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The Klassic® Knee System is intended for prosthetic replacement of the following:

• · Patient conditions of non-inflammatory degenerative joint disease (NID); avascular necrosis and osteoarthritis
• · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
• · Patients with failed previous surgery where pain, deformity, or dysfunction persists
• · Correctable varus-valgus deformity and moderate flexion contracture
• · Revision of a previously failed knee arthroplasty
• · Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, with Cobalt 3D®, the Klassic Tibial Baseplate with Ti-Coat®, and the Universal™ Cones with Ti-Coat® which are also indicated for cementless use.

The Klassic® Tibial Baseplate, Revision (Ti6Al4V) is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Klassic Knee System - Revision Tibial Baseplate) and a summary of the device, its indications for use, and a discussion of non-clinical testing.

However, it does not include any details on:

1. Acceptance criteria and reported device performance in a table format.
2. Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for any clinical or performance studies.
3. Training set sample size or ground truth establishment for a machine learning model.

The document discusses non-clinical testing (e.g., fatigue analysis, modular interface fatigue testing, fretting corrosion analysis, MRI safety testing) and states that "Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities." However, it does not specify what those acceptance criteria were or the precise performance metrics and their achieved values.

Therefore, I cannot fulfill your request based on the provided text.

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The Klassic® Knee System is intended for prosthetic replacement in treatment of the following:

• Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
• Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
• Patients with failed previous surgery where pain, deformity, or dysfunction persists
• Correctable varus-valgus deformity and moderate flexion contracture
• Revision of a previously failed knee arthroplasty
• Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.

The Klassic® Knee System is being updated with additional thicknesses of Tibial Inserts, PS-Post and Additional All Poly Tibia PS-Post implants. Both proposed geometries are fabricated from both Standard Poly and Vitamin E UHMWPE (E-Link).

This document is a 510(k) Pre-Market Notification from the FDA regarding the Klassic® Tibial Insert, PS-Post, and Klassic All Poly Tibia, PS-Post. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study of a novel AI-powered medical device.

Therefore, the requested information regarding acceptance criteria and a study proving a device (implying an AI or software as a medical device) meets these criteria cannot be fully extracted from the provided text. The document describes non-clinical testing and engineering analyses for mechanical components (tibial inserts), not a software or AI device.

However, I can extract the information that is present and explain why other requested information is not applicable to this document.

Information Extracted from the Document (Pertaining to Mechanical Device Evaluation):

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

   The document states: "Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities, demonstrating that the subject components perform as safe and effective compared to the predicate components, and is substantially equivalent to the predicate."

   It lists the types of non-clinical tests performed:

   • Femoral/Tibial Constraint Testing (ASTM F1223)
   • Contact Area/Contact Stress (ASTM F2083)
   • Post Fatigue Testing
   • Range of Motion Evaluation
   • Wear (ISO 14243-3)
   • Tibial Insert Modular Disassembly Strength (ASTM F1814)

   While the types of tests and the conclusion that criteria were met are stated, the specific quantitative acceptance criteria (e.g., minimum load for post fatigue, maximum wear rate) and the measured performance values are not provided in this summary document. This information would typically be in the full submission, not the public summary.

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

   This document describes testing of physical components (tibial inserts), not an AI algorithm. Therefore, "sample size" would refer to the number of physical components tested, which is not specified. "Data provenance" such as country of origin or retrospective/prospective is not applicable in the context of mechanical engineering testing on manufactured parts.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   Not applicable. Ground truth, in the context of an AI device, refers to expertly labeled data. Here, the "ground truth" (or standard) for mechanical performance is established by engineering standards (e.g., ASTM, ISO), not human experts labeling data.

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

   Not applicable. Adjudication methods are relevant for human interpretation of complex data (e.g., medical images) to establish ground truth for AI training/testing. This document is about mechanical 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:

   Not applicable. An MRMC study assesses the impact of an AI algorithm on human diagnostic performance. This document concerns the substantial equivalence of a physical medical implant.

