(111 days)
The RIGI-FIX™ Hip Stem System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to femoral hip stem revisions.
The RIGI-FIX™ Hip Stem System is a non-cemented acetabular cup system with a complete assortment of neutral and 10° hooded poly inserts as well as acetabular screws and screw hole covers (screw hole occluders).
The provided text is a 510(k) Summary and FDA clearance letter for the RIGI-FIX™ Hip Stem System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a detailed study with specific acceptance criteria and performance metrics for the device itself.
Therefore, most of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance is not available in the provided document.
Here's a breakdown of what can be extracted:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific clinical or diagnostic outcome. The acceptance is based on "substantial equivalence" to legally marketed predicate devices.
- Reported Device Performance: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." No specific values or criteria are provided other than the general statement of equivalence and sufficiency for in vivo loading.
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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)
- Not Applicable. The document describes biomechanical testing, not a clinical or diagnostic study with a test set of data.
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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)
- Not Applicable. No ground truth establishment for a diagnostic test set is mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or human interpretation is discussed.
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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
- No. This is a medical implant, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's performance relies on the biomechanical properties meeting established engineering standards and being equivalent to predicate devices.
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The sample size for the training set
- Not Applicable. No training set for an algorithm is discussed.
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How the ground truth for the training set was established
- Not Applicable. No training set is discussed.
Summary based on the provided document:
The RIGI-FIX™ Hip Stem System gained market clearance based on substantial equivalence to predicate devices (BIOMET TAPERLOC Femoral Stem, K921301 and K043537). The performance demonstration relies on biomechanical tests showing equivalence to other similar implants and sufficiency for in vivo loading. Specific quantitative acceptance criteria or detailed study results beyond this general statement are not included in the summary provided. This type of 510(k) submission generally focuses on engineering and material equivalence for an implant rather than diagnostic accuracy studies typically associated with AI or imaging devices.
§ 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.