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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 (NID): 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 +10.5mm offset option for the Femoral Head Adapter Sleeves is a line extension to the currently available predicate adapter head offsets (K100445). The subject device is fabricated from Ti6Al4V per ASTM F136. The subject device is compatible with 32mm and 36mm BIOLOX® OPTION Ceramic Femoral Heads (K143407), and also compatible with the Klassic HD® Femoral Stems (K100445) and the Klassic Blade Femoral Stems (K151440 and K171962). The subject components are provided sterile, for single use, by prescription only.

This document is a 510(k) summary for a medical device called "Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length." It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that the subject components met predetermined acceptance criteria in Design Control Activities, demonstrating safety and effectiveness compared to predicate components. However, specific numerical acceptance criteria (e.g., minimum load, maximum displacement, pass/fail thresholds) and the exact performance values observed during each test are not explicitly provided in this summary. The table below represents the types of tests conducted and infers the general performance outcome as "met acceptance criteria."

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

The document describes non-clinical laboratory testing and engineering analysis. It does not involve a "test set" in the context of clinical data or AI model evaluation. It refers to physical samples of the device (adapter sleeves, femoral heads, femoral stems) that underwent mechanical and biological testing. The sample sizes for each specific mechanical test (e.g., number of units tested for fatigue, burst strength) are not provided in this summary.

Data provenance: The data is generated from laboratory testing. There is no information regarding the country of origin or whether it's retrospective or prospective, as these terms are typically applied to clinical studies.

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 submission, as it deals with the mechanical and biocompatibility testing of a physical medical device, not the evaluation of an AI algorithm on a dataset with expert-defined ground truth.

4. Adjudication Method for the Test Set:

This is not applicable to this submission for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

This is not applicable to this submission. MRMC studies are used to evaluate the performance of diagnostic devices or AI algorithms when interpreted by multiple human readers, often with and without AI assistance. This submission is for a physical orthopedic implant.

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

This is not applicable to this submission, as it does not concern an algorithm or AI.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to established engineering and biological standards and specifications. For mechanical tests, the ground truth is defined by the acceptance criteria specified in the relevant ISO and ASTM standards (e.g., ISO 7206, ASTM F2582), which dictate acceptable levels of load, displacement, and material integrity. For biocompatibility, the ground truth is established by AAMI-ST72 requirements for LAL testing.

8. The Sample Size for the Training Set:

This is not applicable to this submission, as it does not involve an AI algorithm with a training set.

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

This is not applicable to this submission.

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The Klassic 110 BiPolar System is intended for use in combination with a Total Joint Orthopedics Femoral Stem for primary or revision hemiarthroplasty of the hip, without the use of bone cement, for treatment of the following conditions:

• o Femoral neck and trochanteric fractures of the proximal femur
• Osteonecrosis of the femoral head
• Revision procedures where other devices or treatments for these indications have failed.

The Klassic™ BiPolar System includes the Klassic™ BiPolar System BiPolar Head, Klassic 110 BiPolar System Femoral Head (12-14 Taper), 22mm, and Klassic 100 BiPolar System Femoral Head(12-14 Taper), 28mm implant components ("Klassic"") BiPolar System Implants").

The Klassic"10 BiPolar System BiPolar Head includes a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner, cobalt chrome outer shell, and a UHMWPE retention ring with a Ti6A14V spring. The Bipolar Head includes an outer diameter range from 38 to 43 mm with an inner diameter which mates with the 22 mm femoral head, and an outer diameter range from 44 to 60 mm with an inner diameter which mates with the 28mm femoral head. The Bipolar Heads are offered in 1 mm outer diameter size increments.

The Klassic™ BiPolar System Femoral Heads include a 12/14 Taper for interfacing with TJO's Klassic HD10 Femoral Stems (K100445), and TJO's Klassic HD™ Offset Femoral Stems (K133832). These heads available with offsets of Neutral, +3.5mm and +7.0mm for the 22mm Femoral Head, and -3.5, Neutral, +3.5mm and +7.0mm for the 28mm Femoral Head.

This document does not describe a study involving an algorithm or AI. It is a 510(k) premarket notification for a medical device called the "Klassic™ BiPolar System," a hip joint femoral prosthesis. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and non-clinical testing.

Therefore, I cannot provide the requested information about acceptance criteria for an algorithm, study design for AI performance, sample sizes for AI development/testing, expert adjudication, MRMC studies, or standalone algorithm performance.

