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510(k) Data Aggregation
(221 days)
- Non-inflammatory degenerative ioint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity 4) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications.
Biomet Manufacturing Corp. is modifying the manufacturing process of UHMWPE used in the fabrication of polyethylene acetabular components. The modified manufacturing process results in a higher cross-linked polyethylene, that Biomet will herein refer to as ArComXL™.
The provided document describes the ArComXL™ Polyethylene Liners and studies conducted to demonstrate their performance compared to a predicate device. The information is extracted from a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than defining explicit "acceptance criteria" in the same way one might for a new, novel product with performance goals.
However, we can infer the acceptance criteria from the reported performance improvements over the predicate device. The studies are standalone (algorithm only, no human-in-the-loop performance is relevant here as it's a material science evaluation). The ground truth is based on physical material testing and established ASTM standards, not expert consensus or clinical outcomes.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
Note: "Acceptance Criteria" are inferred as improved performance over the predicate device, as this is a 510(k) submission for a modification to an existing device. The goal is to show the new device is "substantially equivalent" or better.
| Category | Acceptance Criteria (Inferred from Predicate Performance Baseline) | Reported Device Performance (ArComXL™) |
|---|---|---|
| Hip Simulator Wear | Volumetric wear rate ≤ predicate (65.8 mm³/10⁶ cycles) | 47% reduction (34.9 mm³/10⁶ cycles) vs. predicate |
| Abrasive Hip Wear | Volumetric wear rate ≤ predicate (309.0 mm³/10⁶ cycles) | 64% reduction (109.8 mm³/10⁶ cycles) vs. predicate |
| Free Radicals | Number of free radicals ≤ predicate (3.82 x 10¹⁵ spins/g) | 94% reduction (0.22 x 10¹⁵ spins/g) vs. predicate |
| Oxidative Stability | Oxidation index ≤ predicate (>=1.1 at 1mm depth) after aging | No measurable oxidation (index < 0.4) after accelerated aging (ASTM F2003-00). Average ultimate load 31% higher (91.8N vs 70.2N). |
| Mechanical Strength | Ultimate tensile strength ≥ predicate (47 MPa) | 30% increase (61 MPa) in ultimate tensile strength vs. predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size (e.g., number of inserts or material samples). Instead, it refers to "ArComXL™ polyethylene acetabular inserts" and "predicate polyethylene liners/material."
- Sample Size: Not explicitly stated as a numerical count beyond referring to "ArComXL™ polyethylene acetabular inserts" or "material" for each test. For the Hip Simulator Wear, it states "All inserts in this study mate with either a 50 or 52mm acetabular shell...", implying multiple samples were tested for each group (ArComXL™ and predicate).
- Data Provenance: The studies are in vitro laboratory tests. There is no mention of data country of origin or whether it's retrospective/prospective, as this is not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for these material science tests is established through objective physical measurements using standardized testing methods (e.g., ASTM standards, hip simulator protocols), not subjective expert assessment. The free radical testing was performed by "an independent laboratory."
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnostic performance assessments, not for material property testing. The results are quantitative measurements.
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 material science study evaluating the physical properties of a polyethylene liner for hip implants, not a diagnostic device involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, all presented studies are standalone physical performance tests of the device material itself, without human intervention in the device's functional performance or a human-in-the-loop element during testing.
7. The Type of Ground Truth Used
The ground truth used is based on:
- Physical Measurements and Mechanical Testing: Volumetric wear rate (mm³/10⁶ cycles), number of free radicals (spins/g), oxidation index (FTIR), ultimate tensile strength (MPa), and ultimate load (N) are objective, quantitative physical properties measured according to established protocols or ASTM standards.
- Established Standards: ASTM F-648 for UHMWPE, ASTM F2003-00 for accelerated aging, ASTM F2183-02 for small punch testing, and ASTM D638-02a for tensile testing.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device. These are material tests of manufactured components.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned or relevant for this type of device and study.
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