DePuy Actis DuoFix Hip Prosthesis

• K Number: K160907
• Device Name: DePuy Actis DuoFix Hip Prosthesis
• Manufacturer: DEPUY (IRELAND)
• Date Cleared: 2016-07-19 ( 109 days)
• Product Code: MEH , KWL , KWY , LPH
• Regulation Number: 888.3353
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K150862

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

Device Description

The DePuy Actis DuoFix Hip prostheses are manufactured from forged titanium alloy (Ti6Al4V) 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 describes the DePuy Actis DuoFix Hip Prosthesis, a hip implant. The submission is a 510(k) premarket notification for a line extension (an additional smaller size hip stem) of an already cleared device (K150862).

Here's an analysis of the acceptance criteria and study data provided:

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

For a medical device like a hip prosthesis, "acceptance criteria" usually refer to meeting specific performance standards in mechanical testing. Since this is a line extension of an existing device, the acceptance criteria would be for the new, smaller size stem to perform equivalently to the predicate devices and meet relevant ISO standards for hip prostheses.

The document states that the subject device (new smaller stem) is substantially equivalent to the predicate device (existing DePuy Actis DuoFix Hip Prosthesis). This implies that the new stem meets the same performance criteria as the previously cleared larger stems.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:

• Neck fatigue testing in accordance with ISO 7206-6:2013 | Met Neck fatigue testing in accordance with ISO 7206-6:2013 |
  | - Distal fatigue testing in accordance with ISO 7206-4:2010 | Met Distal fatigue testing in accordance with ISO 7206-4:2010 |
  | Biocompatibility/Sterility:
• Pyrogenicity testing standards | Met Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST-72:2011 |
  | Material:
• Use of Ti6AL4V with Porocoat and plasma sprayed HA coating | Ti6AL4V with Porocoat and plasma sprayed HA coating (Same as predicate) |
  | Fixation:
• Uncemented | Uncemented (Same as predicate) |
  | Sterile Method:
• Gamma sterilization | Gamma (Same as predicate) |
  | Packaging:
• Inner nylon pouch and outer PETG blister with Tyvek peel lid | Inner nylon pouch and outer PETG blister with Tyvek peel lid (Same as predicate) |
  | Shelf Life:
• 10 years | 10 years (Same as predicate) |
  | Overall:
• Substantial Equivalence to predicate device | Conclusion: "The subject devices are substantially equivalent to the predicate DePuy Actis DuoFix Hip Prosthesis." (This is the ultimate acceptance criterion for 510(k)). |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily refers to non-clinical (bench) testing for mechanical and biocompatibility assessments. Therefore, the "sample size" for the test set would refer to the number of prostheses or components tested in each specific mechanical and pyrogenicity test. This information (e.g., how many stems were subjected to fatigue testing) is not explicitly provided in the summary.

The data provenance is not mentioned in terms of country of origin, but it is non-clinical laboratory data, likely generated internally by DePuy or by contract testing organizations. It would be considered prospective in the sense that the tests were designed and executed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device submission. The "ground truth" for hip prostheses in a 510(k) for a line extension is established through adherence to recognized performance standards (e.g., ISO standards) and comparison to the predicate device's established performance. This does not involve expert consensus on clinical cases or image interpretation.

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

This question is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations of clinical data or images. Since no clinical trials or expert interpretations of such data were conducted for this 510(k) submission, there is no adjudication method.

5. 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices often involving artificial intelligence (AI), not for hip prostheses which are mechanical implants.

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

No, a standalone algorithm performance evaluation was not done. This device is a mechanical implant and does not involve an algorithm.

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

The "ground truth" for this device's performance is based on:

• Adherence to internationally recognized standards: Specifically, ISO 7206-6:2013 for neck fatigue and ISO 7206-4:2010 for distal fatigue, and ANSI/AAMI ST-72:2011 for pyrogenicity. These standards define the acceptable performance limits and test methodologies.
• Demonstration of equivalence to a legally marketed predicate device: The predicate device (K150862) had already established its safety and effectiveness through similar performance data. The new device's ground truth is that it performs similarly to the predicate.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is a mechanical device, not an AI/machine learning algorithm.

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

This question is not applicable for the reasons stated above.

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.