(30 days)
The SimuPlus flexible annuloplasty ring and band are in patients undergoing surgery for diseased or damaged mitral valves. The band is indicated for the same use for tricuspid valves. The SimulPlus flexible annuloplasty ring and band provide support for the mitral annulus or tricuspid annulus (band only) and restrict expansion of the annulus.
The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. The SimuForm semi-rigid annuloplasty ring provides support for the mitral annulus and restricts expansion of the annulus.
The SimuPlus flexible annuloplasty ring (Model 7700FR) and band (Model 7700FB) consist of a flexible braided polyester fabric with a 3 mm cross-section. The ring or band may be implanted in the mitral annulus to stabilize the annulus following valve repair. The band may be implanted in the tricuspid annulus to stabilize the annulus following valve repair. The ring and band are marked at three points by colored sutures. Two markers correspond to the trigones (mitral valve) or septal commissures (tricuspid valve), and a central marker identifies the centerline of the ring or band. The individual ring or band size (26 mm to 42 mm increments) refers to the circumference between the green trigone markers on the ring or band. Silicone markers, impregnated with barium sulfate and tungsten, enable radiographic visualization. The ring and band are mounted to a holder to ease positioning and implantation.
The SimuPlus annuloplasty ring and band holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the holder opening above the typical area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chord knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.
The SimuForm semi-rigid annuloplasty ring (Model 7800RR) consists of a MP35N wire stiffener in the posterior segment, running from trigone to trigone. The ring stiffener is enclosed within a close-coiled MP35N spring that passes around the circumference of the annuloplasty ring. The spring is covered by a thin silicone sheath. Braided polyester fabric is used to cover and form the body of the ring. The ring has two green markers to indicate the anterior and posterior trigones. A green demarcation suture runs around the upper face of the ring. The individual ring size (24 mm to 40 mm in 2 mm increments) refers to the inner circumference between the green trigone markers on the ring. The internal spring and stiffener provide radiographic visualization around the circumference of the ring.
The SimuForm annuloplasty ring holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the ring holder opening above the approximate area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chords knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification for annuloplasty rings and bands, arguing their substantial equivalence to previously marketed predicate devices.
The key points from the document are:
- Device: SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring.
- Purpose: To gain clearance for these devices by demonstrating they are "substantially equivalent" to predicate devices (Simulus Flexible Annuloplasty Ring and Band, Simulus Semi-Rigid Annuloplasty Ring).
- Changes:
- SimuPlus (Flexible): Updates to product name, indications (minor phrasing changes), labeled size range (to align with industry sizing, no change to implant construction or dimensions), handle compatibility, and language for instructions for use (eIFU/paper IFU).
- SimuForm (Semi-Rigid): Updates to product name, handle compatibility, and language for instructions for use (eIFU/paper IFU). No change to the implantable ring, its intended use, principles of operation, or size range.
- Conclusion: "The modifications to the Simulus devices do not impact the intended use or alter the fundamental scientific technology of the devices. There is no change to the implantable rings and bands. The SimuPlus and SimuForm rings and bands are therefore substantially equivalent to the currently marketed predicate devices."
- Performance Data: "Performance testing was not required to support labeling changes made to align with standard industry sizing." This explicitly states that performance testing was not done for this submission, as the changes were deemed not to affect fundamental performance.
Therefore, the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document. This document focuses solely on demonstrating substantial equivalence based on the nature of the changes made and comparison to predicate devices, rather than presenting new performance data against specific acceptance criteria.
§ 870.3800 Annuloplasty ring.
(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”