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MicroPort total hip systems are intended for use in total 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 osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:

• 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
• 3. correction of functional deformity; and,
• 4. revision procedures where other treatments or devices have failed.

The modular Ceramic Femoral Head is composed of alumina matrix composite, manufactured as per ISO 6474-2. It has a 12/14 taper which is identical to the taper on MicroPort Orthopedics' range of femoral heads. The device articulates with an acetabular liner and is compatible for use across any of MicroPort Orthopedics' total hip component range.

This document is a 510(k) premarket notification summary for a medical device, specifically a "Ceramic Femoral Head." This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and human-in-the-loop studies.

Therefore, the information requested in your prompt regarding acceptance criteria for an AI/device, human reader studies, and ground truth establishment for such studies, is not applicable to this specific document.

The document primarily focuses on non-clinical (mechanical) testing to demonstrate that the new Ceramic Femoral Head, manufactured from a different material (Permallon Tru by CoorsTek), performs equivalently or better than the predicate device.

Here's a breakdown of what is available in the document, related to the general concept of "acceptance criteria" for the device's mechanical performance:

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

The document general states: "Non-clinical (mechanical) testing results met the applicable acceptance criteria; therefore, acceptable mechanical performance is expected of the Ceramic Femoral Head manufactured by CoorsTek."

While a table of specific numerical acceptance criteria and their corresponding reported performance values is not explicitly presented, the document lists the types of tests performed:

• Axial compression test
• Fatigue test
• Post-fatigue ultimate compression strength test
• Static pull off test
• Static torsion test
• MR Safety Evaluation (per ASTM F2182-19, FDA Guidance, ASTM F2052-21, ASTM F2119-07)

The "acceptance criteria" for these tests would inherently be standard specifications or thresholds defined within the referenced ASTM standards and FDA guidance for orthopedic implants, ensuring the device's mechanical integrity and MR compatibility. The "reported device performance" is summarized as having "met the applicable acceptance criteria."

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

• Test Set (Mechanical Testing): The specific sample sizes for each mechanical test are not mentioned in this summary document. These would typically be specified in the full test reports, but are not required for the 510(k) summary. Given these are mechanical tests on physical devices, the "provenance" is the manufacturing process of the Ceramic Femoral Head by CoorsTek.
• Data Provenance: The data comes from engineering evaluations performed by the manufacturer, MicroPort Orthopedics, Inc. These are laboratory-based mechanical tests, not human data.

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

• Not applicable. This document describes mechanical testing of a physical medical device, not an AI or diagnostic device that requires expert human interpretation for "ground truth." The "ground truth" here is the physical performance measured against established engineering standards.

4. Adjudication method for the test set:

• Not applicable. There is no "adjudication" in the context of mechanical testing. The results are objective measurements from laboratory equipment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This is not an MRMC study. MRMC studies compare human reader performance with and without AI assistance, which is irrelevant to verifying the mechanical properties of a ceramic femoral head.

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

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

7. The type of ground truth used:

• For mechanical testing, the "ground truth" is defined by established engineering standards and material properties (e.g., ISO 6474-2, ASTM F2182-19, ASTM F2052-21, ASTM F2119-07). The device's performance is measured against the requirements of these standards and compared to the predicate device's established performance under these standards.

8. The sample size for the training set:

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

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

• Not applicable. See point 8.

In summary, this 510(k) notification focuses on demonstrating substantial equivalence of a physical medical implant through established non-clinical mechanical testing, not through AI performance evaluation or human clinical studies.

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The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;

· Acute traumatic fracture of the femoral head or neck;

· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The iNSitu Total Hip System femoral stems are intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.

The subject device Mg-PSZ Ceramic Femoral Head is manufactured from Zirconia Mg-PSZ ceramic material, which is the same material that comprises the predicate BioPro Ziralloy modular ceramic head. The subject device Mg-PSZ Ceramic Femoral Heads, including all sizes and offsets, have the same or similar design features and indications for use as the primary predicate device (Biolox Delta ceramic femoral head). The NextStep Arthropedix Mg-PSZ Ceramic Femoral Heads are packaged and sterilized using identical processes as the primary predicate device Biolox Delta femoral heads.

