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The ONVOY Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.

The ONVOY Acetabular System is used in conjunction with Globus/StelKast Hip Systems. The acetabular components of this hip system are intended for cementless fixation.

The ONVOY™ additional implants consist of acetabular shells, liners, and dual mobility liners and bearings that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. New femoral head sizes are also being introduced. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster-hole design, liners are available in hooded, non-hooded, and lateralized designs used in conjunction with ONVOY shells. Dual mobility polyethylene bearings are used with dual mobility liners.

ONVOY™ acetabular shells are additively manufactured from titanium alloy powder per ASTM F3001. Acetabular liners and dual mobility bearings are manufactured from highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Dual mobility liners are manufactured from Cobalt Chrome (CoCr) alloy and femoral heads are manufactured from alumina matrix composite ceramic.

This document is an FDA 510(k) clearance letter for a medical device called the "ONVOY™ Acetabular System." It details the device's purpose, indications for use, and the basis for its substantial equivalence to other legally marketed devices.

However, it does not contain information about acceptance criteria and a study proving a device meets those criteria for an AI/Software as a Medical Device (SaMD).

This clearance is for an orthopedic implant (hip prosthesis components: acetabular shells, liners, dual mobility implants, and femoral heads), not a software device or an AI application. Therefore, the questions related to MRMC studies, ground truth establishment, training sets, and expert adjudication are not applicable to the content provided in this FDA 510(k) letter.

The "Performance Data" section solely refers to mechanical and material testing standards relevant to orthopedic implants (fatigue, wear, range of motion, material composition, etc.) and states that "Performance data demonstrate substantial equivalence to the predicate devices." It does not describe any clinical study involving human readers or AI performance metrics.

In summary, based on the provided text, I cannot describe acceptance criteria and a study that proves a device meets those criteria, as the document pertains to an orthopedic implant and not an AI/SaMD.

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Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease).
2. Failed previous hip surgery.
3. Dislocation risks.
   EMPHASYS Dual Mobility Liners and Mobile Bearing Heads are intended for cementless applications.

The EMPHASYS Dual Mobility System includes Co-Cr-Mo Dual Mobility Liners and AOX Polyethylene Mobile Bearing Heads as well as other previously cleared compatible components.

This is a 510(k) summary for a medical device called the EMPHASYS™ Dual Mobility System, specifically for hip replacement. The document does not describe a study involving an algorithm or AI, but rather a series of physical performance tests conducted on the device itself to demonstrate its substantial equivalence to existing predicate devices.

Therefore, many of the requested categories related to AI model evaluation, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, and training set details, are not applicable to this type of device clearance submission.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in a table alongside reported performance results in an easy-to-digest format. Instead, it lists various performance tests conducted to demonstrate substantial equivalence to predicate devices. The implicit acceptance criteria are that the device performs "as well as" or equivalently to the predicate devices under these tests.

No direct table of acceptance criteria vs. reported performance is provided in the document. The document states: "Results of performance testing and analyses demonstrate that the EMPHASYS Dual Mobility System performs as well as the predicate devices."

The tests conducted are:

• EMPHASYS Mobile Bearing Head Thickness Assessment
• EMPHASYS Dual Mobility Liner Thickness Assessment
• Range of Motion Analysis- ISO 21535:2007
• EMPHASYS Mobile Bearing Head Impingement-ASTM F2582-20
• EMPHASYS Dual Mobility Impingement Testing to ASTM F2582-20
• EMPHASYS Dual Mobility Liner Push-Out- ASTM F1820-22
• EMPHASYS Dual Mobility Liner Offset Pull-Out- ASTM F1820-22
• EMPHASYS Dual Mobility Liner Torque-Out- ASTM F1820-22
• EMPHASYS Mobile Bearing Head Lever-Out
• EMPHASYS Dual Mobility ASTM F1875 Method I Test
• EMPHASYS Dual Mobility Non-Aged Standard Walking Wear Test- ISO 14242-1:2014 and ISO 14242-2:2016.
• EMPHASYS Dual Mobility Standard Walking with Mode 3 Third Body Abrasive Wear Test - ISO 14242-1:2014, ISO 14242-1 AMD 1:2018, ISO 14242-2:2016 and ISO 14242-4:2018.
• EMPHASYS Dual Mobility High Angle Standard Walking Wear Test- ISO 14242-1:2014, ISO 14242-2:2016 and ISO 14242-4:2018.
• EMPHASYS Dual Mobility Worst Case Outer Bearing Wear of EMSYS DM under Standard Walking Wear- ISO 14242-1:2014 and ISO 14242-2:2016
• EMPHASYS Dual Mobility Friction Test- ASTM F3143-20
• MRI Safety Evaluation Testing of Total Hip Systems- ASTM F2503-23, ASTM F2182 -19e2, ASTM F2052-21, ASTM F2213-17, and ASTM F2119-07

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

Not applicable. This pertains to physical device testing rather than a software or AI evaluation with patient data. The "test set" would be the physical devices and components manufactured for testing. The document does not specify the number of individual devices or components tested for each category.

