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Total joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis; .
• avascular necrosis of the femoral condyle; .
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
• . moderate valgus, varus or flexion deformities;
• Treatment of fractures that are unmanageable using other techniques .
  This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.

Subject of this Traditional 510(k) Premarket Notification is a request for labeling claims for the DJO Surgical 3DKnee HXL VE Tibial Insert. The in vitro wear claim will be made for the use of the 3DKnee femoral component coupled with a 3DKnee HXL VE Insert. It is important to note that there are no new total knee components being introduced as a result of this Traditional 510(k) premarket notification.

Acceptance Criteria and Study for DJO Surgical HXL VE Tibial Insert

This document analyzes the acceptance criteria and supporting studies for the DJO Surgical Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Insert, based on the provided K103223 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The device demonstrates substantial equivalence to predicate devices based on five key claims. The acceptance criteria and reported performance for each claim are detailed below. It's important to note that the acceptance criteria are generally implied as either not showing significant degradation (for properties like oxidation resistance, mechanical strength after aging) or demonstrating performance at least equivalent to, or superior to, control/predicate materials.

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Joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis; .
• . avascular necrosis of the femoral condyle;
• . post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• . moderate valgus, varus or flexion deformities;

This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.

The Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) powder that is blended with pure liquid pharmaceutical grade alpha-tocopheral, compression molded and then highly cross-linked. The tibial inserts are available in 9 sizes (2- 12) and 5 thicknesses (9-19) and are provided in right and left orientations. The HXL VE Tibial Insert design is identical to the 3DKnee Tibial Insert cleared via K020114. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle. The baseplate attachment mechanism is the same as the previously cleared 3DKnee System inserts.

The provided document is a 510(k) summary for a medical device called "Highly Cross-Linked Vitamin E UHMWPE Tibial Insert." This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study to prove acceptance criteria for a new, innovative device with unique performance claims.

Therefore, many of the requested elements for a study proving acceptance criteria (like sample size for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets) are not applicable to this type of regulatory submission. This document describes a device approval based on non-clinical testing demonstrating similarity to existing devices.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This report does not define specific discrete "acceptance criteria" in the way a performance study for an AI algorithm or a novel diagnostic might. Instead, it relies on demonstrating that the new device's material properties, design, and indications for use are substantially equivalent to legally marketed predicate devices. The "reported device performance" is the outcome of various non-clinical tests showing these equivalencies.

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

• Sample Size: Not applicable. This was non-clinical testing of materials and device components, not a clinical study on patient data. The "sample size" would refer to the number of physical samples tested for each material or mechanical property. This specific number is not provided in the summary but would be detailed in the full test reports.
• Data Provenance: Not applicable in the context of clinical data. The data originates from laboratory testing. It is neither retrospective nor prospective clinical data.

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

Not applicable. Ground truth, in the context of this device, would be established by validated engineering and scientific testing standards and methodologies, not by expert medical consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There's no clinical test set requiring adjudication in this submission.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This is a non-clinical submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. This is a physical medical device (an orthopedic implant), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Established material science properties.
• Validated mechanical testing standards (e.g., for wear, strength, fatigue).
• Chemical quantification methods.
• Biocompatibility standards.
• Direct comparison of design specifications to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

Not applicable. There is no "training set" for this device.

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