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

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

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 treation.
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 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.

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.

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

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dvsplasia.
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, hem-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankvloses.

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 hemiarthroplasty.

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 (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.

This document pertains to a 510(k) premarket notification for a medical device, the DePuy Corail AMT Hip Prosthesis. The purpose of this submission, as stated, is to extend the approved shelf life of the device from 5 years to 10 years.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to demonstrating that the device remains safe and effective for the extended shelf life, specifically focusing on the integrity of the Hydroxyapatite (HA) coating after extended aging.

Based on the provided text, while the document confirms the device's substantial equivalence for its extended shelf life, it does not contain the detailed information typically found in an AI/software as a medical device (SaMD) study regarding performance criteria, sample sizes, expert qualifications, or multi-reader studies. The studies mentioned are primarily non-clinical bench tests focused on material properties after aging.

Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is absent:

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

The document mentions specific non-clinical tests performed, implying that the acceptance criteria are related to meeting the standards outlined in those test methods. However, the exact quantitative acceptance criteria (e.g., "HA coating adhesion strength > X MPa") and the numerical results of the device performance against those criteria are not explicitly reported in the text. The document only confirms that these tests were performed and conclude substantial equivalence.

• ISO-13779-3 (Chemical analysis, crystallinity, phase purity)
• ASTM F1854 (Stereological evaluation of porous coatings)
• ASTM E2109 (Area percentage porosity in thermal sprayed coatings) | The tests were performed and supported the conclusion of substantial equivalence for the 10-year shelf life, implying the device met the required specifications for HA coating integrity after extended aging. |

2. Sample sizes used for the test set and the data provenance

• Sample sizes for the test set: Not specified in the provided document. The text states "the following tests were performed," but does not mention the number of units tested.
• Data provenance: The tests were performed on "shelf-aged product." The country of origin of the data is not specified, but the applicant is DePuy (Ireland). The studies are inherently prospective in the sense that they are designed to simulate future aging, but performed in a controlled laboratory setting.

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

• Number of experts and qualifications: Not applicable to this type of non-clinical bench testing. Ground truth for these tests is established by adhering to standardized test methods (ISO, ASTM) and using calibrated laboratory equipment and trained technicians/engineers. There is no human interpretation of images or clinical outcomes that would require expert consensus.

4. Adjudication method for the test set

• Adjudication method: Not applicable to this type of non-clinical bench testing. The results are quantitative measurements against established standards, not subjective interpretations requiring 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

• MRMC study: No. This device is a hip prosthesis, not an AI or imaging device. Therefore, MRMC studies are not relevant to its clearance.

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

• Standalone performance: No. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Type of ground truth: For the non-clinical tests, the "ground truth" is defined by the standardized methodologies and specifications outlined in ISO and ASTM standards. For example, the ground truth for HA coating crystallinity would be the measurement obtained by a specified analytical technique (e.g., X-ray diffraction) that meets the criteria of ISO-13779-3.

8. The sample size for the training set

• Sample size for training set: Not applicable. This device does not involve machine learning or a "training set." The tests conducted are to confirm the physical properties of the device over its extended shelf life.

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

• How ground truth was established: Not applicable. As there is no training set involved, this question is not relevant.

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

1. A severely painful and/or disabled joint from osteoarthritis, 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, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankyloses.

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 treation.

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 stem family 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.

Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that this document is for a medical device (hip prosthesis) and not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories related to AI performance, such as MRMC studies, reader improvements, AI-specific ground truth, and training sets, are not applicable.

The submission is a 510(k) for the DePuy Corail AMT Hip Prosthesis, seeking substantial equivalence to already marketed predicate devices. The reason for the submission is a change in manufacturing and sterilization facility and a slight modification to packaging. The core device design, principle of operation, and materials remain the same as the predicate devices.

Acceptance Criteria and Device Performance (for a Hip Prosthesis)

Since this is a non-AI medical device, the "acceptance criteria" are related to established standards for biocompatibility, sterility, and coating characteristics, rather than diagnostic or analytical performance metrics.

Study Details (Not applicable for an AI device in this context)

Since the provided document is for a physical medical device (hip prosthesis) and not an AI/SaMD, most of the requested fields related to AI performance are not available or applicable.

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

   • Not Applicable (N/A) for AI/SaMD. For this physical device, "test sets" would refer to samples used in engineering and biological testing (e.g., specific hip prosthesis components tested for strength, coating adherence, sterility). The document does not specify the number of units tested for each non-clinical test, nor does it detail data provenance beyond the device's manufacturing origin (Ireland).

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

   • N/A for AI/SaMD. Ground truth as defined for AI is not relevant here. For a physical medical device, "ground truth" might refer to established physical properties or biological responses, which are determined by standardized testing methods and scientific consensus, not expert consensus on interpretations.

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

   • N/A for AI/SaMD. Adjudication methods are typically used in clinical studies or human-reader performance evaluations, which are not detailed for this non-clinical submission.

4. 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:

   • N/A. This is a physical hip prosthesis, not an AI system. No MRMC study was conducted or is relevant.

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

   • N/A. This is a physical hip prosthesis, not an AI algorithm.

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

   • N/A for AI/SaMD. For the physical device, the "ground truth" for non-clinical tests would be defined by the specifications of the standards themselves (e.g., a material is "biocompatible" if it passes ISO 10993 tests, a sterilization process is "validated" if it meets the sterility assurance level (SAL) defined by ISO 11137). There is no "pathology" or "outcomes data" specifically mentioned for establishing "ground truth" in this non-clinical submission.

7. The sample size for the training set:

   • N/A. This is a physical hip prosthesis, not an AI system, so there is no "training set."

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

   • N/A. As there is no training set for an AI system, this question is not applicable.

Ask a specific question about this device

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 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.

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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.

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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.

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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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