(317 days)
The GENICON Single-Use Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
The GENICON Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easily accessible opening, a push-pull rod with thumb ring handle, finger rings, string and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim. A string with a closure suture facilitates closure of the specimen bag after the specimen has been collected. This device is packaged and sterlized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
The provided document is a 510(k) summary for the GENICON Specimen Retrieval Bag. It details the device's description, indications for use, and a statement about nonclinical tests supporting substantial equivalence to predicate devices. However, it does not contain the specific acceptance criteria or a detailed study report that proves the device meets those criteria, as typically found in a clinical trial or performance study report. The document mentions "Bench Testing and Clinical Evaluation performed (ref. TR-12022-A and CLEV-032-A)," but the details of these tests are not provided in this regulatory submission.
Therefore, for aspects requiring detailed study information, the answer will reflect that the information is "Not Available in the provided text."
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly list quantitative acceptance criteria or detailed device performance metrics from a study. It only states that "Successful results support a determination of substantial equivalence" for general operation, seal strength peel, and puncture resistance. Without access to TR-12022-A and CLEV-032-A, specific criteria and performance values cannot be extracted.
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not available in the provided text. The document states "Successful results support a determination of substantial equivalence" for bench testing related to seal strength, puncture resistance, and general operation. | Not available in the provided text. The document refers to internal reports (TR-12022-A and CLEV-032-A) for specifics, which are not included here. |
2. Sample Size for the Test Set and Data Provenance
- Sample size used for the test set: Not available in the provided text. The document mentions "Bench Testing and Clinical Evaluation," but no sample sizes are given for either.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not available in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of experts: Not available in the provided text.
- Qualifications of those experts: Not available in the provided text.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Adjudication method: Not available in the provided text.
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
- MRMC comparative effectiveness study: Not applicable. This device is a physical specimen retrieval bag, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone performance study: Not applicable. This device is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not available in the provided text. For bench testing, ground truth would likely be established by objective physical measurements according to specified test methods. For clinical evaluation, it would typically relate to the device's ability to safely and effectively retrieve specimens in a surgical setting, which could involve surgical observations, successful specimen retrieval without complications, and potentially pathology results of retrieved specimens. However, the document does not specify.
8. The Sample Size for the Training Set
- Sample size for the training set: Not applicable/Not available. This device is a physical specimen retrieval bag, and the concept of a "training set" is usually associated with machine learning algorithms, which is not applicable here. Even if a design verification/validation process involved iterative testing, the term "training set" as used in AI contexts does not apply.
9. How the Ground Truth for the Training Set Was Established
- How the ground truth for the training set was established: Not applicable/Not available, as the concept of a "training set" for a physical device is not relevant in the context of this summary.
§ 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.