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K Number
K192946
Device Name
DePuy Corail AMT Hip Prosthesis
Manufacturer
DePuy Orthopaedics, Inc.
Date Cleared
2019-11-26

(39 days)

Product Code
LZO,KWL,KWY,MEH
Regulation Number
888.3353
Type
Special
Panel
OR
Reference & Predicate Devices
K093736,K123991,K070554,K042992,K173960
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Total hip replacement or hip arthroplasty is indicated in the following conditions:

  1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.

  2. Avascular necrosis of the femoral head.

  3. Acute traumatic fracture of the femoral head or neck.

  4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.

  5. Certain cases of ankyloses.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

  1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.

  2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.

  3. Avascular necrosis of the femoral head.

  4. Non-union of femoral neck fractures.

  5. Certain high subcapital and femoral neck fractures in the elderly.

  6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.

  7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.

HA coated stems of the Corail Hip system are indicated for cementless use only.

Device Description

The DePuy Corail AMT hip stem family are manufactured from forged titanium alloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail AMT stems are available with or without a collar, with various neck angles, and with various neck offsets.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that this document is for a medical device (hip prosthesis) and not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories related to AI performance, such as MRMC studies, reader improvements, AI-specific ground truth, and training sets, are not applicable.

The submission is a 510(k) for the DePuy Corail AMT Hip Prosthesis, seeking substantial equivalence to already marketed predicate devices. The reason for the submission is a change in manufacturing and sterilization facility and a slight modification to packaging. The core device design, principle of operation, and materials remain the same as the predicate devices.

Acceptance Criteria and Device Performance (for a Hip Prosthesis)

Since this is a non-AI medical device, the "acceptance criteria" are related to established standards for biocompatibility, sterility, and coating characteristics, rather than diagnostic or analytical performance metrics.

Acceptance Criterion (Standard/Test)Reported Device Performance (Compliance/Result)
Biological Safety (per ISO 10993-1) "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"Demonstrated. (Implied compliance with the standard)
Sterilization Validation (per AAMI ANSI ISO 11137-1: 2006/(R)2010 and AAMI ANSI ISO 11137-2: 2013)Validated. (Implied compliance with the standard for gamma sterilization)
Characterization Testing of Hydroxyapatite Coating (per FDA Guidance: "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant")Characterized. (Implied compliance with FDA guidance for HA coating properties)
Substantial Equivalence (Overall Conclusion)The subject device is substantially equivalent to the predicate DePuy Corail AMT Hip Prosthesis products (K042992, K070554, K093736, K123991, K173960).

Study Details (Not applicable for an AI device in this context)

Since the provided document is for a physical medical device (hip prosthesis) and not an AI/SaMD, most of the requested fields related to AI performance are not available or applicable.

  1. Sample size used for the test set and the data provenance:

    • Not Applicable (N/A) for AI/SaMD. For this physical device, "test sets" would refer to samples used in engineering and biological testing (e.g., specific hip prosthesis components tested for strength, coating adherence, sterility). The document does not specify the number of units tested for each non-clinical test, nor does it detail data provenance beyond the device's manufacturing origin (Ireland).

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • N/A for AI/SaMD. Ground truth as defined for AI is not relevant here. For a physical medical device, "ground truth" might refer to established physical properties or biological responses, which are determined by standardized testing methods and scientific consensus, not expert consensus on interpretations.

  3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • N/A for AI/SaMD. Adjudication methods are typically used in clinical studies or human-reader performance evaluations, which are not detailed for this non-clinical submission.

  4. 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:

    • N/A. This is a physical hip prosthesis, not an AI system. No MRMC study was conducted or is relevant.

  5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • N/A. This is a physical hip prosthesis, not an AI algorithm.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • N/A for AI/SaMD. For the physical device, the "ground truth" for non-clinical tests would be defined by the specifications of the standards themselves (e.g., a material is "biocompatible" if it passes ISO 10993 tests, a sterilization process is "validated" if it meets the sterility assurance level (SAL) defined by ISO 11137). There is no "pathology" or "outcomes data" specifically mentioned for establishing "ground truth" in this non-clinical submission.

  7. The sample size for the training set:

    • N/A. This is a physical hip prosthesis, not an AI system, so there is no "training set."

  8. How the ground truth for the training set was established:

    • N/A. As there is no training set for an AI system, this question is not applicable.

§ 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.