(29 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
The proposed Exactech BIOLOXdelta femoral heads and Biolox Option femoral heads and adapters are modifications to the existing Exactech 12/14 Alumina heads previously cleared in K032964 and K051682. The proposed femoral heads and adapters have the same general design features as the predicate device. The proposed femoral heads are manufactured from an alumina/zirconia based ceramic material known as Delta per ISO 6474-2. The Biolox Option adapters are comprised of titanium alloy per ISO 5832-3 and are intended for use with the Biolox Option femoral heads for primary and revision applications in which the taper remains intact.
The proposed femoral heads mate with the following devices:
12/14 Femoral Stems
Novation Press-Fit Femoral Stems (K042842)
Novation Splined RDD Femoral Stem (K063279)
Novation Element Press-Fit Femoral Stem (K080980)
Novation Cemented Stems (K052787)
Novation Cemented Plus (K083392)
AcuMatch Press Fit Stems (K041906, K051335)
AcuMatch Cemented Stems (K052787)
AcuMatch M-Series (K032964, K051858)
Acetabular Liners
Novation Crown Cup Standard and GXL UHMWPE Liners (K070479, K100269)
Novation Crown Cup Constrained Liners (K071676)
AcuMatch A-Series Standard and GXL UHMWPE Liners (K993082, K000242, K040613, K051556)
AcuMatch Constrained Liners (K040601)
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
similar indications for use
similar design features
incorporate similar materials
the same shelf life
are packaged and sterilized using the same materials and processes
This document is about the 510(k) summary for BIOLOX® Delta and BIOLOX® Option Femoral Heads, which are medical devices. It primarily details the substantial equivalence to predicate devices based on non-clinical performance data (engineering evaluations). Therefore, the request for information related to clinical studies, human readers, ground truth establishment, and training/test set sizes for an AI/algorithm-based device is not applicable to this document.
However, I can extract the acceptance criteria and the (non-clinical) performance reported for this medical device from the provided text.
1. A table of acceptance criteria and the reported device performance
| Test/Acceptance Criteria (per ISO 7206-10 and Ceramtec specifications / FDA Guidance) | Reported Device Performance |
|---|---|
| Burst strength (ISO-7206-10) | Engineering evaluations conducted to demonstrate substantial equivalence to predicate devices. |
| Fatigue strength (ISO-7206-10) | Engineering evaluations conducted to demonstrate substantial equivalence to predicate devices. |
| Post fatigue strength (ISO-7206-10) | Engineering evaluations conducted to demonstrate substantial equivalence to predicate devices. |
| Pull off force and Torque (Ceramtec specifications and FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems) | Engineering evaluations conducted to demonstrate substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes non-clinical engineering evaluations, not clinical test sets or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for clinical data is not relevant for non-clinical engineering evaluations. The "ground truth" here would be the established international standards (ISO) and regulatory guidance, which are met by the engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or human adjudication was involved.
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 not an AI/algorithm-based device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the engineering evaluations, the "ground truth" or reference points are established international standards (ISO 7206-10) and specific industry/regulatory guidance (Ceramtec specifications and FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems).
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device and does not involve training sets.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm-based 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.