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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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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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The ESKA Modular Hip System is indicated for 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 is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems and heads, acetabular shells and modular liners, bipolar femoral heads, and bone screws. The femoral stems are anatomically designed in left and right configurations, with anteverted femoral necks. There are fully porous, proximally porous. collared and collarless options. The acetabular components are porous, with various liner options and screws for supplementary fixation. Pre-assembled bipolar and unipolar components are also available.

The provided text describes the ESKA Modular Hip System, a total hip replacement system, and its 510(k) premarket notification. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any other data related to clinical or performance testing.

The document is a submission summary to the FDA and the FDA's response letter, which asserts substantial equivalence to predicate devices based on design, function, material, and intended use, rather than detailed performance data from a specific study of the ESKA Modular Hip System itself.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

No information regarding acceptance criteria or a study proving the device meets said criteria is present in the provided text.

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