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General total knee arthroplasty indications include:
• Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis

• · Post-traumatic loss of knee ioint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
  · Revision of previous unsuccessful knee replacement or other soft tissue stability is adequate
  · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques

The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament.

The ACS® LD FB Knee System is intended for cemented use, single use only.

The ACS® LD FB Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The ACS® LD FB Knee System is a modular knee replacement system offering various components that can be combined to replace the knee joint with various options depending upon the size and anatomy of each patient. The ACS® LD FB Knee System consists of:

• . ACS® LD Femoral Components
  • o ACS® LD Femoral Component
  • o ACS® LD Femoral Component Slim
  • o ACS® LD PS Femoral Component Slim
  • o ACS® LD PS Femoral Component
  • o ACS® LD SC Femoral Component
• ACS® LD FB+ Tibial Components ●
  • o ACS® LD FB+ Tibia
  • o Locking Plug for ACS® FB Tibial Component
  • o Cone Plug for ACS® FB Tibial Component
• ACS® FB+ PE-Inserts ●
  • o ACS® FB+ PE-Insert
  • ACS® FB+ PE-Insert Hyperflex o
  • ACS® FB+ PE-Insert Ultra o
  • o ACS® FB+ PS PE-Insert Hyperflex
  • o ACS® FB+ SC PE-Insert
  • ACS® Double Taper
• ACS® Stem ●
• o ACS® LD Extension Stem Male Taper
• o ACS® Stem
• ACS® Spacers .
  • o ACS® FB Tibial Spacer
  • o ACS® FB screw for spacer
  • o MK Femoral Spacer
• o MK Screw for Spacer
• ACS® Patella Replacements
  • o ACS® PE-Patella

The ACS® LD FB Knee System is available as a non-coated (LD) fixed bearing (FB) version. The tibial and femoral components are available in cemented version.

This FDA 510(k) Premarket Notification is for the ACS® LD FB Knee System, a knee replacement system. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through performance testing. It does not describe the acceptance criteria and study for an AI/ML device.

Therefore, I cannot extract the information requested regarding acceptance criteria, study details (sample size, provenance, expert qualifications, etc.), MRMC studies, standalone performance, or ground truth establishment for an AI/ML device from the provided text.

The provided text details the regulatory approval process for a traditional medical device (knee implant) and its physical and mechanical performance testing, not an AI/ML diagnostic or therapeutic device.

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The EcoFit® hip stems are intended to be used in total hip arthroplasty for the following indications:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
• Revision of previously failed total hip arthroplasty.
  The EcoFit® hip stems are intended for uncemented, press-fit fixation.

The EcoFit® hip stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head System for the following indications:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The purpose of this Traditional 510(k) is to expand the EcoFit® Hip System with a line extension to the existing EcoFit® short stems cementless cpTi. The new EcoFit® short stems cementless cpTi are available in two different sizes 16.25 mm and in both standard and lateralized offset versions. The new EcoFit® short stems cementless cpTi included in the subject 510(k) are intermediate sizes, as compared to the EcoFit® short stems cementless cpTi predicate devices

This FDA 510(k) summary is for a medical device, specifically hip stems, and therefore does not involve AI/ML performance testing with acceptance criteria in the same way an AI/ML software would. The "acceptance criteria" here refer to meeting established and recognized standards for mechanical and material performance of an implantable device to demonstrate substantial equivalence to a predicate device.

Here's an interpretation based on the provided document and the typical requirements for non-software medical devices:

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

Note: The document doesn't provide specific numerical results or thresholds for "acceptance criteria" within these tests. Instead, it indicates that the device met the requirements of the cited standards, which inherently defines the acceptance criteria for each test.

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

• Sample Size: The document mentions "test units representative of the finished device" but does not specify the exact number of samples used for each test. In mechanical testing of medical devices, sample sizes are typically determined by relevant standards (e.g., ISO, ASTM) and statistical considerations to ensure sufficient power to detect failures or demonstrate compliance.
• Data Provenance: The testing was performed on physical devices (EcoFit® short stem cementless cpTi). The document does not specify the country of origin of the data beyond the manufacturer being implantcast GmbH, located in Germany. These are likely prospective tests conducted specifically for this 510(k) submission.

