(133 days)
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.
The SuperBall Meniscal Repair System is a suture retention device comprised of two nonabsorbable, soft suture implants along with a SuperBall securing element preloaded within a curved needle delivery system. More specifically, the device consists of suture bundles, a mesh stitch, actuator suture, pulling suture, and SuperBall securing element. 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). The structure of the SuperBall is a self-locking structure enabling the SuperBall securing element to remain in its collapsed position. The SuperBall remains secure as the braided component (Mesh) is collapsed from within by pulling the Actuator Suture. The SuperBall System is provided sterile for single use only.
The provided text is a 510(k) summary for the Arcuro Medical Ltd.'s SuperBall Meniscal Repair System, which is a medical device. This document describes the device, its intended use, and various tests performed to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" as a list with pass/fail thresholds. Instead, it describes performance tests and states that the device "demonstrated compliance," "performs as intended," or "confirm that the SuperBall has appropriate strength."
| Test Category | Reported Device Performance |
|---|---|
| Verification of dimensional attributes | Confirmed that the device performs as intended. |
| Functional evaluation | Confirmed that the device performs as intended. |
| Deployment force | Confirmed that the device performs as intended. |
| Suture knot pull-out | Conducted in accordance with USP-881 - Tensile Strength. Results "demonstrated compliance with the required limits on average knot-pull tensile strength." |
| Implant and suture detachment force | Conducted in accordance with USP-871 - Suture Needle Attachment. Results "demonstrated compliance with the required limits on Needle Attachment." In all instances, the results demonstrated the biocompatibility of the SuperBall implants and delivery system. |
| Implant pullout force | Confirmed that the device performs as intended. |
| Cyclic load | Confirmed that the device performs as intended. |
| Corrosion resistance | Conducted in accordance with ISO 10555-1:2013, Annex A. Results "demonstrated that the devices' stainless steel components are corrosion resistant." |
| Bond strength | Confirmed that the device performs as intended. |
| Biocompatibility | Conducted in accordance with ISO 10993-1:2009 for components that come in direct contact with the patient's body. Results "demonstrated the biocompatibility of the SuperBall implants and delivery system." |
| Sterilization | "Validated EtO sterilization cycle" per ISO11135:2014. Residual levels of Ethylene Oxide (EtO) and Ethylene Chlorohydrin (EC) maintained in compliance with ANSI/AAMI/ISO 10993-7: 2008(R) 2012. |
| Usability | Evaluated by surgeons. Users reported that the device "was easy to use and no use related risks were reported." |
| Shelf-life | Package and device stability evaluations "performed to support the proposed shelf life." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated for most bench tests. For the usability study, "A total of eight surgeons evaluated the usability of the device, with six surgeons evaluating use of the final finished configuration of the device."
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. All studies described are bench tests or usability evaluations, not clinical trials on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question does not directly apply as the studies are primarily bench testing and a usability evaluation. There is no "ground truth" in the sense of a medical diagnosis being established by experts against which the device's diagnostic performance is compared.
- Usability Study: "A total of eight surgeons" evaluated the device. Their specific qualifications (e.g., years of experience, specialty beyond "surgeon") are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The described studies are bench tests and a usability evaluation, not studies requiring adjudication of diagnostic outcomes.
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
Not applicable. This device is a surgical repair system, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As noted in point 3, the studies are focused on the physical and functional performance of the device (bench tests) and its ease of use by surgeons (usability study), not diagnostic accuracy against a ground truth.
8. The sample size for the training set
Not applicable. This document is about a manufactured medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As noted in point 8, there is no AI algorithm training set.
§ 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.