(251 days)
The Well Lead Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery.
The Well Lead Extraction Bag is used for removal of tissue specimens during a suitable laparoscopic surgery.The device consists of a cylindrical sheath, a pusher and a polyurethane bag that minimizes spillage and intraoperative contamination by isolating and containing specimens. The bag is made of biocompatible high strength PU material, it is transparent and soft. which makes a qood visuality.
The device is composed of biologically safe materials. It is supplied sterile and intended for single use only. It's easy to enter, open, close and exit, higher efficiency, and different type and size available. It is offerd in 4 types: Type B, Type C, Type D and range in bag volume from 200ml for different surgery needs. The well thought-out rang of types and sizes are suitable for all laparoscopic procedures. The main differences between all types are the deployment system and operation method.
The provided text describes a 510(k) submission for the "Well Lead Extraction Bag" and focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting. Therefore, many of the requested elements (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not explicitly present in the provided document, as they are not typically required for a 510(k) for this type of device.
However, I can extract information related to non-clinical performance testing and what constitutes the acceptance criteria as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Parameters Tested) | Reported Device Performance |
|---|---|
| General Performance: | |
| - Leakage | Meets pre-determined testing and acceptance criteria |
| - Rated Volume | Meets pre-determined testing and acceptance criteria |
| - Tensile Strength | Meets pre-determined testing and acceptance criteria |
| - Determining the Dimensions | Meets pre-determined testing and acceptance criteria |
| Biocompatibility (as per ISO 10993-1:2009): | |
| - Cytotoxicity (as per ISO 10993-5:2009) | Device components in contact with the patient are biocompatible. |
| - Irritation (as per ISO 10993-10:2010) | Device components in contact with the patient are biocompatible. |
| - Sensitization (as per ISO 10993-10:2010) | Device components in contact with the patient are biocompatible. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Testing datas and results are included in this submission" but does not specify the sample size for the non-clinical performance tests (e.g., how many bags were tested for leakage, tensile strength, etc.).
The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission, likely conducted in China where the manufacturer (WELL LEAD MEDICAL CO., LTD.) is located. The tests are non-clinical, so terms like "retrospective or prospective" do not directly apply in the same way they would to human subject studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not provided. For non-clinical performance testing of a medical device like an extraction bag, ground truth is established through standardized engineering and laboratory testing protocols, not by expert human graders. The "experts" involved would be technicians or engineers conducting the tests and interpreting the results according to the specified standards (e.g., ISO standards for biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment where there might be disagreements in interpretation. For objective, non-clinical performance tests, results are typically quantitative and assessed against a pre-defined pass/fail threshold, not through an adjudication process.
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
No. This device is an extraction bag, a physical surgical tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is entirely irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This question applies to AI algorithms. As mentioned above, the device is a physical surgical tool, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests:
- Engineering specifications and recognized standards (e.g., criteria for what constitutes a "leak," a specified "rated volume," or a minimum "tensile strength").
- Biocompatibility standards (ISO 10993 series) define the ground truth for assessing non-toxic, non-irritating, and non-sensitizing properties of materials.
8. The sample size for the training set
Not applicable/Not provided. This question pertains to machine learning models. The Well Lead Extraction Bag is a physical device, so there is no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there is no training set for this device, this question is irrelevant.
§ 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.