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The Prime Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusio acetabuli, and painful hip dysplasia:
• 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
• 3. correction of functional deformity; and,
• 4. revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

The Prime Acetabular Cup System includes acetabular shells, acetabular liners, and optional cancellous bone screws. The design features are summarized below:

• · Acetabular Shells
  • Manufactured from titanium alloy о
  • BIOFOAM® coated o
  • Available in Solid or Quad configurations o
  • Outer Diameter sizes 42mm to 68mm in 2mm increments O
• Acetabular Liners ●
  • Manufactured from A-CLASS® (highly crosslinked ultra-high molecular o weight polyethylene)
  • Lipped Available in in Standard, or Face-changing Lateralized O configurations with 12 anti-rotational tabs
  • Inner Diameter sizes 22mm to 44mm O
• Bone Screws ●
  • Manufactured from titanium alloy o
  • 6.5mm diameter O
  • 0 Available in lengths 15mm to 80mm in 5mm increments

The subject Acetabular Liner has undergone design changes in regard to the locking detail; all other design aspects, intended use, fundamental scientific technology, and material remain identical to the predicate K170444 Acetabular Liner.

This looks like a 510(k) summary for a medical device (Prime Acetabular Cup System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

As such, it does not contain the specific information requested in your prompt regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.

The document primarily provides:

• Device Description and Intended Use: Details the components of the Prime Acetabular Cup System (Acetabular Shells, Liners, Bone Screws) and their intended applications in total hip arthroplasty.
• Substantial Equivalence Justification: States that the device is substantially equivalent to predicate devices (PROCOTYL® PRIME Acetabular Cup System, K170444) based on identical indications for use, similar materials (for the liner, drawing on K052026), and unchanged design features for shells and screws since K170444.
• Nonclinical Testing: Lists bench tests performed on the subject device (liner push-out, lever-out, torque-out per ASTM F1820, ASTM STP1301) and references tests performed on the predicate device and deemed applicable (deformation, frictional torque, wear, fatigue, range of motion, screw properties).
• Clinical Testing: Explicitly states that clinical data was not provided for the subject devices.
• Biocompatibility: Justifies not performing specific biocompatibility tests on the subject implants as their materials and patient contact are identical to predicate devices.
• Compatibility Tables: Details compatibility with other MicroPort Orthopedics products.
• Sterilization Residuals: Discusses previous evaluations and current applicability.

Therefore, I cannot populate the requested table and answer your questions directly from the provided text. The document does not describe a study with acceptance criteria in the context of clinical performance or diagnostic accuracy, which is implied by your prompt's questions. It focuses on engineering and material equivalence testing for an orthopedic implant.

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The Interface™ Acetabular Cup Liners are intended for use with the Interface™ Acetabular Cup, in combination with the Apex Modular™, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• e Rheumatoid arthritis:
• . Correction of functional deformity;
• . Congenital dislocation:
• . Revision procedures where other treatments or devices have failed;
• Femoral neck and trochanteric fractures of the proximal femur. .

The Interface™ Acetabular Cup Liners are manufactured of compression molded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 28 mm, 32 mm or 36 mm diameter. The subject device adds an option for a 20° elevated rim that was not previously offered.

The provided text describes a 510(k) premarket notification for the "Interface™ Acetabular Cup Liners." This submission focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a study of the device's clinical performance against specific acceptance criteria in the manner of a clinical trial for an AI/ML medical device.

Therefore, the specific information requested about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and training sets (relevant to AI/ML device studies) is not applicable to this 510(k) submission for a physical orthopedic implant.

Here's why and what information is available:

• Nature of the Device: The Interface™ Acetabular Cup Liners are physical medical devices (orthopedic implants) used in total hip replacement procedures. They are not an AI/ML algorithm or software that performs diagnostic or prognostic functions.
• Regulatory Pathway (510(k)): A 510(k) submission demonstrates "substantial equivalence" to a legally marketed predicate device. This typically involves comparing design, materials, manufacturing processes, intended use, and performance characteristics (often mechanical testing for implants) to established, safe, and effective devices. It does not generally require new clinical trials or performance studies against predefined clinical acceptance criteria in the same way an AI/ML device would.

