(140 days)
The hip prosthesis MiniMAX is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Hip Replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.
· Avascular necrosis of the femoral head.
· Acute traumatic fracture of the femoral head or neck.
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The purpose of this submission is to gain clearance for the new MiniMAX, which are anatomical HA coated cementless stems intended to be used in total or partial hip arthroplasty in primary or revision surgery.
The anatomical design of the MiniMAX stems results in a 9° anteversion of the neck which is mirror polished with 12/14 Eurocone taper and a 127° neck-shaft angle. The macrostructures are negative medially and positive laterally which increases the contact area. The lateral flare is rounded and non-invasive. The MiniMAX stems' distal tip have a 5° curvature to follow the contours of the femoral canal to aid in the insertion and avoiding distal interference.
MiniMAX stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).
MiniMAX stems are made of Titanium Aluminum Niobium Alloy (Ti-6Al-7Nb). The surface treatment consists of titanium plasma spray coating, Ra 300μm, in the proximal 2/3 of the shaft to improve proximal fixation and HA (Hydroxyapatite) coating, Ra 80um, along the entire length of the shaft.
MiniMAX stems are similar to predicate devices Howmedica Osteonics' ABG III Monolithic Hip Stem (K123604) and Medacta's MasterLoc Stem (K151531).
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Mechanical Tests | Based on standards and FDA guidance documents (specific values not provided in this summary). | |
| Range of Motion (ROM) | Standards: EN ISO 21535:2009 | Testing was conducted to written protocols with acceptance criteria. The summary states the data supports substantial equivalence, implying the device met these criteria. |
| Fatigue Testing (Stem Endurance) | Standards: ISO 7206-4 Third Edition 2010-06-15 (with Amendment 1, 2016) | Testing was conducted to written protocols with acceptance criteria. The summary states the data supports substantial equivalence, implying the device met these criteria. |
| Fatigue Testing (Head and Neck Region Endurance) | Standards: ISO 7206-6 Second Edition 2013-11-15 | Testing was conducted to written protocols with acceptance criteria. The summary states the data supports substantial equivalence, implying the device met these criteria. |
| Static Fatigue Testing (Modular Femoral Heads) | Standards: ISO 7206-10:2003 | Testing was conducted to written protocols with acceptance criteria. The summary states the data supports substantial equivalence, implying the device met these criteria. |
| Pull Off Force Testing (Taper Connections) | Standards: ASTM F2009-00 (Reapproved 2011) | Testing was conducted to written protocols with acceptance criteria. The summary states the data supports substantial equivalence, implying the device met these criteria. |
| Coating Tests | (Not explicitly stated in this summary, but would be related to coating characteristics, adhesion, etc.) | Coating characterization testing was performed. The summary states the data supports substantial equivalence, implying the device met these criteria. |
| Pyrogenicity | (Based on European Pharmacopoeia §2.6.14 and USP for Bacterial Endotoxin Test, and USP for Pyrogen Test). The device is not labeled as non-pyrogenic or pyrogen-free. | The Bacterial Endotoxin Test (LAL test) and Pyrogen Test were conducted. The summary implies the results were acceptable for the intended labeling. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not explicitly stated in the provided document. The document mentions "testing was conducted to written protocols," but does not detail the number of units tested for each mechanical or coating test.
- Data provenance:
- Country of origin: Not specified beyond the manufacturer being Medacta International SA (Switzerland). The testing standards are international (ISO, ASTM, European Pharmacopoeia, USP).
- Retrospective or Prospective: Not applicable in this context as these are laboratory-based non-clinical performance and material tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for non-clinical performance tests is established by adhering to widely recognized engineering and medical device standards (ISO, ASTM, EN, USP, European Pharmacopoeia) and internal protocols. These tests measure objective properties (e.g., fatigue strength, range of motion, coating characteristics) rather than requiring expert interpretation of clinical data as a "ground truth."
4. Adjudication method for the test set
- Not applicable. This concept typically applies to clinical studies where different readers or experts might have varying interpretations. For non-clinical, objective testing, results are measured against predefined acceptance criteria from established standards. There is no "adjudication" in the sense of reconciling differing expert opinions on the test outcomes.
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
- No, an MRMC comparative effectiveness study was not done. This is a medical device (hip prosthesis), not an AI-based diagnostic or assistive software. The submission focuses on the safety and effectiveness of the implant itself through material properties and mechanical performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This is a hardware medical device, not a software algorithm.
7. The type of ground truth used
- The "ground truth" for the performance data in this submission is based on established international and national standards (e.g., ISO 7206 series for hip prostheses, ASTM F2009 for taper connections, EN ISO 21535 for hip-joint implants, European Pharmacopoeia and USP for pyrogenicity). These standards define the acceptable performance parameters and testing methodologies for such devices.
8. The sample size for the training set
- Not applicable. This submission describes a physical medical device. There is no "training set" in the context of an algorithm or machine learning model. The relevant "data" for development would involve extensive engineering design, material science data, and prior knowledge from similar predicate devices.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set in the AI/ML sense, there is no ground truth established for a training set. The device design and manufacturing process would be informed by decades of biomechanical research, clinical outcomes with similar devices, and engineering principles. The "ground truth" for its design and manufacturing would be validated through the performance testing described.
§ 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.