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Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
A. Proximal femoral fractures.
B. Avascular necrosis of the femoral head.
C. Non-union of proximal femoral neck fractures.
D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
UNISYN stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN stems used with plasma/HA or HA coated bodies are intended for uncemented use only.

The UniSyn Hip System was originally cleared as a modular hip system for Hayes Medical under the name "Triton", modifications to the system were cleared in a subsequent submission by Hayes under the UniSyn name. Hayes Medical changed its name to Consensus Orthopedics in 2008. This system consists of three primary components: the neck, the body, and the stem. This submission is to addition of a set of modified ("Plus") stems.
These minor modifications in body thickness are designed to allow for better contact between the implant and the inner surface of the medullary canal during revision surgery. The sizes of stems offered with the modified design are within the ranges previously cleared for the UniSyn system. The Plus stems are offered in neutral or +1 mm styles, short or long, in 10 to 20 mm diameters, and lengths from 110 to 210 mm. There is no change to the manufacturing, packaging, or sterilization processes. This change will not affect the indications for use nor any of the labeling.

The provided text describes a 510(k) premarket notification for the UNISYN Plus stem, which is part of the UNISYN Hip System. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing new safety and effectiveness through a comprehensive study with acceptance criteria and performance metrics in the way a novel device might.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

For this type of 510(k) submission, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating that the modified device (UNISYN Plus stem) maintains the same fundamental characteristics and performance as its predicate devices. The document does not present a table with specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity) and corresponding performance results. Instead, it relies on the concept of substantial equivalence.

The key "criteria" for this submission are that the new "Plus" stems for the UniSyn hip systems employ the:

• Same materials
• Basic design features
• Manufacturing processes
• Packaging
• Indications as the predicate stems for the UHS.

The "reported device performance" is implicitly that these criteria are met, leading to the conclusion of substantial equivalence.

Specific Performance Data Mentioned:

• Distal fatigue performance: "Distal fatigue performance of the UniSyn Plus grit blasted stem was evaluated per ISO 7206-4 on a worst case example."
  • Acceptance Criteria (Implied): The fatigue performance must be equivalent to, or better than, the predicate device and meet the standards set by ISO 7206-4.
  • Reported Performance: Not explicitly stated with a numerical result, but the conclusion is that "No other nonclinical bench testing was deemed necessary over that used in support of the predicates based on identical design and materials," implying satisfactory performance.

2. Sample Size for Test Set and Data Provenance:

• Sample Size for Test Set: The document explicitly states "a worst case example" was evaluated for distal fatigue performance. This means the sample size for this specific test was very small, likely N=1 or a limited number of test articles representing the worst-case scenario. It is a bench test, not a clinical test involving human subjects.
• Data Provenance: The data comes from non-clinical bench testing conducted by the manufacturer (Consensus Orthopedics, Inc.). It is not from human subjects, so concepts like "country of origin" or "retrospective/prospective" do not apply.

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

Not applicable. The "ground truth" for a device like a hip stem is typically established through engineering specifications, material science standards, and established biomechanical performance criteria (e.g., ISO standards). There are no "experts" in the sense of clinicians establishing a diagnostic ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. This is a non-clinical bench test, not a clinical study involving human assessment or adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is typically done for diagnostic imaging devices or AI-assisted diagnostic tools. The UNISYN Plus stem is a physical orthopedic implant, making an MRMC study irrelevant. There is no human reader improvement with AI assistance discussed as there is no AI component.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. There is no algorithm or AI component in the UNISYN Plus stem. Performance assessment is based on physical material and design testing.

7. Type of Ground Truth Used:

The ground truth used for evaluating the UNISYN Plus stem's performance relies on engineering specifications, material properties, and adherence to recognized international standards such as ISO 7206-4 for fatigue testing. It is not expert consensus, pathology, or outcomes data in the clinical sense, but rather a demonstration of compliance with established biomechanical and material science criteria.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its development and testing are based on traditional engineering design and physical performance verification.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set. The "ground truth" for the overall design and performance of the hip system is established through a combination of biomechanical design principles, material science knowledge, and adherence to relevant ISO standards, accumulated over years of orthopedic implant development.

