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The LapBox Tissue Containment Removal System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.

The LapBox Tissue Containment Removal System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be manually morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.

The FDA 510(k) summary for the LapBox Tissue Containment Removal System does not contain the level of detail typically found in reports of diagnostic device performance, such as sensitivity, specificity, or accuracy. This is a surgical device designed for tissue containment and removal, rather than a diagnostic AI-powered device. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here's an attempt to answer the questions based on the information available in the provided text:

1. A table of acceptance criteria and the reported device performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device through various performance tests, rather than providing specific numerical acceptance criteria and performance data for a diagnostic algorithm. The acceptance criteria described are often a "pass" or "same as predicate" for various engineering and biocompatibility tests.

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 lists "Performance Characterization In-Vivo Study" and "Clinical Simulation Study" as non-clinical performance testing, but does not specify the sample size, type of data (e.g., animal, cadaveric, human), or provenance for these studies. These are likely bench or animal studies rather than human clinical trials based on the context of a 510(k) for this type of device.

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 provided in the document. Given the nature of the device (surgical tissue containment), "ground truth" in the diagnostic sense is not directly applicable. For performance testing, experts might have been involved in assessing the functionality or usability, but details are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is generally not applicable to the type of device and testing described in this 510(k) summary. Adjudication methods are typically relevant for human clinical reads in diagnostic studies.

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 MRMC study was conducted or is applicable as this is not an AI-powered diagnostic device designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable, as this is a physical surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a surgical device, ground truth usually relates to the successful and safe performance of its intended function. The document mentions an "In-Vivo Study" and "Clinical Simulation Study," which would generate data on performance. However, the specific type of "ground truth" or endpoints (e.g., successful tissue containment, absence of leakage, ease of use) and how it was established are not detailed for these studies. For biocompatibility, the ground truth is typically laboratory assay results.

8. The sample size for the training set

Not applicable, as this is a physical surgical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as this is a physical surgical device, not an AI model.

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