(289 days)
The Klassic HD™ Hip System is intended for prosthetic replacement without bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity or dysfunction persists.
- Revision of a previously failed hip arthroplasty.
- Patients who require a total hip replacement.
The Klassic HD Hip System is simple, easy to use, and based on clinically proven design philosophies. The Klassic HD Hip System employs a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum, leg length, offset and version.
The Klassic HD Hip System is comprised of modular components with varying sizes available for each component for a cementless hip joint replacement application. Components of the Klassic HD Hip System include the femoral stem, femoral head, femoral head adapter sleeve, acetabular cup, acetabular insert and cancellous bone screws. The implantable components are intended for single-use for a single patient only.
The titanium alloy femoral stems feature a neck shaft angle of 131°. Femoral stems are available in sizes 1-9 with neck lengths of 26-38mm in 4mm increments and stem lengths of 110-150mm in 5mm increments. The stem's proximal surface is either grit-blasted or porous-coated. Cobalt chromium femoral heads available in 32mm or 36mm diameters attach either directly to the stem trunnion or through the use of an adapter sleeve thereby offering -3.5mm, neutral, +3.5mm and +7mm offsets. The titanium alloy, hemispherical acetabular cups are available in 9 sizes ranging from 48-64mm in 2mm increments and incorporate a porous coated outer surface. The UHMWPE acetabular inserts attach through a snap-fit mechanism to the acetabular cup. Conventional, noncross-linked (32mm inner diameter) and cross-linked (32mm and 36mm inner diameter) UHMWPE insert versions are available in the Klassic HD Hip System. Both types of UHMWPE material have been utilized in previously cleared devices. Optional 6.5mm cancellous, titanium alloy bone screws allow for additional fixation of the acetabular cup to the bone.
The provided text is a 510(k) Premarket Notification for a medical device called the "Klassic HD™ Hip System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through bench testing for mechanical performance, rather than clinical studies on human subjects. Therefore, many of the requested categories related to clinical study design, such as sample size for test/training sets, data provenance, expert qualifications, adjudication methods, and MRMC studies, are not applicable in this context.
Here's an analysis of the provided text based on your request:
Acceptance Criteria and Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating mechanical performance that is "substantially equivalent" to predicate devices, and in accordance with recognized standards for orthopedic implants. The reported performance is that the device "exhibit[s] the appropriate mechanical characteristics for total hip joint replacement."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance equivalent to predicate devices for hip joint replacement. | "Results confirm that all components of the Klassic HD Hip System exhibit the appropriate mechanical characteristics for total hip joint replacement, and are substantially equivalent to the predicate devices." |
| Meets recognized standards for orthopedic implants (e.g., for proximal fatigue, distal fatigue, axial disassembly, torsional disassembly of femoral constructs; push-out, lever-out, torque to rotation of acetabular constructs; wear characteristics; static breaking strength and pull-out strength of cancellous bone screw; characterization of porous coating per FDA guidance). | "All testing was performed in accordance with recognized standards." |
| "Performance data were provided to support the determination of substantial equivalence." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of physical test units, but the testing was "extensive bench testing" conducted on "the worst case femoral constructs" and "the worst case acetabular constructs" and "the worst case cancellous bone screw." This implies a selection of representatives for the most challenging use conditions.
- Data Provenance: The study was a bench test (laboratory testing) of the physical device components. There is no human or patient data involved. Therefore, country of origin is not applicable in the typical sense; the testing was performed to U.S. FDA standards as part of a 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" for bench testing of mechanical properties is established by engineering standards and measurement techniques, not by expert medical opinion or consensus. The "truth" is the physical measurement of the device's performance against predefined engineering specifications.
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Adjudication method for the test set:
- Not Applicable. As this was a bench test evaluating mechanical properties, there was no need for adjudication as typically understood in clinical studies (e.g., resolving discrepancies in expert interpretations). The results are objective physical measurements.
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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:
- No. This was a premarket notification for a physical orthopedic implant, not a diagnostic or AI-driven decision support system. Therefore, MRMC studies and AI-related effectiveness are Not Applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See point 4. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study was engineering specifications and recognized standards for orthopedic implant mechanical performance. The device's performance was compared to these established benchmarks and to the performance of predicate devices.
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The sample size for the training set:
- Not Applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. The device itself is the product being tested, not an algorithm being trained.
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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.