(51 days)
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:
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Dimensional | Meets specifications |
| Needle Functional Testing | Meets specifications |
| Sling Functional Testing | Meets specifications |
| Fatigue | Meets specifications |
| Tensile | Meets specifications |
| Packaging Testing | Meets specifications |
| Usability Testing | Meets specifications |
| Distribution Testing | Meets specifications |
| Biocompatibility | Meets specifications |
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.