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The ESKA-LIBUR Hip Stem is indicated for use in the treatment rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, vascular necrosis, non-union of femoral neck fractures, fracture dislocation of the hip, conversion of unsuccessful arthodeses and revision of previous hip surgeries.

The ESRA LILOR The stem is available in thirteen sizes with a distal M/L dimension ranging alle 150 5645-4. The Stein 120mm to 180mm. It is modular in nature such that a from 7mm to 19.5mm, and lengals xosal body accepts an adaptor that has male tapers on both ends. One end engages the hip stem and the other a modular head. The distal end of the stem is color buffed while proximal body has the same Spongiosa Metal II® Surface cast into same as the predicate ESKA Modular Hip Stem.

This document is a 510(k) summary for the ESKA-LIBUR Hip Stem. It describes the device, its intended use, and provides a summary of nonclinical tests. Based on the provided text, the following information can be extracted:

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

   Acceptance Criteria	Reported Device Performance
   ISO 7206-4	"The ESKA-LIBUR Hip Stem was tested according to ISO 7206-4."

   Note: The document confirms testing was done to the specified standard but does not provide specific performance data or numerical results from this testing in this section.

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

   The document describes nonclinical testing, which typically refers to laboratory or bench testing rather than clinical data from human subjects. Therefore, information regarding human test sets, sample sizes for those sets, or data provenance (country, retrospective/prospective) is not applicable or not provided in this 510(k) summary for clinical performance. The "test set" in this context refers to the physical hip stem devices subjected to mechanical testing. The sample size for these mechanical tests is not specified.

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)

   This information is not applicable as the document describes nonclinical, mechanical testing of a medical device, not a diagnostic or AI-driven decision-making system. "Ground truth" in this context primarily relates to the physical and mechanical properties of the device as measured against the ISO standard.

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

   This information is not applicable for the same reasons as point 3. Mechanical testing does not involve adjudication by experts in the way clinical studies or AI performance evaluations do.

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 information is not applicable. This document is a 510(k) summary for a hip stem, a medical implant. It does not involve AI or human readers for diagnostic interpretation.

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

   This information is not applicable. This device is a physical implant, not an algorithm.

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

   The ground truth for the nonclinical test was the ISO 7206-4 standard for hip joint prostheses. Compliance with this standard indicates the device's mechanical integrity and performance under specified conditions.

8. The sample size for the training set

   This information is not applicable. This document describes the testing of a physical medical device. There is no "training set" in the context of an AI/ML algorithm.

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

   This information is not applicable for the same reasons as point 8.

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The ESKA Modular Hip System Cemented is indicated for cemented use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and post-traumatic arthritis, and the late stages of avascular necrosis, and for the revision of previous hip surgeries.

The ESKA Modular Hip System Cemented is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems, modular femoral heads and acetabular components. The modular femoral stems are anatomically designed in left and right configurations, with anteverted femoral necks. They are available in varying primary and revision lengths. There are collared and collarless options. Standard and lateralized geometries are offered. The stems feature a grit-blasted surface along their entire length and a 12/14 Morse type taper trunnion.

The modular femoral heads are available in various diameters from 26mm to 32mm, and in varying neck lengths.

The acetabular components are hemispherical all-polyethylene designs in a range of inner and outer diameters, with various offset options. The outer diameters incorporate radial and circumferential cement retention grooves and a titanium radiographic marker wire.

Materials: The devices are manufactured from CoCrMo alloy and 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 submission describes a 510(k) premarket notification for the ESKA Modular Hip System Cemented. This type of submission does not typically involve a clinical study to establish acceptance criteria and device performance in the same way a PMA (Pre-Market Approval) or de novo submission would. Instead, the primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device that is already legally marketed.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, expert involvement, and ground truth establishment is not directly applicable in the context of this 510(k) summary.

Here's an explanation of why those categories are not present and what this document does provide:

1. Acceptance Criteria and Reported Device Performance:

   • In a 510(k), the "acceptance criterion" is typically that the device is substantially equivalent to a predicate device. This means it performs as safely and effectively as a legally marketed device.
   • The "reported device performance" is demonstrated through a comparison of technological characteristics to the predicate devices, showing no significant differences that would adversely affect its use. The summary states: "There are no significant differences between the ESKA Modular Hip System Cemented 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."

2. Sample Size used for the test set and the data provenance, Number of experts used to establish the ground truth, Adjudication method, MRMC comparative effectiveness study, Standalone performance:

   • These concepts relate to clinical studies involving human subjects or analyses of clinical data outcomes to validate a device's performance.
   • A 510(k) such as this one for a hip prosthesis, especially one based on established materials and designs, primarily relies on non-clinical performance data (e.g., mechanical testing, materials testing, design specifications) to show substantial equivalence.
   • There is no mention of a human-based test set, data provenance, experts, adjudication, or clinical comparative effectiveness study in this document. The basis for "equivalence" would come from engineering and material comparisons, often against established standards.

3. Type of ground truth used:

   • Since there isn't a clinical performance study with human subjects validating outcomes, the concept of "ground truth" (like pathology, expert consensus, or outcomes data) as it pertains to clinical accuracy or efficacy isn't applicable here.
   • The "truth" established for this 510(k) is that the device's design, materials, and intended use are similar enough to existing, legally marketed devices.

4. Sample size for the training set, How the ground truth for the training set was established:

   • These terms are typically relevant for AI/ML device submissions where a model is trained on a dataset.
   • This document is for a mechanical orthopedic implant, not an AI-powered device. Therefore, there is no "training set" in this context.

Summary of what the document does provide regarding equivalence and "performance":

• Predicate Devices: The device is compared to the following legally marketed predicate devices:
  • Omnifit Hip System (Osteonics)
  • PFC Cemented Total Hip System (Johnson & Johnson)
  • Link SPII Hip System (Link)
  • Exactech Cemented Total Hip System (Exactech)
• Comparison Basis: The document states that the ESKA Modular Hip System Cemented is "substantially equivalent to these other devices in design, function, material and intended use." It specifically highlights:
  • Design: Anatomically designed femoral stems (left/right, anteverted necks, collared/collarless, standard/lateralized geometries), modular femoral heads (various diameters/neck lengths), hemispherical all-polyethylene acetabular components (various inner/outer diameters, offset options, cement retention grooves, radiographic marker wire).
  • Materials: CoCrMo alloy and Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM and ISO standards.
  • Function: Provides pain relief and improved function to the hip, similar to predicate devices.
  • Intended Use: Cemented use for treatment of severely disabled hip joints from painful osteo-, rheumatoid, post-traumatic arthritis, late stages of avascular necrosis, and revision surgeries.

In conclusion, this 510(k) submission establishes the device's marketability by demonstrating its substantial equivalence to existing devices through a detailed comparison of its design, materials, and intended use, rather than through a clinical study with detailed performance metrics and expert-established ground truth.

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