(134 days)
The Cardo Medical Ceramic Head components are for use in total hip arthroplasty as a result of:
• Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip,
• Correction of functional deformity,
• Avascular Necrosis,
• Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur,
• Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results.
These components are single use only and are intended for implantation with or without bone cement.
The previously cleared Cardo Medical Hip System consists of
• commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) femoral stems,
• cobalt chrome (CoCr) femoral heads,
• commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) acetabular shells,
• ultra-high molecular weight polyethylene (UHMWPE) acetabular inserts, and
• titanium alloy (Ti-6Al-4V) bone screws.
The proposed devices are a line extension to the previously cleared system to add 32mm and 36mm alumina ceramic femoral heads.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Cardo Medical Ceramic Head:
The document describes a Premarket Notification Submission (510(k)) for the Cardo Medical Ceramic Head, a line extension to an existing total hip arthroplasty system. This submission aims to demonstrate substantial equivalence to previously cleared devices rather than prove novel safety and effectiveness. Therefore, the "acceptance criteria" and "study" described are focused on meeting the requirements for demonstrating substantial equivalence through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by FDA Guidance Document) | Reported Device Performance |
|---|---|
| Mechanical Testing Requirements for Ceramic Heads | |
| Stem fatigue mechanical testing | Included in submission. Results indicate compatibility with previously cleared femoral heads and capability of withstanding in vivo loading. |
| Push-in, push-out, lever-out, and rotational torque forces for acetabular inserts | Included in submission. Results indicate compatibility with previously cleared femoral heads and capability of with vivo loading. |
| Range-of-Motion (oscillation) of the proposed system | Included in submission. Results indicate compatibility with previously cleared femoral heads and capability of withstanding in vivo loading. |
| Static burst testing of femoral heads | Included in submission. Results indicate the Cardo Medical ceramic femoral heads are equivalent to legally marketed devices. |
| Dynamic fatigue testing of femoral heads | Included in submission. Results indicate the Cardo Medical ceramic femoral heads are equivalent to legally marketed devices. |
| Axial Pull-Off testing of femoral heads | Included in submission. Results indicate the Cardo Medical ceramic femoral heads are equivalent to legally marketed devices. |
| Material Equivalence | Made from alumina ceramic, which is equivalent to the Stelkast ceramic femoral heads (predicate device K033944). |
| Design and Size Equivalence | Same 12/14 trunnion taper as previously cleared cobalt chrome femoral heads. Equivalent in size, design, and sterilization to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in terms of how many individual devices were tested for each mechanical test. It refers to "technical reports for stem fatigue mechanical testing," "the push-in, push-out, lever-out and rotational torque forces for acetabular inserts," etc., implying standard engineering-level test matrices would have been used.
- Data Provenance: The nature of the tests (mechanical performance, material equivalence) suggests these were laboratory-based tests conducted by the manufacturer or a contract testing facility. The data is non-clinical and focused on the physical and mechanical properties of the device components. There is no information regarding country of origin of the data beyond it being part of a US FDA submission. It is prospective in the sense that the testing was performed to support this specific submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable for a non-clinical, mechanical testing study for substantial equivalence. "Ground truth" in this context is defined by established engineering standards and test methodologies, and the acceptance criteria are based on those standards and comparison to predicate devices, not on expert clinical consensus. The experts involved would be engineers and material scientists performing and interpreting the mechanical tests.
4. Adjudication Method for the Test Set
This is not applicable. Mechanical tests have objective, measurable outcomes that either meet or do not meet specified criteria. There is no subjective interpretation requiring adjudication among human observers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states under "Clinical Performance": "Clinical data and conclusions are not needed for this device." This is because the submission is for a material and dimensional modification (adding ceramic heads) to an already cleared system, relying on substantial equivalence to predicate devices and robust non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. This is a medical device (a ceramic hip component), not a software algorithm or AI-driven system.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence is based on:
- Established engineering standards and test methods: The document mentions "required by the guidance document for ceramic heads."
- Comparison to legally marketed predicate devices: The "results indicate that the Cardo Medical ceramic femoral heads and inserts is equivalent to devices currently legally marketed." This implies that the performance of the predicate devices in these mechanical tests (or accepted ranges for such devices) served as the benchmark.
8. The Sample Size for the Training Set
This is not applicable. This submission is for a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 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.