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The Depuy AML® Hip Prosthesis is intended for use in total hip arthroplasty (THA) in either a cementless or cemented application. Total hip arthroplasy 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:

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.

The AML® Hip Stem is indicated for cementless use with fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement.

The subject device, DePuy AML® Hip Prosthesis, is manufactured from ASTM F-799 Forged Controlled-Carbon Cobalt-Chromium-Molybdenum alloy and has a sintered cobalt-chrome molybdenum alloy bead porous coating (Porocoat@) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region. The stems are available in 10.5 and 12.0 mm sizes.

This appears to be a 510(k) premarket notification for a medical device (DePuy AML® Hip Prosthesis), specifically for demonstrating substantial equivalence to previously cleared devices. 510(k) submissions typically do not contain detailed clinical study data with acceptance criteria for device performance in the way that a clinical trial of a novel therapy would, especially for an AI-powered device.

The provided text does not contain any information about acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/ML-powered device.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or MRMC studies, as this information is not present in the provided document.

Here's why and what can be extracted based on the nature of the document:

• Type of Device: The device is a "Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis" (a hip implant). This is a physical medical device, not an AI/ML diagnostic or assistive tool.
• Regulatory Pathway: This is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not to prove the safety and effectiveness of a novel device through extensive clinical trials.
• Focus of the Document: The document focuses on:
  • Device description (materials, design, sizes).
  • Intended use and indications for use.
  • Comparison to predicate devices to establish substantial equivalence based on intended use, indications, sterilization methods, packaging, and design.
  • FDA's letter of clearance.

Therefore, I must state that the requested information (acceptance criteria, study details for performance evaluation, sample sizes, expert qualifications, etc., as typically associated with AI/ML device validation) is NOT present in the provided text.

If this were a submission for an AI/ML-powered device, the content would be drastically different, focusing on metrics like sensitivity, specificity, AUC, F1-score, and rigorous validation studies.

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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 or 3. neck.
• Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• Certain cases of ankylosis. 5.
  The AML® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prostheses to the bone cement.

The AML hip stem is manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy and has a cobalt-chrome-molybdenum alloy bead sintered porous coating (Porocoat®) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region.

It appears the provided text describes a 510(k) submission for a medical device called the "AML® Hip Prosthesis," a total hip joint replacement prosthesis. This submission focuses on establishing substantial equivalence to previously cleared devices rather than providing a performance study with detailed acceptance criteria and a study design to prove those criteria.

Therefore, the information required to populate the table and answer the study-related questions (points 1-9) about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided text.

The document details:

• Device Name: AML® Hip Prosthesis
• Sponsor: DePuy Orthopaedics, Inc.
• Classification: Class II
• Device Product Code: LPH (Hip Semi-constrained, Metal/Polymer, Porous Uncemented)
• Description: Manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy with a cobalt-chrome-molybdenum alloy bead sintered porous coating (Porocoat®) applied to the entire stem (except the tip).
• Intended Use: To provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients with sufficient sound bone to seat and support components.
• Indications for Use: Osteoarthritis, traumatic arthritis, rheumatoid arthritis, 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), and certain cases of ankylosis. Indicated for cementless use (biological tissue ingrowth) and cemented use (porous coating augments fixation to bone cement).
• Substantially Equivalent Device(s): Porocoat® Prodigy™ Hip Prosthesis (K931641), Vision AML® Hip Prosthesis (K953694), AML Hip Prosthesis (K003800).
• Basis for Substantial Equivalence: Similarities of design, commonly used materials, identical sterilization processes, the same indications for use and intended use.
• FDA Clearance Date: October 19, 2001

The document explicitly states: "No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems." This further emphasizes that the 510(k) process for this device relies on demonstrating equivalence to predicate devices, not on meeting specific, pre-defined performance acceptance criteria through a new clinical or non-clinical study detailed in this submission.

Therefore, I cannot provide the requested table and study details as they are not included in the provided 510(k) summary.

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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 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 AML® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as for cemented use and fixation in which the porous coating serves as a bonding surface of the prostheses to the bone cement.

The AML hip stem is manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy and has a cobalt-chrome-molybdenum alloy bead sintered porous coating (Porocoat®) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region.

The provided text is a 510(k) summary for a medical device (AML® Hip Prosthesis), which is a premarket notification for a Class II medical device to show that it is substantially equivalent to a legally marketed predicate device. This type of submission is not a clinical study where acceptance criteria, performance metrics, and detailed study methodologies are typically presented as they would be for a new or novel device requiring extensive clinical validation.

