(90 days)
Components of the Converge Acetabular System are intended for use in total hip arthroplasty for treatment of the following:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of previously failed hip arthroplasty.
The Converge Acetabular System consists of four modular shell options which mate with currently marketed insert components for replacement of the acetabulum during total hip arthroplasty. They are designed to provide congruency with the ability to effectively seal the acetabulum, and may be implanted with or without bone cement.
Common Features:
- Substrate Material: All of the Converge shells are manufactured from titanium alloy (Ti-6AI-4V ELI, ASTM F136).
- Porous Coating: Cancellous Structured Titanium (CSTi) porous coating (commercially pure titanium, ASTM F1580) covers the entire outer surface of the Converge shells, with the exception of regions adjacent to the dome hole and screw holes, and a small band around the opening of the shell. The porous coating allows for biological fixation to occur.
- Shell/Insert Locking Mechanism: Because all four shells of the Converge System share the same internal locking mechanism, they can be used with the currently marketed Sulzer Orthopedics Inter-Op Acetabular inserts (standard polyethylene, Durasul and Metasul).
- Threaded Dome Hole Dome Hole Plug: A threaded dome hole is common to all four shells. During implantation, an impactor/alignment instrument is inserted into the dome hole. Once the shell is inserted and the tool removed, the dome hole provides visual access to the acetabulum. A threaded titanium dome hole plug (ASTM F67) can be screwed into place to prevent unwanted material migration.
Shell Options:
A. Converge Cluster-Hole Porous Shell with Sealed Screw Holes: Hemispherically shaped with screw holes sealed with plugs that can be removed for supplemental fixation. Features superior holes for increased fixation options. Sizes range from 39mm to 71mm in 2mm increments.
B. Converge Rim Flare Porous Shell with Spikes and Sealed Screw Holes: Designed to facilitate load transfer, limit tilting/rotation, and give flexibility in press-fitting. Features an offset radius in the rim region and three dome spikes. Includes two sintered screw hole covers that can be removed for supplemental fixation. Outer diameters range from 39-71mm in 2mm increments.
C. Converge Multi-Hole Porous Shell with Sealable Screw Holes: Hemispherical shell designed for scenarios with deficient acetabular bone stock (e.g., revision cases). Features five to nine screw holes (depending on size) for placement into the ilium, ischium, and pubis. Unused screw holes can be plugged with plugs manufactured from either Ti-6Al-4V (ASTM F136) or unalloyed titanium (ASTM F67). Available in outer diameters ranging from 43mm to 81mm, in 2mm increments.
D. Converge Protrusio Porous Shell with Sealable Screw Holes: Designed to accommodate a deeper acetabular socket caused by protrusio defects. Features a gradual buildup of material from the rim to the dome. Like the Multi-Hole shell, it features five to nine screw holes (depending on size) and uses the same screw hole plugs. Available in external shell diameters ranging from 53mm to 81mm, in 2mm increments.
This document (K012739) is a 510(k) summary for a medical device and therefore does not contain acceptance criteria or detailed study results. 510(k) summaries are intended to demonstrate substantial equivalence to a legally marketed predicate device, not to prove clinical effectiveness or meet specific performance criteria through detailed studies.
Therefore, most of the information requested cannot be extracted from this document.
Here's what can be stated based on the provided text:
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A table of acceptance criteria and the reported device performance
- Not Available: This document does not specify acceptance criteria for performance or report device performance data from a study. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device.
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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/Not Available: This document does not describe a clinical performance study with a test set. This is a premarket notification for a new device based on substantial equivalence.
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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/Not Available: No test set or ground truth establishment by experts is described in this document, as it's not a performance study.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available: No test set or adjudication method is described.
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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
- Not Applicable: This device is a mechanical implant (acetabular system for hip replacement), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant or described.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is a mechanical device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable/Not Available: As no performance study with a test set is described, no ground truth is detailed.
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The sample size for the training set
- Not Applicable/Not Available: This isn't a machine learning algorithm or a study that would involve a "training set" in that context.
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How the ground truth for the training set was established
- Not Applicable/Not Available: As above, the concept of a training set and its ground truth is not relevant to this type of device submission.
Summary of available information related to "proof" of meeting criteria:
The document states that the Sulzer Orthopedics Converge Acetabular System is found to be substantially equivalent to legally marketed predicate devices. This is the "proof" required for a 510(k) clearance, indicating that the device is as safe and effective as a device already on the market.
The basis for this substantial equivalence is described as similarities in:
- Materials: All shells manufactured from titanium alloy (Ti-6AI-4V ELI, ASTM F136) with Porous Coating Cancellous Structured Titanium (CSTi) via commercially pure titanium (ASTM F1580). Dome hole plug material is titanium (ASTM F67) or Ti-6Al-4V (ASTM F136).
- General design features: Modular shell options, internal locking mechanism, threaded dome hole, screw holes with optional plugs, and variations for different anatomical needs (Cluster-Hole, Rim Flare, Multi-Hole, Protrusio).
- Intended uses/Indications for Use: Total hip arthroplasty for noninflammatory degenerative joint disease (NIDJD), inflammatory joint disease (IJD), failed previous surgery where pain/deformity/dysfunction persists, and revision of previously failed arthroplasty.
Predicate Devices cited for substantial equivalence:
- Sulzer Orthopedics Inter-Op Acetabular System
- Zimmer Trilogy Acetabular System
- Stryker/Osteonics/Howmedica System 12 Acetabular System
- Smith & Nephew Orthopaedics Reflection Acetabular System
- DePuy Duraloc Acetabular System
§ 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.