(99 days)
The Arcos Trochanteric Button is intended for use with the Arcos Modular Femoral Revision System, which is cleared only for uncemented use (K090757), as well as the Arcos Interlocking Stems, a line extension to the Arcos Modular Femoral Revision System, added by Special 510(k) K 100469, listed in the compatible component section.
Indications For Use:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
The Arcos Modular Femoral Revision System Trochanteric Button hip components are singleuse implants, intended for uncemented applications.
The Arcos Trochanteric Button is being added to the Arcos Modular Femoral Revision System, K090757, to expand surgical options beyond the claw when increased proximal stability is needed, especially when a greater trochanteric osteotomy has been performed. This assembly allows the greater trochanter to be compressed against the prosthesis or for reattaching the greater trochanter in cases where a trochanteric osteotomy has been performed. The Trochanteric Button comes in one size and is manufactured from Ti-6Al-4V. The design is very similar to the cleared Trochanteric Plate cleared for use with the Mallory-Head Modular Calcar System, K031693.
The provided document describes a 510(k) premarket notification for the Arcos Modular Femoral Revision System Trochanteric Button. This device is an accessory for a hip prosthesis system. The acceptance criteria and supporting study are detailed for this medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The proposed Arcos Modular Femoral Revision System Trochanteric Button should perform as well or better than the referenced cleared Mallory-Head® Trochanter Plate, based on reduced stresses due to the smaller hole and larger contact area. (Performance is related to mechanical integrity and ability to fulfill surgical expectations, specifically for increased proximal stability or reattaching the greater trochanter). | Non-Clinical Testing: |
- **Pull-Through Comparison (FEA):** This analysis was performed.
- **Cross Section Analysis:** This analysis was performed.
The conclusion drawn from these analyses is that "Since the stresses are reduced on the new washer due to the smaller hole and larger contact area, the proposed Arcos Modular Femoral Revision System Trochanteric Button should perform as well or better than the referenced cleared Mallory-Head® Trochanter Plate, thus meeting the acceptance criteria, indicating capability to fulfill surgical expectations." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The study conducted was non-clinical (FEA and cross-section analysis) and did not involve a "test set" of patient data or physical samples in the way a clinical study would. It involved engineering analysis of the device design itself.
- Data Provenance: Not applicable. As it was non-clinical engineering analysis, there is no country of origin or retrospective/prospective designation relevant for patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The "ground truth" in this context is based on engineering principles and comparison to a predicate device's established mechanical performance, not expert consensus on patient data.
- Qualifications of Experts: Not specified, but can be inferred to be engineering professionals capable of Finite Element Analysis (FEA) and mechanical stress analysis, given the nature of the tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical test set requiring adjudication. The evaluation was based on engineering analysis and comparison against the performance characteristics of a predicate device.
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
- MRMC Comparative Effectiveness Study: No, this type of study was not conducted as this is a mechanical medical device (implant accessory), not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: Not applicable. This is not an AI algorithm. The performance was assessed through non-clinical engineering tests (FEA and cross-section analysis) of the device's mechanical properties.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for demonstrating substantial equivalence was the established mechanical performance and safety profile of the predicate device (Mallory-Head® Trochanter Plate) and the application of engineering principles (Finite Element Analysis, stress reduction theory). The objective was to show the new device performs "as well or better" than the predicate.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There was no "training set" in the context of an AI/machine learning model, as this is a mechanical device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. No training set was used.
§ 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.