Instead, the submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the manufacturer is asserting that the new device has the same intended use, technological characteristics, and safety and effectiveness profile as previously cleared devices, and therefore does not require a new premarket approval (PMA) application with extensive clinical trials.

Therefore, the requested information for acceptance criteria and a study proving the device meets those criteria cannot be directly extracted from this document in the traditional sense of a clinical trial report.

However, I can extract the relevant information regarding the basis for acceptance and equivalence, and explain why the study details you're looking for aren't present in this type of regulatory document.

Here's an analysis based on the provided text, addressing your points where possible and explaining limitations:

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

• Acceptance Criteria: In a 510(k) submission, the "acceptance criteria" are not performance metrics in the way a clinical study would define them (e.g., sensitivity, specificity, accuracy). Instead, the primary acceptance criterion for clearance is demonstrating substantial equivalence to legally marketed predicate devices. This is achieved by showing similarities in:

  • Intended Use
  • Indications for Use
  • Technological Characteristics (e.g., design, materials, manufacturing processes)
  • Safety and Effectiveness profile

• Reported Device Performance: The document does not report specific device performance metrics from a dedicated clinical study but rather states the intended functions and relies on the established safety and effectiveness of the predicate devices.

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

• Not Applicable: This document does not describe a clinical study with a "test set" or explicit "data provenance" in the context of clinical performance evaluation. The substantial equivalence argument typically relies on:
  • Bench testing: To demonstrate material properties, mechanical strength, and other physical characteristics are comparable to predicate devices. While not explicitly detailed here, these tests are standard for orthopedic implants.
  • Pre-clinical testing: Biocompatibility and other non-clinical assessments, again, generally compared against established standards or predicate device data.
  • Historical clinical data: The proven track record of the predicate devices in patient populations.

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 clinical outcomes derived from expert consensus is not part of a 510(k) submission for substantial equivalence. The "ground truth" for regulatory clearance is the established safety and efficacy of the predicate devices, as determined by prior FDA clearances and market experience.

4. Adjudication method for the test set

• Not Applicable: Since no clinical "test set" and outcome adjudication are described, this point does not apply.

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 an orthopedic implant for hip replacement, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are entirely irrelevant to this submission.

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

• Not Applicable: As stated above, this is an orthopedic implant and does not involve algorithms or human-in-the-loop performance.

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

• Indirect Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices:
  • Porocoat® Prodigy™ Hip Prosthesis (K931641)
  • Vision AML® Hip Prosthesis (K953694)
  • This "ground truth" is based on the long-term clinical outcomes and regulatory clearances of these previously marketed devices, which would have had their own validation data (which may or may not include expert consensus, pathology, or outcomes data depending on their original approval pathway). The applicant demonstrates that their new device is fundamentally similar enough to these predicates that it can be presumed to be equally safe and effective.

8. The sample size for the training set

• Not Applicable: This submission does not involve machine learning or a "training set" in the computational sense. The "training" for such an application would be the cumulative experience and performance data of the predicate devices over their market lifespan, but no specific "sample size" is reported here for this purpose.

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

• Not Applicable: As there is no "training set" in the context of this 510(k) for an orthopedic implant, this question does not apply.

Summary of Device Acceptance for the AML® Hip Prosthesis:

The device's acceptance by the FDA, as indicated by the 510(k) clearance (K003800), is based on the demonstration of substantial equivalence to existing, legally marketed predicate devices. The study proving this "meets acceptance criteria" is the comprehensive 510(k) submission itself, which details the comparison between the AML® Hip Prosthesis and its predicate devices across several key areas:

• Predicate Devices: Porocoat® Prodigy™ Hip Prosthesis (K931641) and Vision AML® Hip Prosthesis (K953694).
• Basis for Equivalence:
  • Identical Intended Use: To provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation.
  • Identical Indications for Use: Including severe pain from arthritis, avascular necrosis, acute traumatic fracture, failed previous hip surgeries, and certain cases of ankylosis.
  • Similar Design & Materials: Manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy with a cobalt-chrome-molybdenum alloy bead sintered porous coating (Porocoat®). The design "resembles" the predicate.
  • Identical Sterilization Processes: Ensuring comparable safety in preparation for use.
  • Established Safety & Effectiveness of Predicates: The assumption is that because the new device is "substantially equivalent" in design, materials, and intended use, it will have a comparable safety and effectiveness profile to the already cleared predicate devices.

The FDA's review of this submission concluded that the AML® Hip Prosthesis is substantially equivalent to the identified predicate devices, allowing it to be legally marketed. This process does not typically involve new, extensive clinical trials validating specific performance metrics for the new device itself beyond what's required to show equivalence.

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