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

This information is typically not relevant or included in a 510(k) summary for a mechanical device like a hip stem. "Ground truth" in this context refers to the physical properties and performance measured by standardized tests, rather than expert interpretation of clinical data. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the established standards. Their qualifications would include expertise in mechanical testing, biomaterials, and relevant ISO/ASTM standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation where human expert disagreement needs to be resolved to establish ground truth. For physical device testing, the results are objective measurements from laboratory equipment, and interpretation is against predefined engineering standards.

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 for evaluating diagnostic software or AI systems, particularly for image interpretation. This submission is for a physical orthopedic implant.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ISO 7206, ASTM F2582, ASTM F2009). The tests measure objective physical properties and responses of the hip stem under defined conditions. Compliance with these standards indicates the device possesses the necessary mechanical and material properties for its intended use.

8. The sample size for the training set:

Not applicable. "Training set" refers to data used to train AI/ML algorithms. This is a physical medical device.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The EcoFit®, implaFit® and BethaLoc® hip stems are indicated for use in cases of:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

• · Rheumatoid arthritis;
  · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
  · Revision of previously failed total hip arthroplasty.

The EcoFit®, implaFit® and BethaLoc® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended for the following indications:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

• Rheumatoid arthritis
• · Correction of functional deformity
  · Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The EcoFit® hip stems, the implaFit® hip stems cementless and the BethaLoc® hip stems are intended for uncemented, press-fit fixation.

The implaFit® hip stems cemented are intended for cemented fixation.

The ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the BethaLoc® hip stems and EcoFit® Hip System for the following indications:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

• Rheumatoid arthritis
• · Correction of functional deformity
  · Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the BethaLoc® hip stems. The BethaLoc® hip stems are femoral stems for total or hemi hip arthroplasty. The BethaLoc® hip stems are available in standard and lateralized offset configurations. The BethaLoc® hip stems are monoblock, tapered straight stems made from titanium alloy with a partial coating of hydroxyapatite (HA). They are fixed by press-fitting. The BethaLoc® hip stems are intended to be used with previously cleared EcoFit® Hip components.

This is a 510(k) summary for a medical device (hip stems), not an AI/ML device. Therefore, the requested information regarding AI/ML acceptance criteria, study details, human reader improvement with AI assistance, and training/ground truth datasets is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the "BethaLoc® stem cementless HA" device to legally marketed predicate devices. The performance testing section details the physical and biological tests performed on the device to ensure its safety and effectiveness, but these are engineering and biocompatibility tests, not studies related to AI/ML performance.

Therefore, I cannot provide a response that directly answers your prompt as it pertains to AI/ML device evaluation.

If you are looking for information on the acceptance criteria and performance studies for a hip stem (non-AI/ML), the document indicates the following:

1. Table of acceptance criteria and reported device performance:

The document states that "All performance testing conducted for the BethaLoc® hip systems met the predetermined acceptance criteria or were otherwise considered acceptable." Specific numerical acceptance criteria or performance metrics are not explicitly provided in a table format within this summary, but the types of tests performed are listed.

Regarding the AI/ML specific questions (2-9), the document does not contain this information as it describes a non-AI/ML medical device.

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The ACS® LD Uni FB Knee System is indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

This device is single-use implant intended for implantation with bone cement.

The ACS® LD Uni FB Knee System is a unicondylar knee replacement system. It is intended for patients with unicompartmental osteoarthritis and intact cruciate and collateral ligaments.

The ACS® LD Uni FB Knee System consists of the following components:

• ACS® Uni LD Femoral Component .
• Uni FB Tibial Component ●
• Uni FB PE-Insert ●

The provided text is a 510(k) summary for a medical device (ACS® LD Uni FB Knee System), which is a knee replacement system. This document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and performance testing, rather than establishing acceptance criteria and proving performance through a clinical study that would be typical for an AI/ML device or a novel diagnostic.

