(29 days)
The HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem are indicated for use for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed.
The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are the same as each of their predicate(s)- Mallory/Head® Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429, except for the addition of Hydroxyapatite Coating and additional sizes for the standard femoral stems.
The provided document describes the FDA 510(k) premarket notification for the HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem. It states very clearly that no clinical testing was provided as a basis for substantial equivalence.
Therefore, the following information cannot be extracted from the document:
- Acceptance Criteria and Reported Device Performance: This would typically be based on clinical or comparative performance data, which is explicitly stated as not having been provided.
- Sample size used for the test set and data provenance: No clinical test set was used.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth was established from clinical data.
- Adjudication method for the test set: Not applicable as no clinical test set was used.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable as no human-in-the-loop study was conducted.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical medical device, not an algorithm.
- Type of ground truth used: Not applicable as no ground truth based on clinical data was used.
- Sample size for the training set: Not applicable as there is no mention of a "training set" in the context of device development.
- How the ground truth for the training set was established: Not applicable.
The basis for substantial equivalence was Non-Clinical Testing, specifically "Mechanical Testing with an Engineering Justification" which determined that the components presented no new risks and were substantially equivalent to predicate devices. The predicate devices are listed as the Mallory/Head® Porous Femoral Stem (K921181) and Mallory/Head® Lateralized Press-Fit Femorals (K000538 and K003429).
This means the acceptance criteria and performance are based on engineering standards and mechanical properties, not clinical outcomes from a study involving human subjects or expert assessment of data. The document does not provide specific numerical acceptance criteria or performance metrics from this mechanical testing, only that it "determined that the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems' components presented no new risks and were, therefore, substantially equivalent to the predicate device."
§ 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.