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K Number
K011887
Device Name
AVALON CUP SYSTEM
Manufacturer
ORTHOPEDIC SOURCE INC.
Date Cleared
2001-12-27

(192 days)

Product Code
JDI,LWJ,LZO
Regulation Number
888.3350
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following:

    1. Non-inflammatory degenerative joint disease including: osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia,
    1. Inflammatory degenerative joint disease including rheumatoid arthritis;
    1. Correction of functional deformity;
    1. Revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for the "Avalon Cup System." This document is a regulatory approval, not a scientific study describing device performance and acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the document does not contain this type of data.

Specifically:

  • It does not contain a table of acceptance criteria or reported device performance.
  • It does not describe any study, sample sizes, data provenance, expert qualifications, or adjudication methods.
  • It does not mention MRMC comparative effectiveness studies, standalone algorithm performance, or ground truth types.
  • It does not discuss training sets or how ground truth for training sets was established.

This document solely indicates that the FDA has reviewed the submission for the Avalon Cup System and determined it is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It lists the indications for use but does not delve into the specific performance data that led to this determination.

§ 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.