(53 days)
The Tissue Removal System is indicated for the contained removal of tissue, including contained manual tissue sectioning, during minimally invasive surgical procedures.
The Tissue Removal System is comprised of the Tissue Removal Pouch cleared under K150781 and an additional accessory Sectioning Device. It is provided sterile, and is for single patient use.
The Tissue Removal Pouch of the Tissue Removal System includes a bag with a single large opening held open by a thin, opening ring. During laparoscopic surgery, the bag is placed within the peritoneal space via an existing port site. Tissue that has been resected is placed within the bag for isolation, containment and removal from the patient. The bag opening is exteriorized. Two halves of the Tissue Removal Pouch flip ring are attached to each other and to the bag is rolled around the flip ring by inverting the flip ring, in order to draw the resected tissue toward the port site.
The resected tissue is then removed en bloc (for smaller specimens), or by first dividing the specimen using the accessory Sectioning Device. The Sectioning Device is comprised of a blunt wire, a flexible passer and a handle with a blunt hook. The passer is used to encircle the specimen with the wire. The handle includes a blunt hook that can be used to aid in the advancement of the passer. The specimen is divided by the manual application of a back and forth motion to the wire. Use of the accessory Sectioning Device permits division of the specimen while maintaining the containment effectiveness of the Tissue Removal Pouch
Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured according to your request:
Unfortunately, the provided document does not contain information related to an AI/ML device. The document is a 510(k) premarket notification for a medical device called "Tissue Removal System," which is a physical device used in surgery to contain and remove tissue.
Therefore, many of your requested points, such as AI-related performance metrics, sample sizes for training or test sets for an algorithm, expert adjudication, or MRMC studies, are not applicable to this document.
However, I can extract the information that is present regarding the non-clinical testing performed for this physical device.
Description of Acceptance Criteria and Supporting Study for the Tissue Removal System
The document describes non-clinical testing performed to demonstrate the safety and effectiveness of the "Tissue Removal System," particularly focusing on the integrity and containment capabilities of the Tissue Removal Pouch when used with its accessory Sectioning Device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Description | Reported Device Performance |
|---|---|---|
| Containment Integrity | Simulated Use Testing followed by Bubble Leak, Dye Penetration, and Viral Barrier Testing | Demonstrated that the Tissue Removal System performs as intended and that the Tissue Removal Pouch maintains containment integrity after use with the accessory Sectioning Device. |
| Extreme Containment | Extreme Use Testing followed by Bubble Leak, Dye Penetration, and Viral Barrier Testing | Demonstrated that the Tissue Removal System maintains its integrity and containment effectiveness after sectioning of multiple tissue specimens, far in excess of actual clinical conditions. |
| Puncture Resistance | Sectioning Device Puncture Resistance Testing | Demonstrated that the flexible passer of the Sectioning Device will not puncture the Tissue Removal Pouch of the Tissue Removal System. |
| Tear Resistance | Sectioning Device Hook Tear Resistance Testing | Demonstrated that the blunt hook of the hooked handle will not tear the Tissue Removal Pouch of the Tissue Removal System. |
| Film Cutting Resistance | Film Cutting Testing | Demonstrated that forcing the wire of the Sectioning Device into the film of the Tissue Removal Pouch does not result in a cut to the Tissue Removal Pouch. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the sample sizes (e.g., number of pouches, sectioning devices, or test repetitions) used for any of the non-clinical tests.
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, though non-clinical tests are inherently prospective laboratory studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes non-clinical engineering and material integrity tests on a physical device, not an AI/ML diagnostic system requiring expert interpretation or ground truth establishment in the traditional sense. The "ground truth" here is the physical performance of the device against predefined engineering standards (e.g., no leaks, no punctures, no tears).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is not an interpretive diagnostic study requiring adjudication. The outcomes are objective measurements of physical integrity (e.g., presence/absence of bubbles, dye penetration, tears, punctures).
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 a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This document pertains to a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context refers to the objective performance of the physical device as measured by specific non-clinical test methods. For example, for "Bubble Leak" testing, the ground truth for failure would be the observation of bubbles, and for "Dye Penetration," it would be the observation of dye. These are direct physical observations, not interpretive diagnoses.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML model.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set."
Summary of Device and Testing Context:
The Tissue Removal System is a physical device for containing and removing tissue during minimally invasive surgery. Its key innovation over a predicate device is the inclusion of an accessory Sectioning Device that uses a blunt wire for dividing specimens, in contrast to predicate devices that might require sharp instruments.
The non-clinical tests aim to prove that this new Sectioning Device does not compromise the primary function of the Tissue Removal Pouch, which is to maintain containment and integrity. The tests specifically assessed physical characteristics such as leak prevention, puncture resistance, and tear resistance under various conditions, including simulated and extreme use. The "conclusions" state that the device is "as safe and effective as, and performs as well as, or better than, the legally marketed predicate device" based on these non-clinical tests.
§ 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.