The provided text does not contain information about an AI/ML-driven medical device, its acceptance criteria, or a study proving that an AI/ML device meets these criteria. Instead, it is an FDA 510(k) clearance letter for a Mg-PSZ Ceramic Femoral Head, a physical medical device used in hip replacements.

Therefore, I cannot extract the information required for an AI/ML device, such as:

1. Acceptance criteria and reported device performance (for an AI/ML device): The document reports on mechanical performance of a physical hip implant (static burst strength, fatigue testing, disassembly testing), not performance metrics for an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
2. Sample size for test set and data provenance: Not applicable to a physical implant's mechanical testing.
3. Number of experts and qualifications for ground truth: Not applicable to engineering tests of a physical implant.
4. Adjudication method for test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a physical device, not an AI assisting human readers.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Ground truth here refers to actual physical properties and performance under stress, measured in laboratories, not clinical diagnoses or outcomes for AI.
8. Sample size for training set (for an AI/ML device): Not applicable, as there is no AI training. The "training" for this device would be its design and manufacturing process.
9. How ground truth for training set was established: Not applicable.

The document discusses preclinical performance testing for the Mg-PSZ Ceramic Femoral Head to evaluate its strength and performance characteristics and demonstrate substantial equivalence to predicate devices. This involves:

• Testing per ISO7206-10 and ASTMF2345 for:
  • Static Burst-Strength Testing
  • Fatigue Testing
  • Static Burst-Strength, Post-Fatigue Testing
• Disassembly testing per ISO7206-10 and ASTM F2009, and torque testing per ISO 7206-13 for:
  • Static Pull-Off (Axial) Strength
  • Static Torque-Off/Strength
• Material requirements per ASTM F2393.
• Bacterial endotoxin testing per FDA guidance and ANSI/AAMI ST72.

The conclusion is that based on "comparison of technological characteristics and performance testing," the device is substantially equivalent to predicate devices.

To provide the requested information, the input text would need to describe an AI/ML-powered medical device and a study evaluating its clinical or diagnostic performance.

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The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
• Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
• Patients with acute femoral neck fractures.

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
• Patients suffering from disability due to previous fusion.
• Patients with previously failed endoprostheses and/or total hip components in the operative extremity.
• Patients with acute neck fractures.

The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty.

The BIOLOX OPTION Ceramic Femoral Head System consist of a ceramic head fabricated from an alumina matrix composite available in diameters of 28, 32, 36, and 40 mm and a titanium adapter for the femoral stem cone with a range of offsets to accommodate various patient anatomies. The system serves as an alternative to both metal and alumina ceramic femoral heads and is for use in both primary and revision total hip arthroplasty.

This appears to be a 510(k) summary for a medical device (BIOLOX Delta Ceramic Femoral Heads and BIOLOX Option Ceramic Femoral Head System), not a study describing acceptance criteria and performance of a device based on AI/ML or image analysis. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, primarily through engineering analyses and material equivalence, rather than a clinical study with a test set, ground truth, or human reader involvement.

Therefore, many of the requested fields cannot be extracted directly from this document as they are not applicable to this type of regulatory submission. This document does not describe an AI/ML-based device that would typically have the requested performance metrics.

However, I can extract information related to the performance data presented within the context of a 510(k) submission for mechanical/material equivalence.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

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

• Not Applicable in the way implied by the request for an AI/ML study.
• The performance data relies on engineering analyses and material testing, not a "test set" of clinical cases or images. The "samples" would refer to test articles/components used in the mechanical and material tests. The document does not specify the number of individual components tested but refers to the completion of the tests.
• Data Provenance: The tests are likely conducted in a controlled laboratory environment by the manufacturer or a third-party testing facility, adhering to specified ISO/ASTM standards. The country of origin of these tests is not explicitly stated but would typically be where the manufacturer (Zimmer GmbH, Switzerland) conducts or commissions such testing.

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

• Not Applicable in the way implied by the request for an AI/ML study.
• This device is a mechanical implant. "Ground truth" in this context would refer to the validated standards and specifications (e.g., ISO standards) used for material and mechanical properties, not expert consensus on clinical cases. The interpretation of test results would be done by engineers and scientists (who are experts in their field) in accordance with these standards.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth, especially with image interpretation. For mechanical testing, adherence to standardized test protocols and data analysis governs the results.

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 mechanical implant device, not an AI/ML diagnostic aid that involves human readers interpreting cases.

