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The use of CORAIL Cemented Femoral Stems is indicated in Total and Hemi hip replacements.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Avascular necrosis of the femoral head.
3. Non-union of femoral neck fractures.
4. Certain high subcapital and femoral neck fractures in the elderly.
5. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
6. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.

The DePuy CORAIL Cemented Femoral Stems are indicated only for use with bone cement.

The CORAIL Cemented Femoral Stem is manufactured from wrought high nitrogen stainless steel, and is designed to be used as one component of a system of prostheses in hip arthroplasty. The stems are compatible with both unipolar and bipolar femoral heads intended for hemi-hip arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty. The CORAIL Cemented Femoral Stem implants are uncoated with a polished finish, intended for use with bone cement. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for a wide range of patients. The CORAIL Cemented Femoral Stem is designed to provide a cemented version of the primary predicate DePuy CORAIL AMT Hip Prosthesis stem (cleared under 510(k) K123991).

This FDA 510(k) summary describes a new device, the CORAIL Cemented Femoral Stem, and its comparison to predicate devices, but it does not include any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

• "No clinical tests were conducted to demonstrate substantial equivalence." (Page 10)
• The non-clinical tests were conducted "to demonstrate its substantial equivalence of safety and effectivenes to the identified predicate devices." (Page 10)

The "acceptance criteria" presented in the document are primarily the technological characteristics of the device being compared to predicate devices to establish substantial equivalence, rather than performance metrics with specific targets. The "study" mentioned consists of a series of non-clinical tests (mechanical, material, sterilization, biocompatibility, etc.) designed to show that the new device is as safe and effective as the predicate devices, not that it meets specific, predefined performance thresholds against a gold standard in a clinical context.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This detailed information is not included. The document compares features of the new device to predicates as shown in the "SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES" (pages 6-9), but these are comparisons of design and material, not performance against specific acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical study with a test set is described. Non-clinical tests typically use material samples or prototypes, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set requiring expert ground truth.
4. Adjudication method for the test set: Not applicable as there is no clinical test set.
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 device is a physical hip stem, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hip stem.
7. The type of ground truth used: Not applicable as there is no clinical test set requiring ground truth.
8. The sample size for the training set: Not applicable as there is no machine learning component or training set discussed.
9. How the ground truth for the training set was established: Not applicable as there is no machine learning component or training set discussed.

Summary of Non-Clinical Tests Conducted (relevant to the "study" aspect as provided):

The document lists the following non-clinical tests to demonstrate substantial equivalence:

• Distal fatigue and neck fatigue: performed per ISO 7206-4:2010, ISO 7206:2013 and ASTM F2068-3.
• Range of motion: performed per EN ISO 21535:2009+A1:2016.
• MRI Safety: performed per ASTM F2503-23, ASTM F2182-19e2, ASTM F2052-21, ASTM F2213-17 and ASTM F2119-07.
• Biocompatibility testing: performed per EN ISO 10993-1-2018, ISO 10993-3:2014, ISO 1099-5:2009, ISO 1099-6:2016, ISO 1099-10:2010, ISO 10993-11:2017, ISO 10993-12:2012, ISO 10993-18:2020, BS EN ISO 22442-1:2015 and ISO 10993-17:2002.
• Bacterial endotoxins: performed per ANSI/AAMI ST 72:2019.

The conclusion from these non-clinical tests was that "The CORALL Cemented Femoral Stem is substantialy equivalent to the identified predicates with respect to minded use, indications, materials, geometry, range of sizes, and method of fixation. Results of performance that the CORAL Cemented Femoral Stem performs as well as the predicate devices DePuy CORAIL AMT Hip Prosthesis and C-STEM AMT LE Prosthesis (K123991 and K220216)." (Page 10)

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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:

• Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head. 2.
• Acute traumatic fracture of the femoral head 3. or neck.
• Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarhroplasty, surface replacement arthroplasty, or total hip replacement.
• 5. Certain cases of ankylosis.
     The non-porous Corail AMT Hip Stem is indicated for cementless use only.