Therefore, the information required to populate the fields about acceptance criteria, study design, expert involvement, and ground truth, as typically found in submissions for AI/ML or diagnostic devices, is not present in this document. The provided text outlines engineering and material performance tests for a physical implant, not a data-driven system.

However, I can extract the information that is present and explain why other requested information is not applicable to this type of device submission.

Here's how to interpret the request in the context of the provided document:

Acceptance Criteria and Device Performance (as applicable to a physical implant):

The document doesn't define specific "acceptance criteria" in the sense of accuracy metrics (e.g., sensitivity, specificity) for a diagnostic device. Instead, "acceptance criteria" are implied by the successful completion of specified engineering and mechanical performance tests, demonstrating that the device performs as intended and is substantially equivalent to predicate devices.

Notes on the Study (as applicable to a physical implant, not an AI/ML system):

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

   • Sample Size: Not explicitly stated as "sample size" in terms of patient data. The testing was performed on "test units representative of finished devices." The exact number of physical units tested per standard is not detailed.
   • Data Provenance: Not applicable in the sense of patient data. The "data" comes from bench testing of physical implant components.

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

   • Not Applicable. This is a mechanical device, not a diagnostic or AI/ML system requiring expert-adjudicated ground truth from medical images or clinical outcomes. Ground truth for mechanical testing is established by engineering standards and measurements.

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

   • Not Applicable. No human adjudication of results in the clinical or diagnostic sense. Tests follow standardized procedures (ASTM).

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:

   • Not Applicable. This is a physical implant, not an AI/ML diagnostic or assistive device.

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

   • Not Applicable. This is a physical implant.

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

   • Engineering/Mechanical Standards. The "ground truth" is defined by the requirements and performance limits set by the referenced ASTM (American Society for Testing and Materials) standards for knee implants.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" for a physical implant. The design and manufacturing processes are developed based on engineering principles and material science, not machine learning training data.

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

   • Not Applicable. (See point 7)

Summary regarding the provided document:

This document describes a 510(k) submission for a physical medical device (a knee implant). The FDA's review for such devices primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This involves:

• Similar intended use.
• Similar technological characteristics (materials, design).
• Performance testing (bench testing, not clinical trials or AI/ML evaluations) to demonstrate the device performs as intended and meets relevant engineering standards.

The questions provided in the prompt are highly tailored to the evaluation of AI/ML-based medical devices or diagnostic devices that rely on interpreting clinical data, images, or signals. Since the provided text pertains to a mechanical orthopedic implant, most of these questions are not relevant or applicable to its regulatory clearance process as demonstrated in this 510(k) summary.

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The AGILON® XO Shoulder Replacement System is indicated for use for cementless inverse (reverse) total or hemi shoulder replacement in cases of:

• Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, .
• . Post-traumatic osteoarthritis.
• Fractures,
• . Rheumatoid arthritis.

The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:

• Multifragmental comminuted fractures of the humeral head,
• 3- and 4-Fragment-fractures of the proximal humerus,
• . Head-splitting fractures,
• . Dislocated head-splitting fractures,
• . Humeral head depression with more than 40% of joint surface depressed,
• . Interlocking chronic dislocation with deep HILL-SACHS lesion,
• . Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
• Posttraumatic humeral head necrosis, ●
• . Omarthrosis.

AGLON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.

The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:

• . Rotator cuff tear arthropathy,
• . Chronic trauma shoulder,
• . Decentering of the humeral head after implantation of a humeral head prosthesis.

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

In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:

• From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty ●
• . From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure ●
• . From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with various options depending upon the size and of each patient. The components can be combined into an hemi or reverse shoulder:
Hemi Shoulder:

• Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap) ●
• o Humeral Stems (Cementless)
  Reverse Shoulder:
• Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ●
• o Glenoid and Glenosphere Components (AGLION® XO Glenoid Baseplate and AGILON® Glenosphere)
• o Humeral Stems (Cementless)
  Metaphyseal components, stem extension pieces, and component connection fixation screws are intended to be used for hemi and reverse shoulder configurations.