What is provided in the document and how it relates to "acceptance criteria" for a physical device:

The "acceptance criteria" in this context are primarily the demonstration of substantial equivalence to predicate devices. The study proving this involves detailed comparisons rather than a clinical performance study.

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are implicitly meeting the design, material, and functional equivalence to the predicates. The "reported device performance" is the comparison showing these equivalences.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a clinical study involving a test set of patient data. The "test" is the comparison of device characteristics to predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the clinical sense, is not established for this type of submission. The "ground truth" is the established safety and effectiveness of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. 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 is an orthopedic implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. For this 510(k) submission, the "ground truth" (or basis of comparison) is the known safety and effectiveness profiles of the predicate devices (Interface™ (K031110), ApeX-LNK Poly™ (K062489 and K073150), and Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners) as determined by their prior FDA clearances and long-standing use in the market.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) premarket notification that demonstrates substantial equivalence for a physical medical device (acetabular cup liners). The "study" proving it meets "acceptance criteria" involves a detailed comparison of its design, materials, and intended use against already cleared predicate devices. The concepts of test sets, training sets, expert ground truth, and AI-assisted performance are not relevant to this type of regulatory submission.

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The acetabular cup is intended for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJ) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fuscd hip, fracture of the pelvis, and diastrophic variant.

The ZCA Snap-In Cup is a single unit manufactured from ultra-high molecular weight polyethylene (UHMWPE). The interior of the cup is designed to allow snap fitting of a 32 mm head into the articular surface through matcrial interference around the inner diameter rim. The ZCA Snap-In Cup is designed with a neutral face and is provided in outer diameter sizes ranging from 49 to 61 mm in 2 mm increments to fit varying anatomical requirements. The ZCA Snap-In Cup is hemispherical in shape and has four press-fit PMMA cement spacers affixed to the outer diameter to centralize the cup and help maintain a uniform 3 mm cement mantle. Radiopaque stainless steel wires at the dome and equator are used to determine the location and orientation of the component radiographically. Grooves and scallops on the outer surface are used for optimal cement interdigitation.

The provided text is related to a 510(k) premarket notification for a medical device: the ZCA All-Poly Acetabular Cup, Snap-In. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the safety and effectiveness of a novel device through clinical trials and rigorous acceptance criteria studies as might be seen for entirely new technologies, especially those involving AI or imaging.

Therefore, the document does not contain the requested information regarding acceptance criteria studies, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document primarily focuses on:

• Device Description: A physical description and materials of the acetabular cup.
• Intended Use/Indications for Use: The medical conditions the device is designed to address.
• Predicate Devices: A list of existing, legally marketed devices to which the ZCA Snap-In Cup is being compared for substantial equivalence.
• Substantial Equivalence Statement: The FDA's determination that the new device is substantially equivalent to predicate devices.

In the context of this 510(k) summary, the "acceptance criteria" for the device are largely implied by its substantial equivalence to predicate devices, meaning it performs as safely and effectively as already approved devices for the stated indications. Performance data typically involves mechanical testing or material characterization, but explicit details of such studies are not provided in this summary.

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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

The AcuMatch A-Series Porous Coated Acetabular Components are indicated for pressfit and cemented applications.

The A-Series acetabular component is a two piece device consisting of a porous metal acetabular shell and a mating polyethylene liner. The metal component is machined from titanium alloy (Ti-6A1-4V) conforming to ASTM F136-96. Three layers of chemically pure titanium beads conforming to ASTM F67-95, grade 2, are sintered to the outer surface of the metal shell to produce the porous coating.

