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The ADVANCE® Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. Inflammatory degenerative joint disease including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   Porous-coated total knee replacement components are for use without bone cement.

The purpose of this submission is to add patellar components to the ADVANCE® Total Knee System. The design features of the subject patellae are summarized below:

• All-poly patellae manufactured from UHMWPE
• Available in sizes 25-41, single- or tri-peg design
• Metal-backed patellae manufactured from UHMWPE and CoCr alloy
• Available in sizes 29-38, tri-peg design with porous coating

The provided document is a 510(k) Summary for the ADVANCE® Total Knee System, specifically for the addition of new patellar components. It outlines the device's indications for use, description, and claims of substantial equivalence to predicate devices. However, this type of regulatory submission does not typically include detailed acceptance criteria or a dedicated study report with performance metrics in the way a clinical trial or algorithm validation study would.

Here's an analysis based on the information provided, and where the requested details are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the evaluation of the new patellar components through "mechanical testing and engineering analyses." It states a general conclusion rather than specific numerical acceptance criteria and performance data.

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

This information is not provided in the 510(k) summary. The evaluation described involves "mechanical testing and engineering analyses" on the device itself, not a test set of patient data.

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

This is not applicable/not provided as the evaluation is based on mechanical testing and engineering analysis of the device, not a human reader assessment of medical imagery or patient outcomes.

4. Adjudication Method for the Test Set:

This is not applicable/not provided for the same reasons as above.

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

This is not applicable/not provided. The document describes mechanical testing of device components, not a study involving human readers or AI assistance.

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

This is not applicable/not provided. This document pertains to a physical medical device (knee implant components), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the results of standardized mechanical and engineering tests, as well as material characterization, demonstrating that the new patellar components perform equivalently to existing predicate devices and can withstand in vivo conditions. This is a physical/material ground truth, not a clinical one.

8. The Sample Size for the Training Set:

This is not applicable/not provided. There is no "training set" in the context of mechanical device testing.

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

This is not applicable/not provided for the same reasons as above.

Summary of Study (Based on Provided Text):

The "study" described in the 510(k) summary is a mechanical and engineering evaluation of new patellar components for the ADVANCE® Total Knee System.

• Objective: To demonstrate that the new patellar components (all-poly and metal-backed) are substantially equivalent to existing predicate devices and are safe and effective for their intended use.
• Methodology:
  • Mechanical Testing: Performed on the new patellar components to evaluate:
    • Static stability
    • Contact area
    • Interface strength
  • Engineering Analyses: Used to interpret the mechanical testing results and compare them to performance expectations.
  • Material Characterization: Fully characterized the porous coating for the metal-backed design and tested its static shear properties.
  • Comparison to Predicate Devices: The results of these tests and analyses were used to establish "equivalence" with the design features and materials of the predicate devices (ADVANCE® Total Knee System, AXIOM® Total Knee System).
• Conclusion: The review of these results indicated that the subject devices are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

Key Missing Information (for the requested table structure):

As this is a 510(k) Summary for a physical orthopedic implant, the provided document focuses on demonstrating substantial equivalence through mechanical and material characterization, rather than clinical performance data, AI algorithm validation, or human reader studies. Therefore, many categories in your requested table are not directly applicable or are not detailed in this type of submission. Specific numerical values for the mechanical tests (e.g., specific load tolerances, displacement limits, wear rates) would typically be found in a more detailed test report, but are summarized in the 510(k) for regulatory review.

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The ADVANCE® Total Knee System is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. inflammatory degenerative joint disease including rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and
5. treatment of fractures that are unmanageable using other techniques.
   The ADVANCE® Total Knee System components are for use without bone cement and are single use devices.

The ADVANCE® Total Knee System contains femoral components, tibial components, and patellas. The ADVANCE® Total Knee System components are compatible with existing ADVANCE® tibial inserts and patellas. The design features and function of the ADVANCE® Total Knee System are substantially equivalent to the design features and function of the existing ADVANCE® Total Knee System and are highlighted below.