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The indications for the Trinity Acetabular System as a total hip arthroplasty include:

• o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis o
• o Correction of functional deformity
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) o

The Trinity Acetabular System is intended for cementless use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell (48mm through 68mm in 2mm increments) for use with ultra high molecular weight polyethylene (UHMWPE) liners (28mm and 32mm inner diameters in neutral, +4mm offset, EPW and 10° hooded designs) and a dedicated range of 28mm and 32mm modular 12/14 taper femoral heads providing ceramic (i.e., zirconia and Biolox delta in the USA) or metal on UHMWPE articulation for use in total hip replacement procedures using Corin titanium femoral stems with a 12/14 taper connection. The acetabular shell is coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (Bonit™). The acetabular shell is provided with screw holes permitting the use of dedicated titanium bone screws to provide additional fixation if required. Titanium occluders are provided to occlude unused screw holes and an apical introducer hole.

The purpose of this submission is to modify the labeling for the Trinity Acetabular System to include additional Corin titanium femoral stems with a 12/14 taper connection as compatible components, intended for use with the Trinity Acetabular Cup and Liner and the Trinity CoCr Femoral Heads.

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

The provided text describes a 510(k) submission for the Trinity Acetabular System, which proposes to modify the labeling to include additional Corin titanium femoral stems as compatible components. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML device evaluations. This submission is for a medical device (hip prosthesis) and its expanded compatibility, not a diagnostic or prognostic AI system.

However, based on the provided text, I can infer the acceptance criteria and the study in the context of demonstrating substantial equivalence for this device modification.

Acceptance Criteria and Study for K103518: Trinity Acetabular System

Given that this is a 510(k) submission primarily focused on modifying the labeling of an existing device to include additional compatible components, the "acceptance criteria" revolve around demonstrating that the modified device (Trinity Acetabular System with new femoral stems) is substantially equivalent to the previously cleared Trinity Acetabular System.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not applicable in the context of a traditional "test set" for AI. The "test" for this device was a combination of direct comparisons of specifications and specific non-clinical evaluations. The document does not specify a "sample size" for the range of motion study, but it would involve a limited number of test configurations or specimens rather than a large patient dataset.
• Data Provenance: The studies mentioned ("comparison of materials, designs and taper characteristics" and "range of motion study") are non-clinical tests. This means they were likely conducted in a laboratory setting (e.g., in vitro, cadaveric, or simulation) rather than using patient data. The country of origin for the data is not explicitly stated but would presumably be associated with the manufacturer's R&D facilities.

3. Number of Experts and Qualifications for Ground Truth

• Experts: Not applicable. The "ground truth" for this submission is established through engineering specifications, material science principles, and biomechanical testing standards, rather than expert clinical consensus on patient data.
• Qualifications: N/A

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable in the traditional sense for AI/ML performance. The "adjudication" for substantial equivalence would be performed by the FDA based on the submitted non-clinical test reports and comparisons.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This is not an AI/ML diagnostic or image analysis device, so a MRMC study is irrelevant to this submission.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: No. This is a physical medical device (hip prosthesis components), not a software algorithm.

7. Type of Ground Truth Used

• Ground Truth: The "ground truth" for this submission is based on:
  • Engineering specifications and material properties for component comparisons (materials, design, taper characteristics).
  • Biomechanical performance standards and measurements from the range of motion study.
  • The predicate device's established safety and effectiveness as the benchmark for substantial equivalence.

8. Sample Size for Training Set

• Sample Size: Not applicable. There is no "training set" as this is not an AI/ML device. The development of the components would involve engineering design and iterative testing, but not machine learning training.

