(110 days)
PROFEMUR® TL2 stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
Titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.
The PROFEMUR® TL2 stems are monolithic wedge taper style stems manufactured from forged titanium alloy conforming to ASTM F620. The proximal portion (top third) of the TL2 stem possesses a titanium plasma spray coating, manufactured from pure titanium powder conforming to ASTM F1580. The stems will have a glass-beaded finish everywhere except for the trunnion and plasma spray coating region. The PROFEMUR® TL2 stems also have a vertical groove along most of the distal length of the stem to assist in rotational stability in the canal. The PROFEMUR® TL2 stems are designed for use in uncemented total hip arthroplasty. The PROFEMUR TL2 Stem is offered in 3 different neck variants, Standard (STD), High Offset (HO), and Ultra High Offset (UHO). The PROFEMUR TL2 Stems will be offered in sizes 0-12 for Standard (STD) and High Offset (HO), and 1-5, 11 & 12 in Ultra High Offset (UHO) with M/L Width ranging from 27-40mm and A/P width ranging from 13-17mm. All stem variants: standard, high offset, and ultra high offset were designed to accommodate a wide range of patient anatomy and to provide an optimized fit to adequately restore the biomechanics of the respective hip (including restoration of the natural leg length and head center offset). The PROFEMUR® TL2 stems are single use devices which will be provided sterile via Gamma Irradiation.
This document (K191632) describes a 510(k) premarket notification for a hip joint prosthesis, the PROFEMUR® TL2 Stem System. The submission aims to demonstrate substantial equivalence to a predicate device already on the market.
Based on the provided text, the device in question is a medical implant (a hip stem), not a device that relies on algorithms or AI for diagnostic or assistive purposes. Therefore, many of the requested criteria related to "device performance" in terms of imaging analysis, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for training sets are not applicable.
The document focuses on the mechanical and material properties of the hip stem to prove its safety and effectiveness relative to a legally marketed predicate device.
Here's an analysis of the provided text against the requested criteria, highlighting where information is present and where it is not applicable:
1. A table of acceptance criteria and the reported device performance
The document details mechanical testing conducted to demonstrate substantial equivalence. The "acceptance criteria" are implied by successful completion of these tests, demonstrating equivalent performance to the predicate device and meeting relevant standards.
| Acceptance Criteria (Implied by Standards and Comparison) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Endurance properties/Fatigue (Femoral Components per ISO 7206-4) | "Testing was successfully performed and it was confirmed that the worst case implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins – Test methods, routine monitoring" |
| Endurance properties/Fatigue (Neck Region per ISO 7206-6) | "The mechanical testing verifies that the subject PROFEMUR® TL2 Stems are substantially equivalent to the predicate PROFEMUR® TL Classic Hip Stems currently on the market and has met all mechanical testing requirements based on the worst case construct testing." |
| Overall Mechanical Requirements (per ASTM F2068, ISO 21535) | |
| Finite Element Analysis (FEA) Verification (per ASTM-F2996) | "A. Finite Element Analysis, (FEA)" performed. |
| Biocompatibility/Non-Pyrogenicity: | |
| Endotoxin Limit (20 EU/device) | "Testing was successfully performed and it was confirmed that the worst case implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing and USP , Medical Devices – Bacterial Endotoxin and Pyrogen Tests." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "worst case construct testing" for mechanical evaluation and "worst case implants" for endotoxin testing. It does not provide a specific numerical sample size (e.g., how many stems were tested for fatigue). This is typical for mechanical device testing where representativeness often comes from worst-case scenarios and defined samples per standard, rather than large statistical cohorts.
- Data Provenance: The testing was conducted by MicroPort Orthopedics Inc., located in Memphis, Tennessee, USA. The document does not specify if external labs were used or the exact location where testing was performed, but it's presumed to be within the company's testing facilities or by contractors in the US. The data is prospective, in the sense that it was generated specifically for this submission.
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 device is a mechanical implant, not an AI/imaging device requiring expert interpretation for ground truth. Ground truth for mechanical devices is established through adherence to engineering standards and validated physical testing methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As above, no human expert adjudication is involved in the performance evaluation of a hip stem.
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-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by:
- Adherence to recognized international and national standards for orthopedic implants (e.g., ASTM, ISO standards listed within the document).
- Comparative testing showing substantial equivalence to a legally marketed predicate device.
- Successful completion of specified mechanical tests (Fatigue, FEA, ROM, etc.) and biocompatibility tests (Endotoxin).
8. The sample size for the training set
Not Applicable. There is no "training set" as this is not an AI/machine learning model. The design and manufacturing processes are informed by established engineering principles and prior device experience.
9. How the ground truth for the training set was established
Not Applicable. As this is not an AI/machine learning model, there is no training set or associated ground truth establishment process in the context of machine learning. The "ground truth" for the device's design and manufacturing is based on established biomechanical and materials science principles, and regulatory requirements.
§ 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.