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The Tissue Removal Pouch is indicated for the removal of tissue during surgical procedures and for the containment of tissue during extracorporeal manual morcellation.

The Tissue Removal Pouch is contraindicated for laparoscopic power morcellation during gynecologic procedures.

The Tissue Removal Pouch 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 Tissue Removal Pouch includes a polymer film bag, a flip ring packaged in two halves, and a guard. It is provided sterile and is for single patient use.

The bag has 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 and removal from the patient. The bag opening is then exteriorized. The two halves of the flip ring are attached to each other and to the bag opening.

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 extracorporeal manual morcellation (for larger specimens). The guard may be used to protect the bag during manual morcellation. The bag is removed following the removal of sufficient tissue to be pulled out through the port site.

I am sorry, but the provided text does not contain a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) summary for a "Tissue Removal Pouch," which outlines the device's description, intended use, comparison to predicate devices, and a list of non-clinical tests performed.

While the document lists various non-clinical tests conducted (e.g., film impermeability, burst strength, simulated use), it does not provide the acceptance criteria for these tests nor does it report specific performance results in a quantitative manner that would allow for a direct comparison against such criteria. It merely states what each test "verifies" or "demonstrates" (e.g., "Verifies film impermeability," "Demonstrates adequate burst strength").

Therefore, I cannot populate the requested table or provide information about:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or specific performance values are listed.
2. Sample sizes used for the test set and the data provenance: No sample sizes for any tests are provided, nor is the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This type of information is usually relevant for studies involving diagnostic or AI devices with human interpretation, not for mechanical device testing as described here.
4. Adjudication method: Not applicable given the nature of the listed tests.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned or applicable.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not mentioned or applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not explicitly stated; the "ground truth" for mechanical tests would typically be the physical properties measured against engineering specifications, but these specifics are not provided.
8. The sample size for the training set: Not applicable; this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document concludes with a statement that the device is "as safe and effective as, and performs as well as, or better than, the legally marketed predicate devices," based on the provided information, but the detailed data to back this claim against specific acceptance criteria is not present in this summary.

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