(108 days)
The Arthrex LoopLocTM Knotless Suture is intended for soft-tissue approximation for hip capsular closure.
The Arthrex LoopLoc™ Knotless Suture is an all-suture device intended for use in soft-tissue approximation for hip capsular closure. This device is composed of a nonabsorbable suture implant and shuttling suture that are braided polyblend sutures (Arthrex size #2) made of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET) sutures, and preloaded on a single-use high-density polyethylene (HDPE) card with a disposable suture threader made of low-density polyethylene (LDPE), stainless steel, and Nitinol wire.
This 510(k) premarket notification is for the Arthrex LoopLoc™ Knotless Suture. The submission does not describe an AI medical device or an algorithm-driven diagnostic tool. Therefore, the information requested regarding acceptance criteria and study design for an AI/algorithm-based device, such as ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, is not applicable to this submission.
The acceptance criteria and supporting study for the Arthrex LoopLoc™ Knotless Suture are focused on demonstrating its physical performance and biocompatibility as a surgical suture, rather than diagnostic accuracy or algorithmic performance.
Here's the relevant information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document broadly states that the device meets performance specifications and is substantially equivalent to predicate devices. Specific quantitative acceptance criteria and detailed reported performance values are not explicitly laid out in a table format within this summary, but rather described in terms of testing conducted and conclusions drawn.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | - Maintains knotless integrity. |
| - Withstands cyclic loads greater than anticipated during the rehabilitation period following arthroscopic hip surgery. | |
| Biocompatibility | - Meets pyrogen limit specifications (demonstrated through Bacterial endotoxin per EP 2.6.14/USP ). |
| Substantial Equivalence | - Has the same intended use, materials, biocompatibility profile, packaging configuration, shelf-life, and sterilization method as cleared predicate devices. |
| - Technological differences are considered minor and mitigated by cyclic and ultimate load testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Cyclic and ultimate load testing" and "Bacterial endotoxin per EP 2.6.14/USP " but does not specify the sample sizes used for these tests. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified, as these are bench tests on manufactured devices, not clinical data from patients.
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 is a medical device (suture) and the testing involves mechanical and biocompatibility assessments, not a diagnostic or AI-driven system requiring expert consensus for "ground truth." The "ground truth" here is objective physical and chemical properties and performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a diagnostic device or a study involving human interpretation of data for ground truth establishment.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be the direct measurement of physical properties (e.g., load to failure, cyclic fatigue resistance) performed according to established engineering standards relevant to surgical sutures. For the biocompatibility testing (bacterial endotoxin), the "ground truth" is whether the endotoxin levels meet predefined specifications. These are objective measurements rather than subjective assessments requiring expert consensus or pathology.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
§ 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.