(74 days)
The ADVANCE STATURE™ Femoral Component is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
-
- inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and
-
- treatment of fractures that are unmanageable using other techniques.
The Porous ADVANCE STATURE™ Femoral Component is for use without bone cement.
The Non-porous ADVANCE STATURE™ Femoral Component is for use with bone cement only.
All ADVANCE STATURE™ Femoral Components are single use devices.
The design features of the ADVANCE STATURE™ Femoral Component are summarized below:
- Manufactured from Cobalt Chrome Alloy .
- Offered in porous and non porous versions .
- Offered in three sizes .
- Intended to be used with currently available tibial inserts ●
The provided text is a 510(k) summary for the ADVANCE STATURE™ Femoral Component, a medical device for knee arthroplasty. It states that the device is substantially equivalent to a predicate device.
Crucially, this document describes a submission for a 510(k) premarket notification for a medical device (a femoral component for knee replacement), which is based on demonstrating substantial equivalence to a predicate device. It is NOT a study that evaluates the performance of an AI/ML powered device against specific acceptance criteria in the manner described in the prompt's request for information (e.g., sensitivity, specificity, reader studies, ground truth establishment).
Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets those criteria, as this information is not present in the provided document for this type of medical device submission.
Here's why the requested information is not applicable or cannot be found:
- Type of Device: The ADVANCE STATURE™ Femoral Component is a physical implant (a knee replacement component), not an AI/ML powered diagnostic or prognostic device that would typically have performance metrics like sensitivity, specificity, or require reader studies for its primary function.
- 510(k) Process: For this type of device, the 510(k) pathway primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This involves comparing indications for use, technological characteristics (materials, design features), and often includes non-clinical testing (e.g., mechanical, biocompatibility) rather than clinical performance studies with acceptance criteria for diagnostic accuracy.
- "Study That Proves the Device Meets the Acceptance Criteria": The document mentions "substantial equivalence information, materials information, and analysis data," but this refers to information supporting the claim of equivalence, not a clinical study designed to measure the device's diagnostic or predictive performance against specific acceptance criteria in the way AI/ML devices are evaluated.
No information regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a diagnostic algorithm is available in the provided text.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.