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

   Not applicable. Standalone performance refers to the performance of an AI algorithm without human involvement. This evaluation is of a mechanical device.

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

   The "ground truth" for the mechanical components is defined by established engineering and biological safety standards (e.g., ASTM F1223, ASTM F2083, ISO 14243-3, ASTM F1814, and LAL testing for orthopedic implants). These are quantitative, objective measurements against pre-defined engineering and material science criteria.

8. The sample size for the training set:

   Not applicable. There is no "training set" as this is not an AI/machine learning device. The design and testing are based on engineering principles and material science.

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

   Not applicable (no training set).

Summary of Applicable (and Not Applicable) Information from the Provided Text:

• Femoral/Tibial Constraint Testing (ASTM F1223)
• Contact Area/Contact Stress (ASTM F2083)
• Post Fatigue Testing
• Range of Motion Evaluation
• Wear (ISO 14243-3)
• Tibial Insert Modular Disassembly Strength (ASTM F1814)
• LAL testing requirements for orthopedic implants.

Reported Performance: "Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities, demonstrating that the subject components perform as safe and effective compared to the predicate components, and is substantially equivalent to the predicate." | The document confirms that specific mechanical tests were performed against pre-determined acceptance criteria, and the device met these criteria. However, the quantitative values of the acceptance criteria (e.g., "must withstand X N without deformation") and the specific measured results from each test are not detailed in this summary. This is typical for a 510(k) summary, as the full detailed test reports are part of the confidential submission. The "reported device performance" is given as a qualitative statement of meeting the criteria. |
| 2. Sample Size & Data Provenance (for test set) | Not disclosed. | This relates to mechanical testing of physical parts, not a data-driven AI model. The number of physical components tested is not provided. Data provenance (e.g., country, retrospective/prospective) is not relevant for this type of non-clinical, in-vitro testing. |
| 3. Number & Qualifications of Experts for Ground Truth | Not applicable. | Ground truth in this context is established by objective engineering standards and measurements (e.g., ASTM, ISO), not by human expert consensus or labeling of data. |
| 4. Adjudication Method (for test set) | Not applicable. | Adjudication is relevant for resolving discrepancies in human interpretation to establish ground truth for AI algorithms. This is mechanical testing. |
| 5. MRMC Comparative Effectiveness Study | Not applicable. | This type of study evaluates the impact of AI on human reader performance for diagnostic tasks. The device in question is a physical knee implant. |
| 6. Standalone (Algorithm Only) Performance | Not applicable. | This refers to the performance of an AI algorithm independent of human interaction. The device is a physical implant, not an algorithm. |
| 7. Type of Ground Truth Used | Established engineering and material science standards (e.g., ASTM, ISO) and LAL testing. | The "ground truth" for evaluating the performance of the physical device components is based on well-defined and quantitative performance specifications derived from these industry-standard test methods to ensure mechanical integrity, biocompatibility, and safety. |
| 8. Sample Size for Training Set | Not applicable. | This refers to data used to train an AI model. This device is a physical implant, not an AI. |
| 9. How Ground Truth for Training Set was Established (If any) | Not applicable. | As there is no training set for an AI model, this question is not applicable. |

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The Klassic® Revision System is intended for prosthetic replacement in treatment of the following:

• · Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis
• Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
• · Patients with failed previous surgery where pain, deformity, or dysfunction persists
• · Correctable varus-valgus deformity and moderate flexion contracture
• · Revision of a previously failed knee arthroplasty
• · Patients who require a total knee replacement

The Klassic® Revision System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.

The Klassic® Revision System is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty. The Klassic® Revision System includes the following implants and implant materials: Klassic® Stem Extension, Femoral, Cemented (Ti6Al4V), Klassic® Stem Adapter, Femoral (Ti6A14V), Klassic® Posterior Femoral Augment (Ti6A14V), Klassic® Distal Femoral Augment (Ti6Al4V), Klassic® Tibial Augment (Ti6Al4V, UHMWPE), Posterior Femoral Augment Set Screw (Ti6A14V), Distal Femoral Augment Set Screw (Ti6Al4V), Universal Cone™ with Ti-Coat (Ti6A14V and unalloyed Ti powder).

