(112 days)
The Cardo Medical Hip System 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 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 36mm femoral heads and 36mm inserts.
The provided text describes a 510(k) premarket notification for a line extension of the Cardo Medical Hip System, specifically the addition of 36mm femoral heads and inserts. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone clinical study with human subjects.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in the context of this 510(k) submission. The document focuses on demonstrating that the new components do not introduce new questions of safety or effectiveness compared to the existing, cleared device and its predicates.
Here's an analysis based on the information provided, highlighting why certain sections are N/A:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, the acceptance criteria for this 510(k) submission are implicitly met by demonstrating substantial equivalence to existing predicate devices. This means the new components must demonstrate similar technological characteristics and the same intended use as the predicates, and not raise new questions of safety or effectiveness.
- Reported Device Performance: The "performance" here refers to the new components being "equivalent" to the predicate devices in materials, design, packaging, and sterilization. No new performance data (e.g., in terms of clinical outcomes or diagnostic accuracy) compared to defined criteria is presented.
| Feature/Characteristic | Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate devices | "The Cardo Medical Hip System components are for use in total hip arthroplasty as a result of: Hip arthritis..., Correction of functional deformity..., Avascular Necrosis..., Treatment of non-unions..., Difficult clinical management problems..." (Same as predicate) |
| Technology | Similar to predicate devices (materials, design, sterilization) | "The proposed 36mm cobalt chrome femoral heads have the same 12/14 trunnion taper as the previously... cleared... The proposed 36mm heads are equivalent to the Accin Hip System (K073068) in materials, design, packaging, and sterilization..." |
| Performance | Not raise new questions of safety or effectiveness | "Testing has shown that the proposed device eliminates requirements on total hip arthroplasty product and the proposed device is equivalent to the predicate device." "This 510(k) is for the addition of 36mm femoral heads and inserts. These heads and inserts do not present a worst-case scenario (the 28mm femoral head component with the +12mm offset); therefore the previous testing applies to these components." |
| Sterility | Sterile, single use, SAL of 10⁻⁶ | "All Cardo medical implant components are provided as sterile, single use only to a sterility assurance level (SAL) of 10⁻⁶." |
| Material | Equivalent to predicate devices | "The proposed 36mm heads are equivalent to the Accin Hip System (K073068) in materials..." |
| Design | Equivalent to predicate devices | "The proposed 36mm heads are equivalent to the Accin Hip System (K073068) in... design..." |
| Packaging | Equivalent to predicate devices | "The proposed 36mm heads are equivalent to the Accin Hip System (K073068) in... packaging..." |
| Sterilization | Equivalent to predicate devices (gamma sterilized for heads and inserts) | "The heads are gamma sterilized." "The inserts are gamma sterilized." (Same as predicate) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This submission is not based on a clinical test set or data from human subjects but on demonstrating equivalence through technical characteristics (materials, design, etc.) and referencing existing biocompatibility and mechanical testing data for the "worst-case" predicates. No specific patient data or provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This submission does not involve a test set requiring expert ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable, as there is no clinical test set 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
- N/A. This device does not involve AI or human image interpretation; it is a physical medical implant. Therefore, no MRMC study or AI-related effectiveness metrics are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Not applicable, as this device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. Ground truth of this nature is not applicable to a 510(k) submission for a line extension of an orthopedic implant. The "truth" in this context is the regulatory determination of substantial equivalence based on engineering and materials data, and comparison to already cleared devices.
8. The sample size for the training set
- N/A. Not applicable. The device is a physical implant, not a software algorithm requiring a training set.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set mentioned or implied for this device.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.