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510(k) Data Aggregation
(136 days)
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Oxinium Femoral Heads are for single use only and can be used as part of cemented or uncemented total hip arthroplasty.
The Oxinium Femoral Heads are designed for use with femoral stems and acetabular components distributed by Smith & Nephew. The Oxinium Femoral Heads are metal alloy devices processed via a proprietary oxidation process.
The provided document describes the mechanical and clinical data for Oxinium Femoral Heads to support additional marketing claims related to wear particle generation. This is a premarket notification (510(k)) submission for a medical device seeking clearance from the FDA, not a study designed to meet specific acceptance criteria in the typical sense of a diagnostic or predictive device. Therefore, many of the requested elements for a study proving device performance are not directly applicable or available in this document.
However, I can extract the information related to the performance claims and the testing methods used to substantiate them.
Here's a breakdown of the requested information based on the provided text, with explanations for elements not present:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific submission, the "acceptance criteria" are implied by the marketing claims the manufacturer wishes to make: demonstrating a reduction in wear particles compared to a predicate device (CoCr femoral heads). The reported device performance directly addresses these claims.
| Acceptance Criteria (Implied by Marketing Claim) | Reported Device Performance |
|---|---|
| Generate less crosslinked polyethylene particles than CoCr femoral heads. | Oxinium Femoral Heads generate 28% less crosslinked polyethylene particles compared to equivalent sized CoCr femoral heads (under standard conditions). |
| Generate less conventional polyethylene particles than CoCr femoral heads. | Oxinium Femoral Heads generate 30% less conventional polyethylene particles compared to equivalent sized CoCr femoral heads (under standard conditions). |
| Generate less crosslinked polyethylene particles than CoCr femoral heads under roughened conditions. | Oxinium Femoral Heads generate 63% less crosslinked polyethylene particles compared to equivalent sized CoCr femoral heads under roughened conditions. |
| Generate less conventional polyethylene particles than CoCr femoral heads under roughened conditions. | Oxinium Femoral Heads generate 45% less conventional polyethylene particles compared to equivalent sized CoCr femoral heads under roughened conditions. |
| Not detect polyethylene particles with diameters less than 0.05 µm. | The testing conducted did not detect any polyethylene particles with diameters less than 0.05 µm for all wear particle claims. (Note: This is a detection limit, not a performance metric for particle generation per se, but rather a characteristic of the measurement method). |
Important Disclaimer from the Document: "The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that testing was performed "for five million cycles per individual test." It also refers to "a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head" articulating with a liner. This implies at least one Oxinium head and at least one CoCr head were tested for each scenario to compare their wear performance. The exact number of individual heads tested is not explicitly stated as a numerical 'sample size' (e.g., N=X Oxinium heads, N=Y CoCr heads). It sounds like a single test rig per condition, run for 5 million cycles.
- Data Provenance: The data is from "in vitro tests" conducted by Smith & Nephew, Inc. (the manufacturer). This is a prospective test in a laboratory setting, not derived from human patients or a specific country of origin in a clinical context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The "ground truth" here is the physical measurement of wear particles generated in a hip joint simulator, not a clinical diagnosis or expert interpretation of an image. The measurement is quantitative, based on laboratory protocols.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in tasks like image interpretation or clinical diagnosis. The "test set" here involves physical measurements from a hip joint simulator, which are typically analyzed and quantified by laboratory technicians and engineers, not adjudicated by experts in the described manner.
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 and not provided in the document. An MRMC study is relevant for evaluating diagnostic performance where human readers interpret cases, often with or without the assistance of an AI algorithm. This document describes mechanical performance testing of an implantable device, not a diagnostic tool or an AI-assisted interpretation task.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided in the document. "Standalone performance" in this context usually refers to an AI algorithm's performance without human input. The device being described is a physical medical implant (femoral head), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims is the quantified wear particle generation directly measured from the output of the hip joint simulator tests. This is a direct physical measurement (mass or number of particles, depending on the method used) rather than expert consensus, pathology, or outcomes data. The document also mentions that "The testing conducted did not detect any polyethylene particles with diameters less than 0.05 µm," indicating the sensitivity limit of the measurement technique.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. A "training set" is used to develop machine learning models or AI algorithms. This document describes the mechanical testing of a physical medical device, not the development of an AI system.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided in the document, as it pertains to AI/machine learning development, which is not the subject of this submission.
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