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The Prime and DYNASTY® Additive Manufacturing Shells are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

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.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

MicroPort Orthopedics Inc. is introducing the Prime and DYNASTY® Additive Manufacturing (AM) Shells as a line extension of its existing Prime and DYNASTY® Acetabular Systems. The Prime and DYNASTY® AM Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and are designed for cementless use on the bone interfacing surface. The device design is identical to its corresponding predicate devices. The design features of the Prime and DYNASTY® AM Shells are summarized below.

• Prime AM Shells: ●
  • Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
  • Available in the following configurations and their respective sizes: -
    • Solid (46mm-68mm outer diameter)
    • Quad (42mm- 68mm outer diameter) .
  • Sterilization: Gamma Sterilization -
• DYNASTY® AM Shells: ●
  • Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
  • Available in the following configurations and their respective sizes:
    • o Standard (46mm- 76mm outer diameter)
    • Primary (46mm-68mm outer diameter) o
    • Revision (46mm-76mm outer diameter) o
  • Sterilization: Gamma Sterilization -

The subject implants are single-use only, are provided sterile, and are prescription only devices, intended to be implanted only by orthopedic specialists in an operating room setting.

The provided text does not contain information about an AI/ML-based medical device. Instead, it describes a traditional medical device, specifically Prime and DYNASTY® Additive Manufacturing Shells, which are hip implants.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI/ML device meets those criteria. The document details the substantial equivalence of the hip implants to legally marketed predicate devices based on non-clinical bench testing, material properties, and design similarity, not performance metrics for an AI algorithm.

Here's why the requested information cannot be provided from the given text:

• No AI/ML Component: The device described is a physical orthopedic implant. There is no mention of any AI or machine learning algorithm.
• No "Performance" in the AI/ML Sense: The "performance" discussed in the document relates to mechanical properties (tensile strength, fatigue, deformation, corrosion, shear strength, etc.) and biocompatibility of the implant, not the diagnostic or predictive performance of an algorithm.
• No Test Set/Training Set: These concepts are specific to AI/ML model development and evaluation. The document discusses "worst-case constructs" for physical testing and "predicate nonclinical test results," which are entirely different.
• No Experts for Ground Truth/Adjudication: Ground truth establishment and adjudication by experts are crucial for evaluating AI/ML models in medical imaging, but this is irrelevant for a physical implant.
• No MRMC Study: A Multi-Reader Multi-Case study is for evaluating human performance, often with or without AI assistance, in interpreting medical data. This device is not an interpretation tool.
• No Standalone Algorithm: This phrase applies to an AI algorithm operating without human intervention for diagnostic or predictive tasks.

In summary, the provided document does not describe an AI/ML device, and thus, the questions posed (which are relevant to AI/ML device evaluation) cannot be answered from this text.

Ask a specific question about this device

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis:
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.

The KMTI A400 Hip System is intended for cementless applications unless used with the KMTI Cemented Hip Stem.

The KMTI Porous Coated Acetabular Shell System is intended for cementless applications. In addition, the KMTI Porous Coated Acetabular Shell and Universal liners can be used with:
• The Kyocera Corporation ("KYOCERA") Initia Total Hip System femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (28-40mm) femoral head.

The Cemented Hip Stem is intended for cemented applications.

The KMTI Tesera Trabecular Technology (T3) Acetabular Shell System is intended for cementless applications. In addition, the KMTI T3 Acetabular Shell and Universal Liners can be used with:
• The KYOCERA Initia femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (28-40mm) femoral head.

The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:
• The KYOCERA 28mm CoCr and 28mm BIOCERAM AZUL femoral heads and Initia femoral stem can be used with the KMTI 28mm ID Bipolar Head.
• The KYOCERA Initia femoral stem can be used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head.

The Bipolar Head is for uncemented use only.

Bipolar outer heads are not for use with acetabular shells and liners.

The Kyocera Medical Technologies, Inc. ("KMTI") Hip Replacement System includes multiple subsystem offerings, including:
• K132312: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System
• K141676: Renovis Porous Acetabular Cup System
Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification are additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation, Japan Initia Total Hip System (now known as Kyocera Corporation) that may be used with the KMTI K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI Universal Liners.

This document outlines the substantial equivalence of the KMTI Hip Replacement System to legally marketed predicate devices. The information provided primarily focuses on the physical and mechanical properties of the hip replacement components, rather than the performance of a software or AI-driven medical device. Therefore, many of the requested criteria related to AI/software performance, such as MRMC studies, ground truth establishment for AI training/testing, and expert adjudication, are not applicable to this submission.

