(26 days)
The CS2™ Acetabular Cup System is designed for use with the various hip systems manufactured by Consensus Orthpedics, Inc. The CONSENSUS® HIP SYSTEM, CS2™ HIP SYSTEM, and the TAPERSET™ HIP SYSTEM are designed for total or partial hip arthroplasty and is intended to be used with compatible components of the CONSENSUS® HIP SYSTEM. The indications for use are:
A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. B.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
Non-union of proximal femoral neck fractures. ﻨﻨﺎ
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The CONSENSUS® hip stem is indicated for cemented or cementless use. The CS2™ and TAPERSET™ hip stems are indicated for cementless use.
The UNISYN™ HIP SYSTEM is indicated for significantly impaired joints resulting from theumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
A. Proximal femoral fractures.
B. Avascular necrosis of the femoral head.
C. Non-union of proximal femoral neck fractures.
D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
UNISYN™ stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN™ stems used with plasma/HA or HA coated bodies are intended for uncemented use only.
The CS2 Acetabular Cup System consists of a shell and a mating insert. The acetabular component is designed for cemented or uncemented use. The acetabular shell is manufactured from titanium alloy (Ti 6Al-4V ELI, ASTM F620 or ASTM F136), with a porous coating of commercially pure titanium beads (CP Ti ASTM F-67).
The acetabular shells are available with or without screw holes in hemispherical or flared rim versions. The component has matching circumferential scallops on the shell and insert that rotationally secure the insert in the shell and allow for dialing the insert in a desired orientation. The shells with screw holes have up to 10 anatomically placed holes which accommodate optional bone screws to augment initial fixation. An optional apical dome hole plug and cement pod spacer are available. The acetabular insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648); highly cross linked polyethylene (UHMWPE, ASTM F648), or VitalitE (UHMWPE, ASTM F2695). They all feature a titanium alloy X-ray marker (Ti 6Al-4V ELI, ASTM F136).
The cancellous bone screws are manufactured from wrought titanium alloy (Ti 6Al-4V ELI. ASTM F136). The cancellous bone screws are 6.5mm diameter and have a low profile head with a hex drive recess. These are provided with certain versions of the acetabular shell for the option of additional fixation.
The provided document describes a 510(k) submission for a Multi-Hole Shell for use with the CS2™ Acetabular Cup System. This is a medical device, and the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a study on artificial intelligence (AI) performance. Therefore, many of the requested categories related to AI studies (like ground truth, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable to this document.
The acceptance criteria for this type of device are primarily based on demonstrating substantial equivalence in terms of intended use, materials, and design features, and ensuring safety and effectiveness through non-clinical performance data (e.g., engineering design evaluations) if changes are made from predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Device maintains the same intended use as predicate devices. | The intended use of the Multi-Hole Shell for use with the CS2™ Acetabular Cup System is stated to be "substantially equivalent" to predicate devices. The system is designed for total or partial hip arthroplasty for various indications (e.g., impaired joints from arthritis, revision surgeries, fractures, avascular necrosis, etc.). |
| Materials: Device uses substantially equivalent or compatible materials as predicate devices. | The acetabular shell is manufactured from titanium alloy (Ti 6Al-4V ELI) with a porous coating of commercially pure titanium beads, consistent with previous versions. The inserts are manufactured from UHMWPE, highly cross-linked polyethylene, or VitalitE, also existing materials. The cancellous bone screws are titanium alloy. This aligns with or is compatible with predicate devices. |
| Design Features: Any new design features (e.g., additional screw holes) do not negatively impact safety or effectiveness. | The new Multi-hole shell offers up to 10 screw holes, compared to 3 to 5 in previously cleared versions. The submission states, "Engineering design evaluation of the additional screw holes being added to the acetabular shell shows that no additional biomechanical testing was required." This indicates that the design change was evaluated and deemed safe without further testing for this specific aspect, suggesting it met the internal engineering evaluation criteria. |
| Safety and Effectiveness: Overall safety and effectiveness are maintained and supported. | "The safety and effectiveness of the Multi-hole Shell are adequately supported by the substantial equivalence information and materials data provided within this 510(k) submission." |
| Compatibility: Device is compatible with legally marketed components. | The document lists several legally marketed devices from Consensus Orthopedics and Hayes Medical (now Consensus Orthopedics) that are compatible with the system, demonstrating adherence to component interchangeability and compatibility. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a medical device (acetabular cup system) seeking clearance based on substantial equivalence to predicate devices, not an AI/software device undergoing a clinical trial or performance study with a test set of data. The primary "test" was an engineering design evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. Ground truth is not a concept applied in this context for evaluating the device as it's not an AI/diagnostic algorithm.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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. See point 2. This device is an orthopedic implant, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See point 2.
7. The type of ground truth used
- Not Applicable. See point 2. The closest equivalent would be demonstrating equivalence to established physical properties and clinical performance of predicate devices, validated through engineering principles and material science, rather than a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of an AI study.
8. The sample size for the training set
- Not Applicable. See point 2.
9. How the ground truth for the training set was established
- Not Applicable. See point 2.
In summary, this 510(k) submission for the Multi-Hole Shell for use with the CS2™ Acetabular Cup System is based on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" proving it meets acceptance criteria primarily consists of engineering design evaluation and referencing established material data, rather than clinical trials or AI performance evaluations. The key acceptance criteria are that the device shares the same intended use, materials, and fundamental design characteristics as the predicate devices, and any modifications (like the increased number of screw holes) do not introduce new questions of safety or effectiveness and can be supported by existing non-clinical data.
§ 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.