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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 TaperSet™ Hip System is 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.
• B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• C. Proximal femoral fractures.
• D. Avascular necrosis of the femoral head.
• E. Non-union of proximal femoral neck fractures.
• F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
  The TaperSet™ hip stem is indicated for cementless use.

The TaperSet Hip System (THS) is a monolithic, titanium alloy tapered hip stem design with a proximal, plasma sprayed, porous CPTi coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes designated as 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. The TaperSet Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is compatible with previously cleared CoCr heads, zirconia or Biolox delta ceramic heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups. The modification addressed here is the addition of a line of stems with a reduced distal profile (RDP) in sizes 10.5mm to 24mm.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the TaperSet™ Hip System RDP Stems, structured according to your request.

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as might be typical for AI/ML device submissions. Therefore, some of your requested information (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance with specific metrics) is not applicable or not provided in this type of regulatory submission for a traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. This submission relies on an "engineering analysis of the design modification" and comparison to predicate devices, rather than a specific "test set" of patient data as might be used for software or diagnostic devices.
• Data Provenance: Not applicable. The "study" here is a regulatory submission demonstrating substantial equivalence based on prior clearances and engineering analysis.

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. No "ground truth" was established by experts for a test set in the context of this 510(k) submission. Regulatory experts at the FDA ("Division of Surgical, Orthopedic, and Restorative Devices") reviewed the submission for substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There was no test set requiring ground truth adjudication.

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

• No. This is a traditional orthopedic implant, not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.

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

• No. This is a physical orthopedic implant. There is no algorithm or standalone performance to evaluate.

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

• Not applicable in the conventional sense of clinical ground truth. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices and the regulatory framework that deems substantial equivalence as sufficient for clearance. The "truth" is established by demonstrating that the modified device does not raise new questions of safety or effectiveness compared to legally marketed devices.

8. The sample size for the training set

• Not applicable. There is no training set as it's a physical device, not a software or AI/ML product.

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

• Not applicable for the reasons stated above.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) premarket notification process itself, which relies on demonstrating substantial equivalence to existing, legally marketed predicate devices.

The proof described is:

• Comparison to Predicate: The new TaperSet™ Hip System RDP Stems were compared to the predicate TaperSet stems (K102399) and another previously cleared RDP stem design (Biomet Taperloc Complete Hip System, K101086).
• Identical Features: The new RDP stems maintain "identical neck and taper design, porous coating, and sizing" with the predicate TaperSet stems.
• Engineering Analysis: Consensus Orthopedics performed an "engineering analysis of the design modification."
• Justification for No Additional Testing: No new non-clinical testing (like mechanical bench testing) was deemed necessary because:
  • There was "no proximal design change from the predicate TaperSet."
  • Distally, the "new smallest size is still larger than the smallest predicate TaperSet stem which was previously tested." This implies that the previous testing on the predicate covered potentially more challenging (smaller) scenarios.
• Conclusion of Substantial Equivalence: Based on this engineering analysis and comparison, the manufacturer concluded and the FDA agreed that the device is "substantially equivalent" to legally marketed predicates, and therefore "as safe, as effective, and performs at least as safely and effectively as legally marketed predicates."

This type of submission avoids extensive new clinical trials or performance testing by leveraging the safety and efficacy track record of existing, similar devices.

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