(12 days)
The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary intended for the reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular device is miches. component and V40™ femoral heads that can be mated with a TMZF® 5° 40' BG trunnion.
Indications:
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . Cententess primary inf varseular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. .
The existing Accolade® TMZF® HA Hip System features femoral stems in neutral, press-fit versions consisting of a variety of lengths and two neck angles, 132° and 127°. The subject Accolade® RPS Hip Stem is a modification to the existing hip stems. It features a reduction in the area of Commercially Pure Titanium (CP-Ti) plasma spray and PureFixTM HA coatings on the body of the stem. The subject hip stem, like the predicate hip stems, is ured using TMZF® alloy.
The provided text is a 510(k) Summary for a medical device (Accolade® RPS Femoral Stem) seeking market clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study as would be seen for novel devices.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details cannot be extracted from the provided text because it describes a 510(k) submission, not a study designed to establish such criteria and performance.
A 510(k) relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or different technological characteristics that do not raise new questions of safety and effectiveness and are shown to be as safe and effective as the predicate device. This often involves non-clinical testing (e.g., mechanical, material characterization) and comparison to the predicate's performance, but not typically a clinical study with detailed acceptance criteria and expert reviews in the manner you've described for an AI/algorithm-based device.
Key points from the document that explain why the requested information is not present:
- "Substantial Equivalence" is the core principle: The document explicitly states, "The determination of the substantial equivalence of the Accolade® RPS hip stem is based on its similarities in intended use, design and sterilization to the Accolade® TMZF® femoral stem (K994366, cleared March 16, 2000)."
- Device Description: The Accolade® RPS Hip Stem is a modification to an existing hip stem, featuring "a reduction in the area of Commercially Pure Titanium (CP-Ti) plasma spray and PureFixTM HA coatings on I body of the stem." This indicates a change to an already cleared device, not a completely new device requiring extensive de novo clinical validation against new acceptance criteria.
- Focus on intended use and material: The "Intended Use" and "Indications" sections describe common applications for hip stems, aligning with the predicate.
- FDA Letter: The FDA's letter (pages 2-3) confirms the "substantial equivalence determination" and that the device can proceed to market, which is the outcome of a successful 510(k).
In summary, your request describes the documentation typically found for AI/Diagnostic imaging devices or novel therapeutic devices undergoing rigorous clinical trials to establish performance against pre-defined acceptance criteria. The provided text is for a modified hip implant seeking 510(k) clearance, which follows a different regulatory pathway.
§ 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.