However, I can extract information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text, specifically relating to the mechanical and physical performance of the hip prosthetic components.

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

The document describes the tests performed but does not explicitly state numerical acceptance criteria or numerical reported device performance in a table format. The evaluation focuses on compliance with established ISO and ASTM standards and comparison to predicate devices. The "acceptance criteria" are implicitly meeting the requirements of these standards for mechanical and physical properties.

Here's a breakdown of the tests conducted and the implied "performance" (successful evaluation and compliance):

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

• Sample size: The document does not specify the exact number of physical samples (e.g., number of hip stems or heads) used for each mechanical test. Standard testing protocols (e.g., ISO, ASTM) typically define minimum sample sizes for such tests.
• Data provenance: The data provenance is from Kyocera Medical Technologies, Inc. (Redlands, CA, USA). The study is described as "successfully evaluated under Design Controls," indicating it's a prospective set of tests conducted for regulatory submission purposes.

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

• This is not applicable as the "ground truth" for this device is based on objective mechanical properties and compliance with engineering standards, not on expert medical opinion or interpretation of images. The tests are physical measurements.

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

• This is not applicable for mechanical testing. Test results are typically objective measurements, not subject to human adjudication in the same way as, for example, image interpretation by radiologists.

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

• This is not applicable as this submission is for a physical medical device (hip replacement system), not an AI/software product. Therefore, no MRMC study looking at human reader improvement with AI assistance was performed.

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

• This is not applicable as this is not an algorithm or AI product.

7. The type of ground truth used:

• The "ground truth" for this device is based on established engineering standards and physical test methodologies (e.g., ISO and ASTM guidelines for hip prostheses) that define acceptable mechanical performance, durability, and material properties. It also relies on demonstrated equivalence to predicate devices that have a history of safe and effective use.

8. The sample size for the training set:

• This is not applicable as there is no "training set" in the context of AI/machine learning for this physical device submission.

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

• This is not applicable as there is no "training set" for this physical device.

Ask a specific question about this device

The KMTI Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.

The Kyocera Medical Technologies, Inc. ("KMTI") Hip Replacement System includes multiple subsystem offerings, including:

• K132312: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System
• K141676: Renovis Porous Acetabular Cup System
  Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification are additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation, Japan Initia Total Hip System (now known as Kyocera Corporation) that may be used with the KMTI K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI Universal Liners.

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and study details.

Important Note: The provided document is a 510(k) Premarket Notification Summary for a medical device. This type of submission often focuses on demonstrating "substantial equivalence" to a previously cleared predicate device, rather than proving performance against specific clinical acceptance criteria in standalone clinical trials. Therefore, much of the requested information regarding "device performance," "sample size," "ground truth," and "MRMC comparative effectiveness studies" is not typically found in this type of regulatory document, as these are more common for novel devices or those undergoing PMA approval. The studies mentioned here are primarily mechanical and material tests to ensure the new device components are equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

• Static compression burst tests
• Post-fatigue static compression burst tests
• Oblique (off-axis) fatigue test
• Pull-off tests
• Static torsion tests

Compliance with Standards:

• ISO 7206-10:2018 Implants for surgery Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
• ASTM F2345-03(2013) Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
• ISO 7206-13:2016 Implants for surgery Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
• Guidance Document For The Preparation Of Premarket Notification For Ceramic o Ball Hip Systems, Draft, January 10, 1995 |

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

• Sample Size: Not specified in the document. The studies conducted are mechanical tests of components, not clinical studies involving patient data. Therefore, the concept of a "test set" in the context of clinical data or AI systems with patient samples does not apply here.
• Data Provenance: Not applicable. The "data" comes from in vitro mechanical testing, not patient-derived data.

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

• Number of Experts: Not applicable. For mechanical tests, the "ground truth" is determined by the physical properties and performance measured according to established engineering standards (e.g., ISO, ASTM). Expert opinion is typically involved in designing the tests and interpreting the results against those standards, but not in establishing a "ground truth" for individual test items in the way it would be for an AI diagnostic system.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. While engineers and material scientists would be involved in conducting and evaluating these tests, their role is not to establish "ground truth" via consensus for a test set.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in studies involving human interpretation (e.g., radiologists reviewing images). Mechanical tests rely on objective physical measurements against predefined criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This document describes a medical device (hip replacement system) that is not an AI diagnostic tool and does not involve human readers interpreting cases. Therefore, an MRMC study is not relevant.

