(196 days)
The Corail AMT Hip Prosthesis is intended for use in total hip arthroplasty and is intended for press fit (uncemented) use. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The non-porous Corail AMT Hip Stem is indicated for cementless use only.
The Corail AMT Hip Prosthesis is a collarless, hydroxyapatite coated titanium alloy femoral stem. The Corail AMT Hip Prosthesis is similar to the previously cleared Corail AMT Hip Prostheses but has a shorter stem length, shorter neck length and smaller cross-section. The Corail AMT Hip Prostheses is contraindicated in patients weighing more than 84 lbs.
The provided text is a government regulatory document (510(k) premarket notification summary) for a medical device, the DePuy Corail AMT Hip Prosthesis. This type of document focuses on establishing substantial equivalence to a previously cleared device, rather than providing a detailed study demonstrating performance against specific acceptance criteria.
Therefore, the document does not contain the kind of information typically found in a clinical study report that would establish acceptance criteria and prove a device meets them in the way the request implies (e.g., using metrics like sensitivity, specificity, or reader improvement with AI).
Here's an breakdown based on the provided text, highlighting what is (and isn't) present:
Acceptance Criteria and Device Performance (Not directly addressed in this document)
This document does not present a table of acceptance criteria and reported device performance in the form of a clinical study outcome. Instead, it relies on the concept of substantial equivalence. The "acceptance criteria" here implicitly refer to demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The "reported device performance" is not quantified in the way a clinical trial would (e.g., success rates, complication rates from a new study). Rather, it's inferred from the design similarities and in vitro testing (fatigue testing mentioned implicitly).
1. A table of acceptance criteria and the reported device performance
As stated above, this document does not contain such a table. The "acceptance" is regulatory clearance based on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not describe a clinical "test set" in the context of typical AI/medical device performance studies. The basis for substantial equivalence is primarily design similarity, materials, manufacturing methods, and in vitro fatigue testing, not human or patient data.
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 / Not provided. Ground truth establishment by experts is not a component of a 510(k) submission based on substantial equivalence for a hip prosthesis, unless there were specific clinical studies that are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are relevant for studies where multiple observers interpret data; this is not the nature of the evidence presented 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
- No. This is a hip prosthesis, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the typical sense. For this device, the "ground truth" for demonstrating safety and effectiveness implicitly relies on the long-term clinical performance and regulatory clearance of the predicate device. The demonstration of substantial equivalence focuses on showing that the new device (Corail AMT Hip Prosthesis) is similar enough to the predicate (previously cleared Corail AMT Hip Prostheses and DePuy S-Rom Femoral Hip Stem) in design, materials, manufacturing, and intended use as to raise no new questions of safety and effectiveness. The in vitro fatigue testing serves as a basis to show mechanical performance.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is not an AI/machine learning device.
Summary Regarding the Provided Document:
The provided text, a 510(k) summary, demonstrates the device meets regulatory requirements by establishing substantial equivalence to existing, legally marketed devices. This process does not typically involve the kind of rigorous clinical studies with explicit acceptance criteria, ground truth establishment by experts, or sample sizes for test/training sets as one would expect for an AI/diagnostic device or a PMA submission for a novel device. The "study" mentioned is primarily a comparison to predicate devices and in vitro fatigue testing to support the claim of equivalence.
§ 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.