(30 days)
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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.