(279 days)
The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
· Revision of previously failed total hip arthroplasty
The EcoFit® Hip Stem and EcoFit® Acetabular Cup are intended for uncemented, press-fit fixation.
The EcoFit® Hip System consists of EcoFit® femoral hip stems, modular Cobalt Chrome Molybdenum alloy femoral heads, and modular metal backed acetabular cups with ultra-high molecular weight polyethylene liners.
The EcoFit® femoral stem system includes three versions: the standard length stem and a Coxa Vara version. The EcoFit® femoral hip stem is collarless, straight, monoblock, flat tapered wedge design manufactured from TiAlsV4 alloy. The stem tapers from proximal to distal and is designed with a rectangular cross sectional geometry to provide rotational stability. A plasma sprayed coating of commercially pure titanium (cpTi) is applied to the proximal half of the stem. The modular femoral heads are manufactured from Cobalt Chrome Molybdenum alloy and attach to the femoral stem via a Morse style taper in a diameter of 32 mm in several neck lengths.
The EcoFit® Acetabular Cup is a two (2) piece modular cup consisting of a metal shell and a polyethylene liner. The metal shell is manufactured from TiAlsV4 alloy and a plasma sprayed coating of commercially pure titanium (cpTi) is applied to the metal shell. The polyethylene liner is manufactured from ultra-high molecular weight polyethylene and is available with an inner diameter of 32 mm for use with 32 mm outer diameter femoral head. The metal shell has a threaded insertion hole at the apex and the shell is available in two (2) versions, one with three (3) peripheral holes for the placement of bone screws as needed for adjunctive fixation and one without screw holes. A threaded apex hole plug is provided to fill the threaded insertion hole after shell placement while bone screw hole plugs are available to fill screw holes that are not used.
The EcoFit® hip stems and EcoFit® acetabular cups are intended for uncemented press-fit application.
The provided document describes a 510(k) premarket notification for the "EcoFit® Hip System" which is a total hip replacement device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. Therefore, the information provided heavily emphasizes non-clinical (bench) testing, and explicitly states that clinical testing was not necessary.
As a result, a direct answer to all the requested points regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/device performance study as traditionally understood is not available in this document. The device in question is a physical medical implant, not an AI or software device.
However, I can extract the acceptance criteria and performance results available for the non-clinical testing performed:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Metallic Bone Screw Test (Torsional Properties, Driving Torque, Pull-Out Strength) | Complies with ASTM F 543 | Acceptable |
| Liner Disassembly Acetabular Shell – Liner (Push-Out, Lever-Out, Torsionals Properties) | Complies with ASTM F 1820 | Acceptable |
| Taper disassembly (Axial Disassembly Force Head - Femoral Stem) | Complies with ASTM F 2009 | Acceptable |
| Impingement EcoFit® Cup – Stem | Complies with ASTM F 2582 | Acceptable |
| Fatigue Strength EcoFit® Hip Stem – Distal | Complies with ISO 7206-4 | Pass |
| Fatigue Strength EcoFit® Hip Stem - Proximal (Neck Region) | Complies with ISO 7206-6 | Pass |
| Fretting corrosion evaluation | No specific standard listed | Acceptable |
| ROM EcoFit® Hip Stem – EcoFit® Cup | Complies with ISO 21535 Annex A | Acceptable |
| Biocompatibility | Complies with ISO 10993 | Pass |
Explanation of "Acceptable Criteria (Implicit)": For most of the tests, the acceptance criteria are implicit in the listed ASTM or ISO standards. To understand the specific numerical or qualitative criteria, one would need to refer to those standards directly. The document states that the results were "Acceptable" or "Pass," indicating the device met the requirements of the respective standards.
Regarding the other requested information (points 2-9):
These points are primarily relevant for studies evaluating the performance of software, AI models, or diagnostics where a comparison against a "ground truth" established by experts is central. This document pertains to a physical medical device (hip implant) and its substantial equivalence to predicate devices through non-clinical (bench) testing. Therefore, the concepts of test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, and their ground truth establishment do not apply in the context of this 510(k) submission for the EcoFit® Hip System.
The "study" that proves the device meets acceptance criteria is the series of non-clinical, benchtop tests listed in the table. These tests confirm the mechanical properties, durability, and biocompatibility of the hip implant components according to established international and American standards. The successful completion of these tests, demonstrating comparable performance to predicate devices and meeting relevant standards, supported the FDA's determination of substantial equivalence.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.