(111 days)
The Bencox Forte and Bencox Delta ceramic heads is intended for 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 hip arthroplasty
The Bencox Biolox Ceramic Head is a component of a Hip Prosthesis System and intended for mechanical fixation to a mating hip stem, with a standard 12/14 taper. It is intended to articulate between both Highly Cross Linked UHMWPE as well as Conventional UHMWPE.
The Bencox Ceramic Head is available as standard type and is manufactured from bio-inert alumina ceramic, Al2O3 as per ASTM F603 / ISO 6474. The ceramic femoral balls heads range in diameter from 28 mm to 40 mm with small, medium & large versions.
Radiation (gamma) sterilization is used for Bencox Forte and Bencox Delta Biolox ceramic heads. Sterilization by Co-60 gamma irradiation has been validated to a sterility assurance level (SAL) of 10-6 by the bioburden method, according to ISO 11137-1 & ISO 11137-2. Following sterilization packaging was validated for a shelf life of 5 years for BENCOX Forte & Delta ceramic femoral heads.
The provided text describes the 510(k) summary for the BENCOX® Forte & BENCOX® Delta femoral heads, which are ceramic components for hip arthroplasty. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria in the context of AI/software device studies.
Therefore, many of the requested elements pertaining to AI/software device evaluation (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission, as it concerns a physical medical device (femoral heads).
However, I can extract the information on performance testing and acceptance criteria as presented for this physical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Component Testing on Titanium Test Tapers (per CeramTec AG VA 02 04 4129, ISO 7206-10) | Performed. (Implicitly met standards as substantial equivalence was granted. The document states "All required testing per 'Guidance Document for the Preparation of Premarket Notifications of Ceramic Ball Hip Systems' were performed.") |
| Influence of Diameter and Neck Length on Burst Strength (Burst test setup as per ISO 7206-10) | Performed. (Implicitly met standards as substantial equivalence was granted.) |
| Sterilization Validation (per ISO 11137-1 & ISO 11137-2 - Radiation) | Validated to a sterility assurance level (SAL) of 10^-6 by the bioburden method. |
| Shelf Life Validation for Sterilization Packaging | Validated for a shelf life of 5 years for BENCOX Forte & Delta ceramic femoral heads. |
| Substantial Equivalence (Indications, Design Principles, Operating Principles, Materials, Packaging) | Demonstrated to predicate devices: MEDACTA International SA; MectaCer BIOLOX forte Femoral Heads (K073337), DePuy Orthopedics, Inc., DePuy Delta Ceramic Femoral Head (K062748), Corentec Co., Ltd., Coren Total Hip System & Bencox Bipolar Cup System (K103431 & K112019). "Any differences ... do not raise new issues of safety or efficacy." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test, but standard test methods (e.g., ISO 7206-10, ISO 11137) would have defined sample sizes for physical product testing.
- Data Provenance: Not applicable in the sense of patient data. The tests are laboratory-based mechanical and sterilization validations of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for a physical device like a ceramic femoral head is established through adherence to international standards and validated testing procedures by qualified technicians and engineers in accredited laboratories.
4. Adjudication method for the test set
- Not applicable. The "adjudication method" typically refers to expert consensus for ground truth establishment in clinical or imaging studies. For physical device performance, the acceptance is based on meeting the specifications and standards outlined in the test protocols.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical medical device, not an AI/software device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used
- Mechanical Performance: Adherence to international standards (e.g., ISO 7206-10) and established biomechanical testing protocols. The "ground truth" is that the device passes or fails these pre-defined mechanical tests.
- Sterilization: Demonstrated Sterility Assurance Level (SAL) of 10^-6, verified by bioburden methods as per ISO 11137.
8. The sample size for the training set
- Not applicable. There is no concept of a "training set" for this type of physical device submission.
9. How the ground truth for the training set was established
- Not applicable. There is no concept of a "training set" for this type of physical device submission.
§ 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.