9. How Ground Truth for Training Set Was Established

• Ground Truth Establishment: Not applicable. There is no "training set" for ground truth establishment.

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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

The proposed Novation CFS Press-Fit and Cemented Femoral Stems are modifications to the existing Novation Press-Fit and Novation Cemented Plus femoral stem devices previously cleared in K042842 and K083392, respectively. The proposed Novation CFS Press-Fit stem has the same general design features as the predicate device. The modifications include the addition of a calcar collar, grit-blast body, and a satin finish neck. The proposed CFS Cemented stem has the same general design features as the Novation Cemented Plus stem, but the proposed stems are cast instead of forged cobalt chrome alloy and the neck is a satin finish. Both proposed stems contain a modified 12/14 femoral head taper connection.
The proposed stems mate with previously cleared 12/14 Co-28Cr-6Mo femoral heads (K041906), Zirconia ceramic femoral heads (K050398 and K060107) and 12/14 Unipolar Sleeves (K010081). The proposed stems are not compatible with alumina ceramic femoral heads (K032964 and K051682).
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
· the same indications for use
· similar design features
· incorporate the same materials
· the same shelf life
· are packaged and sterilized using the same materials and processes.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is not present as this document is a 510(k) summary for a medical device (femoral stems) and not a study on an AI/ML device:

Important Note: The provided document is a 510(k) Summary for a physical medical device (femoral stems), not an AI/ML device. Therefore, the questions regarding AI/ML performance, sample sizes for training/test sets, expert ground truth, MRMC studies, and standalone algorithm performance are not applicable to this document. The "study" mentioned refers to engineering studies to demonstrate substantial equivalence, not clinical or AI/ML performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document describes a physical medical device. The "test set" in the context of this 510(k) refers to the modified femoral stems themselves undergoing engineering studies (e.g., mechanical testing), not a dataset for an AI/ML algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective clinical data) in the context of an AI/ML test set.

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

• Not Applicable. Ground truth, in the context of AI/ML, involves expert labeling of data. This document pertains to physical device design and engineering validation, not AI/ML.

4. Adjudication Method for the Test Set

• Not Applicable. This refers to AI/ML ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• Not Applicable. This is specific to AI/ML devices assessing reader performance. The document describes a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is specific to AI/ML devices. The document describes a physical medical device.

7. The Type of Ground Truth Used

• Not Applicable. For a physical device like a femoral stem, the "ground truth" relates to material properties, mechanical integrity, and biological compatibility, which are assessed through engineering analyses, material testing, and preclinical/clinical data if required (though for a 510(k), often relies on equivalence to predicates) rather than expert consensus on data labels, pathology, or outcomes data in the AI/ML sense.

8. The Sample Size for the Training Set

• Not Applicable. This implies an AI/ML algorithm. The document concerns a physical device.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. This implies an AI/ML algorithm. The document concerns a physical device.

Summary of Device and Evidence Presented in Document:

The document is a 510(k) summary for new Exactech® Novation® CFS™ Press-Fit and Cemented Femoral Stems. The "study" mentioned refers to engineering studies comparing these modified stems to previously cleared predicate devices (Novation® 12/14 Press-Fit Femoral Stems K042842 and Novation® Cemented Plus Femoral Stems K083392).

The primary acceptance criterion is substantial equivalence to the predicate devices. The device meets this by demonstrating, through engineering studies, that it has:

• The same intended use
• Basic fundamental scientific technology
• Same indications for use
• Similar design features (with specified modifications like calcar collar, grit-blast body, satin finish neck, and cast vs. forged material for cemented stems)
• Incorporates the same materials (except for the casting change)
• The same shelf life
• Packaged and sterilized using the same materials and processes.

The FDA reviewed the submission and concurred that the device is substantially equivalent to legally marketed predicate devices. The specific details of the "engineering studies" (e.g., number of tests, specific parameters measured, statistical analysis) are not provided in this public summary but would have been part of the full 510(k) submission.

