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The VersaStep* single use system is intended to provide dilation access to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures. The VersaStep* single use system is indicated for the following uses: - Laparoscopic access to the abdominal cavity, both primary and secondary punctures - Thoracoscopic access to the thoracic cavity, both primary and secondary punctures

The VersaStep* single use system consists of a sterile insufflation and access needle, a radially expandable sleeve, and a dilator/ cannula. The cannula and dilators are available in 5 mm, 5 mm - 11 mm, and 5 mm - 12 mm diameters.

This document is a 510(k) premarket notification for a medical device called VersaStep*, a single-use system intended for dilation access to abdominal and thoracic cavities. The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in the provided text. The document is for a 510(k) submission, which relies on demonstrating equivalence to existing, legally marketed devices, rather than proving novel performance against specific quantitative acceptance criteria through new clinical trials.

Based on the provided text, here's what can be extracted:

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

   • Not present. The document does not specify quantitative acceptance criteria or report performance metrics in the format of a table. The review is based on "substantial equivalence" to predicate devices, focusing on intended use, technology, and safety aspects, rather than specific performance thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not present. There is no mention of a "test set" for performance evaluation in the context of a new study. The 510(k) process typically relies on demonstrating equivalence through comparison of design, materials, and intended use with predicate devices, and potentially non-clinical (e.g., bench) testing, without requiring large-scale clinical test sets like those used for efficacy studies.

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)

   • Not present. As there's no mention of a "test set" for performance evaluation, there's no information about experts establishing ground truth for such a set.

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

   • Not present. No test set or adjudication method is described.

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 present. This device is a surgical access system (dilator/trocar), not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI performance improvement are not relevant or discussed.

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

   • Not present. This device is a physical medical instrument, not an algorithm.

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

   • Not present. No ground truth establishment is described in the context of a performance study. For a 510(k), "ground truth" relates more to the understanding of the predicate device's safety and effectiveness.

8. The sample size for the training set

   • Not present. There is no mention of a training set for an algorithm or a new clinical study.

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

   • Not present. No training set is mentioned.

Summary of what is present:

The provided text is a 510(k) clearance letter and associated summary information for the VersaStep* device. It focuses on the following:

• Device Name: VersaStep* single use system
• Intended Use: To provide dilation access to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures (laparoscopic and thoracoscopic access).
• Device Description: Consists of an insufflation and access needle, a radially expandable sleeve, and a dilator/cannula in various diameters.
• Materials: Stated to be in accordance with ISO Standard # 10993-1.
• Predicate Devices: InnerDyne Step Trocar Expandable Port, "One-Step*" (K961940) and Auto Suture* Modified Versaport* Trocar (K954108).
• Regulatory Determination: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

The core "proof" in this context is the demonstration of substantial equivalence to existing devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. This type of submission relies on comparison with predicate devices rather than new, extensive clinical studies with specified acceptance criteria and measured performance.

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