This document describes the AGILON® XO Shoulder Replacement System, a modular shoulder replacement system. However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics typically associated with AI/ML-driven medical devices.

Instead, this document is a 510(k) premarket notification summary for a traditional medical device (shoulder replacement system) and focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "performance testing" section refers to mechanical and material property testing, which is standard for orthopedic implants, not performance studies for an AI/ML algorithm.

Therefore, I cannot populate the requested table and sections regarding acceptance criteria and performance study details for an AI system because that information is not present in the provided text. The document is about a physical implant, not a software device with performance criteria like sensitivity, specificity, or reader improvement.

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The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient.

The MUTARS® Proximal Femur System is intended to for uncemented use in total hip arthroplasty for the following indications:

• Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
• Limb salvage procedures including surgical intervention failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.

Use of this prosthesis is generally only indicated in skeletally mature patients

The MUTARS® Proximal Femur Replacement System is a modular hip replacement system, which combines the offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur Replacement System includes the MUTARS® Proximal Femur System. The MUTARS® Proximal Femur System is manufactured of TiAls V4 and includes the proximal femur, femoral stem, stem extension piece, connecting part, and screws. The MUTARS® Proximal Femur Replacement System can be used as a total hip system with previously cleared (K163577) modular cobalt chrome femoral head, Ecofit® uncemented titanium alloy acetabular cup and polyethylene liner.

The provided text describes a 510(k) premarket notification for a medical device, the "MUTARS® Proximal Femur Replacement System." This document is primarily focused on demonstrating substantial equivalence to previously marketed predicate devices rather than proving the device meets specific performance criteria through a clinical or algorithmic study with defined acceptance criteria for classification accuracy or similar measures.

Therefore, the information regarding acceptance criteria, study design for proving performance, and details about training/test sets, ground truth establishment, or expert adjudication as typically seen for AI/ML-based medical devices or diagnostic tools, is not present in this document.

The performance testing mentioned (Construct fatigue, Corrosion, Range of Motion, Modular Disassembly) relates to mechanical and physical properties of the implant, not to a study proving diagnostic or prognostic capabilities and therefore does not include the elements requested in the prompt (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, etc.).

No information for the requested points (1-9) can be extracted from the provided text as it is not relevant to the type of device and submission described.

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The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;

· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and

• Revision of previously failed total hip arthroplasty.
  The EcoFit® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.

The EcoFit® Vit E Acetabular System is a line extension of EcoFit® Hip System, a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The EcoFit® Vit E Acetabular System adds additional liners, CoCr femoral heads, and Biolox® delta heads to the currently cleared system. Additionally, Vit E liners are added as compatible components in the system.

This FDA 510(k) summary for the EcoFit® Vit E Acetabular System does not describe an AI medical device or a clinical study in the typical sense that would involve acceptance criteria and performance against a ground truth as commonly found in AI/ML reviews. Instead, it concerns a medical device (a hip replacement system) and its substantial equivalence to previously cleared predicate devices. Therefore, the questions about acceptance criteria, ground truth, sample sizes for test and training sets, expert adjudication, and MRMC studies are not applicable in this context.

The document primarily focuses on:

• Indications for Use: The conditions for which the hip replacement system is intended.
• Device Description: What the system is and how it extends a previously cleared system.
• Performance Testing: A list of engineering and materials tests performed to ensure the device meets mechanical and material specifications, rather than clinical performance against a diagnostic or predictive outcome.
• Substantial Equivalence: The primary basis for clearance, demonstrating that the new device is as safe and effective as existing legally marketed predicate devices.

Summary of Device Acceptance:

The device is accepted based on its substantial equivalence to predicate devices in terms of materials, indications, function, and/or performance. This is demonstrated through a series of non-clinical performance tests that evaluate the physical properties and mechanical behavior of the components.

Table of "Acceptance Criteria" (interpreted as engineering performance tests) and "Reported Device Performance":

Note: The document states "All necessary testing has been performed for the worst-case configuration... to assure substantial equivalence... and to demonstrate the subject devices perform as intended." It does not provide specific numerical outcomes or thresholds for these tests, only that they were completed and demonstrated performance as intended for substantial equivalence.