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The Metha® Short Stem Hip System (uncemented, press-fit fixation) is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement; patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with acute femoral neck fractures.

The Metha® Short Stem Hip System XL Femoral Head is manufactured CoCrMo and conforms to ISO 5832. The XL femoral head is offered in two diameters (28mm and 32mm). The CoCrMo head allows the surgeon a further option to meet the patient's needs.

The provided text is a 510(k) Pre-market Notification for the "Metha® Short Stem Hip System XL Femoral Head." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria in the manner typical for AI/ML-based medical devices.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of regulatory submission. The document primarily highlights mechanical and material testing to ensure safety and functionality compared to existing devices.

Here's an attempt to address the request based only on the provided information, noting where information is not present:

Acceptance Criteria and Study for Metha® Short Stem Hip System XL Femoral Head

This 510(k) submission primarily demonstrates substantial equivalence to existing predicate devices, K080584 (Metha® Short Stem Hip System) and K040191 (BiContact Hip System and Femoral Head), by showing similar technological characteristics and materials. The performance data presented is focused on meeting existing orthopedic implant testing standards rather than a clinical study with specific performance metrics against a clinical ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of the number of tested devices. The document implies testing was performed on representative samples or prototypes.
• Data Provenance: Not explicitly stated, but testing would typically be performed in a laboratory setting by the manufacturer or a contracted testing facility. No patient data (retrospective or prospective) is mentioned for this type of performance evaluation.

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

• Not Applicable. This submission does not involve expert-established clinical ground truth for a test set in the context of device performance, as it is not an AI/ML device or a device requiring clinical adjudication. The "ground truth" here is adherence to engineering standards and material specifications, which are assessed through standardized laboratory tests.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication method is described. Performance is evaluated against objective engineering standards and material specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not an AI-assisted diagnostic device, and therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

6. Standalone (Algorithm Only) Performance

• No. This is a physical orthopedic implant. The concept of an "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

• The "ground truth" in this context refers to established engineering standards, material specifications (e.g., ISO 5832), and recognized guidance documents for orthopedic implant testing. It is not clinical expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As no training set is relevant, this question does not apply.

Summary of Performance Data (from the document):

The performance data for the Metha® Short Stem Hip System XL Femoral Head relies on demonstrating compliance with various existing guidance documents for orthopedic implant testing:

• "Draft Guidance for the Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements"
• "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"
• "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
• "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components"
• "Draft Guidance Document for Testing Acetabular Cup Prostheses"
• "Points to Consider for Femoral Stem Prostheses"
• "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems"
• "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices" (where applicable)

The statement "All required testing per... were done where applicable" indicates that the device underwent the necessary mechanical and material characterization tests outlined in these documents to support its safety and effectiveness for its intended use, by demonstrating substantial equivalence to predicate devices. Specific quantitative results are not included in this summary but would have been part of the full 510(k) submission.

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Indications for use of the ConsensusTM Hip System or UNISYN™ Hip System

• A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• C) Proximal femoral fractures.
• D) Avascular necrosis of the femoral head.
• E) Non-union of proximal femoral neck fractures.
• F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa vara, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities

Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.

The Consensus Hip 36mm CoCrMo (ASTM F799 or ASTM F1537) femoral head is offered with four different offsets, -5mm, neutral, +5mm and +10mm. Other than size, it incorporates no new design features. Female head taper is identical to the head taper design for the cleared devices.

The 36mm acetabular insert is offered in sizes 54 - 68 (2 mm increments), in neutral, 10 and 20 degree hooded configurations. Material for all 36mm insert sizes is crosslink UHMWPE (ASTM F648). Hooded configurations incorporate a titanium alloy x-ray marker (Ti 6Al-4V ELJ ASTM F136). Insert locking detail of the subject device is identical to the locking detail of the cleared devices.

