Search Results

Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatoid 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, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip replacement or hip hemi-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. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. 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.

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.

Ask a specific question about this device

Total Hip Arthroplasty and Hemi Hip Arthroplasty

Total hip replacement or hip arthroplasty 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, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip replacement or hip hemi-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. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. 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 Corail AMT Hip is a tapered stem available both collarless and collared. The stems are manufactured from titanium alloy (Ti6Al4V) and plasma-sprayed with a biocompatible hydroxyapatite (HA) coating for bone fixation. The Corail AMT stems feature a 12/14 modular taper that accepts 12/14 heads with a wide range of diameters. The compatible components for the hip hemi-arthroplasty application are bipolar heads cleared via 510(k) K812672 and unipolar heads cleared via 510(k) K903084. Corail AMT stems are indicated for cementless use only.

The provided document describes the Corail AMTTM Hip Prosthesis, an orthopaedic device. The submission is a 510(k) to expand the cleared indication for use to include hip hemi-arthroplasty surgical application.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Non-clinical (Performance) Tests: The document does not specify the exact sample sizes (number of devices tested) for the "Validation of the taper/heads dimensional compatibility" or the "Fatigue Resistance tests." It only states that these tests were performed. Given the nature of these tests, they would typically involve a defined number of test articles to meet industry standards (e.g., ISO or ASTM standards for implant testing).
• Clinical Evaluation: No new clinical tests were conducted. The clinical evaluation utilized a "systematic literature review of Corail Hip System for the treatment of femoral neck fractures." The provenance of the data in this systematic review would depend on the included studies, but the document does not provide details on country of origin or whether these studies were retrospective or prospective. It is a compilation of retrospective existing scientific literature.

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. This submission relies on non-clinical performance testing and a literature review for clinical evaluation, not on a test set requiring expert ground truth for interpretation of images or other data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring expert adjudication.

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 a medical device for hip arthroplasty, not an AI-based diagnostic or imaging device that would typically involve MRMC studies or AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hip prosthesis, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Non-clinical (Performance) Tests: Ground truth for these tests is based on engineering specifications, material properties, and established test standards (e.g., demonstrating mechanical compatibility and fatigue life under simulated physiological conditions).
• Clinical Evaluation: The "ground truth" for the clinical evaluation is based on the outcomes data and findings reported in the systematic scientific literature review regarding the safety and effectiveness of the Corail Hip System for femoral neck fractures, by extension supporting the expanded indications for hemi-arthroplasty.

8. The sample size for the training set

Not applicable. This is a medical device for hip arthroplasty, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this type of device submission.

Ask a specific question about this device

A Delta CTA™ Reverse Shoulder Prosthesis is indicated for use in
• Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
• The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
• The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. For US Use Only: All other components are intended for cemented use only.

The Delta CTA™ Reverse Shoulder is DePuy's first generation reverse shoulder system. In a reverse shoulder, the articulation is "inverted" compared to traditional, anatomical total shoulder prosthesis so that the "ball" of the articulation is incorporated into the glenoid prosthesis and the "cup" of the articulation is incorporated into the humeral prosthesis. This inverted design helps stabilize a shoulder in the absence of a functional rotator cuff.

The provided document is a 510(k) premarket notification summary for the DePuy Delta CTA™ Reverse Shoulder System. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing acceptance criteria and performance data for a new AI/software medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for an AI/software device cannot be extracted from this document. This document describes a traditional medical device (shoulder prosthesis) and evaluates its substantial equivalence based on non-clinical performance and material characteristics, not AI performance.

Ask a specific question about this device

The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:

• . severe arthropathy and/or;
• a previously failed joint replacement and/or: ●
• fracture-dislocations of the proximal humerus where the articular surface is severely . comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed Delta Xtend Reverse Shoulder.

The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.

The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use.

All other metallic components are intended for cemented use only.

The DePuy Delta Xtend™ Reverse Shoulder System is a total shoulder prosthesis that consists of monobloc and modular humeral stems, humeral cup, humeral head, humeral spacer, glenosphere, metaglene and metaglene screws.

This document is a 510(k) Substantial Equivalence Determination Letter from the FDA for the DePuy Delta XTend™ Reverse Shoulder System. It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner typically understood for software or AI/ML devices.

The information provided pertains to the substantial equivalence of a medical device (shoulder prosthesis), not a software or AI/ML product. The "acceptance criteria" discussed are related to demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of technological characteristics.

Therefore, many of the requested fields (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size) are not applicable to the information presented in this document.

However, I can extract the relevant information from the document as it would apply to a physical medical device submission for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with numerical performance metrics as expected for software. Instead, the acceptance criteria for a physical device like this revolve around demonstrating equivalence in design, materials, intended use, and performance to a predicate device.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. The "test set" in this context refers to non-clinical testing and comparison of specifications, not a dataset of patient images or outcomes for an algorithm. The document mentions a "stack analysis" for the metaglene devices, implying detailed engineering comparison of physical components.
• Data Provenance: Not applicable. The data is derived from the design specifications and non-clinical testing of the physical device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth, in the context of AI/ML, refers to validated labels for a dataset. For a physical device, the "truth" is established through engineering design, material science, and mechanical testing against recognized standards. The "stack analysis" would likely involve qualified engineers or designers.

4. Adjudication method for the test set:

• Not applicable. There is no "adjudication" in the sense of expert consensus on interpretations for a dataset. The "adjudication" for substantial equivalence is performed by the FDA based on the manufacturer's submission and relevant regulations and guidance.

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 physical medical device (shoulder prosthesis), not an AI/ML product. Therefore, MRMC studies are not applicable.

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:

• Not applicable in the AI/ML context. For this medical device, the "ground truth" for its safety and effectiveness is established through adherence to engineering design principles, material standards, biocompatibility testing, and mechanical performance testing (e.g., fatigue, wear) to demonstrate its equivalence to already approved predicate devices. The document explicitly states "No non-clinical testing was required to demonstrate substantial equivalence" and "No clinical tests were conducted to demonstrate substantial equivalence," implying that the comparison of technological characteristics and design analysis were sufficient.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML product, so there is no training set.

9. How the ground truth for the training set was established:

• Not applicable.

Ask a specific question about this device