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The polypropylene sling is indicated to be placed mid-urethra for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The ArcTO Transobturator Sling System consists of the following:

• 1 ArcTO Sling with bio-resorbable Suture and plastic sheath .
• 2 ArcTO Handle and Needle Delivery Assemblies .
  The Handle and Needle delivery assembly is a sterile, single-use system, consisting of two helical, stainless-steel Needles with attached Handles. The tip portion of each delivery Needle is designed to allow for passage through tissue. The Needles are a tool and together with the Sling Connectors and Sheaths, facilitate placement of the Sling and are not implanted.
  The ArcTO Sling assembly is identical to the predicate, ArcTV Sling assembly and includes one knitted polypropylene mesh with an integrated bioresorbable Suture, two removable plastic insertion Sheaths, and two Sling Connectors. The Suture is an integral feature of the Mesh. The integrated Suture helps to minimize deformation of the mesh during sling insertion and placement and allows for adjustment of the Sling after removal of the Sheaths. The two plastic Sheaths cover and facilitate placement of the Sling. The Mesh and the bioresorbable Suture are permanently implanted.

The provided text describes a medical device, the "ArcTO Transobturator Sling System," and its submission for FDA clearance. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on physical and performance specifications of the device components, rather than clinical efficacy studies with human subjects that would typically involve acceptance criteria for a diagnostic or AI-assisted device.

Here's a breakdown of the specific points you requested, based on the provided text:

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

This information is not provided in the document. The document lists "performance data" as:

• Dimensional
• Needle Functional Testing
• Sling Functional Testing
• Fatigue
• Tensile
• Packaging Testing
• Usability Testing
• Distribution Testing
• Biocompatibility

It states, "The ArcTO meets all its physical and performance specifications." However, it does not specify what those specifications (acceptance criteria) are or provide numerical results of the testing. For example, it doesn't state "Tensile strength must be >X Newtons; device achieved Y Newtons."

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 provided as there is no clinical study described in the document. The "testing" mentioned refers to engineering and material characterization, not patient data sets.

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 as there is no clinical study described that would require expert-established ground truth.

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

This information is not provided as there is no clinical study described that would involve adjudication.

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 information is not provided. This device is a surgical mesh, not a diagnostic or AI-assisted device, so an MRMC study is not applicable.

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

This information is not provided. This device is a surgical mesh; it does not have an algorithm component.

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

This information is not provided as there is no clinical study described that would require ground truth. The "ground truth" for the engineering performance tests would be the established engineering standards and specifications for the materials and components, but these specific standards are not detailed.

8. The sample size for the training set

This information is not provided. There is no training set mentioned as this is not an AI/ML device.

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

This information is not provided. There is no training set mentioned.

In summary, the provided document focuses on the mechanical and material properties of the device components and its substantial equivalence to a predicate device for FDA clearance. It does not contain information related to clinical performance, diagnostic accuracy, or AI model validation, which are typically associated with the type of acceptance criteria and study details you've requested.

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