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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.

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

The studies primarily rely on in vitro and ex vivo bench testing, and animal studies. Therefore, typical "test sets" of human patient data are not applicable here.

• Claim 1 (Oxidation & Impact):
  • Oxidation: Samples of HXL VE tibial inserts at three time points (non-aged, 2 weeks aged, 4 weeks aged). The exact number of samples per time point is not specified but standard deviation is given, implying multiple samples. Comparison to Compression Molded UHMWPE (CM) at 2 weeks aged.
  • Impact: HXL VE test specimens and CM control specimens. Exact numbers not specified but implies multiple specimens for statistical analysis. Pre and post-accelerated aging.
  • Provenance: Laboratory testing (in vitro). Not applicable for country of origin or retrospective/prospective.
• Claim 2 (Mechanical Strength - Tensile & Peel-out):
  • Tensile: CM, Highly Cross-Linked (HXL), and HXL VE material. All test specimens accelerated aged. Exact numbers not specified but standard deviation given.
  • Peel-out: Tibial insert test parts for both CM and HXL VE material. Exact number not specified but standard deviation given.
  • Provenance: Laboratory testing (in vitro).
• Claim 3 (Mechanical Strength after aging - Tensile, Small Punch, Impact):
  • Tensile, Small Punch, Izod Impact: HXL VE material (before and after accelerated aging). Exact numbers not specified but standard deviations given.
  • Provenance: Laboratory testing (in vitro).
• Claim 4 (Wear Rate):
  • Wear testing on 3D™ Knee system, comparing DCM and machined HXL VE tibial inserts. Each test performed for 5 million cycles. Both inserts were Size 6 Left. The study implies multiple replicate tests to generate the average wear rates and standard deviations for both DCM and HXL VE.
  • Provenance: Laboratory testing (in vitro).
• Claim 5 (Biocompatibility/Irritation):
  • Sample Size: Three healthy adult New Zealand White rabbits. Five HXL VE sites and five CM sites implanted for each rabbit (total 15 HXL VE implants and 15 CM implants).
  • Provenance: Animal study (ex vivo tissue analysis). Not applicable for country of origin or retrospective/prospective in a human context.

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

• For in vitro and ex vivo materials testing (Claims 1-4): Ground truth is established by the methodologies and interpretations of standard ASTM and ISO test protocols. This typically involves trained laboratory technicians and engineers who understand the specific test procedures and material science principles. The exact number or qualifications of individuals interpreting these specific test outputs are not provided but are assumed to be experts in materials testing.
• For Biocompatibility (Claim 5):
  • Number of Experts: A single veterinary pathologist microscopically evaluated the H&E stained tissue sections.
  • Qualifications: "veterinary pathologist." No further details on years of experience are provided, but this implies specialized training and certification in veterinary pathology.

4. Adjudication Method for the Test Set

Given that the studies are primarily in vitro and ex vivo bench testing, and an animal study:

• For Claims 1-4 (Materials Testing): Adjudication, in the sense of expert consensus on ambiguous findings, is generally not applicable. Performance is measured objectively according to standard test methods (e.g., ASTM, ISO), which define measurable outputs. Any interpretation would follow established scientific and engineering principles.
• For Claim 5 (Biocompatibility): The microscopic evaluation was performed by a single veterinary pathologist. Therefore, no formal multi-expert adjudication method (like 2+1 or 3+1) was explicitly stated or performed for this specific test. The pathologist's evaluation would constitute the ground truth for irritant scoring.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without AI assistance on diagnostic imaging cases. The provided document details in vitro and animal studies for a medical implant material, not a diagnostic AI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical knee implant component, not an algorithm or a software device. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

• For Claims 1-4 (Material Properties and Wear): The ground truth is based on standardized physical and chemical measurements obtained through established ASTM and ISO protocols. This includes quantitative data for oxidation indices, impact resistance, tensile strength, peel-out force, and wear rates.
• For Claim 5 (Biocompatibility): The ground truth is established by expert pathological evaluation of tissue samples (microscopic analysis by a veterinary pathologist) and subsequent calculation of a quantitative Irritant Ranking Score based on observed tissue reactions.

8. Sample Size for the Training Set

Not applicable. This device is a physical implant, not a software or AI device that requires a "training set" in the context of machine learning. The manufacturing processes and material formulations are based on established engineering principles and prior research, not on a machine learning training dataset.

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

Not applicable, as there is no "training set" in the machine learning sense for this device. The development and validation of the material are based on non-clinical testing against industry standards and comparisons to predicate devices and control materials.

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