(189 days)
The Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.
The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement 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 ●
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
The currently marketed Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems were revised to incorporate a streamlined neck geometry and modify the C-Taper trunnion length.
This 510(k) summary describes a modification to existing hip stems, not a new AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific parameters (like sample size for test sets, ground truth establishment, MRMC studies, etc.) is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence of the modified hip stems to their predicate devices based on design similarities and mechanical testing.
Here's a summary of the relevant information provided:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't present specific quantitative acceptance criteria or a "reported device performance" in the way one would for an AI/ML diagnostic device with metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implicitly met by demonstrating that the modified stems maintain similar neck strength as the predicate devices.
The study presented is a comparison to predicate devices, not a performance study against a predefined clinical metric.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as this is not an AI/ML clinical study. The "test set" here would refer to the mechanical tests performed. These typically involve a small number of carefully manufactured prototypes.
- Data Provenance: Not applicable in the context of clinical data provenance. The "data" originated from mechanical testing performed on the modified hip stems.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. "Ground truth" in this context would be established by engineering specifications and objective mechanical testing results, not expert interpretation of retrospective clinical data.
4. Adjudication Method for the Test Set:
Not applicable. Mechanical testing results are objective measurements, not subject to expert 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:
Not applicable. This is not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used:
Mechanical testing results and engineering specifications demonstrated that the modified stems have similar neck strength to the predicate devices. The "ground truth" is based on the physical properties and performance of the device under testing.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
In summary, the provided text describes a modification to an existing medical device (hip stems) and focuses on demonstrating substantial equivalence to predicate devices through design comparison and mechanical testing, not through clinical performance evaluation of an AI/ML system.
§ 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.