(116 days)
The Applied Medical Tissue Containment System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.
The Tissue Containment System is contraindicated for laparoscopic power morcellation during gynecologic procedures.
The Tissue Containment System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
The Applied Medical Tissue Containment System is a flexible tissue bag that includes an attached tether and guard accessory. The subject system is provided sterile. The Tissue Containment System is used to contain and isolate specimens for surgical removal and/or manual morcellation. After the device is fully inserted into the abdominal or pelvic cavity, the mouth of the bag returns to its original, circular shape, facilitating placement of the specimen in the bag. When the specimen is ready for removal and/or manual morcellation, the tether is used to maneuver the ring to the surface of the extraction site. If the specimen requires manual morcellation, the ring may be repeatedly flipped to shorten the bag and consequently bring the specimen closer to the extraction site. The guard is placed in the bag opening prior to manual morcellation, providing a robust barrier between the bag and sharp instruments.
The FDA 510(k) summary for the Applied Medical Tissue Containment System (K142427) provides information about its performance testing. However, it does not include specific acceptance criteria or detailed results in a tabular format as you've requested for direct comparison.
Instead, the document states that "Results of testing demonstrates that the subject Tissue Containment System is substantially equivalent to the predicates... and that the subject device performs comparably to the current marketed device for the same intended use." This indicates that the device met the performance expectations derived from its predicate devices and relevant standards, but the exact quantitative thresholds are not provided in this public summary.
Based on the provided text, here's what can be extracted and inferred regarding your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or reported performance values. It generally states that "All materials were found to be biocompatible" and that "bench top tests were designed to focus on the functional performance of the specimen containment and retrieval features, as well as its use during morcellation." and "Results of testing demonstrates that the subject Tissue Containment System is substantially equivalent..."
General interpretation of implicit acceptance criteria based on testing categories:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | All materials were found to be biocompatible. |
| Functional Performance | Demonstrated substantial equivalence to predicate devices. |
| Bag Seam Integrity | Performed comparably to predicate. |
| Tether Break Force | Performed comparably to predicate. |
| Puncture Resistance | Performed comparably to predicate. |
| Dye Penetration | Successfully demonstrated device functionality. |
| Viral Penetration | Successfully demonstrated device functionality. |
| Bubble Leak | Successfully demonstrated device functionality. |
| Simulated Use | Successfully demonstrated device functionality. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for any of the tests conducted (biocompatibility or mechanical). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of the tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a medical device for tissue containment, not an AI or diagnostic device that relies on expert interpretation for ground truth establishment. The testing described (biocompatibility and mechanical) uses objective physical measurements and standardized protocols, not human expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of testing conducted. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes, which is not the case here.
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
An MRMC study was not done. This device is a physical tissue containment system, not an AI or imaging device, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable for a physical medical device. "Standalone" performance refers to algorithm performance, which is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical and biocompatibility testing is based on:
- Standardized laboratory methods and established criteria for biocompatibility: Referring to ISO 10993-1, this involves objective measures for cytotoxicity, irritation, and sensitization.
- Physical performance metrics and comparison to predicate devices: For mechanical tests, the ground truth is the measurable physical properties of the device (e.g., actual break force, absence of leakage, resistance to puncture) and its ability to perform its intended function in simulated use, as well as its comparability to the performance of predicate devices.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI or statistical modeling device.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of 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.