(126 days)
The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only.
The Exeter® V40TM Femoral Stem Hip System is indicated for:
· 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 nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Exeter® V40™ Femoral Stems/Orthinox Femoral Heads are sterile, single-use components intended for cemented total and hemi-hip arthroplasty. The femoral stems have a tapered distal portion with a V40™ neck taper. The stems are available in various offsets and body sizer. The Exeter Hip System continues to be manufactured from the same materials, the same design and the same manufacturing process as the previously cleared Exeter® V40™ femoral stems.
The provided text describes a submission for a medical device called the "Exeter® V40™ Femoral Stem Hip System" to the FDA, seeking a determination of substantial equivalence (510(k)). However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness with human readers.
The document focuses on demonstrating substantial equivalence to predicate devices primarily through:
- Intended Use and Indications: Stating that the new device has similar intended uses and indications as the predicate devices.
- Technological Characteristics: Asserting that the materials, design, and operational principles are similar or identical to predicate devices.
- Non-Clinical Testing: Listing various laboratory tests performed, such as Range of Motion Analysis, Femoral Stem Neck and Body Fatigue (according to ISO standards), Bacterial Endotoxin Testing, and Magnetic Resonance Imaging Analysis. These tests are performed to show adherence to established engineering and safety standards, and material properties, rather than diagnostic or clinical performance metrics.
- Clinical Testing: Explicitly stating that "Clinical testing was not required as a basis for substantial equivalence."
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I provide information about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are typically associated with performance evaluations of diagnostic or AI-driven devices, which is not the subject of this 510(k) submission.
The document's purpose is to show that a new version or extension of an existing hip implant system is substantially equivalent to previously cleared devices, meaning it doesn't raise new questions of safety or effectiveness. It does not describe a study to measure the performance of a diagnostic or therapeutic device against specific clinical or computational acceptance criteria.
If you have a different document that details such a study, I would be happy to analyze it.
§ 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.