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The Applied Alexis Wound Retractor is indicated for use to:

• Access the abdominal cavity during surgery through an atraumatically retracted incision.
• Deliver maximum exposure of the abdominal cavity with minimum incision size.
• Protect against wound contamination during laparoscopic and open surgery.
  The smaller two sizes of Alexis are also intended to be used to:
• Scal off the incision opening to permit insufflating the peritoneum.
• Convert the incision wound to an additional trocar port site.

The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. The rings are molded in a plastic material. The Wound Retractor package also includes an incision template. The device will be manufactured in four sizes, small, medium-large and large. The small and medium products will have an iris valve feature that allows the wound protector to be adjusted from fully open to fully closed. This capability allows Alexis to seal the incision area or to seal around a trocar.

The provided 510(k) summary for the Alexis™ Wound Retractor describes a medical device and its substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria from an AI/algorithm performance perspective.

This document is for a physical medical device (a surgical wound retractor), not a software or AI-powered device. Therefore, the questions related to AI/algorithm performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

Instead, the submission focuses on the biological safety, material properties, and functional performance of the physical device, and its sterilization process, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided text based on the questions, acknowledging that the focus is on a physical medical device:

Analysis of the Provided Information

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

The document doesn't present a formal table of acceptance criteria with numerical performance metrics as would be expected for an AI/algorithm. However, it does state that the device underwent specific tests and "passed" or "complied" with relevant standards:

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

This information is not applicable as the device is a physical surgical retractor, not a software or AI-powered diagnostic/analytic tool that processes data from a test set. The "testing" referred to is for material and functional properties, not data analysis.

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 is not applicable for the same reasons as above. "Ground truth" in the context of this device would refer to the successful operation of the device in a clinical setting, which is inferred from its design and material testing, not from expert review of data.

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

This is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not part of the submission for a physical device like this.

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

This is not applicable. An MRMC study is used for evaluating diagnostic performance (often of imaging devices or AI algorithms). This device is a surgical tool, not a diagnostic one, and does not involve "human readers" or AI assistance in decision-making.

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

This is not applicable. This question refers to the performance of an algorithm without human intervention, which is irrelevant for a physical surgical retractor.

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

As it's a physical device, the "ground truth" for its performance is assessed through physical and chemical testing standards, not clinical pathology or outcomes data in the sense of a diagnostic device. The "ground truth" that the device effectively retracts and protects wounds is supported by its design and material properties, and its substantial equivalence to a predicate device that is already cleared for such functions.

8. The sample size for the training set

This is not applicable as there is no AI algorithm being trained.

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

This is not applicable as there is no AI algorithm being trained.

In summary: The provided text details the regulatory submission for a physical medical device (a wound retractor). The "acceptance criteria" and "studies" mentioned relate to the device's material properties, biocompatibility, sterilization, and functional design, ensuring it meets safety and effectiveness standards, primarily through conformance to established ISO and ASTM standards and demonstrated substantial equivalence to a legally marketed predicate device. The questions posed are primarily relevant to AI/software as a medical device submissions.

Ask a specific question about this device

The Applied Wound Retractor is indicated for use to retract and protect an incision in the abdominal wall during both laparoscopic and open surgery. It is intended to allow the surgeon to access the abdominal cavity during surgery through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to protect against wound contamination during both laparoscopic and open surgery.

The Applied Wound Retractors come in-four sizes, small, medium-large and large and in two shapes, round and elliptical. The shape of a wound retractor is defined by its wound retracting ring. The Wound Retractor consists of a wound retractor ring and a wound protecting sheath. The wound retractor ring is molded from a plastic material. The wound protecting sheath is comprised of a cylindrical elastic sheath with a ring at one end. The Wound Retractor package also includes an incision template. The Wound Retractor is a disposable, single-use device and is packaged inside Tyvek/Mylar The would which is standard packaging material for medical products. The packaged product will then be packaged in an outer product carton in 1 to 10 pieces per carton.

This document is a 510(k) summary for a medical device called a "Wound Retractor." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in more detailed performance reports.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample sizes, data provenance, number of experts, qualifications of experts, adjudication method,
• Multi-reader multi-case (MRMC) comparative effectiveness study results,
• Standalone algorithm performance, or
• Details about the ground truth for training or test sets.

The information provided is purely for regulatory clearance based on substantial equivalence, not a detailed technical performance study.

Here's what I can extract from the provided text based on your prompt, even though it doesn't contain the specific performance study details you're looking for:

The document does NOT contain information regarding:

• Acceptance criteria or reported device performance
• Sample sizes for test sets or their data provenance
• Number of experts or their qualifications for establishing ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
• Standalone algorithm (AI) performance (as this is a physical medical device, not an AI/software device)
• Sample size for training sets
• How ground truth for training sets was established

Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document. This 510(k) summary is focused on establishing substantial equivalence to a predicate device for regulatory clearance, rather than presenting detailed performance study results against specific criteria.

Ask a specific question about this device