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The Scorpio® Total Knee System components are for use in total knee arthroplasty to relieve pain and restore knee function for indications such as: painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; post-traumatic loss of knee joint configuration and function; moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; revision of previous unsuccessful knee replacement or other procedure. Additional indications for the posterior stabilized components include: ligamentous instability requiring implant bearing surface geometries with increased constraint; absent or non-functioning posterior cruciate ligament. These products are intended to achieve fixation without the use of bone cement.

The device includes femoral and tibial components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.

The provided text is a 510(k) Premarket Notification for the "Scorpio Total Knee System with Peri-Apatite Coating." This document, issued by the FDA in 2004, is primarily focused on demonstrating "substantial equivalence" of the device to a predicate device, rather than providing detailed acceptance criteria and a study proving those criteria were met in the way one might expect for a novel device or software.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with explicit numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device; or specific mechanical thresholds for an implant). Instead, the acceptance criteria are implicitly linked to demonstrating equivalence to the predicate device and meeting established standards for similar prostheses.

The "reported device performance" is summarized qualitatively:

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

The document describes engineering and laboratory testing, not human-subject or clinical studies with "test sets" in the diagnostic or AI sense.

• Sample Size: Not specified in terms of number of devices or components tested, but implies multiple units for various tests (e.g., fatigue, material properties).
• Data Provenance: Not applicable in the context of human data. The testing refers to "research and development testing" likely performed in a laboratory setting by Howmedica Osteonics Corp.

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

• This is not applicable as the "ground truth" for the device's mechanical and material properties is established through standardized engineering tests and measurements, not expert human evaluation of cases.

4. Adjudication Method for the Test Set:

• Not applicable, as this refers to human expert judgment, which was not used to establish the "truth" for this type of device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was not performed. This type of study is relevant for diagnostic devices (especially those involving image interpretation by humans). The submission is for a knee implant, which undergoes mechanical and material testing.

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

• Not applicable. This is not a software algorithm or AI device. The device is a physical knee implant.

7. The Type of Ground Truth Used:

• The "ground truth" in this context refers to established engineering standards, material specifications, and physical measurements (e.g., strength, fatigue life, pore size, range of motion) as defined by the Class II Special Controls Guidance Document and general engineering principles for medical implants.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

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The Scorpio® Knce System components are for use in total knee arthroplasty as a result of:

• Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function .
• Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adcquate function and stability;
• Revision of previous unsuccessful knee replacement or other procedure; .
• Ligamentous instability requiring implant bearing surface geometries with increased . constraint;
• Absent or non-functioning posterior cruciate ligament. .

These components are single use only and are intended for implantation with bone cenient.

This submission is intended to address a design modification to the Scorpio Total Knee System Posterior Stabilized tibial insert component. The tibial insert components were redesigned to provide for improved hyperextension.

The provided document is a 510(k) summary for a design modification to a knee implant (Scorpio® Total Knee System Posterior Stabilized Tibial Insert Components). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance against specific acceptance criteria for AI/ML devices or clinical studies. Therefore, much of the requested information (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) is not applicable or available in this document.

Here's an attempt to answer the questions based only on the provided text, recognizing its limitations for AI/ML-focused inquiries:

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

2. Sample sized used for the test set and the data provenance
Not applicable. This document describes a mechanical device modification and its testing for substantial equivalence, not an AI/ML algorithm evaluated on a data test set. The tests conducted appear to be engineering/biomechanical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/ML performance evaluation is not relevant here. The "ground truth" for this device's performance would be established through engineering analysis and physical testing.

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. This is a knee implant, not an AI diagnostic device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a knee implant.

7. The type of ground truth used
For the engineering tests mentioned (range of constraint, post stress, contact stress/area), the "ground truth" would be established through biomechanical testing and engineering analysis comparing the modified device's performance to the predicate device and established safety/performance standards for knee implants.

8. The sample size for the training set
Not applicable. This document does not describe an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable.

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The Scorpio® Total Knee System components are for use in total knee arthroplasty to relieve pain and restore knee function for indications such as: painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post- traumatic arthritis; post-traumatic loss of knee joint configuration and function; moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; revision of previous unsuccessful knee replacement or other procedure. Additional indications for the posterior stabilized components include: ligamentous instability requiring implant bearing surface geometries with increased constraint; absent or non-functioning posterior cruciate ligament. These products are intended to achieve fixation with and without the use of bone cement.

The device includes femoral, tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia and patella to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.

The provided text describes the Scorpio® Total Knee System and its substantial equivalence to a predicate device, focusing on its proposed modification for use without bone cement. It details the testing performed to demonstrate this equivalence, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested elements for an AI/device performance study are not applicable or cannot be extracted from this document.

Here's an analysis based on the available information:

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

The document does not explicitly state numerical acceptance criteria in a typical "device performance study" sense. Instead, it refers to demonstrating "equivalence to the predicate devices" and meeting "the requirements of this document" (referring to the Class II Special Controls Guidance Document).

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

This information is not applicable to the provided document, as it describes a series of engineering and materials tests rather than a clinical study involving human subjects or data sets in the context of an AI/diagnostic device. The "tests" here refer to mechanical and material evaluations, not a test set of data for an algorithm.

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 information is not applicable. The "ground truth" for the device's mechanical and material performance was established through standardized engineering tests and material characterization, not expert consensus on medical images or clinical outcomes.

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

This information is not applicable, as the evaluation involved engineering tests, not human reader adjudication of data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The document does not describe a clinical study of diagnostic performance, nor does it involve an AI component for human reader assistance.

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

This information is not applicable. The document describes the evaluation of a physical medical device (a knee implant), not a standalone algorithm.

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

The "ground truth" in this context refers to the established scientific and engineering principles, material specifications, and performance requirements outlined in the FDA's Class II Special Controls Guidance Document for knee prostheses. This would include measurable physical properties, mechanical strength, durability under simulated physiological conditions, and material biocompatibility, confirmed through specific laboratory testing.

8. The sample size for the training set

This information is not applicable. The document does not describe the development or evaluation of an AI algorithm, and therefore there is no "training set."

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

This information is not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established in this context.

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