(304 days)
The MENIX® / MENIX® DUO Meniscal Suture Systems are indicated for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The MENIX® DUO systems are indicated for use in meniscal repairs and allograft transplant procedures. The MENIX® / MENIX® DUO systems are intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures. The MENIX ® / MENIX® DUO devices are intended for single use only.
The MENIX® / MENIX® DUO devices are intended to be used for all-inside meniscal repair:
- The MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed of one anchor pre-tied with a suture.
- MENIX® DUO system consists of a single-use launcher which deploys a nonabsorbable implant composed of two anchors connected by a suture.
Each anchor is pre-mounted on a needle to allow its deployment through the meniscus by pressing on the associated button. A transparent sheath acts as a penetration depth limiter and as a protection for users. As the MENIX® meniscal suture system consists of only one anchor associated with a suture, this suture must be tied to another MENIX® / MENIX® DUO meniscal suture system. The devices are supplied sterile, individually packaged and ready to use
The provided text is a 510(k) summary for the Menix®/Menix® Duo Meniscal Suture Systems. It describes a medical device and its equivalence to a predicate device, based on non-clinical performance data. This document does NOT describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it establish ground truth with human experts.
Therefore, I cannot provide information for most of the requested points, as they are not relevant to the content of this 510(k) summary. I can only provide details on the acceptance criteria and performance as they relate to the mechanical and biological testing for this specific type of medical device (surgical suture system).
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document states:
- "The mechanical performance data demonstrates that MENIX ® / MENIX® DUO meniscal suture system met performance specifications for traction strength and fatigue displacement traction strength through Dynamic then static tensile tests based on established acceptance criteria taken from the state of the art (Baraber's studies) and in comparison to the predicate device FAST-FIX 360 Meniscal Repair System (K121861)."
- "All acceptance criteria were met and MENIX ® / MENIX® DUO meniscal suture system were deemed biologically safe."
However, specific numerical acceptance criteria or the reported performance values (e.g., actual traction strength in Newtons or displacement in mm) are not provided in this summary. The table below reflects the general statements made.
| Test Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Met ISO 10993-1 (2018) requirements through risk analysis; existing data and chemical characterization assessed. | "All acceptance criteria were met and MENIX ® / MENIX® DUO meniscal suture system were deemed biologically safe." |
| Mechanical Performance | Performance specifications for traction strength and fatigue displacement traction strength, based on "state of the art (Baraber's studies)" and comparison to predicate device (FAST-FIX 360 Meniscal Repair System (K121861)). | "MENIX ® / MENIX® DUO meniscal suture system met performance specifications for traction strength and fatigue displacement traction strength through Dynamic then static tensile tests based on established acceptance criteria taken from the state of the art (Baraber's studies) and in comparison to the predicate device FAST-FIX 360 Meniscal Repair System (K121861)." |
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: Not specified in the document for any of the tests (biocompatibility or mechanical performance).
- Data Provenance: The device manufacturer (S.B.M. SAS) is located in Lourdes, France. The studies are non-clinical, likely laboratory-based. No mention of retrospective or prospective data.
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)
- Not applicable. This relates to human expert review for AI/ML ground truth, which is not described in this document. The "ground truth" for this device's performance is established via standardized laboratory mechanical and biological testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This relates to human expert review for AI/ML ground truth, which is not described in this document.
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, an MRMC study was not done. This document describes a medical device, not an AI/ML diagnostic or assistive tool. The comparison is between the new device's mechanical properties and those of a predicate device, using non-clinical testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's safety and effectiveness relies on results from standardized mechanical performance tests (traction strength, fatigue displacement traction strength) and biocompatibility tests (per ISO 10993-1), compared against established specifications and a predicate device. It is not based on expert consensus, pathology, or outcomes data in the traditional sense for diagnostic tools.
8. The sample size for the training set
- Not applicable. This document does not describe an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This document does not describe an AI/ML device that requires a 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.