• Manufactured from Cobalt Chrome Alloy or Titanium Alloy .
• Manufactured with porous coating .
• Accessory components available without porous coating .
• Available with or without HA coating .
• Intended for use without bone cement .

This 510(k) summary (K061223) is for the ADVANCE® Total Knee System, a knee arthroplasty device.

Based on the provided document, there is no acceptance criteria or study mentioned that proves the device meets specific performance criteria in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics typically associated with AI/software devices.

The document is a traditional 510(k) submission for a medical implant (a knee replacement system) which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting analytical or clinical performance data that would involve acceptance criteria and a study design as described in the prompt.

Therefore, I cannot populate the table or provide the requested information. The document pertains to a mechanical device, not an AI/software-based medical device.

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

• Type of Device: The "ADVANCE® Total Knee System" is a knee implant (femoral components, tibial components, patellae). It is a physical, mechanical medical device.
• Regulatory Pathway: The submission is a 510(k), which for devices like these, primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves comparing materials, design features, intended use, and sometimes mechanical testing (e.g., fatigue, wear resistance) if new materials or designs are introduced. It does not involve diagnostic accuracy studies, human reader studies, or AI algorithm performance metrics.
• Content of the Document: The document explicitly discusses "intended use, material, type of interface, and design features" and states that "The ADVANCE® Total Knee System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." This "testing results" would refer to mechanical or biocompatibility tests, not clinical performance studies in the context of AI.
• Absence of AI/Software Indicators: There is no mention of algorithms, AI, machine learning, image analysis, diagnostic capabilities, or any other terms that would suggest an AI component that would require the kind of performance metrics outlined in your prompt.

If this was an AI/Software-based device, the 510(k) summary would typically include sections detailing:

• Algorithm description
• Training data characteristics
• Test data characteristics
• Ground truth establishment
• Performance metrics (e.g., sensitivity, specificity, AUC)
• Results of standalone studies
• Results of human-in-the-loop studies (MRMC studies)

Since none of this information is present, it confirms that the device is not an AI/software device and therefore does not have the "acceptance criteria" and "study" as envisioned in your prompt.

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Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. inflammatory degenerative joint disease including rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and
5. treatment of fractures that are unmanageable using other techniques.
   This device is intended for use with bone cement.

The ADVANCE All Polyethylene Tibial Component, size 8mm, is manufactured from ultra high molecular weight polyethylene. The device features cement pockets on the underside of the component. The device is designed to be used with bone cement.

The provided text describes a medical device submission (K974328) for the ADVANCE® Total Knee System, 8mm All Polyethylene Tibial Component. It outlines the device's description, intended use, and a summary of the testing conducted. However, the document does not present acceptance criteria in a structured table or a detailed study report that explicitly "proves the device meets the acceptance criteria" in the format typically associated with AI/ML model performance evaluation. Instead, it describes mechanical testing for a physical implant.

Therefore, many of the requested fields regarding AI/ML model evaluation, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for training sets, are not applicable to the information provided.

Based on the available information, here is a breakdown of what can be extracted concerning acceptance criteria and device performance for this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other information points, based on the provided text, the following apply:

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

• Not Applicable. This document describes mechanical testing of a physical implant, not a data-driven device where a "test set" in the context of AI/ML evaluation would be relevant. The testing would have involved physical specimens of the tibial component.

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 this context would refer to the physical and mechanical properties of the device, established through engineering testing, not expert consensus on data interpretation.

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

• Not Applicable. Adjudication methods are relevant for human interpretation tasks, not for mechanical device 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. This is a physical orthopedic implant, not an AI/ML-driven diagnostic or assistive device.

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

• Not Applicable. No algorithms or AI are mentioned in the context of this device's performance evaluation.

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

• The ground truth for the mechanical testing would be established by
  • Engineering specifications and standards: These would define the acceptable limits for load, stress, and constraint.
  • Physical measurements and observations: Direct measurements from the testing (e.g., fatigue life, stress distribution visualizations, displacement under load) against predetermined thresholds.

8. The sample size for the training set

• Not Applicable. No training set for an AI/ML model is mentioned.

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

• Not Applicable. No training set for an AI/ML model is mentioned.

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