(76 days)
The subject hip stems are single-use devices intended for cementless fixation. They are intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. These devices are intended for use with any currently available Howmedica Osteonics acetabular component and V40® femoral heads labeled for use with V40® Titanium stems. The indications for use remain identical to those of the predicate devices, and are restated here.
Indications:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, .
- Rheumatoid arthritis, .
- Correction of functional deformity, .
- Revision procedures where other treatments or devices have failed, .
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
The subject Accolade™-J Hip Stems feature the geometry of the predicate TMZF® HA Hip Stems and Accolade™ TMZF® Plus HA Hip Stems, but feature the same substrate material and same HA coating as the predicate Omnifit® M-HA Hip Stems.
The provided text describes a 510(k) premarket notification for the Accolade™-J Hip Stem Series. A 510(k) submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, many of the requested elements (acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) are not applicable in this context, as this submission is for a medical device that has demonstrated substantial equivalence through a non-clinical testing summary.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated as such, but inferred from testing) | Reported Device Performance |
|---|---|
| Mechanical Strength (Neck and Body Regions) (Inferred from FEA) | Evaluated using Finite Element Analysis (FEA) to confirm strength. |
Explanation: The document states, "Finite Element Analysis (FEA) was used to evaluate the strength of the neck and body regions of the subject Accolade™-J Hip Stems." This type of testing is used to demonstrate that the device's mechanical properties are comparable and acceptable, often against internal specifications or established industry standards, but specific numerical acceptance criteria and performance results directly from the FEA are not provided in this summary. The goal of a 510(k) is to show equivalence, implying that if the predicate was deemed safe and effective, and the new device performs similarly on relevant non-clinical tests, it is also safe and effective.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. Finite Element Analysis (FEA) is a computational simulation and does not typically involve a "test set" of physical devices in the context of clinical studies. It would involve a model of the device.
- Data Provenance: Not applicable. FEA is a simulation based on engineering properties and designs.
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)
- Not applicable. This is a non-clinical submission, and ground truth as defined for diagnostic performance is not relevant. The "truth" in FEA is based on engineering principles and material science.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are not relevant for Finite Element Analysis.
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 a hip stem, a mechanical implant, not a diagnostic AI device requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm. However, the "standalone" performance could be considered the results of the FEA simulation, which predicts the device's mechanical behavior without human interaction during its operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for the FEA would be the physical laws governing material behavior and structural mechanics, validated through prior understanding of similar designs and materials, and potentially physical testing of components (though not described in this summary).
8. The sample size for the training set
- Not applicable. There is no "training set" for FEA, as it is a deterministic simulation based on engineering models, not machine learning.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.