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

• Not Applicable. This is a mechanical implant device, not an AI/ML algorithm.

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

• For this type of device, the "ground truth" (or reference standard) is primarily international standards and specifications (e.g., ISO, ASTM) for mechanical properties, material composition, and performance under specific simulated conditions (like wear and range of motion). There is no "pathology" or "outcomes data" ground truth directly described for the performance testing in this summary for substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is a mechanical implant device, not an AI/ML algorithm, so there is no "training set."

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

• Not Applicable. No training set exists for this type of device.

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The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.

· Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.

• · Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
  · Revision of a previously failed hip arthroplasty.

· Patients who require a total hip replacement.

The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add BIOLOX CONTOURA® Ceramic Femoral Heads in diameters of 28mm, and 36mm, in various head offsets.

The provided text describes a 510(k) premarket notification for a medical device, the BIOLOX CONTOURA Ceramic Femoral Head. It focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and function, supported by various mechanical tests and engineering analyses.

However, the document does not contain information about acceptance criteria and study details related to the performance of an AI/algorithm-driven device. The text describes a traditional medical device (a ceramic femoral head for hip replacement), and the performance evaluation is based on mechanical testing (burst strength, fatigue, pull-off, torque disassembly) and engineering analyses for physical characteristics like impingement, range of motion, and wear, rather than clinical performance or AI algorithm performance.

Therefore, I cannot fulfill the request as it pertains to AI/algorithm acceptance criteria and studies. The provided document is about a manufactured medical implant and its mechanical properties.

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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, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems, SignaSure Cementless Cup and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve and Cemented TSI femoral stems, and SignaSure Cemented Cup are intended for cemented fixation only. 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 modular Signature Ceramic Femoral Head is composed of alumina matrix composite with zirconia reinforcement, manufactured as per ISO 6474-2. It has a 12/14 taper which is identical to the taper on Signature Orthopaedics' range of femoral heads. The device is compatible for use across any of Signature Orthopaedics' total hip component range, and articulates with UHMWPE acetabular liner.

This document is a 510(k) Premarket Notification for a medical device called the "Signature Ceramic Femoral Head." It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. Thus, the questions regarding AI/algorithm performance related to acceptance criteria, ground truth, expert opinions, and training/test sets are not applicable to this type of medical device submission.

This document pertains to a physical orthopedic implant, not a software algorithm or AI-powered diagnostic tool. The "acceptance criteria" discussed in this document refer to the results of non-clinical (mechanical) testing of the physical implant, not the performance metrics of an AI model.

Therefore, I cannot provide the requested information regarding AI device performance metrics, sample sizes for AI test/training sets, or expert involvement in establishing AI ground truth, as this information is not present in the provided text and is not relevant to this type of device submission.

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The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following:

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, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion: patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40 mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BIOLOX delta Ceramic Femoral Heads:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device, its intended use, and a comparison to a predicate device. It does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., specific fatigue limits, wear rates, a certain number of cycles successfully passed). Instead, the performance is assessed against the substantial equivalence to a predicate device.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: Not specified. The document refers to "non-clinical testing" which implies mechanical and engineering tests, not patient data in the traditional sense of a "test set" for an AI or diagnostic device.
• Data Provenance: The "non-clinical testing" was likely conducted by Zimmer GmbH, which is located in Winterthur, Switzerland. However, the exact location of the testing facilities is not explicitly stated. The data is non-clinical/engineering (not patient data), so the concept of retrospective or prospective doesn't directly apply in the same way as clinical trials.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable. For this type of device (femoral head prosthesis), "ground truth" is established through engineering principles, material science, and mechanical testing standards, rather than expert consensus on medical images or clinical diagnoses.
• Qualifications of Experts: Not specified, but implied to be engineers, material scientists, and regulatory specialists involved in medical device design, testing, and regulatory submissions.

4. Adjudication Method:

• Adjudication Method: Not applicable. This document describes a 510(k) submission for a medical device (a ceramic femoral head), not a study involving human readers or interpretation of results that would require an adjudication method like 2+1 or 3+1. The assessment is based on objective engineering test results and regulatory review.

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

• MRMC Study: No. This is a physical orthopedic implant, not a diagnostic or AI-assisted device that would involve human readers interpreting cases.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No. There is no algorithm involved in this device. The performance is assessed through non-clinical (mechanical) testing of the physical implant.

