(252 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.
- . Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
The proposed Novation Crown Cup Acetabular Liners and associated Liner Trials are a modification to the Novation Crown Cup Acetabular Liners and associated Liner Trials cleared through premarket notification #K070479.
The proposed 12/14 Cobalt Chromium, Bioloxdelta and Biolox Option Femoral Heads and associated Head Trials are a modification to the 12/14 Cobalt Chromium, Bioloxdelta and Biolox Option Femoral Heads and associated Head Trials cleared through premarket notifications #K041906 and #K103012.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology.
The modified devices share the following similarities with the predicate devices:
- . Indications for use
- . Design features
- Material ●
- Shelf life
- . Packaging and sterilization materials and processes
This submission proposes the following design change:
- The proposed acetabular liners have a minimum polyethylene thickness of 4mm . for compatibility with 32mm, 36mm and 40mm femoral heads.
- The proposed femoral heads have an outer diameter of 40mm. .
The provided document describes a Special 510(k) submission for modifications to Exactech femoral heads and Novation Crown Cup acetabular liners. This is a medical device submission, not an AI/ML software submission, therefore many of the requested categories are not applicable.
Here's an analysis of the provided text in the context of the requested information:
Acceptance Criteria and Device Performance
The submission demonstrates substantial equivalence to predicate devices through various engineering analyses. The acceptance criteria essentially revolve around demonstrating performance that is "equivalent or better" than the predicate devices, or demonstrating that the proposed devices are "substantially equivalent" to them according to specific testing standards.
Table of Acceptance Criteria and Reported Device Performance
| Test/Analysis | Acceptance Criteria (Demonstrated) | Reported Device Performance |
|---|---|---|
| Wear testing (ASTM F1714) | Equivalent or better wear results than predicate devices. | Results demonstrated equivalent or better wear than predicate devices. |
| Lever-out testing (Tradonsky, et al. 1993) | Substantially equivalent to predicate acetabular liner devices. | Results demonstrated substantial equivalence to predicate devices. |
| Axial push-out (ASTM F1820) | Substantially equivalent to predicate acetabular liner devices. | Results demonstrated substantial equivalence to predicate devices. |
| Torque testing | Substantially equivalent to predicate acetabular liner devices. | Results demonstrated substantial equivalence to predicate devices. |
| Impingement fatigue testing | Substantially equivalent to predicate acetabular liner devices. | Results demonstrated substantial equivalence to predicate devices. |
| Burst Testing (ISO 7206-10) | Engineering justification supported applicability of predicate device testing to proposed devices. | Covered by engineering justification, assumed equivalent performance. |
| Fatigue (ISO 7206-10) | Engineering justification supported applicability of predicate device testing to proposed devices. | Covered by engineering justification, assumed equivalent performance. |
| Post Fatigue (ISO 7206-10) | Engineering justification supported applicability of predicate device testing to proposed devices. | Covered by engineering justification, assumed equivalent performance. |
| Pull-Off (Ceramtec specifications, FDA Guidance, ASTM F2009) | Engineering justification supported applicability of predicate device testing to proposed devices. | Covered by engineering justification, assumed equivalent performance. |
| Torque (Ceramtec specifications, FDA Guidance) | Engineering justification supported applicability of predicate device testing to proposed devices. | Covered by engineering justification, assumed equivalent performance. |
| Range of Motion (ISO 21535) | Engineering justification supported applicability of predicate device testing to proposed devices. | Covered by engineering justification, assumed equivalent performance. |
1. A table of acceptance criteria and the reported device performance:
See table above.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify exact sample sizes for each test in terms of the number of individual devices tested beyond mentioning the standards (e.g., ASTM F1714, ISO 7206-10). It refers to "engineering analyses" and "wear testing," which implies that appropriate sample sizes were used as per clinical and regulatory standards for device testing. There is no information regarding data provenance (country of origin) or whether it was retrospective or prospective, as these are typically not relevant for bench testing of medical devices.
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. This is a medical device submission based on physical and mechanical testing, not an AI/ML algorithm requiring expert ground truth for interpretation. The "ground truth" here is the physical performance measured against established engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. See point 3.
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 medical device submission, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device submission, not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For this medical device, the "ground truth" or reference for performance is established by international and industry-recognized engineering standards (e.g., ASTM F1714, ISO 7206-10, ASTM F1820, Ceramtec specifications, FDA Guidance) and comparative performance against previously cleared predicate devices. The goal is to demonstrate that the modified device performs to these established physical and mechanical criteria.
8. The sample size for the training set:
Not applicable. This is a medical device submission based on physical and mechanical testing, not an AI/ML algorithm that is "trained."
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 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.