(26 days)
The ENDOCOLLECT Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
The ENDOCOLLECT Specimen Retrieval Bag ("ENDOCOLLECT") is a disposable device used as a receptacle for the collection and extraction of tissue specimens during laparoscopic surgery and is intended to be used with an endoscopic trocar. ENDOCOLLECT is comprised of a flexible plastic bag with a large, easily accessible opening, a spring finger, deployment shaft, shaft handle, and an insertion tube. In the fully deployed condition, the specimen bag opening is maintained during the retrieval of a specimen. When the specimen is placed in the bag, the bag is closed with the cinch cord and the device may be removed from the body.
This FDA 510(k) summary does not describe a study involving AI or human readers, therefore, much of the requested information is not applicable. The device in question is a medical tool, the ENDOCOLLECT Specimen Retrieval Bag, used in laparoscopic procedures to capture organs or tissue. The 510(k) submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, not on AI performance or human reader studies.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with numerical performance metrics for an AI device. Instead, it lists the types of non-clinical bench testing conducted to demonstrate that the device meets established specifications and consistently performs for its intended use. The "reported device performance" is a general statement that "The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the ENDOCOLLECT Specimen Retrieval Bag meet the established specifications necessary for consistent performance during its intended use."
The categories of testing performed are:
| Acceptance Criterion Category | Reported Device Performance (Summary) |
|---|---|
| Force and Volume Testing | Met established specifications and consistent performance. |
| Durability Testing | Met established specifications and consistent performance. |
| Puncture Testing | Met established specifications and consistent performance. |
| Spring Finger Deflection Testing | Met established specifications and consistent performance. |
| Weight Capacity and Air Leak Testing | Met established specifications and consistent performance. |
| Sterilization Validation | Met established specifications and consistent performance. |
| Shelf-Life Testing | Met established specifications and consistent performance. |
| Transportation Testing | Met established specifications and consistent performance. |
| Usability Validation Testing | Met established specifications and consistent performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes non-clinical bench testing of a physical medical device, not a study involving a "test set" of data for an AI algorithm.
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)
This information is not applicable as the document describes non-clinical bench testing of a physical medical device, not an AI algorithm requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical bench testing of a physical medical device, not an AI algorithm requiring adjudication of 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
There was no MRMC comparative effectiveness study done. The device is a specimen retrieval bag, not an AI-assisted diagnostic tool. No comparison to human readers with or without AI assistance is relevant or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document is about a physical medical device, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as the document describes non-clinical bench testing of a physical medical device. The "ground truth" for such testing is typically based on pre-defined engineering specifications and industry standards rather than medical consensus or pathology.
8. The sample size for the training set
This information is not applicable as there is no training set mentioned in the context of this device.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set mentioned in the context of this 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.