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510(k) Data Aggregation
(120 days)
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
The AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
The Apogee and Perigee prolapse repair systems are part of the AMS Pelvic Floor Repair System family of devices. They consist of a permanently-implanted mesh assembly and non-implanted surgical instruments (needle passers) that are used as aids to place the mesh assembly in the pelvic floor.
This K081710 510(k) submission describes a modification to an existing surgical mesh device. The core of the submission revolves around demonstrating that the modified device (with a PC coating) is "substantially equivalent" to its predicate device (without the coating). This type of submission rarely includes detailed studies with acceptance criteria in the way a new device would. Instead, the "acceptance criteria" are implicitly met if the new device performs similarly enough to the predicate device.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a modified device, the "acceptance criteria" are not explicitly stated for clinical performance as they might be for a novel device. Instead, the study aimed to show "substantial equivalence" to a predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: Demonstrated no adverse biological reactions due to the new PC coating. | Components of Apogee and Perigee systems were tested for biocompatibility and found to be substantially equivalent to the predicate device. |
| Mechanical Performance (Tensile Strength): Maintained similar tensile strength in both weft and warp directions compared to the predicate. | Tensile testing was performed in both the weft and warp directions of the mesh, comparing the mesh with and without the PC coating. Results indicated substantial equivalence. |
| Mechanical Performance (Cycle): Maintained similar cyclic loading performance in both weft and warp directions compared to the predicate. | Cycle testing was performed in both the weft and warp directions of the mesh, comparing the mesh with and without the PC coating. Results indicated substantial equivalence. |
| Mechanical Performance (Elongation): Maintained similar elongation characteristics in both weft and warp directions compared to the predicate. | Elongation testing was performed in both the weft and warp directions of the mesh, comparing the mesh with and without the PC coating. Results indicated substantial equivalence. |
| Mechanical Performance (Stiffness): Maintained similar stiffness characteristics in both weft and warp directions compared to the predicate. | Stiffness testing was performed in both the weft and warp directions of the mesh, comparing the mesh with and without the PC coating. Results indicated substantial equivalence. |
| Dimensional Characteristics (Fiber Diameter): Maintained similar fiber diameter compared to the predicate. | A comparison of the dimensional characteristics was completed and included fiber diameter. Results indicated substantial equivalence. |
| Dimensional Characteristics (Pore Size): Maintained similar pore size compared to the predicate. | A comparison of the dimensional characteristics was completed and included pore size. Results indicated substantial equivalence. |
| Dimensional Characteristics (Mesh Density): Maintained similar mesh density compared to the predicate. | A comparison of the dimensional characteristics was completed and included mesh density. Results indicated substantial equivalence. |
| Dimensional Characteristics (Mesh Thickness): Maintained similar mesh thickness compared to the predicate. | A comparison of the dimensional characteristics was completed and included mesh thickness. Results indicated substantial equivalence. |
| Indications for Use: The modified device has the same intended use as the predicate device. | The Indications for Use for the Apogee® and Perigee® Systems with PC Coated IntePro® Lite™ are identical to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for mechanical testing or biocompatibility studies. The studies were likely bench-top (mechanical) and potentially in-vitro/in-vivo (biocompatibility) tests.
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting, typically in the country of the manufacturer or a contracted testing facility. It's retrospective in the sense that the data is generated for the submission, not from a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of 510(k) submission, focused on material and mechanical equivalence for a modified surgical mesh, does not involve expert-established ground truth in the way a diagnostic AI device would. The "ground truth" for the mechanical tests would be the objective measurements themselves against established engineering standards or direct comparison to the predicate device's measured properties. For biocompatibility, it refers to standardized testing results.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or clinical outcomes requiring adjudication. The tests described are objective, physical, and biological assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This submission is for a surgical mesh, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
Not applicable. This submission is for a surgical mesh, which is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the tests mentioned (tensile, cycle, elongation, stiffness, dimensional characteristics, and biocompatibility) would be based on:
- Objective physical measurements: Using standardized testing methodologies and equipment to quantify mechanical properties and dimensions.
- Biocompatibility standards and assays: Results from validated in-vitro and potentially in-vivo tests comparing the new material's biological response to known standards or the predicate material.
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical medical device (surgical mesh), not an AI algorithm, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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