The provided text is a 510(k) summary for a medical device: a 36mm CoCrMo Femoral Head and Acetabular Insert for the Consensus Hip System. This document focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study with acceptance criteria and a detailed performance evaluation of a new AI/software device.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission.

This 510(k) relies on the following for demonstrating safety and effectiveness:

• Comparison to Cleared Device: The primary argument is that the new 36mm femoral head and acetabular insert are substantially equivalent to existing, legally marketed devices. The only change is the addition of a new size (36mm).
• Intended Use, Material, Design Features, and Type of Interface: These aspects of the new components are stated to be identical or highly similar to predicate devices.
• Materials Data: The submission mentions "materials data" was provided to support safety and effectiveness, implying biocompatibility and mechanical properties testing relevant to the materials used (CoCrMo and UHMWPE) rather than clinical performance data.

In summary, this document does not contain the kind of study design and performance data typically associated with evaluating a novel AI/software medical device against specific acceptance criteria.

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This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• 1. Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• 2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
• 3. Correction of function deformity;
• 4. Revision procedures where other treatments or devices have failed; and
• 5. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
     This device is a single use implant and intended for cementless use only.

The U2 Hip Stem, Ti plasma spray is composed of a metallic femoral stem, which is designed to articulate with commercially available U1 and U2 acetabular components and They are manufactured from titanium alloy (ASTM F620). The stems femoral heads. are designed to provide secure fit and fixation in revision hip arthroplasty for anteroposterior bone loss, calcar area defects, metaphyseal bone loss situation. The U2 Hip Stem have a 130° neck angle and Morse taper to receive modular femoral heads. The U2 Hip Stem are available in with collar and collarless types. Each type is available in two lengths, 180mm and 230mm, and 7 diameters: 11mm, 12mm, 13mm, 14mm, 15mm, 16.5mm, 18mm. Distally, the stem is cylindrical with a polished bullet shape tip. The 180mm U2 Hip Stem is available as a straight stem, the 230mm femoral stem has an anterior bow for left and right specific applications. The U2 Hip Stem are fully coated with CP Ti (ASTM F1580). The coating is sprayed with CP Ti powder in thickness 500 um +/-100 um using 200~350 um powder to establish a rough surface for press-fit fixation. This device is a single use implant and intended for cementless use only.

This 510(k) summary (K062978) for the U2 Hip Stem, Ti Plasma Spray, does not contain specific acceptance criteria or details of a study proving the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as would be expected for an AI/ML powered device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on materials, design, and indications for use. For medical implants like this hip stem, the "acceptance criteria" primarily relate to demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through characterization of its mechanical properties, biocompatibility, and manufacturing processes, rather than performance metrics measured against a ground truth.

Therefore, many of the requested categories related to AI/ML device studies (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of traditional medical device submission.

Here's a breakdown of the information that is available or implied in the provided text:

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

• Acceptance Criteria (Implied for Substantial Equivalence): The primary "acceptance criteria" for a 510(k) submission for this type of device is demonstrating substantial equivalence to predicates. This means showing that the U2 Hip Stem is as safe and effective as the predicate devices, the Reach® Hip Stem, Ti plasma spray (K000760) and United U2 HA/Ti Plasma Spray (K003237). This is typically achieved by demonstrating comparable performance in areas like:

  • Material composition (ASTM F620 titanium alloy, CP Ti coating per ASTM F1580).
  • Design features (130° neck angle, Morse taper, cylindrical distal stem, collar/collarless options, lengths, diameters, anterior bow for 230mm stem).
  • Intended Use/Indications (same clinical conditions as predicates).
  • Mechanical properties, fatigue strength, and wear characteristics (though not detailed in this summary, these would be evaluated in the full submission).
  • Biocompatibility of materials.
  • Manufacturing processes (implicitly assessed for consistency and quality).

