(85 days)
BENCOX Delta Option Heads of BENCOX Total Hip System is intended for Cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:
a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty
The BENCOX Delta Option Head consists of a delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the BIOLOX® delta ceramic material, which is a high-purity alumina composite material according to ISO 6474-2 Type X, and come in various outer diameters.
The ceramic BIOLOX® delta ball head is assembled with the corresponding titanium sleeve and is then placed over the titanium alloy tapers of an in-situ hip stem prosthesis. The titanium sleeve has an inner taper which fits the dimensions of a metallic hip stem prosthesis, and the BIOLOX® delta ball head has a taper which fits to the dimensions of the outer diameter of the titanium sleeve.
This document is a 510(k) premarket notification for a medical device (BENCOX Delta Option Heads, a hip joint prosthesis component). It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device.
Crucially, this document is NOT a study describing the performance of an AI/ML medical device. It details the engineering and material properties of a physical orthopedic implant. Therefore, the questions related to AI/ML device performance, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to this document.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical (bench) testing performed to demonstrate the device's safety and effectiveness compared to predicate devices, rather than clinical performance or AI/ML algorithm validation.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria values and the device's reported performance against those criteria. It lists the types of non-clinical tests performed to demonstrate substantial equivalence. These tests are implicitly conducted against established engineering and material standards for orthopedic implants.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance | Demonstrated substantial equivalence to predicate devices. Specific tests include: |
| Burst Testing | Performed |
| Fatigue Testing | Performed |
| Post-fatigue Burst Testing | Performed |
| Pull-off Testing | Performed |
| Torque-out Testing | Performed |
| Biocompatibility/Safety | Demonstrated substantial equivalence to predicate devices. Specific tests include: |
| Range of Motion | Performed |
| Corrosion Testing and Assessment | Performed |
| Pyrogen Testing (USP, ANSI/AAMI ST72) | Conducted, met recommended limits per FDA guidance, Endotoxin limit of , ANSI/AAMI ST72 for pyrogenicity)** for mechanical and biocompatibility testing of hip prostheses. Equivalence is demonstrated to legally marketed predicate devices which conform to these standards. |
8. The sample size for the training set
Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.
9. How the ground truth for the training set was established
Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.
§ 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.