(139 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, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed.
The DYNASTY™ Acetabular Shell is for both cemented and uncemented use.
The design features of the DYNASTY™ Ceramic Femoral Head and DYNASTY™ Neck Sleeve are summarized below:
- Heads manufactured from Alumina Ceramic .
- Head sizes: 28, 32, 36, 38, 40, 42, 46mm outer diameter .
- Neck sleeves manufactured from Titanium alloy .
- Neck sleeve sizes: short, medium, long, x-long .
The provided text is a 510(k) summary for the DYNASTY™ Acetabular System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria through a clinical study. Therefore, the requested information regarding acceptance criteria and a study to prove the device meets these criteria is not typically found in this document.
However, based on the information provided, here's what can be inferred or explicitly stated regarding the device's characteristics and the basis for its clearance:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the 510(k) summary. A 510(k) submission for this type of device typically relies on demonstrating equivalence to predicate devices in terms of design, materials, and intended use, rather than setting and meeting novel quantitative performance criteria through a specific study with reported performance metrics. The implicit "acceptance criteria" here would be achieving "substantial equivalence" to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No specific test set or associated sample size, data provenance, or study type is mentioned in this 510(k) summary. The submission focuses on comparing the new device's design and materials to existing cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable and not provided. There wasn't a "test set" in the context of clinical performance that required expert adjudication for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the DYNASTY™ Acetabular System is a joint replacement device, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable, as the device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of a performance study for this device. The "ground truth" for a 510(k) in this context is the safety and effectiveness of the legally marketed predicate devices to which the new device is compared.
8. The sample size for the training set:
Not applicable. There is no mention of a training set as this is not an algorithm-based device.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is provided regarding device acceptance (i.e., substantial equivalence):
- Implicit Acceptance Criterion: The device must be "substantially equivalent" to legally marketed predicate devices.
- Proof of Meeting Criterion: The submission argues for substantial equivalence based on:
- Identical Indications for Use: The DYNASTY™ Acetabular System has the "identical" indications for use as the previously cleared predicate devices.
- Similar Design Features: The ceramic femoral heads and titanium alloy neck sleeves have comparable design features (e.g., head sizes, neck sleeve sizes) to predicate devices.
- Similar Materials: The heads are manufactured from Alumina Ceramic, and neck sleeves from Titanium alloy, which are common and established materials for such devices, implying similarity to predicate device materials.
- Fundamental Scientific Technology: The submission states that "The fundamental scientific technology of the modified device has not changed relative to the predicate devices."
In essence, the "study" proving the device met "acceptance criteria" in this 510(k) context was a robust comparison by the manufacturer to existing, cleared devices, demonstrating that no new questions of safety or effectiveness were raised. The FDA's letter (K072656) confirms that they reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, thereby allowing it to be marketed.
§ 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.