The document does mention "Non Clinical Testing, including fatigue, disassembly and range of motion," which was completed to demonstrate that the Klassic™ BiPolar System did not create a new worst case. However, this refers to mechanical device testing, not AI performance.

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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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The Klassic HDTM 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.
• Patients who require a total hip replacement.

The Klassic HD Offset Femoral Stem is a femoral component to be used within the Klassic HD Hip System as a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by helping to achieve proper leg length and offset. The Klassic HD Offset Femoral Stem is offered in both porous and non-porous options. Each configuration of the Klassic HD Offset Femoral Stem is offered in 9 sizes, is sterilized by gamma irradiation and is intended for single-use only.

Here's an analysis of the provided text regarding the Klassic HD™ Offset Femoral Stem, focusing on the acceptance criteria and the study performed, structured according to your requested points:

The provided 510(k) summary for the Total Joint Orthopedics Klassic HD™ Offset Femoral Stem describes a medical device component, not a software or AI-driven diagnostic device. Therefore, the information typically requested for AI/ML device studies regarding ground truth, expert adjudication, MRMC studies, and training/test sets is not directly applicable in this context.

Instead, the "acceptance criteria" and "study" refer to bench testing to demonstrate the physical and mechanical performance of the femoral stem and its substantial equivalence to predicate devices. The primary goal is to show that the new design (with a different neck shaft angle and offset) performs as safely and effectively as existing, legally marketed devices.

Here's the breakdown based on the provided text, reinterpreting the questions for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The exact numerical acceptance criteria (e.g., specific load cycles for fatigue testing, exact force for disassembly) are not explicitly stated in this summary but are implicit by referring to industry guidance and ASTM standards. The reported performance is a general statement that the device meets these criteria and is equivalent to predicates.

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

This concept is not applicable as this is a physical medical device. The "test set" would refer to the number of physical samples of the femoral stem tested. The text does not specify the exact number of stems tested for each physical test (e.g., 5 stems for fatigue, 3 for disassembly).

• Data Provenance: Not applicable in the sense of patient data. The "provenance" of the testing is non-clinical bench testing, conducted in a laboratory environment, guided by FDA guidance (e.g., "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses") and ASTM standards (e.g., "ASTM F1814-97a - Standard Guide for Evaluating Modular Hip and Knee Joint Components").

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

Not applicable. "Ground truth" for a physical device like this is established through validated engineering tests following recognized standards, not by expert consensus on clinical data. The "experts" involved would be engineering and testing personnel, but their number and specific qualifications are not detailed beyond the general statement of following guidance and standards.

4. Adjudication Method for the Test Set

Not applicable. Test results for physical device characteristics are typically quantitative and objective (e.g., did it break or not, what was the force to disassemble). There is no "adjudication" in the sense of reconciling different expert opinions.

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

For this physical device, the "ground truth" is based on:

• Physical and Mechanical Performance Standards: Demonstrated by adherence to recognized national/international standards (e.g., ASTM F1814-97a) and FDA guidance for similar devices.
• Comparison to Predicate Devices: The key "ground truth" here is the performance characteristics of the legally marketed predicate devices. The new device must demonstrate "substantial equivalence" in these characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

Not applicable. There is no training set for this type of device.

Summary of the Study and Conclusion for the Klassic HD™ Offset Femoral Stem:

The study involved non-clinical bench testing on physical samples of the Klassic HD™ Offset Femoral Stem. These tests included:

• Neck fatigue testing
• Stem fatigue testing
• Axial disassembly evaluation
• Torsional disassembly evaluation
• Range of motion determination

The testing was conducted based on established guidance from the FDA ("Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses, Document 1647 dated September 17, 2007") and ASTM standards ("ASTM F1814-97a - Standard Guide for Evaluating Modular Hip and Knee Joint Components").

The objective of the study was to demonstrate that the Klassic HD™ Offset Femoral Stem is substantially equivalent to its predicate devices (Klassic HD Hip System, K100445, and Alloclassic Zweymuller SL Offset Femoral Stem, K033664) in terms of safety and efficacy. The conclusion drawn from these bench tests was that "All bench testing and evaluation demonstrates the Klassic HD Offset Femoral Stem is equivalent in regards to safety and efficacy, is suitable for Total Hip Arthroplasty and is substantially equivalent to predicate devices." This substantial equivalence determination was upheld by the FDA in their 510(k) clearance letter (K133832).

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