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

• Standalone Performance: Not applicable. This device is a physical hip replacement system, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical tests performed, the "ground truth" is defined by established engineering standards, material properties, and mechanical performance limits (e.g., fatigue strength specified by ASTM, static load resistance specified by ISO). The tests aim to demonstrate that the device components meet these objective engineering benchmarks and are equivalent to predicate devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI system that requires a "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for a physical device.

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The KMTI Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.

Qualifiers:
The KMTI A400 Hip System is intended for cementless applications unless used with the KMTI Cemented Hip Stem.
The KMTI Porous Coated Acetabular Shell System is intended for cementless applications. In addition, the KMTI Porous Coated Acetabular Shell and Universal liners can be used with the Kyocera Corporation ("KYOCERA") Initia Total Hip System femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
The Cemented Hip Stem is intended for cemented applications.
The KMTI Tesera Trabecular Technology (T3) Acetabular Shell System is intended for cementless applications. In addition, the KMTI T3 Acetabular Shell and Universal liners can be used with the KYOCERA Initia femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. Bipolar outer heads are not for use with acetabular shells and liners.

The Renovis Surgical Hip Joint Replacement System (K112897) includes multiple subsystem offerings, including:
K132312: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System
K141676: Renovis Porous Acetabular Cup System
Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification are additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation, Japan Initia Total Hip System (now Kyocera Corporation, Japan; "KCJ") that may be used with the KMTI K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI universal acetabular liners.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (hip replacement system). This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance acceptance criteria through clinical studies or AI algorithm evaluations.

Therefore, this document does not contain the information required to answer the questions about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document primarily focuses on:

• Device Name: Kyocera Medical Technologies, Inc. (KMTI) Hip Replacement System, including the Tesera Trabecular Technologies (T3) Acetabular Shell System and Porous Acetabular Cup System.
• Regulatory Information: Class II device, regulation number, product codes, and predicates.
• Indications for Use: Specifies the conditions for which the hip replacement system is intended.
• Substantial Equivalence: States that there are no changes in intended use, implant materials, manufacturing, packaging, or sterilization, and that the equivalence of certain components has been demonstrated.
• Compliance: Mentions assessment under Design Controls and compliance with ISO and ASTM standards for mechanical testing.

There is no mention of AI, software algorithms, or clinical studies that would involve establishing ground truth with experts, performing multi-reader multi-case studies, or evaluating standalone algorithm performance. The "performance" discussed in this document refers to the mechanical and biological performance of the implant, typically evaluated through bench testing and material analyses to ensure safety and effectiveness, rather than a diagnostic or predictive AI algorithm's performance.

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Joint replacement is indicated for patients suffering from disability due to:

• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
• rheumatoid arthritis;
• correction of functional deformity;
• femoral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts.

This device is to be used for uncemented applications.

This Traditional 510(k) is a line extension to the X-alt Highly Cross Linked Acetabular Liner with Vitamin E product line to expand femoral head compatibility within the system by making larger femoral heads compatible with smaller acetabular cups.

The provided text describes a medical device called "FMP Extended Liners" for hip joint replacement. However, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

• Acceptance Criteria and Device Performance (Question 1): The document states "All evaluations determined that the devices are substantially equivalent to the applicable predicate devices" after listing non-clinical tests (wear, impingement, push-out, lever-out, torsion, range of motion). This indicates that the device met the performance standards demonstrated by the predicate devices. However, the specific acceptance criteria (e.g., "wear not to exceed X mm^3/million cycles") and the reported device performance values for each test are not provided.

• Sample Size, Ground Truth, Adjudication, MRMC, Standalone, Training Set (Questions 2-9): The document explicitly states: "Clinical Testing: Clinical testing is not required." This means that no human-based studies (like those involving test sets, ground truth establishment, expert adjudication, or MRMC studies) were conducted or reported for this submission. The tests performed were non-clinical (mechanical and material tests). Similarly, there is no mention of a training set or how ground truth for a training set would be established, as algorithm-only performance (standalone) studies typically apply to software or AI/ML devices, not mechanical implants.

In summary, based on the provided text, I cannot answer questions 1-9 comprehensively because the submission focuses on demonstrating substantial equivalence through non-clinical laboratory testing, rather than clinical trials or AI/ML performance studies with specific acceptance criteria and performance metrics for such studies.

The information available is:

• Device Name: FMPT™ Extended Liners
• Tests Performed: Wear per ISO 14242-2/3, impingement per ASTM F2582-14, push-out, lever-out, torsion per ASTM F1820-13, and range of motion per ISO 21535:2009.
• Conclusion of Tests: "All evaluations determined that the devices are substantially equivalent to the applicable predicate devices."
• Clinical Testing: Not required.

