(287 days)
The Quatro-M Plasma Spray Femoral Component is for press-fit, uncemented use. It is intended to be used for:
- 1 . Noninflammatory degenerative joint disease including osteoarthritis
- ನ Rheumatoid arthritis
- .
Pri Avascular necrosis - Correction of functional deformity 4.
- ર . Revision procedures where other treatments or devices have failed
- Treatment of non-unions, femoral neck and trochanteric fractures of the proximal Q. femur with head involvement that are unmanageable using other techniques
The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6AL-4V (ASTM 1472) stem with tapered proximal end and is intended to seat a conventional modular spherical head. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. The distal portion will be a smooth taper anterior-posteriorly and medial – laterally with a grit blasted distal surfaces. The proximal stem will be porous coated with commercially pure titanium plasma spray on all proximal surfaces excluding the articular interface trunion.
The femoral component is made of wrought titanium 6A1-4V (ASTM F1472). The proximal portion of the stem will be porous coated on all surfaces, excluding the ball trunion. The distal portion of the stem will be grit blasted. Sterilization will be 100% ethylene oxide and nitrogen in accordance with AAMI guidelines for sterilization.
This document is a 510(k) summary for a medical device (Quatro-M Femoral Component) and does not contain the information required to answer the questions about acceptance criteria and device performance as it pertains to clinical study data.
A 510(k) summary is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This typically involves comparing design, materials, and intended use, and often relies on bench testing and sometimes animal testing for performance, rather than extensive human clinical trials with specific acceptance criteria in the manner of an AI diagnostic device.
Therefore, I cannot provide the requested information from the given text. The text does not detail:
- A table of acceptance criteria and reported device performance (in the context of clinical outcomes or diagnostic accuracy).
- Sample size for a test set or data provenance for a clinical study.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The provided document describes the device, its classification, and its substantial equivalence to a predicate device, along with its indications for use. It's a regulatory approval document, not a clinical study report.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.