7. Type of Ground Truth Used:

• Ground Truth: The "ground truth" in this context is established through engineering principles, material standards, mechanical testing results, and comparison to established performance characteristics of predicate devices. This includes:
  • Results from pull-off testing.
  • Results from range of motion analyses.
  • Results from fatigue strength analysis.
  • Adherence to material specifications (alumina matrix composite).
  • Compliance with relevant ASTM or ISO standards for orthopedic implants (though not explicitly listed, this is inherent in regulatory submissions).

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device that uses a "training set." The development of the device relies on established engineering design principles, material science, and manufacturing processes, which are refined through iterative design and testing rather than a statistical training set.

9. How Ground Truth for Training Set was Established:

• Ground Truth for Training Set: Not applicable, as there is no training set in the context of an AI/ML model for this device. The "truth" for the device's design and manufacturing is derived from decades of knowledge in biomedical engineering, orthopedics, materials science, and testing standards for implantable medical devices.

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This device is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; 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 procedures where other treatment or devices have failed arthroplasty or other procedure.

"UNITED" 36 mm Ceramic Femoral Head – Delta is an additional size extension to the previously cleared "UNITED" Ceramic Femoral Head (K103497). The materials, design, safety and effectiveness of this subject are identical to the previously cleared Ceramic Femoral Head - Delta Components (available in sizes 28 mm and 32 mm), except for its larger diameter (available in sizes 36 mm). 36 mm Ceramic Femoral Head - Delta manufactured from zirconia-toughened alumina ceramic is available in -3, +1, +5 and +9 mm of neck length. This device is intended to articulate against XPE cup liners (K111546) and can be used in conjunction with U2 Acetabular Cups and U2 Hip Stem made of titanium. U2 Acetabular Cups include U2 HA/Ti Plasma Spray Cup (K050262). U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Cup (K111546), while U2 Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), Ti Plasma Spray Revision Stem (K062978), Ti Press-fit Stem (K111546) and UTF Stem (K110245). The size extension does not affect the intended use of the device or alter the fundamental scientific technology of the device.

This document describes the acceptance criteria and the study conducted for the "36 mm Ceramic Femoral Head, Delta" device (K112463).

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly detail specific quantitative acceptance criteria or a performance table for the "36 mm Ceramic Femoral Head, Delta" device in terms of clinical outcomes or specific thresholds for mechanical tests. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.

The performance data section states: "This 510(k) was prepared in accordance with 'Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems'. Burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test. completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device."

This implies that the acceptance criteria for each of these tests were met by comparing the results to those of the predicate devices or to established industry standards outlined in the referenced guidance document. Without the specific guidance document or detailed test reports, the precise numerical acceptance criteria and the exact reported performance cannot be extracted from the provided text.

However, based on the text, the following can be inferred:

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

The text does not specify the exact sample sizes used for each of the "burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test." The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being "completed as part of the design assurance process." Given the nature of these tests for an orthopedic implant, they would typically be laboratory-based mechanical tests performed on newly manufactured devices.

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

This information is not applicable and not provided in the document. The study described is a mechanical performance study, not one requiring expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. The study described is a mechanical performance study, not one requiring adjudication by human experts.

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

This information is not applicable and not provided in the document. The device is a physical orthopedic implant, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

This information is not applicable and not provided in the document. The device is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance tests (burst, fatigue, rotational resistance, pull-off) would be the objective, quantitative measurements derived from the tests themselves, as compared against established engineering standards and performance of legally marketed predicate devices. It is based on objective physical properties and not on expert consensus, pathology, or outcomes data in the context of this specific 510(k) submission for mechanical properties.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The described study is a mechanical performance evaluation of an orthopedic implant, not a machine learning model that requires a training set.

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

This information is not applicable and not provided in the document, as there is no training set mentioned.

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The Ortho Development Biolox Delta Ceramic Femoral Head is inteded for use in total hip arthroplasty procedures with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the stem) and the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem).

Total hip arthroplasty is indicated for the following conditions:

• Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post l . traumatic arthritis.
• 2. Previously failed hip surgery.
• Fractures of the femoral neck or head. 3.
• Avascular necrosis of the femoral head. 4.
• Congenital dysplasia or other structural abnormalities where sufficient bone stock ട്. exists to properly seat the prosthesis.

