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The ESKA Modular Total Hip System Acetabular Components are indicated for uncemented use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and posttraumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.

The ESKA Modular Hip System Acetabular Components are modular components used in conjunction with the company's femoral stems, for the replacement of severely disabled hip joints. The system consists of porous acetabular shells, modular femoral heads, and modular acetabular liners. The acctabular components are porous coated hemispherical shells with modular UHMWPE inserts.

Materials: The devices are manufactured from CoCrMo alloy, Ultra High Molecular Weight Polyethylene ( UHMWPE ), per ASTM and ISO standards.

Function: The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma.

This document is a 510(k) summary for a medical device (ESKA Modular Hip System Acetabular Components) seeking market clearance, not a study report proving device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment is not available in these provided pages.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the basis for 510(k) clearance. It does not present a performance study with acceptance criteria in the way a clinical trial or a standalone algorithm validation study would.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

• Not Applicable. This document does not describe specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or durability thresholds) for device performance. The "acceptance" in a 510(k) is primarily about demonstrating substantial equivalence to a predicate device based on design, function, material, and intended use, rather than meeting quantitative performance benchmarks from a specific study against a set of newly defined acceptance criteria.
• The document states: "There are no significant differences between the ESKA Modular Hip System Acetabular Components and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material, and intended use." This statement is the core "performance" claim in the context of a 510(k) for this type of device – i.e., its performance is expected to be equivalent to safely marketed devices.

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

• Not Applicable. No explicit "test set" or performance study data is described in these pages. This is a premarket notification, not a report of a clinical or technical performance study.

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

• Not Applicable. No test set or ground truth establishment process is described.

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

• Not Applicable. No test set or adjudication process is described.

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 device is an acetabular component for total hip replacement, not an AI or imaging diagnostic device that would involve human "readers" or AI assistance.

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

• Not Applicable. This is a mechanical implant, not software or an algorithm.

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

• Not Applicable. No ground truth is established for a performance study in this document. Substantial equivalence relies on comparing the device's characteristics (materials, design, intended use) to those of existing, legally marketed predicate devices.

8. The sample size for the training set:

• Not Applicable. This device is a mechanical implant, not a machine learning model, so there is no training set in this context.

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

• Not Applicable. As above, no training set.

In summary: The provided text is a regulatory submission for premarket clearance (510(k)) that focuses on establishing substantial equivalence of a medical implant to existing devices. It does not contain information about a specific performance study with acceptance criteria, sample sizes, expert involvement, or ground truth generation, as would be expected for, for example, a diagnostic device or a drug.

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