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The Renovis Surgical Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.
   The Renovis A400 Hip System is intended for cementless applications unless used with the Renovis Cemented Hip Stem.
   The Renovis Surgical Porous Coated Acetabular Shell System is intended for cementless applications.
   The Cemented Hip Stem is intended for cemented applications.
   The Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System is intended for cementless applications.
   The Bipolar Head is for use in conjunction with Renovis femoral heads and femoral stems.
   Bipolar outer heads are not for use with acetabular shells and liners.

The subject of this application is Renovis Extended Lateral Offset Femoral Stems which are an expansion of the FDA cleared Renovis Surgical Hip Replacement System. Extended Lateral Offset Femoral Stems are provided in a variety of sizes to fit patient need. This application also includes a new device specific neck trial and X-ray template, and additional implants and instruments.
The Extended Lateral Offset Femoral Stems are manufactured from the same material as other FDA cleared Renovis femoral stems. The instruments are manufactured from the same material as other instruments included in FDA cleared submissions.

This document is a 510(k) summary for a medical device (Renovis Surgical Hip Replacement System), not a clinical study report. Therefore, it does not contain the information required to answer your questions regarding acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system.

The document discusses the substantial equivalence of an expansion to an existing device (Extended Lateral Offset Femoral Stems) to previously cleared predicate devices. It relies on bench performance testing and material equivalence, rather than a clinical study with human subjects or AI-assisted diagnostic performance.

Here's why the requested information cannot be extracted from this document:

• AI/Machine Learning Context: The document is about a physical medical device (hip prosthesis components), not a software or AI-driven diagnostic/decision support system. Therefore, concepts like "acceptance criteria" for AI performance, "test set," "training set," "ground truth," "experts," or "MRMC studies" are not applicable in this context.
• Study Type: The "study" mentioned is "Performance Testing - Bench," which refers to laboratory tests of the device's physical properties and durability, not clinical trials or comparative effectiveness studies involving human readers or AI.
• Device Performance: The "reported device performance" refers to successful completion of specific ISO and ANSI/AAMI standards for physical and sterilisation properties, not diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).

Summary of what can be extracted, and why the rest cannot:

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

   • Acceptance Criteria (implicit): Compliance with ISO 7206-4, ISO 7206-6, ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11137-2, ANSI/AAMI ST72:2011(R)2016 for bacterial endotoxin testing, and material standards like ASTM F136-13, ASTM A564-13, ASTM A276-17.
   • Reported Device Performance: "Renovis successfully completed the following performance tests." (Lists the standards). "endotoxin limits are in compliance with ANSI/AAMI ST72:2011(R)2016." The results indicate the device met the requirements of these standards.
   • Why partial: These are engineering and material performance criteria for a physical implant, not diagnostic performance metrics for an AI system.

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

   • Cannot be provided. This refers to bench testing of physical components, not a clinical study or AI model evaluation. There is no "test set" of patient data in the sense you're asking about.

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):

   • Cannot be provided. This is not relevant to a physical device's bench testing. "Ground truth" in this context would be physical measurements and material properties confirmed by engineering and quality control experts, not clinical diagnosis.

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

   • Cannot be provided. This is for clinical or AI performance evaluation, not bench testing.

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:

   • Cannot be provided. This type of study is for AI-assisted diagnostic tools, not physical implants.

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

   • Cannot be provided. This is about an algorithm's performance, which is not applicable to this device.

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

   • Cannot be provided (in the AI/clinical sense). For bench testing, the "ground truth" is adherence to established engineering standards (e.g., fatigue limits, material composition specifications).

8. The sample size for the training set:

   • Cannot be provided. There is no "training set" for a physical device in this context, as there is no AI model being trained.

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

   • Cannot be provided. Not applicable.

In conclusion, the provided FDA document is for a traditional medical device (hip prosthesis) and focuses on engineering, material, and sterilization compliance, not AI algorithm performance or clinical diagnostic accuracy.

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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 Total Joint Orthopedics Klassic HD® Hooded Acetabular Insert with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly are permanently implanted devices for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The subject inserts are fully compatible for use with the previously cleared Klassic HD® Hip System and are manufactured from UHMWPE crosslinked by gamma irradiation and infused with vitamin E. The subject inserts are sterilized by ethylene oxide gas and intended for single-use only.