There are three basic shell designs, each of which is available in 14 sizes. Each shell type is available with and without a hydroxyapatite (HA) coating on the beaded surface. The HA coating characteristics are defined in FDA Master File MAF 339 (BioCoat, Inc.).

The A-Series cups are intended for press-fit applications. Components without the HA coating may also be used in cemented applications. Instrumentation is used to prepare the cavity of the acetabulum for implanting of the shell. The A-Series shells are designed such that an interference condition is created between the prepared acetabulum and the rim diameter of the porous coated shell. Instrumentation is used to impact the shell into the bone for a secure fit. The cluster and multi-hole designs allow for use of Ti-6Al-4V bone screws to supplement fixation if desired.

The A-Series acetabular liner is composed of ultra-high-molecular-weight polyethylene (UHMWPE) as called out in ASTM F648-98. There are five primary liner designs with various sizes having the ability to accept 22, 26, 28, and 32 mm diameter femoral heads. The minimum bearing thickness for each liner type is greater than 6 mm.

The A-Series has an apical hole locking mechanism and a 12-tab anti-rotational indexing system at the rim of the cup.

The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device, specifically the Exactech® AcuMatch A-Series Porous Coated Acetabular Component. This document is a premarket notification to the FDA, demonstrating substantial equivalence to legally marketed predicate devices, rather than a study proving new acceptance criteria for the device's performance.

Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as it relates to performance metrics typically found in AI/ML medical device evaluations (e.g., sensitivity, specificity, F1 score, effect size from MRMC studies).

Here's why the requested information isn't present in this document type:

• Acceptance Criteria and Reported Device Performance: This document establishes "substantial equivalence" based on similar materials, design, intended use, and technological features to previously approved devices. It does not define new, specific performance acceptance criteria (like diagnostic accuracy metrics) for the A-Series acetabular component itself. The "performance" discussed is primarily related to mechanical properties and design aspects compared to predicate devices.
• Sample Size and Data Provenance: This is not applicable as it's not an AI/ML study with a test set of data.
• Number of Experts and Qualifications: Not applicable for this type of device submission.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable as it's not an algorithm.
• Type of Ground Truth: Not applicable, as there's no diagnostic task or "ground truth" in the AI/ML sense.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does provide in relation to "performance":

The document focuses on demonstrating that the A-Series component is substantially equivalent to existing, legally marketed hip prosthesis acetabular components. This equivalence is shown through:

• Material Equivalence: Identical material specifications (titanium alloy for the shell, UHMWPE for the liner) as predicate devices.
• Design Equivalence (with variations and comparative testing):
  • Similar hemispherical outside geometries.
  • Similar surface coatings (three uniform layers of titanium beads, optional HA coating).
  • Differences in shell hole configurations (no-hole, multi-hole, cluster hole) and liner designs (extended coverage, lateralized options) compared to the MCS line.
  • Mechanical Testing for Design Differences: "Tests were performed to determine the torsional strength of the proposed A-Series system in comparison to Exactech's MCS cup. The torsional study shows that the locking mechanism on the A-Series is stronger than the same size MCS component. Another engineering evaluation shows that the force required to disengage an A-Series liner from its shell exceeds the force required to disassemble the MCS component."
  • Clearance Modeling: An "engineering report modeling the clearance between the spherical radius of the A-Series shell and liner shows a 0.008 inch difference for the least material condition and 0.001 inch difference for the maximum material condition."
  • Lever Out Torque Analysis: "Lever out torque analysis of the new Exactech A-Series component places the strength of the locking mechanism in the range of other legally marketed devices."

Essentially, the "study" demonstrating performance here is an engineering evaluation and comparative mechanical testing (torsional strength, disengagement force, lever out torque) against predicate devices to show that any design changes do not negatively impact safety and effectiveness or, in some cases, show improvement. However, these are not quantified in terms of specific acceptance criteria or an AI/ML study format.

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