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The CONSERVE® Thin Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
• 3. correction of functional deformity; and,
• revision procedures where other treatments or devices have failed 4.

The CONSERVE® Thin Shell is intended for cementless hip arthroplasty.

Design features of the shells are summarized below:

• Monoblock acetabular cup .
• . Available in 12 sizes
• Manufactured from CoCr alloy with a CoCr porous bead coating .

The CONSERVE® Thin Shells are identical to previously cleared devices, except that the subject device does not possess HA coating. Additionally, the CONSERVE® Thin Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results indicates that the CONSERVE® Thin Shells are equivalent to predicate devices.

This document describes the CONSERVE® Thin Shell, an acetabular cup intended for use in cementless total hip arthroplasty. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than conducting a new clinical study with specific acceptance criteria and performance metrics for this particular device.

Here's an analysis of the provided information, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain explicit acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical thresholds for novel designs) that the CONSERVE® Thin Shell needed to meet to be cleared. This is typical for a 510(k) submission based on substantial equivalence, especially when the changes are minor.

Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance is assessed by comparing the device's characteristics and functionality to those of already cleared devices.

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

The document does not describe a specific "test set" or a clinical study with human subjects for the CONSERVE® Thin Shell itself. The evaluation relied on bench testing and comparison to predicate devices.

• Sample Size: Not applicable in the context of a human clinical test set. The "samples" would relate to the number of CONSERVE® Thin Shell units used for the post-impaction analysis. This specific number is not provided.
• Data Provenance: Not applicable for human data. The "data" comes from engineering analysis and comparisons to existing device specifications.

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

This information is not applicable as there was no test set involving human subjects where expert ground truth was established by human readers/assessors. The "ground truth" here is derived from engineering standards, material science, and the established performance and safety profiles of the predicate devices as understood by the FDA and the manufacturer.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring multi-expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission establishes equivalence through design, materials, and bench testing, not through human reader performance studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical implant, not an algorithm or software requiring performance evaluation in a standalone or human-in-the-loop context.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

• Predicate device safety and effectiveness: The established performance and safety of the CONSERVE® HA Shells and CONSERVE® Acetabular Shell (TRANSCEND® Articulation System) serve as the benchmark.
• Engineering specifications and material science: Compliance with recognized standards for materials (CoCr alloy) and design features is the basis for evaluation.
• Bench testing data: Specifically, the post-impaction analysis of clearance, form, and frictional torque provided objective data to support the claims of equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable. As there is no training set for this physical device.

In summary: The K113322 submission for the CONSERVE® Thin Shell relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This type of submission typically uses bench testing, material characterization, and comparison of design features and intended use to establish safety and effectiveness, rather than new clinical trials with acceptance criteria based on patient outcomes or expert reads. The key "study" mentioned is the "post-impaction analysis of clearance, form and frictional torque," which supported the claim that the device is equivalent to its predicates despite the absence of an HA coating.

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