CONSENSUS APEX DOME HOLE PLUG by U.S. MEDICAL PRODUCTS, INC.

1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
1. Osteoarthrosis involving femoral and acetabular articular surfaces.
1. Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
1. Fracture-dislocation of the hip.
1. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

Device Description

The Consensus® Apex Dome Hole Plug (PMMA) is intended for use with the Consensus® Total Hip System as an addition to the the metal acetabilar shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Apex Dome Hole Plug (PMMA) is designed for use with size compatible Consensus® Total Hip System components:

Porous coated Acetabular Shell K922561 SE 07/21/93
Nonporous Acetabular Shell K922561 SE 07/21/93
Acetabular Insert, UHMWPE K922561 SE 07/21/93

The Concensus® Apex Dome Hole Plug (PMMA) will be provided sterile and will be available in one size. The material will be polymethylmethacrylate (PMMA), ASTM F451.

AI/ML Overview

The acceptance criteria and study information cannot be extracted from the provided text. The document is a 510(k) summary for a medical device (CONSENSUS® Apex Dome Hole Plug (PMMA)) and primarily focuses on establishing substantial equivalence to previously approved predicate devices, rather than presenting a performance study against specific acceptance criteria.

Here's why the requested information cannot be found:

No acceptance criteria or device performance table: The document states "Performance Data: The Consensus® Apex Dome Hole Plug (PMMA), device performs with substantial equivalence to predicate devices." This is a claim of equivalence, not a presentation of specific performance metrics against defined acceptance criteria.
No sample sizes, data provenance, expert information, or adjudication methods: Since no performance study (clinical or standalone) with a test set is described, there's no mention of these details.
No MRMC comparative effectiveness study: The document does not describe any study involving human readers or AI assistance.
No standalone (algorithm only) performance study: The device described is a physical medical implant, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
No specific ground truth: The concept of "ground truth" as it applies to AI/algorithm performance studies is not relevant to this type of device submission.
No training set information: Similarly, as this is a physical device, there is no "training set" in the context of machine learning.

The 510(k) process for this device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and material properties, rather than new, extensive performance trials with defined acceptance criteria and ground truth. The statement "Clinical Data: None Required" further supports this, indicating that new clinical trials were not deemed necessary for this submission.

Summary

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KL0340

ATTACHMENT 8

K960340

Summary of Safety and Effectiveness 510(k) SUMMARY

US MEDICAL PRODUCTS, INC. CONSENSUS® Apex Dome Hole Plug (PMMA)

MAR 1 5 1996

US Medical Products, Inc.12201 Technology Blvd.Suite 100Austin, Texas 78727	William N. Thompson, DirectorQuality Assurance and Regulatory AffairsVoice (512) 257-4835Fax (512) 257-8300Date of Preparation:	15 Dec 1995
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Trade Name:	CONSENSUS® Apex Dome Hole Plug
Common Name:	Hip replacement prosthesis, Acetabular Shell Apex Dome HolePlug (PMMA)

Classification Name: Class II device, under the following classification:

Prosthesis, Hip, Semi-Constrained Metal/ Polymer classification 21 CFR 888.3350

Substantial Equivalence: equivalent Apex Dome Hole Plug (PMMA) components are as follows:

Consensus® Acetabular Cement Pods K922561 SE 07/21/93

Device Description: The Consensus® Apex Dome Hole Plug (PMMA) is intended for use with the Consensus® Total Hip System as an addition to the the metal acetabilar shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Apex Dome Hole Plug (PMMA) is designed for use with size compatible Consensus® Total Hip System components:

Porous coated Acetabular Shell	K922561	SE 07/21/93
Nonporous Acetabular Shell	K922561	SE 07/21/93
Acetabular Insert, UHMWPE	K922561	SE 07/21/93

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The Concensus® Apex Dome Hole Plug (PMMA) will be provided sterile and will be available in one size. The material will be polymethylmethacrylate (PMMA), ASTM F451.

Intended Use: The CONSENSUS® Apex Dome Hole Plug (PMMA) is indicated for use in:

1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
1. Osteoarthrosis involving femoral and acetabular articular surfaces.
1. Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
1. Fracture-dislocation of the hip.
1. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

Summary of Technological Characteristics: The Consensus® Apex Dome Hole Plug (PMMA), is designed function as an optional plug for the acetabular shell dome apex hole. The Concensus® Apex Dome Hole Plug (PMMA), will be provided sterile and will be available in one size. The material will be polymethylmethacrylate (PMMA), ASTM F451.

Performance Data: The Consensus® Apex Dome Hole Plug (PMMA), device performs with substantial equivalence to predicate devices.

Clinical Data: None Required

Conclusions from Non-clinical and Clinical Data: The Consensus® Apex Dome Hole Plug (PMMA), is substantially equivalent to predicate devices.

Other Necessary Information: None Required

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.