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

Not applicable. The "ground truth" for these physical tests is established by recognized engineering standards (e.g., ISO, ASTM) and comparative performance against predicate devices, not by expert medical interpretation of data.

4. Adjudication method for the test set

Not applicable. This applies to medical imaging or diagnostic studies, not physical device performance testing against 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. This is a hardware device (hip prosthesis) clearance, not an AI software clearance.

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

Not applicable. This is a hardware device clearance.

7. The type of ground truth used

The "ground truth" in this context refers to the established performance requirements and benchmarks defined by international and national engineering standards (ISO and ASTM) and the performance characteristics of previously cleared predicate devices. The device must demonstrate that its performance meets these standards and is equivalent to the predicate.

8. The sample size for the training set

Not applicable. This is a hardware device clearance, not an AI software clearance.

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

Not applicable. This is a hardware device clearance, not an AI software clearance.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• · Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia
• · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture

· Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

• · Dislocation risks (when used with SignaSure range)
  Signature Orthopaedics' Origin. Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• · Certain high subcapital and femoral neck fractures in the elderly
• · Degenerative arthritis involving only the femoral head

The SignaSure Dual Mobility System is available in two configurations, a Monobloc configuration and a Modular configuration. The Monobloc configuration is a Dual Mobility acetabular system consisting of a metallic shell, cemented, and a mobile polyethylene insert to articulate within the shell as a femoral head. The Modular configuration (subject device) is a dual mobility acetabular system consisting of 2 components; a mobile polyethylene component and a metallic insert which can be used with interfacing cemented or cementless cups.

The SignaSure Poly, used in both configurations, is manufactured from highly crosslinked polyethylene (as per ASTM F648) and is spherical in geometry with outer and inner spherical conforming articular surfaces. The inner articular surface mates and retains a femoral head. The outer articular surface articulates within the highly polished inner diameter of the SignaSure Cementless or Cemented Cup to be used, or the metallic insert. The SignaSure Poly components are available in size 37 to 41 mm (outer diameter) allowing use with 22 mm and 39 to 59 mm femoral heads.

The SignaSure Logical Insert is manufactured from Cobalt Chrome (CoCr) alloy (as per ASTM F1537 and ISO 5832-12) and mates with Signature Orthopaedics' Logical Shell to be implanted without bone cement and the SignaSure World Insert is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and mates with Signature Orthopaedic's World Cup to be implant without bone cement. The SignaSure Logical Insert is available in 34 to 48 mm sizes whereas the SignaSure World Insert is available in 38 to 46 mm (internal diameter) sizes.

The SignaSure Cementless Cup is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and is sequentially plasma sprayed with titanium coating (as per ASTM F1580) and hydroxyapatite (as per ISO 13779-1 and ISO 13779-2) to gain cementless fixation. The SignaSure Cemented Cup is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and is grit blasted and macro textured to aid in fixation via bone cement. These cups, as from K211742, underwent no changes and were included in this submission as they interact with the subject SignaSure Poly devices.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the "SignaSure Dual Mobility System." It is a notification of the agency's substantial equivalence determination for the device, and it details the device description, indications for use, and a summary of performance testing to support the claim of substantial equivalence to predicate devices.

Acceptance Criteria and Study for the SignaSure Dual Mobility System

The provided document describes the "SignaSure Dual Mobility System" and demonstrates its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI or diagnostic device. The acceptance criteria in this context refer to the performance benchmarks used to determine that the new device is as safe and effective as existing legally marketed predicate devices.

The information provided does not relate to an AI or diagnostic device, therefore, many of the requested fields (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training set, and ground truth type) are not applicable.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" are typically related to meeting established standards and demonstrating performance comparable to predicate devices in terms of mechanical, material, and functional characteristics. The "reported device performance" in this context refers to the results of the non-clinical tests and engineering evaluations.

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

• Sample Size: Not explicitly stated as this is a non-clinical, engineering testing summary, not a human clinical trial. The "test set" would refer to the number of physical device units or components subjected to each specific test. This information is typically detailed in the full test reports, not in the 510(k) summary.
• Data Provenance: Not applicable in the context of human data. The tests are non-clinical, conducted in a laboratory setting to evaluate material and mechanical properties.

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 this context would refer to established engineering standards (ASTM, ISO), and the experts would be the engineers and technicians performing and verifying the tests, who are qualified in biomechanics, materials science, and medical device testing. Their qualifications are not specified in this summary.

4. Adjudication method for the test set

• Not applicable. Performance against engineering standards is typically determined by measurements and comparison to defined limits, not through a human adjudication process.

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 hip replacement prosthesis, not an AI or diagnostic device.

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

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

7. The type of ground truth used

• Ground Truth: Established international and national standards for medical device materials and mechanical performance (e.g., ASTM F648, F1537, F1580, F1820, F1875, F2582-14, ISO 5832-12, ISO 13779-1, ISO 13779-2, ISO 21535:2007). These standards define the acceptable performance characteristics. The predicate devices also serve as a comparative "ground truth" for substantial equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of a physical hip implant seeking 510(k) clearance based on non-clinical testing.

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

• Not applicable.

