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

• · Non- inflammatory deqenerative 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:

• · Multi-fragmental 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.

AGILON® 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 Anatomic Total Shoulder Arthroplasty
• · 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
• From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• · From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
  The device is intended for adults.

The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.

The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The qlenoid cementless is intended for cementless use with the addition of screws for fixation.

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 options depending upon the size and anatomical needs of each patient. The subject submission is for new cancellous screws for use in a total reverse shoulder replacement with the previously cleared K231657 components:

• Humeral Head Components ●
• Glenoid and Glenosphere Components ●
• Humeral Stems and Stem Extension Pieces
• Metaphyseal Components ●
• Fixation and Cancellous Screws ●

The subject line extension components are intended for use with previously cleared AGILON XO Shoulder System instruments. There are no changes to packaging, sterility, shelf life, or materials subject to this submission.

The provided text describes a 510(k) premarket notification for the AGILON® XO Shoulder Replacement System, focusing on new cancellous screws. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt regarding AI/algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and limited performance testing of the new cancellous screws. Therefore, I cannot provide all the requested information.

Here's what I can extract and infer from the provided text, along with what is explicitly not available:

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

• Driving Torque (ASTM F543)
• Axial Pull-out Strength (ASTM F543) |
  | Predetermined acceptance criteria met (specific numeric criteria not provided) | Testing demonstrated sufficient performance and met predetermined acceptance criteria. |
  | Biocompatibility (per ISO 10993-1) | Evaluation completed per ISO 10993-1. |
  | Cleaning, sterilization, packaging, shelf-life, and endotoxin standards met | Leveraged from the predicate AGILON® XO Shoulder Replacement System (K231657). |

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

• Sample Size: Not specified for the cancellous screw testing (Torsional Properties, Driving Torque, Axial Pull-out Strength).
• Data Provenance: Not specified. The manufacturer is implantcast, GmbH, located in Buxtehude, Germany, but the location where testing was performed is not mentioned. The study is part of a 510(k) submission, generally involving laboratory testing rather than clinical data provenance in this context.

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 device is a mechanical shoulder replacement system, and the testing described is mechanical performance (e.g., strength, torque) and biocompatibility, not an AI or diagnostic device that requires expert ground truth for interpretation of medical images or conditions.

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

Not applicable. This device is a mechanical shoulder replacement system, not a diagnostic or AI device that requires adjudication of expert interpretations.

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 (shoulder replacement system), not an AI-assisted diagnostic tool. No AI component or human reader study is mentioned.

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

Not applicable. This is a medical device (shoulder replacement system), not a standalone algorithm.

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

For the mechanical testing of the cancellous screws, the "ground truth" is established by adherence to recognized ASTM standards (ASTM F543) and engineering principles. For biocompatibility, the ground truth is adherence to ISO 10993-1. This is not related to clinical outcomes or expert consensus on pathologies for AI model training.

8. The sample size for the training set

Not applicable. This device is a mechanical shoulder replacement system, not an AI/machine learning device that requires a training set.

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

Not applicable. This device is a mechanical shoulder replacement system, not an AI/machine learning device.

Summary of what is present:

The document describes the submission of a medical device (AGILON® XO Shoulder Replacement System) for regulatory clearance. The specific focus of this submission (K241944) is the addition of new cancellous screws to an existing system. The performance testing for these screws involved:

• Engineering analysis.
• Characterization per ASTM F543 for torsional properties, driving torque, and axial pull-out strength.
• Biocompatibility evaluation per ISO 10993-1.
• Leveraging existing data for cleaning, sterilization, packaging, shelf-life, and endotoxin from the predicate device (K231657).

The conclusion is that the testing demonstrated "sufficient performance for the intended use" and "met the predetermined acceptance criteria." However, the specific quantitative values for these criteria and the test results are not detailed in the provided text.

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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 for cemented use in total hip arthroplasty or hemiarthroplasty 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 for severe trauma, 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 purpose of this Traditional 510(k) is to expand the MUTARS® Cemented Femoral Stems and MUTARS® Proximal Femur Replacement System with a line extension to the existing stems. The new stems are available with longer lengths (160 and 200mm).

