(87 days)
The Restoration™ ADM is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 and 28 mm diameter femoral heads.
The indications for use of total hip replacement prostheses 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;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Dislocation risks
This acetabular cup is intended for cementless use only.
The Restoration™ Anatomic Dual Mobility (ADM) System consists of an acetabular cup and an acetabular insert. The Restoration™ ADM insert retains a femoral head. The outer diameter of the insert articulates on the inner surface of the polished metal acetabular cup. The polyethylene insert therefore functions as a bipolar head as there are two articulating surfaces.
The Restoration™ ADM Acetabular Cup has a highly polished inner surface to help reduce wear between the cup and the insert and an anatomical shaped rim to limit cup impingement with the stem or the psoas muscle. The Restoration™ ADM Acetabular Cup is manufactured from wrought Cobalt Chromium alloy with a Commercially Pure Titanium and Hydroxylapatite coating.
The provided document, K072020, is a 510(k) summary for the Restoration™ ADM System, an artificial hip replacement component. It aims to establish substantial equivalence to predicate devices and does not describe a study involving acceptance criteria and device performance in the way a clinical trial or a validation study for an AI/ML device would.
Therefore, most of the requested information cannot be extracted from this document, as the submission appears to rely on established equivalence to existing devices rather than new performance studies with specific acceptance criteria in a clinical context.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The document does not specify performance metrics or acceptance criteria for the Restoration™ ADM System itself, nor does it present the results of a study demonstrating its performance against such criteria. The submission relies on demonstrating substantial equivalence to predicate devices, implying that their established performance is sufficient.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. No test set or clinical study to establish performance is described. The submission focuses on device characteristics and indications for use, comparing them to legally marketed predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. There is no mention of a test set requiring ground truth established by experts.
4. Adjudication Method for the Test Set:
Not applicable. No test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a medical device (hip implant), not an AI/ML diagnostic or image analysis system that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used:
Not applicable. No performance study requiring ground truth is described.
8. Sample Size for the Training Set:
Not applicable. No training set for an algorithm is relevant to this device submission.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set for an algorithm is relevant to this device submission.
Summary based on the document:
The 510(k) K072020 for the Restoration™ ADM System focuses on demonstrating substantial equivalence to predicate devices (Trident® Acetabular System, Biomet Tri-Polar System, Plus Orthopaedics Ag Polarcup Dual Mobility System and UHR Bipolar System) regarding its intended use, design, materials, and operational principles. This is a regulatory pathway that typically does not require new clinical performance studies or the establishment of specific acceptance criteria beyond demonstrating that the new device is as safe and effective as a legally marketed device.
The FDA's letter (on page 3 of the document) confirms that they have reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This determination allows the device to be marketed, subject to general controls provisions.
§ 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.