(173 days)
The GRAVITY™ Soft Tissue Repair Systems are indicated for the following:
GRAVITY™ Plantar Plate Repair System:
- Distal metatarsal osteotomy (screw)
- Plantar plate repair (suture)
GRAVITY™ Needle Driver:
- Approximation of soft tissues, including the use of allograft tissue for orthopedic surgeries
The GRAVITY™ Soft Tissue Repair System is available in two offerings: the plantar plate repair system (suture, screws, and accessories) and the Needle Driver Device (free strand suture). The subject device is composed UHMWPE suture and ASTM F136 Titanium alloy screws. The system is conveniently sterile packed with disposable instruments.
The provided document is a 510(k) premarket notification for the GRAVITY™ Soft Tissue Repair System. It establishes substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.
This document primarily focuses on:
- Regulatory classification and product codes: Class II medical device (suture and bone fixation screw).
- Device description: UHMWPE suture and ASTM F136 Titanium alloy screws, sterile-packed with disposable instruments.
- Intended use: Plantar plate repair (suture, screws, accessories) and approximation of soft tissues (free strand suture with Needle Driver).
- Technological characteristics comparison: States equivalence to predicate devices in material and design, noting differences in preloading on a needle driver device and needle design for the suture component.
- Non-clinical evidence: Mentions "Performance testing and analysis demonstrated substantial equivalence in construct tensile strength to the reference predicate." However, it does not provide specific acceptance criteria, test methodology, or detailed results of this performance testing.
- Clinical evidence: States "A comprehensive clinical literature review was completed and used to support the subject free strand suture indications for use." This is not a de novo clinical study on the device itself but a review of existing literature, and no specific study data for the device is presented.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment directly from this document.
The document explicitly states:
- (b)(1). Substantial Equivalence - Non-Clinical Evidence: "Performance testing and analysis demonstrated substantial equivalence in construct tensile strength to the reference predicate." - This is a summary statement, not detailed study results.
- (b)(2). Substantial Equivalence - Clinical Evidence: "A comprehensive clinical literature review was completed and used to support the subject free strand suture indications for use." - This is a literature review, not a primary clinical study report.
To provide the requested information, a more detailed study report or performance data section would be required, typically found in a full 510(k) submission or a separate technical report.
§ 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.