(29 days)
The Arthrex SpeedCinch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
The Arthrex SpeedCinch is an implantable suture retention device which consists of implants and an implant delivery mechanism. The implants are composed of PEEK Optima® (polyetheretherketone) anchors and FiberWire (Polyethylene/Polyester) suture offered in #2-0 size. The implant delivery mechanism is a handheld manual surgical instrument with trigger for implant delivery.
The Arthrex SpeedCinch is intended as a suture retention device to facilitate percutaneous or endoscopic soft tissue repairs, specifically meniscal tears. The device's performance was evaluated through mechanical testing to demonstrate substantial equivalence to the predicate device (Arthrex Meniscal Cinch, K073149).
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria values that the device needed to meet. Instead, it describes a comparative study showing the device's performance relative to a predicate device. The primary performance metrics were tensile strength (pull-out strength) and cyclic displacement.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile strength (pull-out strength) substantially equivalent to or better than predicate device | Tensile strength (pull-out strength) substantially equivalent to or better than the predicate device. |
| Cyclic displacement substantially equivalent to or better than predicate device | Cyclic displacement substantially equivalent to or better than the predicate device. |
| Implant materials and general function comparable to predicate device | Implant materials and general function the same as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Mechanical testing data" but does not specify the sample size used for the mechanical testing of either the Arthrex SpeedCinch or the predicate device.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given it's mechanical testing of a physical device, it's typically prospective testing conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable as the study involved mechanical testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation. Performance was measured objectively through physical tests.
4. Adjudication Method for the Test Set
This question is not applicable for mechanical testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study was mechanical testing comparing device performance to a predicate device. This is not an AI-assisted diagnostic or interpretation study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not applicable. The device is a physical implantable suture retention device, not an algorithm.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" (or the reference for comparison) was the objective mechanical measurements of tensile strength and cyclic displacement, compared against the same measurements from the predicate device. There was no expert consensus, pathology, or outcomes data used in this specific submission for substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. There is no software algorithm or AI model mentioned that would require a training set. The device is a physical medical device.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set mentioned or implied for this 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.