The Ortho Development Biolox Delta Ceramic Femoral Heads mate with the existing Ortho Development Ovation and Encompass 12/14 taper femoral hip stems and articulate against Ortho Development polyethylene acetabular liners. The femoral heads are available in 28mm, 32mm, and 40mm diameters in a variety of offsets.

This document is a 510(k) Premarket Notification for the Ortho Development Biolox Delta Ceramic Femoral Heads. The submission asserts substantial equivalence to previously cleared devices based on similarities in design, materials, manufacturing, and mechanical performance. The "study" proving the device meets the acceptance criteria is a series of mechanical tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily states that mechanical testing data demonstrates equivalence to currently marketed devices and the ability to withstand expected in vivo loading. It references "burst fracture, taper dissemble (pull off) and wear tests as described in the Summary of Design Control Activities." However, the specific acceptance criteria (e.g., minimum load for burst fracture, maximum wear rate) and the numerical results for the Ortho Development Biolox Delta Ceramic Femoral Heads are not detailed within this Summary of Safety and Effectiveness. The document relies on comparison to predicate devices rather than absolute performance metrics being explicitly stated as acceptance criteria within this summary.

Based on the information provided, a table explicitly outlining acceptance criteria and numerical performance is not entirely possible, as the specific criteria are only generically mentioned as being "equivalent" to predicates.

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

• Sample Size for Test Set: Not specified in the provided summary. Mechanical testing typically involves a certain number of samples for each test (e.g., 5, 10, or more per test type), but the exact numbers are not detailed here.
• Data Provenance: The tests are conducted by the manufacturer, Ortho Development Corporation. The data would be prospective for the specific device being submitted, generated in a laboratory setting. There is no information about country of origin of data or use of retrospective data in this summary.

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

This type of information is not applicable to this device and study. The "ground truth" for mechanical testing of an orthopedic implant is typically established by engineering standards (e.g., ISO, ASTM) and the performance of well-established predicate devices, not by expert medical consensus on individual cases. The "study" here is a set of mechanical engineering tests, not a clinical study involving human patients or evaluations by medical experts.

4. Adjudication Method for the Test Set

This is not applicable to mechanical laboratory testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies or image review where multiple human readers assess data and discrepancies need to be resolved. For mechanical tests, the results are typically quantitative measurements, and the interpretation and reporting are done by test engineers.

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

This is not applicable. This submission is for a physical orthopedic implant (a ceramic femoral head) and involves mechanical testing, not an AI-driven diagnostic or assistive device that would involve human readers.

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

This is not applicable. This submission is for a physical orthopedic implant and does not involve any algorithms or software.

7. The Type of Ground Truth Used

The "ground truth" used for this type of device and study is primarily engineering standards and the established performance characteristics of predicate devices. The goal is to demonstrate that the new device performs at least as well as, or equivalently to, devices already on the market that have a known safety and effectiveness profile through their long-term clinical use and prior mechanical testing.

8. The Sample Size for the Training Set

This is not applicable. This is a physical device undergoing mechanical testing, not a machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a mechanical testing study of a physical implant.

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The Consensus hip systems are designed for total or partial hip arthroplasty and are only intended to be used with compatible Consensus components per the appropriate system specific indications.

The general indications for use are:

• 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 plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

Consensus hip system implants are intended for uncemented or cemented use per the system specific indications.

The Consensus hip systems are semi-constrained, hip prosthesis designed for either The Consensuring bio surgery. They include the Consensus® Hip System (CHS), the Unisyn™ Hip System, and the TaperSet™ Hip System (THS). All three hip systems utilize the exact same 12/14 Morse taper trunnion. These hip stems are compatible with previously cleared CoCr heads, zirconia heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for Consensus Orthopedics, Inc.'s hip systems, discussing their device description, indications for use, and substantial equivalence to predicate devices. It explicitly states:

"Clinical Performance Data: No clinical studies were performed."

The "Non-Clinical Performance Data" section mentions "All required testing per 'Guidance Document for the Preparation of Premarket Notifications of Ceramic Ball Hip Systems' were performed," and component testing according to ISO standards, but it does not provide specific acceptance criteria or report device performance against such criteria. It only lists the types of tests done.

Therefore, I cannot provide the requested table or information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.

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