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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 Align® Urethral Support System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Align® Urethral Support System and Align® TO Urethral Support System (Align® System) include a sterile, single use permanent implant that provides support for the urethra in female patients with stress urinary incontinence. The mesh consists of a knitted, open porosity, monofilament, polypropylene mesh strip, which is self-anchoring. The open porosity of the mesh design and large pore sizes allow for macrophage penetration and the creation of an inert scaffold for tissue ingrowth to create a permanent support for the urethra. The knitted polypropylene mesh is made from a small diameter fiber which creates a soft and pliable material. The mesh sling is encased in a removable, protective sheath assembly. The sheath assembly consists of a PTFE tube with a Peel-Away tab that is used to separate the two sections of the sheath for removal of the sheath assembly after the implant has been placed. At the ends of the sheath are flexible green polyurethane tubes to aid in placing the device and for easy visualization during cystoscopy. The sheath incorporates a stainless steel dilator that smoothes the transition from the green tubing to the protective sheath to aid in sheath removal. Push on polypropylene connectors at each end of the green tubes are used to connect the device to the introducers. Because of the different surgical approaches that may be used to place the device, the same implant is offered in several kit configurations depending on the surgical approach (retropybic, suprapubic, or transobturator) to be used for placement of the mesh implant.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

• Sheath removal is easy. | - Demonstrated ability of the sheath to easily glide through tissue during implantation.
• Demonstrated ease of sheath removal. |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The text mentions a "cadaver study" but does not specify the number of cadavers (i.e., the sample size) used for this test.
• Data Provenance: The cadaver study is a type of prospective non-clinical study, as it involves physical testing performed specifically for the device evaluation. The country of origin is not specified, but given the submission is to the FDA, it is likely that the study was conducted under U.S. or internationally recognized standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Experts: The text does not explicitly mention the use of experts to establish ground truth for the cadaver study in the way one might for a diagnostic imaging device. Instead, the "ground truth" for the non-clinical tests (dimensional, tensile, insertion force, cadaver study) would be based on engineering specifications and direct observation/measurement. For the cadaver study, the assessment of "ease of glide" and "ease of removal" would likely be subjective evaluations by the operators performing the study (e.g., surgeons or medical device engineers experienced with such procedures). No specific number or qualifications are provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable in the context of these non-clinical performance studies. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical studies or for diagnostic evaluations where multiple human readers interpret data. For mechanical and cadaveric testing, the results are typically objectively measured or observed, and consensus among experts for subjective assessments (like "ease of use") would be part of the testing protocol rather than a formal adjudication process described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data is not necessary to determine substantial equivalence." The comparison for effectiveness is primarily based on non-clinical performance against predicate devices' characteristics and performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• Standalone Performance: Not applicable. This device is a surgical implant system, not an AI algorithm or a diagnostic tool that would have a "standalone" or "human-in-the-loop" performance metric. The performance is related to its physical and functional characteristics.

7. The Type of Ground Truth Used:

• Ground Truth: For the non-clinical tests (dimensional, tensile, insertion force), the ground truth is based on engineering specifications and direct measurements. For the cadaver study, the ground truth for "ease of glide" and "ease of removal" is based on direct observation and subjective assessment during the simulation of the surgical procedure.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is a medical device (a surgical mesh system), not an AI algorithm that requires a training set. The device design and materials are based on established engineering principles and prior predicate devices, not machine learning.

9. How the Ground Truth for the Training Set Was Established:

• Training Set Ground Truth: Not applicable, as there is no training set for this type of medical device.

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