(28 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 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 ankyloses.
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 treation.
- 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 stem family are manufactured from forged titanium alloy (Ti6A14V) 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 provided text is a 510(k) summary for the DePuy Corail AMT Hip Prosthesis. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel device performance through extensive clinical trials or AI/ML studies.
Therefore, many of the requested criteria (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, effect size of AI assistance, standalone performance, and details about training sets for AI devices) are not applicable to this type of regulatory submission as it does not involve an AI/ML device or a comparative effectiveness study with human readers.
However, the document does describe non-clinical tests conducted to support modifications to an existing device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in the format of a typical clinical trial or AI device validation study with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it lists various non-clinical tests performed to demonstrate product specifications and safety for changes introduced (new manufacturing site, increased shelf life, alternate manufacturing process). The "performance" is demonstrated by conforming to these established testing standards.
I will attempt to structure this into a table based on the non-clinical tests mentioned.
| Acceptance Criteria (Test Performed) | Reported Device Performance (Goal/Outcome) |
|---|---|
| HA Coating Characterization (per FDA Guidance 1997) | Supported addition of alternate HA coating site; full suite of characterization and testing completed. |
| Body Fatigue Testing (per ISO 7206-4) | Supported addition of alternate HA coating site; results demonstrate conformational design verification. |
| Neck Fatigue Testing (per ISO 7206-6) | Supported addition of alternate HA coating site; results demonstrate conformational design verification. |
| Visual Inspection (per ASTM F1886-16) | Supported increase in shelf life; integrity of seals confirmed. |
| Dye Leak Test (per ASTM F1929-15) | Supported increase in shelf life; seal leaks in porous medical packaging confirmed absent. |
| Seal Strength Test (per ASTM F88/F88M-15) | Supported increase in shelf life; strength of flexible barrier materials confirmed. |
| HA Coating Testing (per ISO-13779-2) on shelf-aged product | Supported increase in shelf life; characteristics of thermally sprayed HA coatings maintained after aging. |
| HA Coating Testing (per ISO-13779-3) on shelf-aged product | Supported increase in shelf life; chemical analysis, crystallinity, and phase purity of HA coatings maintained after aging. |
| HA Coating Testing (per ASTM F1854) on shelf-aged product | Supported increase in shelf life; stereological evaluation of porous coatings maintained after aging. |
| HA Coating Testing (per ASTM E2109) on shelf-aged product | Supported increase in shelf life; area percentage porosity in thermal sprayed coatings maintained after aging. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each non-clinical test. These tests typically involve a limited number of device samples or components subjected to specific mechanical, chemical, or aging conditions. There is no "data provenance" in terms terms of country of origin for patients, as no clinical data was used for this specific 510(k) submission. These are laboratory-based, non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for non-clinical engineering tests is established by documented industry standards (e.g., ISO, ASTM) and internal quality control processes, not by expert consensus in a medical diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring medical adjudication was used.
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
Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria specified by the relevant ISO and ASTM standards cited. For example, a seal strength test has a numerical minimum requirement for a "pass."
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.