(156 days)
The DYNASTY® Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acctabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, 3.
- revision procedures where other treatments or devices have failed. 4.
The size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or malunion of the acetabulum, and/or revision.
The DYNASTY® Acctabular Shell is for both cemented and uncemented use and is a single use device.
The design features of the DYNASTY® Acctabular System are summarized below:
- Shells manufactured from Titanium alloy, coated with CP Titanium
- Shell sizes: 46mm-76mm outer diameter
- Liners manufactured from UHMW Polyethylene
- Polyethylene liner sizes: 28mm, 50mm, 54mm inner diameter
- Liners manufactured from Cobalt Chrome alloy
- Cobalt Chrome liner sizes: 52mm, 56mm inner diameter
- Heads manufactured from Alumina Ceramic
- Head sizes: 50mm, 54mm diameter
The provided text is a 510(k) Summary for the DYNASTY® Acetabular System, which describes an orthopedic implant. This type of regulatory submission in the medical device industry focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics typically found for AI/ML-based software devices.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not applicable to this document.
Specifically, there is no information in the provided text about:
- A table of acceptance criteria and reported device performance (as it's not an AI/ML device being evaluated for diagnostic/predictive performance).
- Sample size used for a test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This 510(k) summary primarily focuses on:
- Intended Use: For total hip arthroplasty in skeletally mature patients with various degenerative joint conditions, functional deformities, and revision procedures.
- Device Description: Details on materials (Titanium alloy, UHMW Polyethylene, Cobalt Chrome, Alumina Ceramic) and sizes of shells, liners, and heads.
- Substantial Equivalence: A statement that the device's indications for use, design features, materials, and fundamental scientific technology are "substantially equivalent" to previously cleared predicate devices. The safety and effectiveness are supported by "substantial equivalence information, materials information, and analysis data," but these specific data are not detailed in this summary.
This document is a regulatory approval document for a physical medical device, not a software as a medical device (SaMD) that relies on AI/ML and would typically have the requested performance study details.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.