(260 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 provided is a 510(k) premarket notification for a medical device, specifically the DePuy Corail AMT Hip Prosthesis. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a study. Therefore, the information requested (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training set information) is generally not applicable or available within this type of regulatory document.
The 510(k) submission focuses on comparing the new device to existing legally marketed devices to show that they are as safe and effective. The "Performance Data" section primarily lists non-clinical tests conducted to support substantial equivalence, rather than detailed studies with acceptance criteria and reported performance values in the way you've described for an AI/algorithm-based device.
Here's why each point is largely unaddressable and what information is available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in this context. This document doesn't present acceptance criteria for an AI algorithm's performance. Instead, it describes physical and material characteristics of a hip prosthesis and confirms it meets standards typically through engineering tests.
- Available Information: The document lists non-clinical tests performed, such as:
- Neck fatigue testing in accordance with ISO 7206-6:1992
- Distal fatigue testing in accordance with ISO 7206-4:2010
- Taper compatibility test
- Range of motion in accordance with ISO 21535:2009
- Reamer verification test
- Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST72:2011
- Hydroxyapatite coating process validations
- However, specific acceptance criteria values (e.g., "fatigue strength must exceed X MPa") and the exact reported performance values from these tests are not provided in this summary document. The submission implicitly states these tests were conducted successfully to demonstrate substantial equivalence, meaning the results were comparable to the predicate device and met relevant industry standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. As this is for a physical orthopedic implant, there isn't a "test set" of data in the sense of a dataset for an AI algorithm. The tests mentioned are engineering and material science tests.
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)
- Not Applicable. "Ground truth" in the context of an AI algorithm is not relevant here. The "ground truth" for the performance of a hip prosthesis would be defined by engineering standards, material properties, and clinical outcomes over time, rather than expert interpretation of a specific dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are associated with reviewing and resolving discrepancies in expert labeling or diagnoses on data, which is not relevant for this device.
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. MRMC studies are used to evaluate diagnostic imaging systems, often in conjunction with AI. This document pertains to a physical hip implant, so such studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. See point 3. "Ground truth" for this device would relate to validated engineering specifications, biomechanical properties, material analyses, and ultimately long-term clinical follow-up data (which is not part of a 510(k) submission for substantial equivalence).
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI algorithm. There is no "training set" of data.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical device, not an AI algorithm. There is no "training set" of data or ground truth to be established for it.
In summary: The provided document is a 510(k) premarket notification for a physical medical device (hip prosthesis). It demonstrates substantial equivalence to predicate devices through comparisons of intended use, materials, design features, and by stating that non-clinical engineering and material tests were conducted in accordance with relevant standards. It explicitly states that "No clinical tests were conducted to demonstrate substantial equivalence." The questions posed are primarily relevant to the evaluation of AI/software as a medical device, which is not what this document addresses.
§ 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.