This is a 510(k) premarket notification for a medical device, specifically the MUTARS® femoral stem cemented 160 mm and 200 mm. Such notifications focus on demonstrating "substantial equivalence" to a legally marketed predicate device rather than establishing new acceptance criteria and proving performance against them in the same way one might for a novel device or software.

In this context, the "acceptance criteria" for the new device are implicitly that it performs comparably or acceptably to the predicate device, as demonstrated through adherence to relevant standards and performance testing.

Here's a breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

"- Distal Stem Fatigue Testing (ISO 7206-4)"

"All performance testing conducted for the MUTARS® femoral stem cemented 160 mm and 200 mm met the predetermined acceptance criteria or were otherwise considered acceptable." |
| Biocompatibility: Materials should be biocompatible and not elicit adverse biological responses. | While not explicitly detailed in the provided snippets, a 510(k) submission for an implantable device would typically include or reference biocompatibility testing to relevant ISO standards (e.g., ISO 10993 series). The statement "All necessary testing has been performed" implies this was addressed. |
| Material Properties: The materials used in the device should meet specified mechanical and chemical properties. | Not explicitly detailed in the provided snippets, but implied by the "All necessary testing" statement and comparison to the predicate device. |
| Design Equivalence/Similarity: The design features should be comparable to the predicate device for the intended use. | "The MUTARS® femoral stem cemented 160 mm and 200 mm subject to this submission possess the same intended use and technological characteristics as the predicate device system components." |
| Dimensional Specifications: The device dimensions (e.g., length) should meet manufacturing specifications and be within the expected range for the intended application (extension to 160mm and 200mm lengths). | The submission is for a "line extension to the existing stems" with "new stems... available with longer lengths (160 and 200mm)." This implies the dimensional specifications for these new lengths are defined and were adhered to. The testing of "worst-case" further supports this. |
| Manufacturing Quality: The device should be manufactured under a Quality System (QS) Regulation (21 CFR Part 820). | The FDA letter explicitly states, "Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820)..." and references design controls, nonconforming product, and corrective/preventive action. This is a regulatory requirement for acceptance of the device into the market. |

The crucial phrase indicating acceptance criteria were met is: "All performance testing conducted... met the predetermined acceptance criteria or were otherwise considered acceptable."

Regarding the study that proves the device meets the acceptance criteria:

The document describes performance testing conducted on the device.

• Type of Study: This was a bench testing study, specifically focused on Distal Stem Fatigue Testing (ISO 7206-4). This standard is designed to assess the endurance of femoral components of hip prostheses under simulated physiological loading conditions.
• Proof of Meeting Criteria: The conclusion states that "All performance testing conducted for the MUTARS® femoral stem cemented 160 mm and 200 mm met the predetermined acceptance criteria or were otherwise considered acceptable." This directly confirms the device performed as required by the established standard and internal criteria.

The remaining sections are not applicable to the provided document, as this is a mechanical medical device (femoral stem for hip replacement) and not an AI/software device. Therefore, questions related to sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not relevant to this 510(k) submission for a physical implant.

Specifically:

2. Sample size used for the test set and the data provenance: Not applicable. For mechanical testing like fatigue, the sample size is determined by the testing standard (e.g., ISO 7206-4) and statistical requirements for demonstrating meeting performance thresholds. The data provenance is from the specific test laboratory where the bench tests were conducted.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth in this context refers to engineering specifications and performance standards, not diagnostic interpretations by experts.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable as this is not an AI/software imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: For mechanical devices, the "ground truth" is defined by established engineering principles, material science, and international performance standards (like ISO 7206-4).
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.

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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 AGILON® XO Shoulder Replacement System is indicated for use for 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.

AGILON® 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 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 Anatomic Total Shoulder Arthroplasty
• 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
• · From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty

The device is intended for adults.

The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.

The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The glenoids cementless are intended for cementless use with the addition of screws for fixation.

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 for use in a total (anatomic and reverse) or a hemi shoulder replacement:

Hemi Shoulder:

• Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap)
• Humeral Stems (Cementless)

Total Anatomic Shoulder:

• Humeral Head Components (AGILON® XO Cap)
• Glenoid Components (AGILON® PE-Glenoid, Cemented)
• Humeral Stems (Cementless)

Total Reverse Shoulder:

• Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ●
• Glenoid and Glenosphere Components (AGILON® XO Glenoid Baseplate and AGILON® ● Glenosphere)
• Humeral Stems (Cementless)

Metaphyseal components (including a new line extension 145°), stem extension pieces, and component connection fixation screws are intended to be used for hemi and total (anatomic and reverse) shoulder configurations.