The provided text is an FDA 510(k) clearance letter for the Klassic® Revision System, a knee replacement system. It details the device's indications for use, description, predicate devices, and a summary of non-clinical testing.

However, this document does not contain information on an AI/ML-driven medical device, nor does it provide details about acceptance criteria, study methodologies (like sample sizes, expert involvement, ground truth establishment, MRMC studies, or training set details) related to the performance of such a device.

The "Discussion of Non-Clinical Testing/Performance Data" section solely refers to mechanical and material testing (fatigue, torque disassembly, fretting corrosion, augment fixation, porous coating characterization) relevant to the physical components of the knee replacement system. This type of device does not involve AI/ML components that would require a study proving its diagnostic or predictive performance, nor does it refer to human readers or human-in-the-loop performance.

Therefore, I cannot provide the requested information based on the given text.

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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 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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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 larger sizes of the Klassic® Blade Femoral Stems and add a new material for previously cleared Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems.

The provided text is a 510(k) summary for the Klassic HD® Hip System. It describes the device, its indications for use, and claims substantial equivalence to predicate devices based on design control activities. However, it does not contain the specific information required to complete the table and answer the study-related questions.

The document focuses on demonstrating substantial equivalence through design control activities and worst-case fatigue testing, rather than a clinical study measuring device performance against specific acceptance criteria in a patient population. It outlines that the "modified Klassic Blade Femoral Stems and modified Klassic® Blade Offset Femoral Stems met the pre-determined acceptance criteria for the verification activities" and that "The fatigue and characterization results demonstrated that the modified stems are substantially equivalent to the predicate components."

Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, study design parameters (sample size, data provenance, expert truth, etc.), or comparative effectiveness studies.

Based on the provided text, here's what can be inferred and what is missing:

Acceptance Criteria and Device Performance:

Study Details (Information NOT present in the provided text):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present. The document refers to "verification activities" and "fatigue testing" but does not detail a test set of patient data, so no sample size or provenance is available.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No human expert ground truth is mentioned as this is not a study assessing diagnostic or prognostic performance of an AI/human-in-the-loop device.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. See above.
4. 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 present. This is a hip implant, not an AI diagnostic tool. No MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This refers to a physical device (hip implant), not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the engineering tests would be the specific quantitative results of the fatigue and characterization tests compared against established engineering standards and predicate device performance. No patient-related ground truth (like pathology or outcomes) is mentioned.
7. The sample size for the training set: Not applicable/Not present. This is a physical medical device, not an AI algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable/Not present. See above.

In summary: The provided document is a regulatory submission for a medical device (hip implant) seeking substantial equivalence, not a clinical study report for an AI/diagnostic device. As such, it details engineering tests and verification activities, but does not include the specific types of studies and data points (e.g., patient sample sizes, expert ground truth, MRMC studies) you've requested for AI device evaluations.

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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 (NDJD): 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® Acetabular Insert with XLPE ("Insert with XLPE") is a permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The Insert with XLPE is fully compatible for use with the previously cleared Klassic HD® Hip System and is manufactured from UHMWPE crosslinked by gamma irradiation. The Insert with XLPE is sterilized by ethylene oxide gas and intended for single-use only.

The provided text describes a 510(k) premarket notification for a medical device, the Klassic HD® Hip System, specifically focusing on the Klassic HD® Acetabular Insert with XLPE. This filing addresses substantial equivalence to predicate devices rather than proving a device meets specific performance criteria in a clinical setting in the way an AI/ML medical device might.

Therefore, the information required to answer your specific questions about acceptance criteria and a study that proves the device meets the acceptance criteria regarding AI/ML device performance (e.g., sensitivity, specificity, expert ground truth, MRMC studies) is not present in the provided document.

The document discusses non-clinical bench testing to support substantial equivalence. While it mentions "pre-determined acceptance criteria" for this bench testing, it does not specify what those criteria are or provide detailed results from a clinical study.

