(77 days)
The Anchor Bag-Alone® Tissue Retrieval System™ by CONMED is a sterile disposable pouch used for the encapture and removal of an organ or tissue from the body cavity during laparoscopic or minimally invasive surgery.
The Anchor Bag-Alone® Tissue Retrieval System™ by CONMED is a sterile, disposable retrieval pouch for the encapture and removal of an orqan or tissue from the body cavity during laparoscopic surgery. The Anchor Bag-Alone® Tissue Retrieval System"" by CONMED consists of a ripstop nylon pouch with polyurethane laminate and a braided drawstring that loops through the ripstop nylon pouch.
The provided text describes a 510(k) submission for a medical device called the "Anchor Bag-Alone Tissue Retrieval System by CONMED." This is a tissue retrieval system and not an AI/ML device, therefore the standard acceptance criteria, study design, and performance metrics typically associated with AI/ML devices (such as sensitivity, specificity, MRMC studies, training set data, etc.) are not applicable here.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device through non-clinical performance testing. The "acceptance criteria" in this context refer to the successful completion and outcomes of these engineering and performance tests, showing the device performs as intended and is safe and effective.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-AI/ML device, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity, specificity, or AUC) but rather as successful completion of various engineering and performance tests ensuring the device's functionality, material properties, and safety. There isn't a direct table of these with specific pass/fail values in the document, but the text states:
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Functional / Bench Testing | Demonstrated substantial equivalence to predicate |
| Material Properties | Ripstop nylon with polyurethane laminate and polyester yarn for the pouch and drawstring. |
| Sterilization | Complies with ISO 11135:2014 (Ethylene Oxide) |
| Biocompatibility | Complies with ISO 10993-1:2009 |
| Packaging & Shelf Life | Complies with ISO 11607-1:2006 |
| Risk Management | Complies with ISO 14971 (risks mitigated to an acceptable level) |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as non-clinical bench and simulated use testing.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in terms of a "test set" as one would define it for an AI/ML device. The testing involved various quantities of the device to perform the bench and simulated use tests. The document does not specify the number of individual units tested for each specific test (e.g., how many bags were subjected to tensile strength testing).
- Data Provenance: Not applicable in the context of clinical data provenance. The testing was performed in a laboratory/engineering environment on the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. For a non-AI/ML device, ground truth is established through engineering specifications, validated test methods, and compliance with recognized standards. There were no human experts establishing a "ground truth" for a diagnostic or predictive task.
4. Adjudication method for the test set:
Not applicable. There was no need for adjudication as the tests performed were objective engineering and performance tests with predefined pass/fail criteria based on standards and comparison to the predicate device.
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:
Not applicable. This is not an AI/ML device, so MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance is based on:
- Engineering specifications and design requirements.
- Performance of the predicate device (K172940).
- Compliance with recognized international standards (e.g., ISO 11607-1:2006 for packaging, ISO 11135:2014 for sterilization, ISO 10993-1:2009 for biocompatibility, ISO 14971 for risk management).
8. The sample size for the training set:
Not applicable. This device does not involve machine learning and therefore does not have a "training set."
9. How the ground truth for the training set was established:
Not applicable. This device does not involve machine learning and therefore does not have a "training set" with ground truth to be established.
§ 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.