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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

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.

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The CONSENSUS® Acetabular Shell, All UHMWPE is indicated for use in:

1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
2. Osteoarthrosis involving femoral and acetabular articular surfaces.
3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
4. Fracture-dislocation of the hip.
5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

The Consensus® Acetabular Shell, All UHMWPE is intended for use with the Consensus® Total Hip System as an alternative to the the metal acetabular shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Acetabular Shell, All UHMWPE is designed for use with size compatible Consensus® Total Hip System components. The Concensus® Acetabular Shell, All UHMWPE will be provided sterile and will be available in fourteen sizes for 22mm heads (42mm to 68mm increments), in twelve sizes for 26mm heads (46mm to 68mm in 2mm increments), and in eleven sizes for 28mm heads (48-68mm in 2mm increments). The material will be ultra high molecular weight polyethylene (UHMWPE), ASTM F648.

This document describes a medical device, the Consensus® Acetabular Shell, All UHMWPE, which is a component of a hip replacement system. The submission is for a 510(k) premarket notification, aiming to demonstrate substantial equivalence to predicate devices. As such, the concept of "acceptance criteria" and "study proving the device meets acceptance criteria" as it typically applies to AI/software performance metrics is not directly applicable here.

Instead, the "acceptance criteria" for a 510(k) submission generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparison of technological characteristics and, where applicable, performance testing to show that differences do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, reinterpreting "acceptance criteria" and "study" within the context of a 510(k) for a physical medical device:

Analysis of Acceptance Criteria and Evidence for the Consensus® Acetabular Shell, All UHMWPE

1. A table of acceptance criteria and the reported device performance

• Sterility: Provided sterile. This is a standard characteristic for implantable devices.
• Sizing: Available in a range of sizes (e.g., 42mm to 68mm for 22mm heads) which are comparable to predicate devices. |
  | Performance Equivalence (Mechanical/Functional) | The text states: "The Consensus® Acetabular Shell, All UHMWPE, device performs with substantial equivalence to predicate devices." While no specific test results are provided in this summary, this statement implies that mechanical performance (e.g., wear, fatigue strength) was evaluated and found comparable to predicate devices. |
  | Clinical Safety & Effectiveness Equivalence | "Clinical Data: None Required." This indicates that the FDA did not require new clinical studies for this device, implying that its technological characteristics and performance were sufficiently similar to predicate devices such that existing clinical data for the predicates could be leveraged. |

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a physical orthopedic implant. There isn't a "test set" of patient data in the way one would analyze for an AI algorithm. The performance evaluation would typically involve in-vitro mechanical testing of the device itself.
• Data Provenance: Not applicable for a software/AI context. Any mechanical testing would be conducted within a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable to a physical medical device submission like this. Ground truth establishment with experts is relevant for diagnostic or AI-driven devices where interpretation of medical images or data is involved.

4. Adjudication method for the test set

• This is not applicable to a physical medical device submission of this nature. Adjudication methods are used to establish ground truth in datasets, typically for AI or diagnostic performance studies.

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

• This is not applicable. MRMC studies are used to evaluate the performance of diagnostic devices or AI-assisted interpretation, often involving human readers. This submission is for a hip implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable. This device is a physical implant, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For a physical implant, "ground truth" generally refers to established scientific principles, engineering standards (e.g., ASTM F648 for UHMWPE), and the known performance characteristics of predicate devices. The "truth" is that the material meets its specifications and the device performs mechanically in a manner demonstrably equivalent to already approved devices.

8. The sample size for the training set

• This is not applicable. There is no concept of a "training set" for a physical medical device in the typical AI/machine learning sense.

9. How the ground truth for the training set was established

• This is not applicable for the reasons stated above.

In summary: The provided document is a 510(k) summary for a physical orthopedic implant. The "acceptance criteria" and "study" in this context refer to demonstrating substantial equivalence to predicate devices through comparisons of material, design, intended use, and implied mechanical performance testing (as evidenced by the "Performance Data: The Consensus® Acetabular Shell, All UHMWPE, device performs with substantial equivalence to predicate devices" statement), rather than clinical efficacy trials or AI algorithm performance metrics. No specific details about mechanical testing (like sample sizes or specific test results) are provided in this high-level summary but would have been part of the full 510(k) submission.

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