The subject system also includes device-specific reusable instruments for use with the subject implants, including an osteotomy guide, implant trials, and a humeral cutting block.

The provided text describes a 510(k) premarket notification for the AGILON® XO Shoulder Replacement System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria for a novel AI/software component.

Therefore, many of the requested sections regarding acceptance criteria, device performance metrics (such as sensitivity, specificity, or AUC), sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.

The document primarily relies on "Performance Testing Summary" through engineering analyses and leveraging previous predicate device testing to establish substantial equivalence for a line extension (a new 145° Metaphyseal component).

Here's an attempt to answer the questions based on the provided text, indicating when information is not available or not applicable:

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

This document does not specify quantitative acceptance criteria for a novel device performance study, nor does it report specific performance metrics like sensitivity, specificity, or AUC as would be expected for an AI/software device. Instead, it relies on demonstrating substantial equivalence to predicate devices through engineering analysis and leveraged testing.

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. This submission concerns a physical medical device (shoulder replacement system) and a line extension, not an AI/software device requiring a test set of data. The "testing" primarily refers to engineering analyses and biocompatibility/sterilization testing, not a clinical data evaluation in the context of AI.

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. There is no mention of experts establishing a ground truth for a test set of data, as this is not an AI/software device.

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

Not applicable. No adjudication method is mentioned as there is no human-reviewed test set data in the context of an AI/software 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. This submission is for a physical shoulder joint replacement system, not an AI/software device designed to assist human readers.

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

Not applicable. This submission is for a physical shoulder joint replacement system, not an AI/software algorithm.

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

Not applicable. There is no mention of ground truth in the context of data for an AI/software device. The "ground truth" for a physical device refers to its physical properties, biocompatibility, and mechanical performance under various conditions, which are addressed through specifications, engineering analyses, and standardized testing (e.g., ISO for biocompatibility).

8. The sample size for the training set

Not applicable. As this is not an AI/software device, there is no training set mentioned in the document.

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

Not applicable. As this is not an AI/software device, there is no training set or associated ground truth establishment mentioned in the document.

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The Actinia® 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 Actinia® hip stems cementless are intended for uncemented, press-fit fixation.

The Actinia® 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 Actinia® hip stems are femoral stems for total or hemi hip arthroplasty. The Actinia® hip stems include collared and collarless variants in standard and lateralized offset configurations. Additionally, the scope includes the coxa vara hip stem variant in a standard offset configuration.

The Actinia® hip stems are monoblock, tapered straight stems made from titanium alloy with a coating of hydroxyapatite (HA). They are fixed by press-fitting.

The Actinia® hip stems are to be used alongside other previously cleared components to make a complete prosthesis. Specifically, Actinia® hip stems are compatible with legally marketed heads used with the implantcast EcoFit® Hip System (K163577, K180263 and K191569) and the implantcast ic-Bipolar Head System (K191569).

This is a 510(k) premarket notification for a medical device called "Actinia® hip stems". The document doesn't pertain to an AI/ML device, but rather a traditional implant. Therefore, the questions related to AI/ML device performance and ground truth establishment are not applicable.

Here's the relevant information provided about the device and its testing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states that "All testing was performed on test units representative of or worst-case compared to the finished device." However, specific sample sizes for each test are not provided. Data provenance (e.g., country of origin of data, retrospective or prospective) is not applicable or specified for this type of mechanical device testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a mechanical safety and performance test of an implant, not an AI/ML diagnostic or measurement device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is a mechanical safety and performance test, not a diagnostic study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable. This is not an AI/ML device, and an MRMC study is not relevant for its evaluation.

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 mechanical tests, the "ground truth" or reference is established by the specified international and national standards (ISO, ASTM). The device's performance is measured against the criteria established within these standards to ensure safety and efficacy.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning and therefore has no "training set."