• Reported Device Performance: The summary states: "Features comparable to predicate devices, United U2 HA/Ti Plasma Spray (K003237), Reach® Hip Stem, Ti Plasma Spray (K000760), include same materials, design and indications." This is the core "performance" claim for substantial equivalence. No specific quantitative performance metrics (e.g., in vivo survival rates, specific biomechanical test results) are provided in this summary document beyond the physical characteristics.

Regarding items 2-7 (which are primarily relevant for AI/ML device studies):

These items are not applicable to this 510(k) submission for a mechanical implant. This document is a summary for a traditional medical device, not an AI/ML software device or diagnostic tool. Therefore, there's no discussion of test sets, training sets, ground truth derived from experts or pathology, or multi-reader studies.

However, to address them directly for completeness:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* N/A. This device is a mechanical implant, not an AI/ML diagnostic tool requiring a test set of data. Substantial equivalence is typically proven through bench testing, material characterization, and comparisons to predicate device designs and indications.

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)
* N/A. No expert ground truth establishment for a diagnostic test set.

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

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
* N/A.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* N/A. The "ground truth" for this device type would be established standards for implant design, material science, and biocompatibility, as well as clinical experience with similar predicate devices.

8. The sample size for the training set
* N/A. This is not an AI/ML device.

9. How the ground truth for the training set was established
* N/A. This is not an AI/ML device.

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Indications for use of the UNISYN™ HIP SYSTEM

A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.

B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.

C) Proximal femoral fractures.

D) Avascular necrosis of the femoral head.

E) Non-union of proximal femoral neck fractures.

F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities

The Body, HA Plasma, Modular Hip is part of the Unisyn modular hip system. The system consists of three parts; the neck, the body, and the stem. There are thirty-three different proximal bodies with six different cone diameters with multiple medial projections for each size. There are also cone-only bodies with and without collars. The surface of the body is plasma sprayed with a secondary coating of hydroxylapatite.

This document is a 510(k) summary for a medical device (Hayes Medical, Inc. UniSyn Modular Hip System) seeking clearance from the FDA. It does not describe a traditional clinical study with acceptance criteria and device performance as one would find for a software or diagnostic device.

Instead, this 510(k) pertains to a physical orthopedic implant and is a "Special 510(k)" because the only change made to a previously cleared device (UniSyn Hip System, K003649) is the addition of a hydroxylapatite coating to the existing TPS coating on the surface of the bodies.

Therefore, the typical metrics, sample sizes, expert ground truth, and study types requested in your prompt (e.g., MRMC, standalone algorithm performance) are not applicable to this type of regulatory submission for a physical implant. The "acceptance criteria" here are met by demonstrating "substantial equivalence" to predicate devices, primarily through material and design information, rather than a performance study as you've outlined.

However, I can extract information related to the substantial equivalence argument, which is the closest analogy to "acceptance criteria" in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation for the "Reported Device Performance": In a 510(k) for an implant device, particularly a Special 510(k) that involves a minor modification to a previously cleared device, the "performance" is demonstrated by showing that the modified device remains as safe and effective as the predicate device(s). This is achieved by comparing various attributes (intended use, materials, design, technological characteristics) to predicates and arguing that any differences do not raise new questions of safety or effectiveness. The text explicitly states: "The safety and effectiveness of the Body, HA Plasma, Modular Hip are adequately supported by the substantial equivalence information and materials data provided within this Special 510(k) submission."

The remaining points of your request are not applicable to this 510(k) submission type, as it relates to a physical orthopedic implant device, not an AI/software device or a diagnostic requiring performance metrics like sensitivity/specificity derived from expert reviews.

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. This pertains to a physical implant, not a software or diagnostic device. Substantial equivalence for this type of device is typically demonstrated through engineering assessments, material characterization, and comparison to predicate devices, not through a "test set" of patient data in the context of performance metrics.

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 submission does not involve a "ground truth" derived from expert consensus on patient data.

