DePuy Actis Duofox Hip Prosthesis

• K Number: K150862
• Device Name: DePuy Actis Duofox Hip Prosthesis
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Date Cleared: 2015-09-25 ( 177 days)
• Product Code: MEH , KWL , KWY , LPH
• Regulation Number: 888.3353
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K011489 , K123991

Intended Use

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

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, 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, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

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 treated with internal fixation.
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.

The Actis DuoFix Hip Prosthesis is indicated for cementless use only.

Device Description

The DePuy Actis DuoFix prostheses are manufactured from forged titanium alloy (Ti-6Al-4V) and have a sintered commercially pure titanium bead porous coating (Porocoat®) and thin layer of plasma-sprayed hydroxyapatite (HA) coating.
The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hemi-arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty.

AI/ML Overview

This document is a 510(k) premarket notification for the DePuy Actis DuoFix Hip Prosthesis. As such, it focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than establishing new performance criteria for a novel device or AI algorithm.

Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, and ground truth establishment, which are typical for assessing new medical devices or AI algorithms, is not explicitly present in the provided text.

Here's why and what information is available:

• Type of Device: The "DePuy Actis DuoFix Hip Prosthesis" is a physical medical device (an uncemented hip implant), not an AI-powered diagnostic or therapeutic tool.
• Purpose of Submission: This is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing technological characteristics and non-clinical performance data (e.g., mechanical tests, biocompatibility) rather than new clinical effectiveness studies with explicit acceptance criteria for diagnostic accuracy, sensitivity, or specificity.
• No Clinical Tests: The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." This directly negates the possibility of finding information about clinical test sets, ground truth, expert adjudication, or MRMC studies.

However, I can provide the information that is available from the document regarding the non-clinical tests conducted.

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Based on the provided document, here's what can be inferred and what information is not present:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the context of comparative performance as would be for an AI device. The acceptance is based on demonstrating substantial equivalence to the predicate devices through non-clinical testing.
   • Reported Device Performance: The document only lists the types of non-clinical tests performed. It does not provide the numerical results of these tests or specific performance metrics against an acceptance criterion. It simply states that these tests were "conducted for determination of substantial equivalence."

   Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
   Mechanical properties (e.g., fatigue strength) comparable to predicate devices.	Non-clinical tests were conducted for:

• Distal fatigue
• Neck fatigue
• Range of motion
• Biocompatibility |
  | Biocompatibility comparable to predicate devices. | |

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

   • Sample Size: Not specified for any of the non-clinical tests.
   • Data Provenance: Not applicable as no clinical data or test sets are mentioned. The testing would be laboratory-based on the physical devices.

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

   • Not applicable, as no clinical test set or ground truth (in the diagnostic sense) was established. The "truth" for mechanical integrity is inherent in material science and engineering standards.

4. Adjudication method for the test set:

   • Not applicable, as no clinical test set requiring expert adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. The document explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence." An MRMC study is a type of clinical study involving human readers.
   • Effect size: Not applicable, as no such study was performed.

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

   • Not applicable. This device is a physical hip prosthesis, not a software algorithm.

7. The type of ground truth used:

   • Not applicable in the context of diagnostic/AI devices. For this physical device, "ground truth" for non-clinical testing would refer to established engineering standards, material properties, and biocompatibility protocols.

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI model requiring a training set.

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

   • Not applicable. This is a physical device, not an AI model.

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Summary of available information:

• Non-Clinical Tests Conducted: Distal fatigue, neck fatigue, range of motion, biocompatibility.
• Clinical Tests Conducted: None.
• Comparison Basis: Substantial equivalence to predicate devices (DePuy Summit DuoFix Hip Prosthesis (K011489) and DePuy Corail AMT Hip Prosthesis (K123991)) based on technological characteristics and non-clinical performance.

Regulation Number and Section

§ 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.