The Corail AMT Hip is a tapered stem available both collarless and collared. This hip stem is manufactured from F-136 titanium (Ti-6Al-4V) and has a layer of hydroxyapatite (HA) coating applied. The Corail AMT Hip is available in standard offset, lateralized high offset and a Coxa vara lateralized offset. The standard offset stems, collared and collarless, are available in 11 sizes (Size 8 to Size 20). The lateralized high offset and the lateralized Coxa vara high offset are available in 8 sizes (Size 9 to Size 16).

The provided text is a 510(k) summary for the Corail AMT™ Hip Prosthesis. It does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document primarily focuses on:

• Device Description: What the Corail AMT Hip is, its materials, and available sizes.
• Intended Use and Indications for Use: Why the device is used and the conditions it's designed to treat (e.g., osteoarthritis, avascular necrosis).
• Substantial Equivalence: A declaration that the Corail AMT Hip is substantially equivalent to previously marketed predicate devices (HA Coating K953111 DePuy Corail® Hip stem and DePuy Titan™ K001991). This is the primary mechanism for clearance for Class II and some Class III devices in the US, rather than proving performance against specific acceptance criteria.
• Regulatory Classification: Identifying the device as Class II and Class III and the relevant CFR sections.
• FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot fulfill your request for: Acceptance Criteria, Reported Device Performance, Sample Size, Data Provenance, Number of Experts, Adjudication Method, MRMC study details, Standalone study details, Type of Ground Truth, Training Set Sample Size, or how Training Set Ground Truth was established.

The 510(k) process for this type of device (a hip prosthesis) typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials that establish acceptance criteria and performance against them in the way a novel AI or diagnostic device might. The focus is on comparing the new device's technological characteristics, materials, and intended use to those of the predicate device. If they are sufficiently similar, the new device is deemed as safe and effective as the predicate.

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The CORAIL® Total Hip Prosthesis is designed to restore hip mobility.

CORAIL® is a single-use, non-cemented, HA-coated prosthesis. The CORAIL® Total Hip Prosthesis is a complete set and consists of:

• femoral stem, made of titanium alloy and completely coated with hydroxyapatite, with a 12/14 morse taper; available with or without collar. It is grooved both vertically and horizontally to provide stability against driving in and rotation.
• Alumina or cobalt chrome femoral head
• acetabular cup, made of titanium alloy and coated with HA. Primary fixation is with two to five titanium screws, secondary fixation through HA.
• PE inserts available in flat-rim, anti-dislocation and reorientation.

This document is a 510(k) summary for the CORAIL® Total Hip Prosthesis. It does not contain the information required to answer your request in the specified format. Here's why:

1. Acceptance Criteria and Reported Device Performance Table: The document provides "success rates" (98% after 2 years, 97% after 5 years, 95% after 6 years) which could be interpreted as performance metrics, but it doesn't define formal "acceptance criteria" or present them in a comparable table as requested. This is a summary of clinical data, not a detailed study report.
2. Sample Size and Data Provenance (Test Set): The document states "over 38,000 implants... performed in Europe." This is a cumulative number of implants, not a specific sample size for a defined test set in a scientific study. The provenance is "Europe," and the data is retrospective ("Since its introduction in 1986").
3. Number and Qualifications of Experts (Test Set Ground Truth): This information is not provided. The data comes from general "success rates" in clinical practice, not a specific ground truth established by experts for a test set.
4. Adjudication Method (Test Set): This information is not provided.
5. MRMC Comparative Effectiveness Study: There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size for human readers with or without AI assistance. This device is a physical hip prosthesis, not an AI diagnostic tool.
6. Standalone Performance Study: There is no mention of a standalone performance study in the context of an algorithm's performance without human intervention. The "success rates" refer to the clinical performance of the device in patients.
7. Type of Ground Truth: The "ground truth" used appears to be clinical "success rates" over time from patient outcomes, reported by "Vidalain, J.P., MD, ARTRO Group - France." This is outcomes data, not expert consensus or pathology in the typical sense of a diagnostic device study.
8. Sample Size for Training Set: This device is a physical product, not an algorithm that requires a "training set" in the machine learning sense.
9. Ground Truth for Training Set: Not applicable, as it's not an AI/ML device.

In summary, this document is a regulatory submission for a medical device (hip prosthesis) and focuses on substantial equivalence and real-world clinical outcomes. It does not describe a study involving an AI/ML device with acceptance criteria, test sets, or ground truth establishment in the way your prompt is structured.

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