(116 days)
- 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 procedures where other treatment or devices have failed.
The Arcos One-piece Femoral Revision System hip components are single-use implants, intended for uncemented use only.
The Arcos One-piece Femoral Revision System is to be used as a femoral stem component in hip replacement surgery. The system is designed for both primary and revision total hip and hemi hip arthroplasty. All implants included in this system are intended for single use only. The system also includes implant specific instrumentation for all stem variants.
This document is a 510(k) premarket notification for the Arcos One-piece Femoral Revision System, a hip prosthesis. It does not describe an AI/ML powered medical device. Therefore, it does not contain the specific information requested in the prompt, such as acceptance criteria for AI performance, details of a study proving AI performance, sample sizes for test sets, data provenance, ground truth establishment, MRMC studies, or training set details.
The document focuses on demonstrating substantial equivalence of the new device to existing legally marketed predicate devices based on design, materials, and principle of operation, along with non-clinical performance data.
Below is a summary of what is available in the document related to performance and equivalence, which stands in for the requested "acceptance criteria and reported device performance" as much as possible given the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of quantitative acceptance criteria typical for AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating that the new device shares similar technological characteristics and performance (where applicable) to its predicate devices, or that any differences do not raise new questions of safety and effectiveness.
| Performance Aspect (as described for a mechanical device) | Reported Device Performance (as described in the document) |
|---|---|
| Technological Characteristics | The Arcos One-piece Femoral Revision System has the same design, material, and principle of operation as the predicate devices (K090757 Moduar Femoral Revision System (Arcos) and K000760 Reach Femoral Component), with "slight modifications." |
| Monolithic variant | It is a monolithic variant of the Modular Femoral Revision System (Arcos) (K090757), designed as a porous-coated femoral stem available in multiple lengths and proximal bodies for primary and revision procedures. |
| Material Equivalence | The reference devices (K150503, K070274) were used to demonstrate equivalence in implant materials/instrument materials/Type I taper Trunnion and implant stem diameters. |
| Non-clinical Tests | Femoral Stem Fatigue: Performed (details not provided). |
| Range of Motion: Performed (details not provided). | |
| Clinical Tests | None provided as a basis for substantial equivalence. |
| Safety and Effectiveness Conclusion | Differences from predicates "do not raise new questions of safety and effectiveness" and "the proposed device is at least as safe and effective as the marketed predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/ML device that uses a test set of data for performance evaluation in the way an algorithm would. The "tests" mentioned are non-clinical (e.g., fatigue), and no specific sample sizes for these tests are provided in the summary.
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. Ground truth, in the context of expert consensus, is not relevant for this type of mechanical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a mechanical device like this is typically established through engineering standards, material science testing, and clinical experience with predicate devices, rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an AI model.
9. How the ground truth for the training set was established
Not applicable.
§ 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.