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The Freedom® PCK Components are designed to be used with the Freedom® Stemmed Tibial Components and as a part of the Freedom® Total Knee System, and is indicated for the following:

• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods
• Revision surgery where sufficient bone stock and soft tissue integrity are present
  The Freedom® PCK Components are intended for cemented use only. The optional Freedom Stemmed Tibial Augments are intended for screw attachment to the Stemmed Tibial Base Plate. This device is for single use only.

The Freedom® PCK Components is a progressive constraint cemented prosthesis system. The PCK Components consists of CoCrMo composed Stemmed Femoral Component, UHMWPE composed Tibial Liner and Ti-6A1-4V composed Posterior and Distal Femoral Augments. The components are a modification of the previously cleared Freedom® Stemmed Tibial Components (tibial augment) and Freedom® Total Knee System (PS femoral component and PS tibial liner). Also, the Freedom® PCK Components are intended for use with the Freedom® Stemmed Tibial Components and as a part of the Freedom® Total Knee System for total knee replacement (TKR) surgery. The Components will be prescription products consisting of single use only, implantable devices for implanting into patients in an operating theatre by a qualified surgeon.

The devices are to be packaged and terminally sterilized by gamma radiation or ethylene oxide. The packaging is to keep devices sterilized for 5 years. The packaging will be able to be opened easily in an operating theatre without instruments and in a manner that allows the implant to remain sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Freedom® PCK Components:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for each test. Instead, it describes the objective of each non-clinical test. The document implies that the device "meets" its objectives through these tests, but no pass/fail thresholds are given.

Explanation of "Assumed to meet performance for substantial equivalence": In 510(k) submissions, for devices deemed substantially equivalent, direct numerical results and their comparison to specific acceptance criteria are often presented in detailed test reports not typically included in the public 510(k) summary. The FDA's clearance (K131481) implies that the provided data (including these performance tests) was sufficient to demonstrate that the device performs as safely and effectively as the predicate devices.

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

• Sample Size: Not explicitly stated. The tests are non-clinical, likely involving a number of physical specimens of the device components. The document doesn't provide a count of how many components were tested for each study.
• Data Provenance: The studies are non-clinical (laboratory/mechanical testing) performed on the device components themselves. There is no mention of human data, country of origin related to human data, or whether it's retrospective or prospective, as clinical testing was not required.

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

This information is not applicable as the studies are non-clinical engineering/mechanical tests, not human studies requiring expert interpretation of results for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical engineering/mechanical tests. Adjudication methods are typically used in clinical studies for interpreting human 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor was it required. This is a medical device (knee implant) and not an AI/imaging diagnostic device that would involve human readers interpreting output. Clinical testing in general was not required for this submission.

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

No, this is not an algorithm-based device. It is a physical implantable medical device. Therefore, standalone algorithm performance is not relevant.

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

For the non-clinical tests, the "ground truth" would be established by engineering and biomechanical principles and standards for knee prostheses. For example:

• Standard ASTM or ISO test methods for fatigue, strength, stability, and range of motion for orthopedic implants.
• The performance of the predicate devices.
• The documented design specifications of the Freedom® PCK Components.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" for physical mechanical testing.

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

This information is not applicable as there is no "training set" for physical mechanical testing.

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