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The ArcSP Suprapubic Sling System 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 ArcSP Suprapubic Sling System consists of the following:

• 1 ArcSP Sling with bio-resorbable Suture with plastic sheath
• 2 ArcSP Handle and Needle Delivery Assemblies.
  The Handle and Needle delivery assembly is a sterile, single-use system, consisting of a two curved, stainless-steel Needles with attached Handles. The conical tip 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 ArcSP 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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ArcSP Suprapubic Sling System:

Device: ArcSP Suprapubic Sling System

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it states that "The ArcSP meets all its physical and performance specifications." The performance data is presented as a list of tests performed. Without the specific quantitative requirements for each test, a precise comparison table cannot be created from the provided text.

Here's a table based on the types of performance specifications listed:

Note: The document states that for "Fatigue", "Tensile", "Packaging Testing", and "Biocompatibility", "No testing was repeated for this submission since the Sling implant assembly and packaging are identical to the predicate, ArcTV." This implies that the acceptance criteria for these aspects were met by the predicate device and are assumed to be met by the subject device due to identical components.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set for the "Needle Functional Testing," "Usability Testing," or "Distribution Testing."

For the Sling implant assembly (including Fatigue, Tensile, Packaging, and Biocompatibility), the data provenance is by reference to the predicate device, ArcTV Transvaginal Sling System (K183134). The original sample sizes and provenance for these tests on the predicate device are not detailed in this document.

The studies mentioned are likely prospective studies, as they involve testing the device to ensure it meets specifications. However, the specific details of the study design (e.g., number of units tested per batch or simulation scenario) are not provided.

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

This information is not provided in the document. For a medical device like a surgical sling, "ground truth" establishment in terms of expert consensus would typically relate to clinical efficacy or surgical usability. The listed tests are primarily engineering and mechanical performance tests, for which "ground truth" is typically defined by engineering standards and specifications rather than expert consensus in the traditional sense of clinical imaging or diagnostic AI. Usability testing, however, would typically involve healthcare professionals, but their number and qualifications are not detailed.

4. Adjudication method for the test set

This information is not provided in the document. The tests described (dimensional, functional, fatigue, tensile, packaging, distribution, biocompatibility, usability) are typically evaluated against predefined specifications. Adjudication methods like "2+1" or "3+1" are usually applied to subjective assessments, such as those in clinical trials or image interpretation, where multiple reviewers' opinions need to be reconciled. For the engineering tests mentioned, the results are typically quantitative and objective, meaning an adjudication method is less applicable. For usability testing, if subjective feedback was collected, the adjudication method is not specified.

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 comparative effectiveness study was done or is applicable here. This type of study is specifically relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The ArcSP Suprapubic Sling System is a surgical implantable device, not a diagnostic imaging or AI-driven diagnostic tool.

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

No standalone algorithm performance study was done or is applicable here. As above, this device is a physical surgical implant, not an AI algorithm.

7. The type of ground truth used

For most of the performance tests (Dimensional, Needle Functional, Sling Functional, Fatigue, Tensile, Packaging, Distribution):

• The "ground truth" is established by predefined engineering specifications and standards. These are objective, measurable criteria that the device must meet.

For "Biocompatibility":

• The "ground truth" is established by ISO 10993-1:2009, Biological evaluation of medical devices requirements. This refers to international standards for assessing the biological compatibility of medical devices with the human body.

For "Usability Testing":

• While not explicitly stated, the "ground truth" for usability testing would typically be based on observational data, user feedback, and adherence to established usability engineering principles and task completion rates/error rates.

8. The sample size for the training set

This information is not applicable as the ArcSP Suprapubic Sling System is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable as the ArcSP Suprapubic Sling System does not involve a "training set" for an AI model.

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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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The ArcTV Transvaginal Sling System is a retropubic sling indicated for a transvaginal (TV) placement of a midurethral sling for the treatment of adult female stress urinary inconting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The ArcTV Transvaginal Sling System is a sterile, single-use system, consisting of a Handle, two delivery Needles and a Sling assembly. The tip portion of each delivery Needle is configured to allow for passage through tissue. The opposite end of the Needle is configured to connect with the Handle. The Handle is detachable and is used to direct both delivery Needles through tissue. The Sling assembly includes one piece of loosely knitted polymeric 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 Suture and Mesh allow for adjustment of the Sling after initial placement in the patient without the use of additional tools. The two plastic Sheaths facilitate the placement of the Sling. The Sling Connectors, Sheaths, Needles, and Handle are used to facilitate placement of the Sling assembly, and are not implanted. The Mesh and the bioresorbable Suture are permanently implanted.

The provided document is a 510(k) summary for the ArcTV Transvaginal Sling System. This document details the device, its intended use, and its substantial equivalence to a predicate device. However, it does NOT contain detailed information about acceptance criteria for a "device" in the context of an AI/ML algorithm or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as this document is for a physical medical device (a surgical mesh system) and not an AI/ML powered device.

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