(27 days)
Total hip replacement or hip arthroplasty is indicated in the following conditions.
- A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dvsplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hem-arthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankvloses.
Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
- Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
- Avascular necrosis of the femoral head.
- Non-union of femoral neck fractures.
- Certain high subcapital and femoral neck fractures in the elderly.
- Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
- Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.
HA coated stems of the Corail Hip system are indicated for cementless use only.
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.
This document pertains to a 510(k) premarket notification for a medical device, the DePuy Corail AMT Hip Prosthesis. The purpose of this submission, as stated, is to extend the approved shelf life of the device from 5 years to 10 years.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to demonstrating that the device remains safe and effective for the extended shelf life, specifically focusing on the integrity of the Hydroxyapatite (HA) coating after extended aging.
Based on the provided text, while the document confirms the device's substantial equivalence for its extended shelf life, it does not contain the detailed information typically found in an AI/software as a medical device (SaMD) study regarding performance criteria, sample sizes, expert qualifications, or multi-reader studies. The studies mentioned are primarily non-clinical bench tests focused on material properties after aging.
Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
The document mentions specific non-clinical tests performed, implying that the acceptance criteria are related to meeting the standards outlined in those test methods. However, the exact quantitative acceptance criteria (e.g., "HA coating adhesion strength > X MPa") and the numerical results of the device performance against those criteria are not explicitly reported in the text. The document only confirms that these tests were performed and conclude substantial equivalence.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Inferred from conclusion) |
|---|---|
| Meeting specifications for HA coating characteristics on shelf-aged product per: |
- ISO-13779-3 (Chemical analysis, crystallinity, phase purity)
- ASTM F1854 (Stereological evaluation of porous coatings)
- ASTM E2109 (Area percentage porosity in thermal sprayed coatings) | The tests were performed and supported the conclusion of substantial equivalence for the 10-year shelf life, implying the device met the required specifications for HA coating integrity after extended aging. |
2. Sample sizes used for the test set and the data provenance
- Sample sizes for the test set: Not specified in the provided document. The text states "the following tests were performed," but does not mention the number of units tested.
- Data provenance: The tests were performed on "shelf-aged product." The country of origin of the data is not specified, but the applicant is DePuy (Ireland). The studies are inherently prospective in the sense that they are designed to simulate future aging, but performed in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts and qualifications: Not applicable to this type of non-clinical bench testing. Ground truth for these tests is established by adhering to standardized test methods (ISO, ASTM) and using calibrated laboratory equipment and trained technicians/engineers. There is no human interpretation of images or clinical outcomes that would require expert consensus.
4. Adjudication method for the test set
- Adjudication method: Not applicable to this type of non-clinical bench testing. The results are quantitative measurements against established standards, not subjective interpretations requiring adjudication.
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
- MRMC study: No. This device is a hip prosthesis, not an AI or imaging device. Therefore, MRMC studies are not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone performance: No. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of ground truth: For the non-clinical tests, the "ground truth" is defined by the standardized methodologies and specifications outlined in ISO and ASTM standards. For example, the ground truth for HA coating crystallinity would be the measurement obtained by a specified analytical technique (e.g., X-ray diffraction) that meets the criteria of ISO-13779-3.
8. The sample size for the training set
- Sample size for training set: Not applicable. This device does not involve machine learning or a "training set." The tests conducted are to confirm the physical properties of the device over its extended shelf life.
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable. As there is no training set involved, this question is not relevant.
§ 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.