Here's an breakdown of why your questions cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document states that "bench testing results demonstrated that the Klassic HD® Acetabular Insert with XLPE is substantially equivalent and does not raise new questions of safety or effectiveness for total hip joint replacement when compared to the predicate devices." It also says the device "met the pre-determined acceptance criteria." However, it does not list these specific criteria (e.g., thresholds for wear, strength, etc.) nor does it present the quantitative results against those criteria.
2. Sample sizes used for the test set and the data provenance: This refers to clinical data for performance evaluation. The document only mentions "non-clinical bench testing" and "extensive material characterization." There is no mention of a human test set, data provenance (country, retrospective/prospective), or data collection methods for a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts for the test set: Not applicable as no clinical test set using expert judgment is described.
4. Adjudication method for the test set: Not applicable as no clinical test set using expert judgment is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. The study described is non-clinical bench testing, not a study involving human readers or cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hip implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical bench testing, "ground truth" would relate to engineering standards, material properties, and mechanical performance metrics (e.g., ultimate tensile strength, wear rates). The specific metrics are not detailed, but the document mentions "material characterization," "sterility validation," "Push Out, Lever Out, Axial Torque Disassembly and Impingement testing."
8. The sample size for the training set: Not applicable. This document describes a physical medical device (hip implant), not an AI/ML model that requires training data.
9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML model or training set discussed.

In summary, the provided document details a 510(k) submission for a physical medical device (hip implant), focusing on non-clinical bench testing for substantial equivalence. It does not provide the kind of information typically found in an AI/ML device submission regarding clinical performance, expert readers, or ground truth establishment relevant to AI algorithm validation.

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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 (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 a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum, leg length, offset and version. The Klassic HD™ Hip System can be mated with metal (CoCrMo) or ceramic femoral heads and UHMWPE acetabular components.

This document is a 510(k) summary for a medical device called the "Klassic HD™ Hip System." It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a previously cleared device. However, it does NOT include the specific details needed to answer most of your detailed questions about acceptance criteria and study particulars for a standalone AI algorithm.

This document pertains to a physical orthopedic implant (hip system), not software, AI, or an imaging device. Therefore, many of your questions about AI study design, such as sample size for test/training sets, expert adjudication, MRMC studies, and ground truth types like pathology or outcomes data, are not applicable in this context.

Here's what can be extracted and what cannot:

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

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

• Sample Size for Test Set: Not specified. The document only mentions "the company performed burst strength testing, fatigue testing, post-fatigue burst strength testing and pull-off testing." It does not state how many units were tested for each.
• Data Provenance: Not applicable in the context of device performance testing. These are material/mechanical tests, not patient data trials.

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):

• This question is not applicable. The "ground truth" here refers to the physical properties and mechanical performance of the femoral heads. These are established through standardized engineering tests, not expert consensus or clinical evaluation in the way an AI algorithm's ground truth would be.

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

• This question is not applicable. Adjudication methods are relevant for subjective assessments or when multiple human readers interpret data. For mechanical testing, the "ground truth" is typically the measured value against a pre-defined engineering specification.

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 question is not applicable. This document describes the testing of a physical hip implant component, not an AI or imaging device that would involve human readers.

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

• This question is not applicable. The device is a physical hip system, not an algorithm.

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

• The "ground truth" here is based on engineering specifications and measurements from mechanical testing (burst strength, fatigue, post-fatigue burst strength, and pull-off testing). This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• This question is not applicable. There is no training set for a physical device being evaluated through mechanical testing.

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

• This question is not applicable. There is no training set mentioned in this document.

In summary: This 510(k) pertains to a physical medical device (hip implant) and its mechanical properties. The provided text outlines that mechanical tests were performed to demonstrate substantial equivalence, and those tests met pre-determined acceptance criteria. However, it lacks the specific numerical results of those tests and the detailed methodologies that would be required to answer questions typically asked about AI/software device studies.

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