(63 days)
The indications for use for total hip arthroplasty include:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of ABG™ II Monolithic Hip Stem with compatible Howmedica Osteonics Constrained Liners:
- When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Stem is intended for cementless, press-fit use only and is intended for total and hemiarthroplasty procedures'.
Howmedica Osteonics is introducing a monolithic femoral hip prosthesis. The basic design of the ABG™ II Monolithic Hip Stem, referred as the ABG™ II, is similar to other total hip systems commercially distributed such as the Stryker ABG™ II Modular Hip System.
The subject hip stem is a TMZF (Ti-11.5 Mo-6Zr-2Fe) alloy femoral stem with a roughened hydroxylapatite coating in the proximal region. It is intended for cementless, press-fit application and designed for use with the currently available compatible Howmedica Osteonics' femoral heads, bipolar heads, and their compatible acetabular components.
The ABGTM II Monolithic Hip Stem is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40 CoCr Heads, V40 LFIT CoCr Heads, C-Taper Alumina Heads when used with the V40/C-taper Adaptor, C-Taper Delta Heads when used with C-taper Adaptor, UHR Universal Head, Unitrax Heads when used with the Unitrax V40 Modular Adapter.
The ABGTM II Monolithic Hip Stem will be available in 8 sizes ranging from size 1 through 8 with one neck angle of 130°. The ABG™ II Monolithic Hip Stem anatomic stem is made with 12° of anteversion built into the proximal portion of the stem.
This 510(k) summary (K110807) describes the ABG™ II Monolithic Hip Stem, a femoral hip prosthesis. The acceptance criteria and supporting study are detailed in the "Non-Clinical Testing" section.
Here's a breakdown of your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Standard | Reported Device Performance | Based on the FDA Guidance Document "Non-clinical Information for Femoral Stem Prostheses (17 September 2007)", specifically related to fatigue testing. This implies the device must meet the performance requirements (e.g., endurance limits, strength) outlined in relevant standards cited or referenced within that guidance. | "The testing demonstrated that the ABG™ II Monolithic Hip Stem is substantially equivalent to devices currently cleared for marketing." This statement indicates the device successfully met the performance criteria established by the guidance document, specifically in relation to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The study was non-clinical (laboratory 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 applicable as the study was non-clinical laboratory testing. Ground truth in this context refers to engineering measurements and assessments, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the study was non-clinical laboratory testing.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes the non-clinical testing of a hip implant device, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document describes the non-clinical testing of a hip implant device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this non-clinical testing would be the engineering specifications and performance requirements outlined in the "FDA Guidance Document entitled 'Non-clinical Information for Femoral Stem Prostheses (17 September 2007)'". This includes metrics derived from fatigue testing and Finite Element Analysis.
8. The sample size for the training set
This information is not applicable as the study was non-clinical laboratory testing of a physical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable as the study was non-clinical laboratory testing of a physical device. The "ground truth" for the non-clinical tests would have been established by established engineering principles and standards for fatigue testing of medical implants, as guided by the FDA document mentioned. Finite Element Analysis (FEA) was used to determine "worst-case sizes" for testing, which implies the FEA models themselves were built upon accepted engineering principles and material properties.
§ 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.