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ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

ONE Planner™ Hip (OPH) is an interactive software application intended to be used as a preoperative tool for Total Hip Arthroplasty. It enables 2D sizing and positioning of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on the patient's pelvic kinematics. The biomechanical measurements include measurements related to leg length and femoral offset. The functional analysis includes determination of pelvic parameters (e.g. pelvic tilt), and cup orientation calculations.

The software application consists of an automated templating system and a web-based templating user interface.

The provided document is an FDA 510(k) clearance letter for the ONE Planner™ Hip, a software device for preoperative surgical planning in total hip arthroplasty. It details the device's intended use, technological characteristics, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

However, the document does not provide information on:

• Specific acceptance criteria and reported device performance in a table format.
• Details of the test set: sample size, data provenance, number/qualifications of experts, or adjudication methods.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used for performance evaluation.
• Details about the training set: sample size, or how its ground truth was established.

The document explicitly states:

• "Software verification and validation testing was conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process)."
• "The software is considered a 'moderate' level of concern, a malfunction in the device could lead to a minor injury."
• "Non-clinical testing was performed to assess the usability and performance of the ONE Planner™ Hip to demonstrate that the device functions as intended."
• "Clinical testing was not necessary for the determination of substantial equivalence."

This indicates that the clearance was based on non-clinical software verification and validation, and usability/performance testing, demonstrating that the device functions as intended and does not introduce new questions of safety and effectiveness compared to the predicate device. It does not describe a study involving an AI component with specific performance metrics against a ground truth, expert readers, or a test/training set in the context of an AI-driven medical device. The "Acceptance Criteria" and "Study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, or reader improvement) are not present in this document.

Therefore, many of the requested details cannot be extracted from the provided text.

Based on the available information, here's what can be addressed:

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

• Not provided in the document. The document mentions "Software verification and validation testing" and "Non-clinical testing to assess the usability and performance...to demonstrate that the device functions as intended." It does not specify quantitative performance metrics or acceptance criteria for those metrics.

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

• Not provided in the document. The document refers to "non-clinical testing" but does not detail the size or provenance of any "test set" in the context of evaluating an AI model's performance; instead, it refers to software V&V and usability.

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

• Not provided in the document. Since "clinical testing was not necessary" and no AI performance study with a test set evaluated by experts is described, this information is absent.

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

• Not provided in the document.

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 provided in the document. The document does not describe any MRMC study or AI assistance to human readers.

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

• Not provided in the document. The device is described as "interact[ing]" with the user, suggesting a human-in-the-loop, but no standalone performance data is presented.

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

• Not provided in the document.

8. The sample size for the training set

• Not provided in the document. There is no mention of a training set as would be relevant for an AI model.

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

• Not provided in the document.

Summary of what's described in the document regarding testing:

• Type of Testing: Software Verification & Validation Testing and Non-Clinical Testing (Usability and Performance).
• Purpose of Testing: To satisfy FDA guidance (IEC 62304) and demonstrate that the device functions as intended and does not introduce new safety and effectiveness questions compared to the predicate device.
• Level of Concern: Moderate (malfunction could lead to minor injury).
• Clinical Testing: Not deemed necessary for substantial equivalence determination.

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The Exactech Alteon Modular Dual Mobility (MDM) System is a component of the Alteon Acetabular System. The Alteon MDM System is indicated for skeletally mature individuals undergoing surgery for hip replacement due to osteoarthritis, theumatoid arthritis, osteonecrosis or post-traumatic degenerative problems of the hip. The Alteon Modular Dual Mobility System is also potentially indicated for ankylosing spondylitis, congenital hip dysplasia and to restore mobility resulting from previous fusion. The Alteon MDM System is also indicated for use in primary or revision patients at a high risk of hip dislocation.

The Alteon Acetabular System is intended for press-fit fixation.

The Alteon® MDM System provides modular implants for use in total hip arthroplasty (THA) to restore patient joint function. The Exactech® Alteon® Modular Dual Mobility (MDM) System is intended for use in total hip replacement as an interface between the acetabulum and femoral heads. The Alteon® MDM liners and inserts are manufactured from CoCr alloy and Ultra-High Molecular Weight Polyethylene containing vitamin E (alpha tocopherol), respectively. The Alteon® MDM liners and inserts are each available in seven configurations. The Alteon® MDM insert inner diameter (femoral head compatibility) includes 22mm or 28mm, while the Alteon® MDM liners are compatible with acetabular shells with outer diameters 46-68mm.

This document describes the Exactech® Alteon® Modular Dual Mobility (MDM) System, a medical device, and its 510(k) submission for FDA clearance. However, the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.

The document details the device's indications for use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to predicate devices for regulatory clearance. The non-clinical tests are standard for orthopedic implants, such as biocompatibility, wear analysis, mechanical testing (fretting/corrosion, impingement, lever-out, axial push-out, torque out, offset pull-out), and range of motion analysis.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This device is a physical orthopedic implant, not an AI/ML software device, and thus the type of studies and acceptance criteria you are asking about (related to AI/ML performance) are not applicable to this 510(k) submission.

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