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K Number
K953111
Device Name
CORAIL
Manufacturer
LANDOS, INC.
Date Cleared
1996-12-27

(543 days)

Product Code
LZO
Regulation Number
888.3353
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CORAIL® Total Hip Prosthesis is designed to restore hip mobility.

Device Description

CORAIL® is a single-use, non-cemented, HA-coated prosthesis. The CORAIL® Total Hip Prosthesis is a complete set and consists of:

  • femoral stem, made of titanium alloy and completely coated with hydroxyapatite, with a 12/14 morse taper; available with or without collar. It is grooved both vertically and horizontally to provide stability against driving in and rotation.
  • Alumina or cobalt chrome femoral head
  • acetabular cup, made of titanium alloy and coated with HA. Primary fixation is with two to five titanium screws, secondary fixation through HA.
  • PE inserts available in flat-rim, anti-dislocation and reorientation.
AI/ML Overview

This document is a 510(k) summary for the CORAIL® Total Hip Prosthesis. It does not contain the information required to answer your request in the specified format. Here's why:

  1. Acceptance Criteria and Reported Device Performance Table: The document provides "success rates" (98% after 2 years, 97% after 5 years, 95% after 6 years) which could be interpreted as performance metrics, but it doesn't define formal "acceptance criteria" or present them in a comparable table as requested. This is a summary of clinical data, not a detailed study report.
  2. Sample Size and Data Provenance (Test Set): The document states "over 38,000 implants... performed in Europe." This is a cumulative number of implants, not a specific sample size for a defined test set in a scientific study. The provenance is "Europe," and the data is retrospective ("Since its introduction in 1986").
  3. Number and Qualifications of Experts (Test Set Ground Truth): This information is not provided. The data comes from general "success rates" in clinical practice, not a specific ground truth established by experts for a test set.
  4. Adjudication Method (Test Set): This information is not provided.
  5. MRMC Comparative Effectiveness Study: There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size for human readers with or without AI assistance. This device is a physical hip prosthesis, not an AI diagnostic tool.
  6. Standalone Performance Study: There is no mention of a standalone performance study in the context of an algorithm's performance without human intervention. The "success rates" refer to the clinical performance of the device in patients.
  7. Type of Ground Truth: The "ground truth" used appears to be clinical "success rates" over time from patient outcomes, reported by "Vidalain, J.P., MD, ARTRO Group - France." This is outcomes data, not expert consensus or pathology in the typical sense of a diagnostic device study.
  8. Sample Size for Training Set: This device is a physical product, not an algorithm that requires a "training set" in the machine learning sense.
  9. Ground Truth for Training Set: Not applicable, as it's not an AI/ML device.

In summary, this document is a regulatory submission for a medical device (hip prosthesis) and focuses on substantial equivalence and real-world clinical outcomes. It does not describe a study involving an AI/ML device with acceptance criteria, test sets, or ground truth establishment in the way your prompt is structured.

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.