This document is a 510(k) premarket notification for a medical device, a hip implant. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing details of a study on device performance that would typically include acceptance criteria and specific performance metrics like those for an AI/ML diagnostic tool. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this text.

However, I can extract the following:

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

The document states that "The information summarized in the Design Control Activities Summary demonstrates that the Klassic HD® Hooded Acetabular Inserts with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly meet the pre-determined acceptance criteria for the verification activities." It also lists the types of tests performed.

Note: The specific numerical values for the acceptance criteria and the device's performance are not provided in this summary. The document only confirms that the "pre-determined acceptance criteria" were met.

The remaining questions (2-9) are largely not applicable or cannot be answered from the provided text, as this is a regulatory submission for a physical orthopedic implant, not a software or AI/ML-based diagnostic device. The document describes mechanical performance testing and equivalency to a predicate device, not a "study" in the sense of clinical trials or AI model validation.

Here's why and what limited information could be inferred:

• 2. Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical implants, not a "test set" of data. The document does not specify the number of implants tested in each category.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance tests is established by engineering standards and measurements, not expert radiologists or similar medical professionals.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is irrelevant for mechanical testing of an 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 for AI/ML diagnostic tools, not an orthopedic implant.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML diagnostic tools, not an orthopedic implant.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical tests, the ground truth would be physical measurements and established engineering standards and methodologies. The document does not elaborate further.
• 8. The sample size for the training set: Not applicable. This is for AI/ML models. For a physical device, "training" would refer to design iterations and early testing.
• 9. How the ground truth for the training set was established: Not applicable for AI/ML sense. For device development, "ground truth" during design would involve engineering principles, materials science, and testing against industry standards.

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The Renovis Surgical Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

2. Rheumatoid arthritis;

3. Correction of functional deformity;

4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and

5. Revision procedures where other treatment or devices have failed.

The Renovis A400 Hip System is intended for cementless used with the Renovis Cemented Hip Stem.

The subject of this application are Renovis 4.5mm femoral stems (and a 5.25 mm broach) which are an expansion of the FDA cleared Renovis A400 Surgical Hip Joint Replacement Prosthesis (K112897) which is now known as the Renovis Surgical Hip Replacement System. The 4.5mm and 5.25mm femoral stems are the same material, the same configuration and will be offered in the same standard and lateralized offsets, as are the FDA cleared Renovis A400 femoral stems.

In addition, this application includes an update of Letter-to-File expansions and changes to the Renovis Surgical Hip Replacement System.

Renovis implants and instruments comply with the following material standards:

• ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-. 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
• ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes
• ASTM F1537-11 Standard Specification for Wrought Cobalt-28Chromium-● 6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• ASTM A276-13a Standard Specification for Stainless Steel Bars and Shapes
• ASTM A240-14 Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications

The document provided is a 510(k) premarket notification decision letter from the FDA to Renovis Surgical Technologies, Inc., regarding their "Renovis Surgical Hip Replacement System." This document primarily focuses on the regulatory clearance of a medical device and describes its intended use, design, and comparison to a predicate device.

It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm's performance. The document is for a traditional surgical implant (hip replacement system), not a software device or an AI/ML-driven diagnostic or therapeutic tool.

Therefore, I cannot extract the requested information based on the provided text. The questions posed in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) are relevant to the evaluation of AI/ML-based medical devices, which this document does not cover.

The "Non-clinical Testing" section (G) refers to bench testing of the femoral stems according to ISO 7206-4 and coating characterization, but this directly relates to the mechanical performance and material properties of the physical implant, not the diagnostic accuracy or performance of a software algorithm.

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Joint replacement is indicated for patients suffering from disability due to:

• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
• rheumatoid arthritis;
• correction of functional deformity;
• femoral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cementless use only

A highly cross linked polyethylene acetabular liner infused with pure liquid pharmaceutical grade alpha-tocopheral. This application is for the addition of size 32 ID, with neutral, 10° and 20° hooded configurations available.

This document is a 510(k) premarket notification for a medical device called the "X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E". This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials. As such, the information you're looking for regarding acceptance criteria and studies proving the device meets them, in the context of a diagnostic or AI-driven device, is largely not applicable to this document.

Here's why and what information can be extracted:

• This is a hip implant component, not a diagnostic device. The concepts of "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, and studies involving ground truth from experts, sample sizes for test/training sets, or MRMC studies, are primarily relevant to diagnostic algorithms or AI-driven systems. This document describes a physical medical implant.

