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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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EMPOWR Dual Mobility (Metal Liner and Poly Bearing) is indicated as part of a total hip replacement for patients suffering from pain and dysfunction due to:

• Noninflammatory 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 by other techniques
• Revision of previously failed total hip arthroplasty
• Dislocation risks
• To be used for uncemented applications

EMPOWR Dual Mobility (Metal Liner and Poly Bearing) introduces a modular dual mobility bearing to the current acetabular system. The benefit of the new system is enhanced stability due to a larger femoral head with more ROM for a given cup size than the previously cleared single articulation liners. Bearings are offered in nominal OD sizes of 38-58mm compatible with previously cleared cups.

The subject bearing includes a Metal Liner made of CoCr alloy that locks to the cup with a modular taper junction and a Poly Bearing (Head) made from highly crossed linked UHMWPE infused with Vitamin E that captures an Inner Head made of ceramic or CoCr. The bearing provides two articulating surfaces. The Poly Bearing component articulates inside the Metal Liner and the permanently captured Inner Head articulates inside the Poly Bearing. The two articulations can occur independently or simultaneously.

The provided text is a 510(k) summary for the EMPOWR Dual Mobility Metal Liner and Poly Bearing. This document indicates that clinical testing was not required for this device. Therefore, the comprehensive information regarding acceptance criteria and a study proving device performance as requested cannot be extracted from this document, as such a study was not performed or submitted for this regulatory clearance.

However, I can provide the available information:

1. A table of acceptance criteria and the reported device performance:
   Since no clinical study was required or performed, there is no "reported device performance" in terms of clinical outcomes or specific acceptance criteria for clinical efficacy. The device's substantial equivalence was based on non-clinical mechanical testing.

   Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
   Demonstrated ability to perform under expected conditions for: Wear Testing, Metal Liner Disassembly, Head Disassembly, Metal Liner Corrosion, Impingement Testing, Range of Motion.	Mechanical testing demonstrated the device's ability to perform under expected conditions for all listed tests.
   Pyrogen limit specifications met.	Device testing assures pyrogen limit specifications are met via Kinetic Chromogenic method for bacterial endotoxin testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not applicable, as no clinical test set was used. Non-clinical testing would involve physical prototypes or samples rather than patient data.

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, as no clinical test set was used requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no clinical test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This device is a physical medical implant (hip replacement component), not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical medical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as no clinical study or patient data requiring ground truth was used for this submission. The "ground truth" for non-clinical mechanical testing would be the engineering specifications and performance expectations.

8. The sample size for the training set:
   Not applicable, as no AI algorithm or clinical training set was used.

9. How the ground truth for the training set was established:
   Not applicable, as no AI algorithm or clinical training set was used.

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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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The modification does not alter the intended use of the predicate systems as cleared in the referenced premarket notifications. The subject ADM and ADM/MDM Acetabular Inserts are sterile, single-use devices intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. These devices are intended to be used only with currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.

The indications for use for total hip arthroplasty include:

• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis: l )
• 2. Rheumatoid arthritis:
• 3. Correction of functional deformity:
• 4. Revision procedures where other treatments or devices have failed:
• 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• 6. Dislocation risks

The ADM and MDM Systems are intended for cementless use only.

The Restoration® Anatomic Dual Mobility (ADM) and Modular Dual Mobility (MDM) Systems utilize Duration® and X3® Polyethylene Acetabular Inserts that retain a femoral head. The outer diameter of the insert articulates on the inner surface of either the polished ADM Acetabular Cup or, for certain sizes of inserts, the MDM Acetabular Liner. The Duration® and X30 polyethylene inserts therefore function as a dual mobility device as there are two articulating surfaces.

The provided submission is a 510(k) summary for the Restoration® Anatomic Dual Mobility™ and Modular Dual Mobility™ Systems Duration® and X3® Acetabular Inserts. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical trials. Therefore, much of the requested information cannot be extracted from this document as it pertains to clinical study results.

Here's a breakdown of what can be inferred and what cannot:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices through engineering and risk analysis, and laboratory testing.

• Device comparison (intended use, materials, operational principles)
• Engineering and risk analysis
• Laboratory testing (Wear, lever-out and pull out force testing, and range of motion analysis) |

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

The document states: "Clinical Testing: Clinical testing was not required for this submission." This indicates there was no clinical "test set" in the context of a traditional clinical study with human subjects. The "test set" for demonstrating substantial equivalence consisted of laboratory tests on the device itself.

• Sample Size: Not specified as it refers to laboratory testing, not human subjects.
• Data Provenance: Laboratory testing.

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

Not applicable. There was no clinical ground truth established by experts for a patient test set as clinical testing was not performed.

4. Adjudication method for the test set

Not applicable, as there was no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an orthopedic implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used

For the laboratory testing, the "ground truth" would be the measured physical and mechanical properties of the device, compared against known industry standards, design specifications, and the performance of predicate devices. This is a technical "ground truth" rather than a clinical one.

8. The sample size for the training set

Not applicable. There was no "training set" in the context of machine learning. The design and validation of the device were based on engineering principles and knowledge, not data-driven training.

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

Not applicable. Without a training set, this question is not relevant.

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