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

• Not applicable. There is no "test set" in the context of expert adjudication for this physical implant.

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 physical implant, not an AI-assisted diagnostic or imaging system.

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

• Not applicable. This is a physical implant, not an algorithm.

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

• Not applicable. "Ground truth" in the context of expert review or pathology is not relevant for this implant's regulatory clearance. The "truth" here is established via engineering principles, material science, and the regulatory history of predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. As above, there is no "training set" or need for "ground truth" establishment in this context.

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The Excia Hip System is intended to replace a hip joint.

The device is intended for:

• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral . ephiphysis
• Patients suffering from disability due to previous fusion ●
• Patients with acute femoral neck fractures .

The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti. With a Ti. Plasma spray.

The Acetabular Cups (Plasmacup® NSC and MSC) are manufactured from Ti. and are offered with a plasmapore® coating. The Plasmacup® is offered in two designs: NSC and MSC (no holes or multiple holes). Both designs are available in sizes ranging from 40mm - 68mm. The new Plasmacup® Acetabular Cups are a line extension to the existing Excia Total Hip System.

The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti. With a Ti. Plasma spray.

This document is a 510(k) Premarket Notification for a line extension of the Excia Total Hip System, specifically for new Acetabular Cups (Plasmacup® NSC and MSC). This submission is for a medical device and thus does not include information about artificial intelligence (AI) performance, study design, or expert review panels typically found in AI/ML medical device submissions.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device meets acceptance criteria as these pertain to AI/ML device performance and are not present in this 510(k) submission.

This submission focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics (material, shape, size) and compliance with relevant orthopedic device testing guidance documents, not on performance criteria measured through clinical studies or AI algorithm evaluation.

Key points from the document indicating a lack of AI/ML information:

• Device Type: The device is a "Total Hip System Line Extension," specifically acetabular cups, which are physical orthopedic implants.
• Performance Data: The "PERFORMANCE DATA" section states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable." It then lists several guidance documents related to testing orthopedic implants, metallic surfaces, modular components, acetabular cup prostheses, femoral stem prostheses, ceramic ball hip systems, and UHMWPE. These are all related to mechanical, material, and biocompatibility testing of physical implants, not AI/ML algorithm performance.
• No mention of AI/ML: There is no mention of software, AI, algorithms, diagnostic performance (e.g., sensitivity, specificity), ground truth, training sets, test sets, or expert review in the context of an AI/ML-driven device.
• Substantial Equivalence: The primary goal of this 510(k) is to demonstrate "Substantial Equivalence" to the predicate device (Plasmacup® SC) based on similar design and materials.

Therefore, all requested sections related to acceptance criteria, study details, sample sizes, ground truth, and expert review directly applicable to AI/ML performance cannot be filled from the provided document.

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The BetaCone is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is indicated in the treatment of the following:

• Patient conditions of noninflammatory degenerative joint disease, e.g., avascular necrosis and osteoarthritis; and inflammatory joint disease, e.g., rheumatoid arthritis;
• Those patients with failed previous surgery where pain, deformity, or dysfunction persists; and
• Revision of a previously failed hip arthroplasty.

Both the BetaCone and the predicate Encore, CLS, and Alloclassic Hip Stems use titanium alloy straight, tapered stems to replace the femur in hip replacement procedures. The BetaCone is fabricated from Ti-6Al-4V titanium alloy. BetaCone stems are available in 9 standard and 9 XL sizes. with lengths ranging from 135 to 175 mm. The BetaCone stem has a rectangular cross-section slightly rounded in both planes. BetaCone XL neck lengths are 5 mm longer than standard stem neck lengths. The Beta Cone neck angle is 126°. A 12/14 taper connects with Link's prosthesis heads using the same size taper. The BetaCone is compatible with Link standard acetabular cups. The BetaCone stem is designed for uncemented, press-fit fixation. A proximal trochanter fin supports proximal press-fit fixation.

