(267 days)
Total hip replacement or hip arthroplasty is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
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 hemi-arthroplasty.
HA coated stems of the Corail Hip System are indicated for cementless use only.
The DePuy Corail AMT hip stems 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. The stems are compatible with both unipolar and bipolar heads intended for hip hemi-arthroplasty and with modular femoral heads intended for total hip arthroplasty.
The document describes a 510(k) premarket notification for the DePuy Corail AMT Hip Prosthesis, which is a medical device. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (DePuy Corail AMT Hip Prosthesis K123991) and includes additional sizes, neck angles, and neck offsets as a line extension.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a tabular format for the device's overall performance. Instead, it lists non-clinical tests conducted for determination of substantial equivalence, implying that compliance with these test standards is the performance criteria. The reported performance is that the device passed these tests, indicating it met the requirements of each standard.
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| Neck fatigue testing in accordance with ISO 7206-6:1992 | Passed / Compliant |
| Distal fatigue testing in accordance with ISO 7206-4:2010 | Passed / Compliant |
| Validation of taper dimension | Passed / Compliant |
| Validation of taper to head and neck to head dimension | Passed / Compliant |
| Range of motion in accordance with ISO 21535:2007 | Passed / Compliant |
| Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST72:2011 | Passed / Compliant |
| Hydroxyapatite coating characterization, as specified by FDA Guidance 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants, in accordance with ASTM F1160-05:2011, ASTM F1044-05:2011, ASTM F1147-05:2011, ASTM F1926:2010 and ISO 13779-3:2008 | Passed / Compliant |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to non-clinical (laboratory) testing, not clinical studies with patients. Therefore, the concept of a "test set" in the context of patient data, data provenance, or retrospective/prospective data does not apply here. The sample sizes for the mechanical and material tests (e.g., number of hip stems tested for fatigue) are not specified in the provided summary.
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 pertains to clinical studies and the establishment of ground truth by human experts. Since no clinical tests were conducted for substantial equivalence, this information is not applicable and thus not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical tests with patient data were performed, there was no "test set" requiring expert adjudication. This information is not applicable.
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
The device described is a hip prosthesis, a physical implant. It is not an AI/software device that would involve human readers or MRMC studies to assess improvement with AI assistance. Therefore, this information is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of an algorithm without human intervention, which is relevant for AI/software devices. The DePuy Corail AMT Hip Prosthesis is a physical medical device, not an algorithm. Therefore, this information is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the respective ISO, ASTM, and ANSI/AAMI standards. The device's components (neck, distal region, taper, coating) were tested against the performance parameters defined by these engineering and material standards.
8. The sample size for the training set
This question is typically relevant for machine learning or AI models, where a "training set" of data is used to develop the algorithm. Since the device is a physical hip prosthesis and its substantial equivalence was determined through non-clinical (mechanical and material) testing, there is no "training set" in this context.
9. How the ground truth for the training set was established
As there is no training set for this type of device, this information 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.