(104 days)
The indications for use of the total hip replacement prostheses 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 and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Accolade II Femoral Stems 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 intra-operative instability.
Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.
Howmedica Osteonics is introducing the Accolade II Femoral Hip Stem, a tapered non-porous coated femoral stem intended for cementless, press-fit application. The basic design of the Accolade II Femoral Hip Stem is similar to other total hip stems commercially distributed such as the Accolade TMZF Hip Stem. There are the design of the subject hip stem. such as a variable medial curvature which increases with each size in order to faciliate press fit stability and load transmission in the proximal region of the stem geometry is designed to address variations in patient femoral morphology. The overall stem length has been reduced, compared to the Accolade TMZF hip stem, to facilitate intra-operative stem insertion. The stem is manufactured from a Ti-6Al-4V substrate materially Purc (CP) Titanium coating and Purefix hydroxylapatite (HA) coating identical to the previously cleared 2 Piece Modular Hip Stem (K013106). The 2 Piece Modular Hip Stem (K013106) is now marketed and will be referred to throughout this submission as the Restoration Modular Hip Stem. The Accolade II Femoral Hip Stem will be available in 12 sizes ranging from size 0 through 11 with two neck angles (127° and 132°) that provide dual head offsets. The stem is designed for use with the currently available compatible Howmedica Osteonics' femoral heads and their compatible acetabular components. All instrumentation is listed in the Surgical Protocol attached. The Accolade II Femoral Hip Stem is a sterile, single-use in primary and revision total hip arthroplasty to alleviate pain and restore function. The subject hip stem is compatible with V40 heads, C-Taper heads when used with the V40/C-Taper Adaptor Sleeve, Universal Heads when used with the V40/Universal Adaptor Sleeve and Unitrax Heads.
The provided text describes a 510(k) summary for the "Novel Tapered Hip Stem (aka Accolade II Femoral Hip Stem)". This is a medical device application for a hip prosthesis, not an AI/ML powered device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, F1-score, effect size for human readers, etc.) is not applicable here.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing. The evaluation of this type of medical device centers around materials, design, intended use, and mechanical performance to ensure it is as safe and effective as legally marketed predicate devices.
Therefore, I cannot provide the requested information in the format of AI/ML performance metrics, as the device is a physical hip stem and not an AI/ML product.
However, I can extract the relevant information regarding the non-clinical testing and the basis for its acceptance if interpreted within the context of a traditional medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in intended use, design, materials, and operational principles to predicate devices. | "The Accolade II Femoral Hip Stem is substantially equivalent to other commercially available hip stems in regard to intended use, design, materials and operational principles as a hip prosthesis." |
| Mechanical performance comparable to predicate devices to ensure safety and effectiveness. | "Based upon the mechanical testing, the Accolade II Femoral Hip Stem is substantially equivalent for its intended use to other press-fit femoral replacement hip stems currently on the market." |
| Satisfactory results from non-clinical bench testing (Range of Motion, Proximal Fatigue, Distal Fatigue). | "All of the observed results indicate that the Accolade II Hip System is substantially equivalent to devices currently marketed." |
2. Sample size used for the test set and the data provenance: Not applicable. This involves non-clinical bench testing of a physical device, not a test set of data.
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 AI/ML is not relevant here. The evaluation relies on established engineering principles and materials science for hip prostheses.
4. Adjudication method for the test set: Not applicable for non-clinical bench 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: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used: Not applicable in the AI/ML sense. The "ground truth" here is the established safety and efficacy of the predicate devices and the physical performance standards for hip prostheses.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Study Description (Non-Clinical Testing):
Study Title (Implicit): Non-Clinical Bench Testing for Substantial Equivalence of the Accolade II Femoral Hip Stem.
Objective: To demonstrate that the Accolade II Femoral Hip Stem is substantially equivalent in terms of safety and effectiveness to legally marketed predicate devices through non-clinical bench testing.
Methodology:
The study involved various non-clinical bench tests. The specific tests mentioned are:
- Range of Motion analysis: This likely assessed the functional movement capabilities of the hip stem when articulating with compatible components.
- Proximal fatigue testing: This would have evaluated the resistance of the proximal (upper) part of the stem to material failure under repetitive loading, simulating physiological stresses.
- Distal fatigue testing: This would have evaluated the resistance of the distal (lower) part of the stem to material failure under repetitive loading.
Results:
The submission states, "All of the observed results indicate that the Accolade II Hip System is substantially equivalent to devices currently marketed." This general statement implies that the device met the performance expectations and parameters established by the predicate devices for these tests.
Conclusion:
"Therefore, the subject device is as safe and effective, and performs at least as safely and effectively as legally marketed predicates identified." This concludes that the non-clinical testing supports the claim of substantial equivalence.
Predicates Used for Comparison:
Data Provenance for Non-Clinical Testing:
The data provenance is from the manufacturer's internal bench testing ("Howmedica Osteonics Corp."). The testing would have been conducted in a controlled laboratory environment. The country of origin of the data is implicitly the location of the manufacturing and R&D facilities.
§ 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.