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The Step®family of products are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic and operative instruments into the abdominal and thoracic cavities. The device is configured to be used as either a primary or secondary stick.

The Step® family of products consist of an expandable dilator sheath assembly with an access (Veress-type) needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal/thoracic tissue into the abdominal/thoracic cavity. After insufflation of the cavity, (if deemed necessary), the access needle is removed. The dilator cannula assembly, which consists of a blunt obturator, dilation cannula, and a pneumo valve, is inserted through the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. Following dilation the obturator is removed, leaving the expanding dilation sheath and dilator cannula in place to provide a sealed port for passage of diagnostic and surgical instruments.

This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments.

The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.

This document is a Summary of Safety & Effectiveness Information for a medical device called the InnerDyne Step Trocar Expandable Port, "MiniStep®". It's a 510(k) submission, comparing the MiniStep® to existing predicate devices to demonstrate substantial equivalence.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum insertion force, specific clinical outcomes) are not explicitly stated. Instead, the submission focuses on substantial equivalence to predicate devices. The "performance" is largely described in qualitative terms and by referencing studies that show similarity or improvement over existing methods.

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

• Test Set Sample Size: The primary testing mentioned utilized porcine models. The text does not specify a numerical sample size (e.g., how many pigs, how many insertions).
• Data Provenance: The studies mentioned were conducted at the University of California, San Francisco. The studies appear to be prospective in nature, as they involve actively using the device in a controlled setting (porcine models, clinical overviews of user experiences). The study examining tissue defects by Drs. Bhoyrul, Mori, and Way seems to be a specific prospective study comparing the Step® devices with conventional trocars.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Study on Tissue Defects: Conducted by Drs. Bhoyrul, Mori, and Way at the University of California, San Francisco. The text does not explicitly state their specializations (e.g., "radiologist with 10 years of experience") but implies they are medical professionals and researchers involved in surgical or related fields, given their focus on "tissue defects" and "trocar related complications." The number of experts stated is three.
• Clinical Overviews: "Additional clinical overviews have been published within the literature by other users outlining their experience with Step® products." The number and specific qualifications of these "other users" are not detailed.

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

• The text does not describe an adjudication method for establishing ground truth, such as 2+1 or 3+1 consensus. The studies mentioned appear to be direct observations and comparisons by the researchers.

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, a MRMC comparative effectiveness study was not done. This document is for a mechanical surgical device (trocar), not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

• No, a standalone algorithm-only performance study was not done. As mentioned above, this is a mechanical surgical device, not an algorithm.

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

For the specific study mentioned by Drs. Bhoyrul, Mori, and Way, the ground truth appears to be based on:

• Direct observation and measurement of tissue defects: This would likely involve macroscopic and potentially microscopic examination of the tissue after device use, which is a form of pathology/histology or direct anatomical assessment.
• Clinical assessment of ecchymosis: This is a form of outcomes data related to tissue trauma.
• Clinical observation of functionality and ease of use: In porcine models ("access for instruments," "primary and secondary sticks made without difficulty").

For the "additional clinical overviews," the ground truth would be based on clinical experience and outcomes data reported by other users.

8. The sample size for the training set:

• Not applicable / Not mentioned. This document describes a surgical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

• Not applicable / Not mentioned. (See point 8).

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