(209 days)
The subject ESL Marathon" Polyethylene Liners are intended to be used with the DePuy Pinnacle® metal acetabular shells, modular femoral heads, unipolar femoral heads, and selfcentering heads to resurface the acetabular socket in cementless total hip arthroplasty.
The subject Ultima" " Unipolar and the Sclf-Centering" Hip Prosthesis, originally cleared for hemi-arthroplasty procedures, are also intended for use in total hip replacement when used in conjunction with a metal backed UHMWPE bearing surface having an inside diameter corresponding to the outside diameter of the metallic head/cup that is utilized.
The Pinnacle" Enhanced Stability Liner is indicated for use in total hip replacement procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
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- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
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- Avascular necrosis of the femoral head.
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- Acute traumatic fracture of the femoral head or neck.
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- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
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- Certain cases of ankylosis.
The Pinnacle" ESL is indicated for use with the Pinnacle" Acetabular Cup in cementless application.
Self-Centering™ Hip Prostheses and unipolar femoral heads are also intended to be used for total hip arthroplasty to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components, when used in conjunction with a UHMWPE bearing surface having an inside diameter corresponding to outside diameter of the metallic cup that is utilized. Use in total hip replacement is indicated in the following additional conditions:
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A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia
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Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty ,or total hip replacement.
The Pinnacle® Acetabular System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner manufactured from cross-linked ultra high molecular weight polyethylene (UHMWPE), which locks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.
The subject Pinnacle® Enhanced Stability (ESL) Marathon™ liners are cross-linked UHMWPE acetabular cup liners that are available in a lateralized neutral, or lateralized face-changing orientation. The liners have inner diameters (ID) intended for use with modular, unipolar, or self-centering (bipolar) femoral heads within the 28mm-48mm size range. The outer diameters geometrically the same as other Pinnacle Acetabular Cup Liners, in a 44mm-76mm size ra offering. There is an addition of a Charnley-style bore on sizes 36mm-48mm ID to increase stability.
The Ultima" Unipolar femoral head is provided in a size range of 38mm to 63mm OD, in Imm increments. The subject heads have a tapered bore which can receive a variety of adapter sleeves, originally cleared in K965156 (01-24-07) which are machined from CoCrMo alloy in wrought bar. The femoral head is also used in total hip arthroplasty when used in conjunction with a UHMWPE bearing surface having an inside diameter corresponding to the outside diameter of the modular femoral head that is utilized.
The Self-Centering " Hip Prosthesis is a component consisting of a metallic cup and an UHMWPE insert and plastic retaining ring. It is used with a DePuy femoral hip stem and modular metal ball with a head diameter corresponding to the inside diameter of the Self-Centering " Hip polyethylene insert (22mm - 28mm), to replace the femoral head and neck. The Self-Centering Hips are provided in a size range of 39mm through 57mm OD, in 2 mm increments. The bearing inserts are offered in two inner diameters, to accept 22mm and 28mm femoral components. The Self-Centering Hip is being submitted as part of a Total Hip Prosthesis when used in conjunction with a UHMWPE bearing surface having an inside diameter corresponding to the outside diameter of the metallic cup that is utilized.
The provided text describes a 510(k) premarket notification for the DePuy Pinnacle® Acetabular Cup System and its components. This regulatory submission process for medical devices focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through clinical studies or extensive testing that generates "acceptance criteria" and "reported device performance" in the way a new drug or novel medical intervention might.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this 510(k) summary.
Here's why and what information is provided:
Key Takeaways from the document:
- Device Type: This is a submission for an orthopedic implant system (hip replacement components).
- Regulatory Pathway: 510(k) Premarket Notification. This pathway is for devices that are "substantially equivalent" to legally marketed predicate devices.
- Basis of Substantial Equivalence: The document states that the new devices (ESL Marathon Polyethylene Liners, Ultima Unipolar, and Self-Centering devices) are substantially equivalent to predicate devices based on similarities in design, intended use, material, and manufacturing methods.
- Indications for Use: The document clearly outlines the medical conditions for which the devices are intended.
- No Clinical Study Details: The 510(k) summary does not present data from patient-level clinical trials that would establish performance metrics like sensitivity, specificity, accuracy, or effect sizes from MRMC studies. The FDA's letter (K033273) confirms the substantial equivalence determination but does not refer to clinical study results for performance metrics.
Response to your specific questions based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Not applicable / Not provided. The 510(k) process focuses on demonstrating substantial equivalence, not on establishing quantitative performance against specific acceptance criteria derived from a clinical study. The document does not describe such acceptance criteria or reported performance data.
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Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The document does not describe a "test set" in the context of clinical performance evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No "ground truth" establishment for performance evaluation is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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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 device is an orthopedic implant, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided.
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The sample size for the training set:
- Not applicable / Not provided. The concept of a "training set" in the context of machine learning is not relevant to this device's regulatory approval process as described.
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How the ground truth for the training set was established:
- Not applicable / Not provided.
In summary, the provided document is a regulatory submission demonstrating the substantial equivalence of new hip replacement components to existing ones. It does not contain information about clinical studies designed to measure specific performance criteria as you would find for a diagnostic device or a new therapeutic intervention requiring extensive clinical trial data.
§ 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.