(55 days)
Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems:
• Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed hip arthroplasty
The Alloclassic® Zweymüller® SL Femoral Stem is designed as a conical straight stem with a rectangular cross section to ensure rotational stability. The general design of the Alloclassic Zweymüller SL Femoral Stem comprises a slim neck and a short taper. Alloclassic Zweymüller SL Femoral Stems are available in 14 sizes and can be implanted to achieve primary stability in cases of unexpected poor bone quality. Distally the stem is anchored primarily by its edges; proximally the surfaces anchor against the bone cortex. The Alloclassic Zweymüller SL Femoral Stem is manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM 1295-16). The entire stem below the neck of the hip stem is grit basted to provide enhanced bone/prosthesis interface.
The design of Alloclassic® Zweymüller® SL Offset Femoral Stem is very similar to the previously cleared Alloclassic Zweymüller SL Femoral Stems (K962101, K030373), and identical to the previously cleared Alloclassic Zweymüller SL Offset Femoral Stem (K033664). Similar to the Alloclassic Zweymüller SL Femoral Stem, the Alloclassic Zweymüller SL Offset Femoral Stem is a conically shaped straight stem with a rectangular cross section for rotational stability. The entire stem below the neck of the hip stem is grit blasted to provide enhanced bone/prosthesis interface. The stem is available in 14 sizes and is manufactured from the wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM 1295-16). In contrast to the Alloclassic Zweymüller SL Femoral Stem, the Alloclassic Zweymüller SL Offset Femoral Stem provides an additional 6.25 mm of offset (per size) and has a CCD/neck angle of 121° (vs 131° for SL stem). Overall the Alloclassic Zweymüller SL Offset Femoral Stem design provides a higher offset sometimes needed for correcting insufficient soft tissue balancing, restoration of leg length, and sufficient joint stability following total hip arthroplasty.
The provided text is a 510(k) summary for the Alloclassic® Zweymüller® SL Femoral Stem and Alloclassic® Zweymüller® SL Offset Femoral Stem. It does not describe an acceptance criteria table or a study proving the device meets an established acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and modifications to packaging and instrument classification.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to performance studies with specific metrics, sample sizes, ground truth establishment, and expert involvement, which are not detailed here.
However, I can extract the following relevant information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than reporting against specific acceptance criteria for performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No specific test set or data provenance for performance evaluation is mentioned. The document states that "Packaging Configuration testing was conducted by representative worst-case products," but it does not specify the sample size or provenance for this testing.
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):
This information is not provided in the document, as it does not detail a study involving expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document, as it does not detail a study involving 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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a hip implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable, as the device is a hip implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable as there is no mention of ground truth establishment for performance evaluation. The document focuses on demonstrating equivalence through design, materials, and mechanical integrity rather than clinical outcomes data for the modified components.
8. The sample size for the training set:
This information is not applicable as there is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established:
This information is not applicable as there is no mention of a training set for an algorithm.
Summary of available information regarding compliance/testing:
The document mentions two types of non-clinical performance activities:
- Packaging configuration change: Testing was performed to verify package integrity (sterile barrier, protection during sterilization, handling, distribution, and storage) according to ISO 11607-1:2006 and ISO 11607-2:2006. This testing was conducted on "representative worst-case products."
- Correction of instrument classification from Class I to Class II: This involved an "Amendment of Design Controls with verification of mechanical integrity and resistance."
The document explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that no clinical studies were performed to demonstrate performance or meet specific acceptance criteria in a clinical setting. The justification for clearance is based on substantial equivalence to predicate devices and non-clinical testing for specific modifications.
§ 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.