(262 days)
The SuperBall™ 18ºUp, "24ºUp" and "12ºReverse" Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair procedures.
The SuperBall™ 18ºUp, "24ºUp" and "12ºReverse" Meniscal Repair System(s) is a suture retention device comprised of two non-absorbable, soft suture implants along with a SuperBall securing element preloaded within a curved needle delivery system. The SuperBall System is provided sterile for single use only.
The SuperBall implants and sutures are composed of polyester and ultra-high molecular weight polyethylene. The system allows for repair procedures in the lateral and medial meniscus, located within the outer 2/3 region of the meniscal zone (i.e., medial and posterior).
This is not an AI/ML device, therefore the requested information regarding AI/ML device performance and study design is not applicable.
Device Name: SuperBall™ "18º-Up", "24º-Up" and "12º-Reverse" Meniscal Repair System
Device Description:
The SuperBall™ 18ºUp, "24ºUp" and "12ºReverse" Meniscal Repair System(s) is a suture retention device comprised of two non-absorbable, soft suture implants along with a SuperBall securing element preloaded within a curved needle delivery system. The SuperBall System is provided sterile for single use only. The SuperBall implants and sutures are composed of polyester and ultra-high molecular weight polyethylene.
Indications for Use:
The SuperBall Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair procedures.
Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Evaluation | Verification of sequential operation per IFU and proposed mode of operation. Tests confirmed the device operates as intended throughout routine, sequential operation resulting in deployment of the SuperBall implant in a meniscal simulating material. |
| Evaluation of Deployment Force | Force characterization tests determined the forces applied to the system throughout sequential operation. Each operating step was evaluated using a designated force measuring gauge suitable for the applied force. Results indicate appropriate force profile for operation. |
| Suture Knot-Pull (in accordance with USP-881 – Tensile Strength) | Demonstrated compliance with the required limits on average knot-pull tensile strength for the suture strands in the implant. |
| Implant and Suture Detachment Force (in accordance with USP-871 – Suture Needle Attachment) | Demonstrated compliance with the required limits on Needle Attachment for the suture strands comprising the SuperBall implant. |
| Implant Pullout Force following Cyclic Load | Demonstrated that the device can withstand cyclical tensile forces and maintain a minimal displacement, comparable to the predicate device under identical loading conditions. |
| Corrosion Resistance (in accordance with ISO 10555-1:2013, Intravascular catheters - Sterile and single-use catheters, Annex A) | Demonstrated that the devices' stainless steel components are corrosion resistant. |
| Bond Strength | Bonded components detachment tests verified that the bonded elements of the subject device(s) delivery system(s) can withstand forces greater than those that may be experienced during clinical use and as derived from the functional evaluations. |
| Shelf-Life Stability (following 2-year shelf-life period) | Validation processes conducted indicated qualified the subject devices' stability throughout transportation and shelf life (storage), verifying that the system complies with predefined specifications and acceptance criteria following a shelf-life period of 2 years (24 months). |
Study Information (Not Applicable for this type of device submission as it is not an AI/ML device):
- Sample size used for the test set and the data provenance: Not applicable. Performance testing was conducted on physical devices and simulating materials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance is based on established engineering and material science standards and physical measurements, not expert human interpretation.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for this device's performance is based on engineering specifications, material properties, and standardized mechanical test results.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.