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 AGILON® XO Shoulder Replacement System is indicated for use for 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 and 4-fragment fractures (secondary dislocation, material loosening),
• Posttraumatic humeral head necrosis,
• . Omarthrosis.
  AGILON® 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 in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary 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.
  AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement.
  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 Anatomic Total Shoulder Arthroplasty
• 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
• From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
  The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint.
  The device is intended for adults.
  The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.

The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the ALIGON® XO Glenoid Cemented components to the AGILON XO Shoulder System. The components are a line extension to the previously cleared AGILON XO Shoulder Replacement System which add all polyethylene cemented glenoids to the current system. The components introduced with this submission are intended to mate with other previously cleared implantcast shoulder components to make a complete prosthesis.

This document describes the AGILON XO Shoulder System, a Class II medical device. The information provided outlines the regulatory submission, specifically a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device.

However, the provided text does not contain the information requested regarding the acceptance criteria and a study proving the device meets those criteria, specifically concerning advanced AI/algorithm-based performance. The context of the request (acceptance criteria, test set, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) is typical for the clinical validation of AI/ML-driven medical devices.

The document instead describes performance testing related to the mechanical and physical properties of the shoulder implant components, not the performance of an AI/ML algorithm.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The "Performance Testing" section explicitly mentions:

• . Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028-17)
• . Range of Motion (ROM) Evaluation

These are engineering/mechanical tests to characterize the physical device, not an assessment of an AI algorithm's diagnostic or predictive capabilities.

To answer your prompt, I would need a document that discusses the performance of an AI/ML component of a medical device, including details about its clinical validation study design and results.

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The implaFit® 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 implaFit® 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 implaFit® hip stems cementless are intented, press-fit fixation. The implaFit® hip stems cemented are intended for cemented fixation.

The implaFit® hip stems are femoral stems for total or hemi hip arthroplasty. The implaFit® hip stems include cementless and cemented configurations (i.e., the implaFit® hip stems cementless and the implaFit® hip stems cemented).

The implaFit® hip stems cementless are monoblock, collarless tapered straight stems made from titanium alloy with a partial coating of commercially pure titanium (cpTi). They are fixed by press-fitting.

The implaFit® hip stems cemented are monoblock, collared, tapered straight stems made from cobalt chromium (CoCrMo). They are fixed using cement.

The provided text describes a 510(k) premarket notification for a medical device, the implaFit® hip stems, and primarily focuses on demonstrating its substantial equivalence to legally marketed predicate devices. This type of submission relies heavily on non-clinical performance testing rather than clinical study data involving AI.

Therefore, the information required to answer the prompt regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm study (which would involve concepts like sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training sets) is not present in the provided document.

The document describes performance testing for the physical device components (e.g., fatigue testing, impingement testing, coating testing). These tests have "predetermined acceptance criteria" related to the physical properties and performance of the hip stems, and the document states that "All performance testing conducted for the implaFit® hip systems met the predetermined acceptance criteria or were otherwise considered acceptable." However, this is not an AI-driven study.

In summary, this document does not contain the information needed to fill out the table or answer the questions related to an AI/algorithm study as requested.

If the request were about the acceptance criteria and study for a physical medical device, a different table and set of questions would be appropriate.

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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® Acetabular Cup is intended for uncemented, press-fit fixation.

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 for uncemented use in total hip arthroplasty or hemiarthroplasty 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 for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.

The MUTARS® 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 EcoFit® Hip System and MUTARS® Proximal Femur Replacement 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 existing EcoFit® Hip System portfolio with a line extension inclusive of additional acetabular inserts and cementless femoral stems.

The provided text is a 510(k) summary for a medical device (EcoFit® Hip System). It describes the device, its indications for use, and declares substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria through performance metrics.

Instead, it states that "All necessary testing has been performed for the 'worst case' components of the line extension of the EcoFit® Hip System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended." It then lists the types of tests performed.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer the questions related to sample size, data provenance, ground truth establishment, or clinical study specifics like MRMC effect size or standalone performance, as this information is not present.

The document indicates that the following types of performance tests were conducted:

• Fatigue Testing (ISO 7206-4 and ISO 7206-6)
• Impingement Testing (ASTM F2582-14)
• Liner Disassembly Testing (ASTM F1820)
• Range of Motion

Without the actual test reports, specific acceptance criteria (e.g., minimum cycles for fatigue, maximum force for impingement) and the results demonstrating compliance cannot be extracted.

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