(29 days)
The indications for the use of the Osteonics® C-Tapered Titanium Stems , in keeping with those of other legally marketed Osteonics femoral components, are as follows:
For Use as a Bipolar Hip Replacement:
- Femoral head/neck fractures or non-unions. .
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular ● involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum.
- . Salvage of failed total hip arthroplasty.
For Use as a Total Hip Replacement:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
The Osteonics® C-Tapered Titanium Stems (Osteonics® Omnifit HA Hip Stem Series, Osteonics® Secur-Fit Hip Stem Series, Osteonics® Primary Secur-Fit Plus HipStem Series) are currently marketed devices that are being modification involves shortening the trunnion and reducing the diameter of the stem neck. All other aspects of the Osteonics® C-Tapered Titanium Stems will remain unchanged.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Osteonics® C-Tapered Titanium Stems:
Analysis of Acceptance Criteria and Performance Study for Osteonics® C-Tapered Titanium Stems
The provided document is a 510(k) submission for a device modification, not a comprehensive clinical study report for a new device. Therefore, the information typically associated with detailed acceptance criteria, test sets, ground truth establishment, and multi-reader studies for AI/ML devices is not present. This submission focuses on demonstrating substantial equivalence of a modified hip stem design to its predicate devices through mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Performance Standard/Goal | Reported Device Performance (Modified Device) | Conclusion on Acceptance |
|---|---|---|---|
| Fatigue Strength | Substantial equivalence to predicate stem designs | Demonstrated substantial equivalence to predicate stem designs (through mechanical testing) | Met |
Explanation of Criteria:
The core acceptance criterion for this 510(k) submission is that the modified device maintains substantial equivalence to its predicate devices, particularly concerning its fatigue strength. This is crucial because it indicates that the design changes (shortened trunnion, reduced neck diameter) do not negatively impact the mechanical integrity and longevity of the hip stem, which is a critical safety and effectiveness aspect for orthopedic implants.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or "test set" in the context of a clinical trial. The testing appears to be mechanical in nature.
- Data Provenance: The nature of mechanical testing usually involves engineered samples or actual device prototypes. No mention of human patient data, retrospective, or prospective studies in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. Ground truth in this context is the outcome of mechanical fatigue testing, which is determined by engineering standards and measurements, not expert human interpretation of data.
4. Adjudication Method for the Test Set
- Not applicable. As mechanical tests are objective measurements, there's no "adjudication" between multiple interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) study was performed. This document pertains to a physical medical device (hip stem) and its mechanical performance, not a diagnostic or AI-assisted interpretation device that would involve human readers.
6. Standalone Performance Study (Algorithm Only)
- No standalone (algorithm only) performance study was performed. This is not an AI/ML device. The "device" is a physical hip stem.
7. Type of Ground Truth Used
- Mechanical Test Results (Fatigue Strength): The "ground truth" here is derived from standardized mechanical fatigue testing methods, typically aligned with ASTM (American Society for Testing and Materials) standards relevant to orthopedic implants (e.g., ASTM F-620 for titanium alloys, potentially other standards for fatigue testing of hip prostheses).
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device and therefore does not involve a "training set" in that sense. The design process for such a device involves engineering principles and potentially iterative physical prototyping and testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no concept of a "training set" or "ground truth" establishment for training in the context of this device type and submission. The design of the hip stem is based on established biomechanical principles and material science.
Summary:
This 510(k) submission for the Osteonics® C-Tapered Titanium Stems is a regulatory filing for a device modification. The "acceptance criteria" and "study" described are focused on mechanical testing to demonstrate substantial equivalence in fatigue strength to previously cleared predicate devices. It is crucial to understand that the concepts of "test set," "ground truth," "experts," and "multi-reader studies" are primarily relevant to diagnostic devices, AI/ML algorithms, or clinical effectiveness studies in a way that doesn't directly apply to this type of device modification submission. The FDA's clearance is based on the finding of substantial equivalence through these engineering tests, implying that the modified design does not introduce new questions of safety or effectiveness compared to the predicate devices.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.