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Indications for use with the CONSENSUS® Hip System or UNISYN™ Hip System:
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
Acetabular components are indicated for cemented and cementless use.
Consensus femoral stems are indicated for cemented and cementless use.
UniSyn femoral stems are indicated for cementless use only.
HA coated implants are indicated for cementless use only.

The Consensus® Hip System (CHS) currently offers a semi-constrained metal-backed acetabular component comprising a porous coated shell manufactured from Titanium alloy (ASTM F620 or F136) (K922561, K020153, K060635) and a mating insert manufactured from ultra-high molecular weight polyethylene (UHMWPE) (K922561) (ASTM F648) or highly crosslinked UHMWPE (ASTM F648) (K021466, K070061). The shell is designed for uncemented press-fit or cemented use to the prepared acetabulum, and is designed to mate with the insert via secure insert/shell locking mechanism. The previously cleared inserts are designed to articulate with the CHS femoral heads.
The CS2™ Plus acetabular insert adds a lateralized configuration to the current line of CHS crosslinked UHMWPE acetabular inserts (i.e. CS2™ inserts) (K021466, K070061). The design intent is to allow the surgeon more intraoperative flexibility to medialize the acetabular cup or lateralize the head center, while maintaining substantial insert wall thickness.

This document describes the 510(k) summary for the Consensus Orthopedics, Inc. CS2™ Plus Acetabular Insert (K100933). It is not a study proving device performance against acceptance criteria in the manner typically seen for software or diagnostic devices. Instead, it is a submission demonstrating substantial equivalence to predicate devices for a medical implant.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, sample size for training set, ground truth for training set) are not applicable or cannot be extracted from this type of document.

However, I can extract information related to non-clinical testing performed to support the substantial equivalence claim, which serves as the "study" for this device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in the same way a diagnostic algorithm's performance metrics would have. Instead, the "acceptance criteria" are implied by demonstrating that the CS2™ Plus Acetabular Insert performs comparably or better than the predicate CS2™ insert in specific mechanical tests, and that it is substantially equivalent in design and materials. The "reported device performance" are the results of these comparative tests.

2. Sample Size Used for the Test Set and Data Provenance

This is a materials and mechanical testing submission, not a data-driven algorithm submission. Therefore:

• Sample Size for the Test Set: Not specified in terms of clinical or image data. The "test set" would refer to the number of physical devices or components subjected to mechanical testing. This number is not disclosed in the summary, but typically would involve a standard number of samples per test type for statistical validity in engineering.
• Data Provenance: Not applicable in the sense of country of origin for clinical data. The tests are non-clinical (laboratory/mechanical).
• Retrospective or Prospective: Not applicable. These are laboratory tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in this context refers to engineering specifications and performance benchmarks, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. This document describes mechanical testing, not a clinical trial requiring adjudication of patient outcomes or expert reviews.

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 a medical implant, not an AI/imaging 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. The non-clinical testing performed is effectively "standalone" in that it tests the device's mechanical properties directly.

7. The Type of Ground Truth Used

The "ground truth" for this submission are established engineering standards for medical devices, the performance characteristics of the predicate devices, and the design specifications of the device itself (e.g., ensuring wall thickness, range of motion, locking mechanism integrity). It's based on mechanical testing results and CAD verification against design specifications and predicate device performance.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set" in the context of an algorithm.

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The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability due previous fusion Patients with acute femoral neck fractures. The Metha® Hip System (uncemented, press-fit fixation) is Intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur, patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion patients with acute femoral neck fractures. Indications for use of the CONSENSUS® HIP SYSTEM-PRIMARY HIP: A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic 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 plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities. Acetabular components are indicated for cemented and cementless use.

The Consensus Acetabular Cup from Hayes Medical is a Titanium alloy shell with a highly cross linked polyethylene insert. The Consensus acetabular cups are available in 28mm, 32mm, and 36mm ID's, a variety of sizes, and in either standard or hooded versions. The shells are available with or without screws. The Aesculap Excia hip systems also comes in 28mm - 36 mm ID's, it is available in both cemented and uncemented variants, and a wide range of sizes. Aesculap's Metha hip system also comes in 28 - 36 mm ID's but is for uncemented use, and also comes in a variety of sizes. The PlasmaCup acetabular cup from Aesculap is cleared for use with both the Excia and Metha systems.

This document describes the 510(k) summary for the Consensus Acetabular Cups for use with Aesculap Excia and Metha Hip Systems. It outlines the substantial equivalence to previously cleared devices based on technological characteristics and engineering evaluation, rather than new performance data from a specific study.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity for diagnostic devices; or mechanical test results for orthopedic implants) are listed in the document. The filing is based on the substantial equivalence of the device's design to existing cleared devices.

2. Sample Size Used for the Test Set and Data Provenance

No specific test set or clinical study yielding performance data was conducted or described in this 510(k) submission for the Consensus Acetabular Cups. The submission relies on the engineering evaluation of dimensions and the equivalence to previously cleared devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable, as no new performance data requiring ground truth establishment from experts was generated or presented in this submission.

4. Adjudication Method

Not applicable, as no new performance data requiring adjudication was generated or presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or described. This K081978 submission is for an orthopedic implant and does not involve AI or human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is an orthopedic implant, not an algorithm.

7. Type of Ground Truth Used

Not applicable, as no primary performance study needing ground truth was performed for this submission. The basis for clearance is technological equivalence and previous clearances.

8. Sample Size for the Training Set

Not applicable. This device is an orthopedic implant, and there is no mention of a training set as would be relevant for an AI/algorithm-based device.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set or ground truth for such a set is mentioned.

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