Regarding the other questions:

• Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical test units of the device, not a dataset for an AI model.
• Number of experts used to establish the ground truth... and qualifications: Not applicable, as there's no diagnostic or predictive "ground truth" being established by experts in this context.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.
• The type of ground truth used: Not applicable. Performance is assessed against mechanical and material standards, not a diagnostic ground truth.
• The sample size for the training set: Not applicable, as there is no training set for an AI model.
• How the ground truth for the training set was established: Not applicable.

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The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
  · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
  · Revision of previously failed total hip arthroplasty
  The EcoFit® Hip Stem and EcoFit® Acetabular Cup are intended for uncemented, press-fit fixation.

The EcoFit® Hip System consists of EcoFit® femoral hip stems, modular Cobalt Chrome Molybdenum alloy femoral heads, and modular metal backed acetabular cups with ultra-high molecular weight polyethylene liners.
The EcoFit® femoral stem system includes three versions: the standard length stem and a Coxa Vara version. The EcoFit® femoral hip stem is collarless, straight, monoblock, flat tapered wedge design manufactured from TiAlsV4 alloy. The stem tapers from proximal to distal and is designed with a rectangular cross sectional geometry to provide rotational stability. A plasma sprayed coating of commercially pure titanium (cpTi) is applied to the proximal half of the stem. The modular femoral heads are manufactured from Cobalt Chrome Molybdenum alloy and attach to the femoral stem via a Morse style taper in a diameter of 32 mm in several neck lengths.
The EcoFit® Acetabular Cup is a two (2) piece modular cup consisting of a metal shell and a polyethylene liner. The metal shell is manufactured from TiAlsV4 alloy and a plasma sprayed coating of commercially pure titanium (cpTi) is applied to the metal shell. The polyethylene liner is manufactured from ultra-high molecular weight polyethylene and is available with an inner diameter of 32 mm for use with 32 mm outer diameter femoral head. The metal shell has a threaded insertion hole at the apex and the shell is available in two (2) versions, one with three (3) peripheral holes for the placement of bone screws as needed for adjunctive fixation and one without screw holes. A threaded apex hole plug is provided to fill the threaded insertion hole after shell placement while bone screw hole plugs are available to fill screw holes that are not used.
The EcoFit® hip stems and EcoFit® acetabular cups are intended for uncemented press-fit application.

The provided document describes a 510(k) premarket notification for the "EcoFit® Hip System" which is a total hip replacement device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. Therefore, the information provided heavily emphasizes non-clinical (bench) testing, and explicitly states that clinical testing was not necessary.

As a result, a direct answer to all the requested points regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/device performance study as traditionally understood is not available in this document. The device in question is a physical medical implant, not an AI or software device.

However, I can extract the acceptance criteria and performance results available for the non-clinical testing performed:

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

Explanation of "Acceptable Criteria (Implicit)": For most of the tests, the acceptance criteria are implicit in the listed ASTM or ISO standards. To understand the specific numerical or qualitative criteria, one would need to refer to those standards directly. The document states that the results were "Acceptable" or "Pass," indicating the device met the requirements of the respective standards.

Regarding the other requested information (points 2-9):

These points are primarily relevant for studies evaluating the performance of software, AI models, or diagnostics where a comparison against a "ground truth" established by experts is central. This document pertains to a physical medical device (hip implant) and its substantial equivalence to predicate devices through non-clinical (bench) testing. Therefore, the concepts of test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, and their ground truth establishment do not apply in the context of this 510(k) submission for the EcoFit® Hip System.

The "study" that proves the device meets acceptance criteria is the series of non-clinical, benchtop tests listed in the table. These tests confirm the mechanical properties, durability, and biocompatibility of the hip implant components according to established international and American standards. The successful completion of these tests, demonstrating comparable performance to predicate devices and meeting relevant standards, supported the FDA's determination of substantial equivalence.

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