(285 days)
The SP-CL Hip Stem and LCU Hip System are indicated for patients with mobility-limiting hip diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
The hip systems are indicated for the following conditions:
- Primary and secondary coxarthrosis
- Osteoarthritis
- Necrosis of the femoral head
- Femoral neck fractures
The stems are indicated for cementless use only.
The submission includes a straight stem, LCU Hip Sytem, and an anatomically curved stem, SP-CL Hip Stem. Both stems are comprised of titanium alloy (Ti6A14V acc. to ISO 5832-3, ASTM F136) available with HX (CaP) (ASTM F1609) coating. The stems are available in a range of sizes, lengths, and offsets. In total hip replacement, the SP-CL Hip Stem and LCU Hip System are combined with a corresponding prosthesis head and the acetabular implant components manufactured by Waldemar Link. The change that is subject of this 510(k) is to add calcium phosphate coating (CaP) done by Waldemar Link inhouse to the above listed systems. The devices are already commercially available with CaP coating applied by an external vendor. There is no change to the fundamental scientific technology of the referenced hip systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufactured. All components are sterile and for single use only.
This document is a 510(k) Premarket Notification for a medical device (SP-CL Hip Stem and LCU Hip System) and is primarily focused on demonstrating substantial equivalence to a predicate device rather than undergoing a new, rigorous clinical performance study with predefined acceptance criteria for a novel AI/software device.
Therefore, the information requested in your prompt regarding acceptance criteria for device performance, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this type of FDA submission. This submission is for a physical orthopedic implant seeking to demonstrate that a change in manufacturing (applying a coating in-house instead of by an external vendor) does not alter its safety or efficacy compared to an already cleared device.
However, I can extract the relevant information that is available in the document:
1. A table of (implied) acceptance criteria and the reported device performance
Since this is a 510(k) for an orthopedic implant and not a novel AI device, the "acceptance criteria" are not about AI performance metrics (like sensitivity, specificity, AUC). Instead, the acceptance criteria are met by demonstrating that the modifications (in-house CaP coating) do not negatively impact the physical and chemical properties of the hip stems compared to the predicate device.
| Implied Acceptance Criteria (Demonstrates Equivalence) | Reported Device Performance (Summary of Non-Clinical Testing Results) |
|---|---|
| Mechanical Properties: | |
| Shear strength of coating adhesion (ASTM F1044-05) | Results demonstrate suitability for intended purpose and substantial equivalence to predicates. |
| Tension strength of coating adhesion (ASTM F1147-05) | Results demonstrate suitability for intended purpose and substantial equivalence to predicates. |
| Material Properties: | |
| Coating morphology and structure (Stereological Evaluation - ASTM F1854-15) | Results demonstrate suitability for intended purpose and substantial equivalence to predicates. |
| Chemical composition of coating (Infrared Spectroscopy, Elemental Analysis - ASTM F1609-08, Chemical Analysis - ASTM F1609-08) | Results demonstrate suitability for intended purpose and substantial equivalence to predicates. |
| Coating dissolution/solubility rate (ASTM F1926/F1926M-14) | Results demonstrate suitability for intended purpose and substantial equivalence to predicates. |
| Biocompatibility/Sterility: | |
| Endotoxin levels | Results demonstrate suitability for intended purpose and substantial equivalence to predicates. |
| Product Stability: | |
| Shelf life | Results demonstrate suitability for intended purpose and substantial equivalence to predicates. |
The study that "proves the device meets the acceptance criteria" is the non-clinical performance testing conducted by the manufacturer. The conclusion is that "The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and substantially equivalent to the predicates."
The remaining points (2-9) are largely not applicable to this type of 510(k) submission for a physical implant with a manufacturing change.
- 2. Sample size used for the test set and the data provenance: Not applicable. Testing involved material samples of the implants, not a "test set" of patient data for an AI algorithm.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. The "truth" is established by adherence to ASTM standards for material testing.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. The "ground truth" for this device's performance is derived from its adherence to established material and mechanical testing standards (e.g., ASTM F1044-05 for shear testing, ASTM F1609-08 for elemental analysis).
- 8. The sample size for the training set: Not applicable. This is not an AI device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.
In summary, this 510(k) submission relies on non-clinical engineering and material science testing to demonstrate substantial equivalence, rather than clinical studies or evaluations of AI performance.
§ 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.