The acceptance criteria and study proving the device meets them are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Five samples of the same sized, worst-case stem were tested.
• Data Provenance: The study appears to be a laboratory bench test, rather than a clinical study with patient data. Its provenance isn't explicitly stated as a country but is implied to be internal testing by the manufacturer, Waldemar Link GmbH & Co. KG (Germany).
• Retrospective/Prospective: Not applicable, as this was a bench test.

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

Not applicable. This was a physical bench test to evaluate mechanical properties, not a study requiring expert clinical judgment or ground truth derived from expert consensus.

4. Adjudication Method for the Test Set

Not applicable. This was a physical bench test; there was no human adjudication of results in the traditional sense of clinical studies. The failure or non-failure of the prosthesis in a dynamic fatigue test is an objective measurement.

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. The document describes a medical device (hip prosthesis) and a bench test for its mechanical integrity, not an AI-based diagnostic tool that would involve human readers.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this bench test was the objective physical behavior of the prosthesis under specified dynamic fatigue conditions. The standard ISO 7206-4: 2002 defines the parameters and expected outcomes for qualifying a hip prosthesis for fatigue resistance.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device and a bench test, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set was used.

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This device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• Inflammatory degenerative joint disease such as rheumatoid arthritis;
• Correction of function deformity;
• Revision procedures where other treatments or devices have failed; and
• Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The U2 Acetabular Components are designed for uncemented application and single use only.

The U2 Acetabular Component is designated to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U2 Acetabular Component has 14 sizes, hemispherical design and without or with clustered bone screw holes for variable screw locking angle. The metallic shell is manufactured from forged Titanium alloy (ASTM F620) and its outer surface has two types of coating. Ti plasma spray and IIA/Ti plasma spray. The acetabular liner is machined from extruded UHMWPE bars (ISO 5834/1) and its minimum thickness is 4 18 mm to reduce contact stress. If supplemental bone screw fixation is deemed necessary, Titanium Cancellous Bone Screws (ASTM F136) can be inserted through the screw holes without interfering with the seating of the acetabular liner.

This 510(k) summary for the U2 Acetabular Component describes a medical device, not an AI/ML medical device. Therefore, a study demonstrating the device meets acceptance criteria using the specified AI/ML-centric framework (test set, ground truth, experts, MRMC studies, standalone performance, etc.) is not applicable here.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through design, material composition, HA coating, and a locking mechanism, supported by mechanical test data.

However, I can extract information related to "acceptance criteria" and the "study" conducted from the provided text, reinterpreting them in the context of a traditional medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" and "Reported Device Performance":

For this type of device, the "acceptance criteria" are implicitly defined by the performance characteristics of the legally marketed predicate devices. The "reported device performance" demonstrates that the new device's mechanical properties (static tensile, static shear, push-out, lever-out, and torque-out for the liner-cup locking mechanism) are comparable to, and thus "substantially equivalent" to, these predicate devices. The goal is to show it performs at least as well as, or within acceptable limits of, the established predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML algorithm evaluated on a data set of images or clinical data. The "test set" would refer to physical prototypes or samples of the device undergoing mechanical testing. The document does not specify the number of samples used for these mechanical tests.

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 is not established by human experts reviewing data, but rather by standardized mechanical testing methods (e.g., ASTM standards for material properties and device performance). The "data provenance" (country of origin, retrospective/prospective) is also not relevant in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Mechanical test results are objective measurements, not subjective evaluations 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 is not an AI/ML device.

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.): The "ground truth" for the performance claims of the U2 Acetabular Component is derived from mechanical testing results, adhering to established engineering standards for orthopedic implants (e.g., ASTM F620 for Titanium alloy, ISO 5834/1 for UHMWPE bars) and comparative performance against legally marketed predicate devices.

8. The sample size for the training set: Not applicable. This is not an AI/ML device with a "training set."

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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