(226 days)
Indications For Use:
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- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
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- Rheumatoid arthritis.
- Correction of functional deformity. 3.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
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- Revision procedures where other treatment or devices have failed.
Porous coated components are intended for uncemented biological fixation.
Taperloc® Complete Size 4mm Stems
The Taperloc® Complete Size 4mm stems will combine the design features of the Taperloc® Complete fulllength stems (K101086 and K103755) and the shortened design of the new Taperloc® Complete Microplasty, K110400. This submission is extending the implant size range to 4mm for the Full Profile (full-length and Microplasty), the Reduced Distal Profile (full-length and Microplasty), and the Traditional Reduced Distal Profile (full-length only). The design characteristics of the size 4mm full-length stems and Microplasty stems are identical to the Taperloc® Complete implants (K101086, K103755 and K110400); this is simply a line extension of our current offerings. These characteristics include: trapezoidal neck design, short taper, 133° neck angle, same material properties of the stem and plasma spray, a reduced profile distal stem, and an updated insertion/extraction hole.
Taperloc® Complete XR 123° Stems
The Taperloc® Complete XR 123° implants incorporate all the benefits of the Taperloc® Complete system, both full-length and Microplasty, as mentioned above, with a single offset neck option for the Full Profile and the Reduced Distal Profile. The only change is the 123° offset option, which was developed to reduce vertical offset (leg length), while maximizing horizontal offset. This option is supported through additional mechanical testing.
The provided text describes mechanical testing conducted on the Taperloc® Complete Size 4mm and XR 123° hip stems to demonstrate their substantial equivalence to predicate devices. This is a submission for a medical device (hip prosthesis), and the "acceptance criteria" and "study" refer to mechanical fatigue testing rather than a clinical study evaluating AI performance.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Set by) | Reported Device Performance |
|---|---|---|
| Taperloc® Complete 4mm 133° | ||
| Proximal Pot Fatigue Test (MT6461) | 10 million cycles to 120lbs (ASTM F2068-03) | Passed. 6 stems tested, all passed 10 million cycles. |
| Distal Pot Fatigue Test (MT6540) | 5 million cycles to 67lbs - 517lbs (FDA guidance) | Passed. 6 stems tested, all passed 5 million cycles. |
| Taperloc® Complete XR 123° | ||
| Proximal Pot Fatigue Test (MT6579) | 10 million cycles to 120lbs - 1,200lbs (ASTM F2068-03) | Passed. 6 stems tested, all passed 10 million cycles. |
| Distal Pot Fatigue Test (MT6609) | 5 million cycles to 67lbs - 517lbs (ASTM 1612-95 (Reapproved 2005)) | Passed. 6 stems tested, all passed 5 million cycles. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 6 stems were used for each individual test (Proximal Pot Fatigue and Distal Pot Fatigue) for both the 4mm 133° and XR 123° models.
- Data Provenance: The tests are explicitly referred to as "Non-Clinical Testing." They are laboratory-based mechanical fatigue tests, not human subject studies. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the same way it would be for clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a mechanical engineering study, not one using expert human interpretation for "ground truth." The "ground truth" here is the physical performance of the device under simulated physiological conditions.
4. Adjudication Method for the Test Set
Not applicable. This is mechanical testing, not a study requiring adjudication of expert opinions.
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 document is for a medical device (hip prosthesis) and its mechanical performance, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a medical device (hip prosthesis) and its mechanical performance, not an AI-powered algorithm.
7. The type of ground truth used
The "ground truth" for these mechanical tests is the physical failure or survival of the device when subjected to specified loads for a defined number of cycles, as per established ASTM standards and FDA guidance. This is an objective, measurable outcome from engineered testing.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" in this non-clinical mechanical testing context. The tests are designed to validate the mechanical properties of the final device, not to train an algorithm.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.