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510(k) Data Aggregation
(45 days)
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
The subject devices are single use components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, .
- . rheumatoid arthritis,
- . correction of functional deformity,
- revision procedures where other treatments or devices have failed, and .
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
The subject Crossfire™System 12® Acetabular Inserts are the same as the predicate non-Crossfire™System 12® Acetabular Inserts, except that the subject devices are fabricated from polyethylene that has been crosslinked via the procedure described in, and found Substantially Equivalent in, 510(k) #K974685.
This document describes a 510(k) submission for "Additional Crossfire™ Acetabular Components," specifically Crossfire™ System 12® Acetabular Inserts. It focuses on demonstrating substantial equivalence to previously marketed devices and does not present a typical "study" in the sense of a clinical trial or algorithm performance evaluation. Instead, it relies on materials comparison, design equivalence, and mechanical testing to show the new components are safe and effective.
Here's a breakdown based on the provided text, addressing your points where applicable:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are implied by the performance of the predicate devices and the focus of the additional testing. The primary "performance" assessed here is the structural integrity and locking strength of the acetabular inserts, particularly after the Crossfire™ crosslinking process.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Structural integrity (no gross evidence of impending catastrophic failure) after fatigue testing | "All inserts were inspected for signs of structural compromise with no gross evidence of impending catastrophic failure." |
| Sufficient locking strength pre- and post-fatigue testing | "Axial distraction test results demonstrated sufficient locking strength pre-and post- fatigue testing." |
| Not adversely affected by Crossfire™ process (locking/fatigue strength) | "Additional testing has been performed on Crossfire™ versions of the System 12® Acetabular Inserts to validate that these inserts are not adversely affected, with regard to locking strength or fatigue strength, as a result of the Crossfire™ process." |
| Wear Rate (in specific configurations, compared to standard polyethylene) | 90% reduction in gravimetric wear rate (unaged) |
| 88% reduction in gravimetric wear rate (aged) | |
| 78% reduction in gravimetric wear rate (abrasive wear) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Structural/Locking Test: "After 107 cycles, three inserts were axially distracted (pushed-out) and two were carefully removed by sectioning their metal shells." For the wear claims, specific insert models (e.g., 2041C-2850) were used, but the exact number of samples for each wear test condition isn't explicitly stated beyond implying "inserts."
- Data Provenance: The tests are described as in vitro mechanical and wear simulator tests. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities (Howmedica Osteonics Corp.). These are prospective tests performed for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is objective mechanical performance data, not expert subjective interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable. Mechanical tests follow defined protocols and yield objective measurements, not subjective evaluations requiring adjudication.
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 is not applicable. This submission is for a medical device (acetabular components), not an AI algorithm or an imaging study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm, and there is no human-in-the-loop component relevant to its mechanical function.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the acetabular components is based on:
- Objective Mechanical Measurements: Axial distraction force measurements for locking strength, and gravimetric wear measurements from hip wear simulation.
- Visual Inspection: Gross inspection for signs of structural compromise.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8.
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