14971. |
| Compliance with Standards | Design specifications and applicable sections of ISO 11607-1:2006, ISO 11135:2014, ISO 10993-7:2008. | Meets criteria; compliance demonstrated through design verification testing. |
| User Needs and Intended Use | Conforms to user needs and the intended use. | Meets criteria; demonstrated through design validation testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" with a particular sample size from a patient population, nor does it mention data provenance in terms of country of origin or retrospective/prospective nature. The studies conducted were primarily targeted performance and design verification/validation testing.
- Sample Size for performance testing: The document mentions "bench and simulated use testing" and "redeployment verification testing." It doesn't specify the exact number of devices or trials for these tests.
- Data Provenance: The studies are "non-clinical bench and simulated use testing," implying laboratory-based testing rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described is primarily engineering and performance-based validation rather than clinical studies requiring expert ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The testing described does not involve a process of adjudication by experts for a test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not conducted. This device is a surgical tissue retrieval system, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Design Specifications: The device is tested against its established design specifications.
- Performance Standards (Industry/Regulatory): Compliance with relevant ISO standards (e.g., ISO 11607-1:2006 for packaging, ISO 11135:2014 for sterilization, ISO 10993-1:2009 & ISO 10993-7:2008 for biocompatibility).
- User Needs: Demonstrated conformance to user needs and intended use from design validation.
- Substantial Equivalence to Predicate: Performance is compared to a legally marketed predicate device (K091930) to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of this traditional medical device. This term is typically used for machine learning or AI models.
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.