• Substantial Equivalence, not novel performance claims. The 510(k) pathway focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness and the device is as safe and effective as the predicate device. It's not about proving superior or novel performance against acceptance criteria in the way an AI diagnostic would.

Therefore, many of your requested points are not present or applicable. However, I can still parse the document for the information that is there, even if it highlights its absence in other areas:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the sense of predictive performance metrics (e.g., sensitivity, specificity, AUC). For a physical implant like this, "performance" relates to mechanical properties, material biocompatibility, and meeting certain design specifications, all compared to predicate devices. The document states:

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

• Test Set Sample Size: Not applicable. There is no "test set" in the context of diagnostic performance. Mechanical testing for implants typically involves a specified number of samples (e.g., n=3 or n=5 for various types of tests according to standards), but these details are not provided in this summary.
• Data Provenance: Not applicable for clinical data. For non-clinical (mechanical) testing, the data would be generated in a lab setting, presumably by the manufacturer.

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

Not applicable. "Ground truth" established by experts is a concept for diagnostic performance evaluation.

4. Adjudication Method for the Test Set

Not applicable.

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 device is a physical hip implant component, not an AI diagnostic.

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

Not applicable.

7. The Type of Ground Truth Used

Not applicable in the sense of expert consensus, pathology, or outcomes data for diagnosis. For an implant, "ground truth" would relate to accepted engineering standards for material properties, mechanical integrity, and biocompatibility, as confirmed by laboratory testing.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for an implant of this nature.

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

Not applicable.

Summary based on the document:

This 510(k) premarket notification describes a hip implant component. The concept of "acceptance criteria" and "study" in the context of diagnostic performance (as implied by your questions, e.g., sensitivity, expert ground truth) does not apply to this type of device.

The study referenced is "Non-Clinical Testing", which states: "The 32 mm liner does not create a new worst-case for mechanical testing compared to the predicate devices." This is the core "proof" presented in this summary for the specific change (addition of 32mm size) in relation to the predicate devices. This implies that the device's mechanical performance (e.g., wear, strength) is considered equivalent or acceptable based on comparisons to known predicate devices and presumably relevant engineering standards, without explicit performance numerical targets provided in this summary. No clinical testing was provided as it was deemed unnecessary for this 510(k) submission.

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The Klassic HD™ Acetabular Insert with E-Link™ Poly, for use within the Klassic HD™ Hip System, is intended for prosthetic replacement without bone cement 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. ●
• o Patients who require a total hip replacement.

The Total Joint Orthopedics Klassic HD™ Acetabular Insert with E-Link™ Poly ("Insert with E-Link'') is a permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The Insert with E-Link is fully compatible for use with the previously cleared Klassic HD™ Hip System and is manufactured from Vitamin E blended UHMWPE crosslinked by gamma irradiation. The Insert with E-Link is sterilized by ethylene oxide gas and intended for single-use only.

The provided FDA 510(k) summary for the "Klassic HD™ Acetabular Insert with E-Link™ Poly" does not contain the type of acceptance criteria and study details commonly associated with AI/ML medical devices. This document describes a traditional medical device (an acetabular insert for hip replacement) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing.

Therefore, many of the requested items related to AI/ML device performance (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.

However, I can extract the information that is present and indicate where information is not provided.

Here's the analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The document states "Non-clinical bench testing was conducted," implying physical samples of the device were tested, but the number of samples for each test type is not detailed.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). This refers to bench testing performed on manufactured devices.

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

• Number of Experts: Not applicable. Ground truth for non-clinical bench testing is established by recognized standards (ASTM, ISO) and laboratory measurements of physical properties, not by human expert interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Bench testing results are typically evaluated against pre-defined specifications or predicate device performance, not adjudicated by a panel of human reviewers.

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

• MRMC Study: No. This is a traditional medical device, not an AI/ML device, so MRMC studies are not relevant.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Study: No. This is not an AI/ML algorithm.

7. The type of ground truth used

• Type of Ground Truth: For the non-clinical testing, the "ground truth" (or reference against which performance was assessed) was established by:
  • Recognized Standards: When available (e.g., ASTM, ISO standards for material properties, sterility, mechanical strength).
  • "Non-recognized standards from ASTM and ISO" used as a guide: For tests where no directly recognized standard existed.
  • Established Specifications: The document states that the device "meets the established specifications necessary for consistent performance during its intended use."
  • Predicate Device Performance: Comparison of technological characteristics and performance to legally marketed predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device.

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

• Training Set Ground Truth Establishment: Not applicable. This is not an AI/ML device.

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