(187 days)
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:
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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."
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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.
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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.
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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.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.