(89 days)
The Athena Surgical RMUS System is indicated for use as a pubourethral sling for treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The Athena Surgical RMUS System consists of a sterile, single-use Retropubic Mid-Urethral Sling (RMUS) Implant Assembly and a non-sterile, reusable RMUS Handle Assembly. Each RMUS Implant Assembly contains one blue polypropylene mesh sling implant (1.1cm x 46cm), covered by a non-implantable clear plastic sheath and attached on each end to nonimplantable stainless steel needles. The mesh implant is constructed of knitted filaments of extruded polypropylene strands and is approximately 0.63mm thick. The Athena Surgical RMUS Implant Assembly is designed to be used with the non-sterile, reusable Athena Surgical RMUS Handle Assembly, which consists of two parts: the Handle Body and the Handle Insert. The stainless steel needles from the RMUS Implant Assembly are designed to fit inside the RMUS Handle Assembly, which is used to position the implantable mesh in the patient from a vaginal incision up through the abdominal wall.
This FDA 510(k) summary is for a medical device called the Athena Surgical RMUS System, a pubourethral sling for treating female stress urinary incontinence.
Here's an analysis of the acceptance criteria and the study information, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving individual clinical effectiveness based on a completely novel set of performance criteria. Therefore, many of the typical "acceptance criteria" for clinical efficacy studies (like sensitivity, specificity, accuracy) are not explicitly defined or measured in this type of submission. Instead, the "acceptance criteria" are primarily related to comparison with the predicate device and the results of non-clinical (bench) testing.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, for a 510(k) submission, explicit "acceptance criteria" of the type one would see in a clinical trial for a new drug or novel device (e.g., "sensitivity must be >90%") are not typically provided. Instead, the criteria relate to demonstrating similarity to a predicate device and meeting relevant safety and performance standards through non-clinical testing.
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Summary from Non-Clinical Testing) |
|---|---|
| Substantial Equivalence to Predicate Device | Device found to be substantially equivalent to the Ethicon GYNECARE TVT EXACT™ based on similarities in intended use, design, materials, sterilization, and performance. |
| Mechanical Performance (Mesh) | Successful evaluation of: Ultimate Tensile Strength, Elongation at Break, Stiffness Bending Length, Burst Strength, Dimensional Analysis (monofilament diameter, device width, pore size, mesh thickness, mesh density, mesh weave characteristics). (Specific values not provided in this summary, but implied to meet standards). |
| Sterilization Validation | Validated per ISO 11135:2014 (Ethylene Oxide sterilization, sterility assurance level (SAL) 10-6, single-use). |
| Reprocessing Validation (Reusable Instruments) | Successfully validated for reusable instruments. |
| Shelf Life Testing | Evaluated for packaging integrity and mechanical performance. (Implied to meet shelf-life requirements). |
| Biocompatibility (Implant Sheath & Needles - 30 days contact) | Successfully passed: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Implantation, Subacute toxicity, Subchronic toxicity, Genotoxicity, and Carcinogenicity (through chemical characterization and toxicological risk assessment) (per ISO 10993-1). |
| Pyrogenicity Testing | Successfully passed Pyrogenicity testing. |
| No New Questions of Safety/Efficacy | "The technological characteristics do not raise any new questions of safety and efficacy." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) summary. No clinical test set (i.e., patient data) was used for evaluation. The safety and effectiveness were demonstrated through non-clinical (bench) testing and comparison to a predicate device.
- Data Provenance: Not applicable. The "study" for this submission was primarily non-clinical bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There was no clinical test set requiring expert adjudication of ground truth.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." The focus was on non-clinical testing and comparison to a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical surgical implant and its associated delivery system, not an algorithm or AI-based diagnostic tool. Therefore, "standalone performance" in the context of an algorithm does not apply.
7. The Type of Ground Truth Used
- For the non-clinical testing, the "ground truth" was established by engineering and biological standards and specifications. For instance, the ground truth for mechanical properties would be defined by established ASTM or ISO test methods and acceptance limits (e.g., "ultimate tensile strength must be X MPa"), and for biocompatibility, it would be the absence of toxic reactions as determined by ISO 10993 standards.
- For the overall submission, the "ground truth" for "acceptability" is the demonstration of substantial equivalence to a legally marketed predicate device (Ethicon GYNECARE TVT EXACT™), meaning it shares the same intended use, fundamental technological characteristics, and performs as safely and effectively as the predicate.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
§ 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.