(28 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 ostecarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
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- correction of functional deformity; and,
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- revision procedures where other treatments or devices have failed.
The design features of the DYNASTY™ Acetabular Shell and DYNASTY™ A-CLASS™ Poly Acetabular Liner are summarized below:
- Shells manufactured from cast titanium (Ti) alloy .
- Shells porous coated with Ti alloy sintered beads .
- Shell sizes: 50mm-58mm outer diameter .
- . Shells provide 3 screw holes in a single quadrant for additional fixation
- Liners manufactured from UHMWPE .
- Liner sizes: 32mm-42mm inner diameter
Here's an analysis of the provided text regarding the DYNASTY™ Acetabular System, focusing on the absence of specific testing data for AI/ML device criteria:
The provided document is a 510(k) Premarket Notification for the DYNASTY™ Acetabular System, a medical device for total hip arthroplasty. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel performance against detailed acceptance criteria through a clinical study for AI/ML.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document because the approval pathway (510(k) for a physical implant) does not typically require or present this type of data, especially not for an AI/ML device as it pre-dates widespread AI/ML medical device submissions.
The document states:
"The safety and effectiveness of the DYNASTY™ Acetabular System are adequately supported by the substantial equivalence information, materials information, and analysis :lata provided within this Premarket Notification."
This indicates that the primary method of demonstrating safety and effectiveness was by showing similarity to existing, approved devices, along with materials testing and engineering analysis, not by clinical performance metrics based on expert-derived ground truth or AI/ML model output.
Despite the lack of the specifically requested AI/ML-related information, here's an attempt to structure the answer based on the provided text, highlighting what can be inferred and what is explicitly missing:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided 510(k) Premarket Notification for the DYNASTY™ Acetabular System focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria through the kind of study described for AI/ML devices. Therefore, the document does not contain information on detailed performance metrics, sample sizes for AI/ML testing, ground truth establishment, or expert reviews in the context of an AI/ML algorithm's output.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a mechanical implant seeking 510(k) clearance based on substantial equivalence, there are no "acceptance criteria" in the sense of predictive performance metrics (like sensitivity, specificity, AUC) for an AI/ML device. The "acceptance criteria" for a 510(k) are met by demonstrating that the device is as safe and effective as a legally marketed predicate device.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (Summary from Submission) |
|---|---|
| Intended Use: Identical to predicate device. | "The indications for use of the DYNASTY™ Acetabular System are identical to the previously cleared predicate devices." |
| Design Features: Substantially equivalent to predicate device. | "The design features and materials of the subject devices are substantially equivalent to those of the predicate devices." |
| Materials: Substantially equivalent to predicate device. | "The design features and materials of the subject devices are substantially equivalent to those of the predicate devices." |
| Fundamental Scientific Technology: Unchanged relative to predicate device. | "The fundamental scientific technology of the modified device has not changed relative to the predicate devices." |
| Safety and Effectiveness: Adequately supported by equivalence, materials, and analysis data. | "The safety and effectiveness of the DYNASTY™ Acetabular System are adequately supported by the substantial equivalence information, materials information, and analysis :lata provided within this Premarket Notification." |
Note: The "reported device performance" here refers to the claims made in the 510(k) about its equivalence and safety/effectiveness, not quantitative performance metrics from a dedicated clinical study for distinguishing AI/ML output.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided within this 510(k) submission. The document does not describe a "test set" for evaluating an AI/ML algorithm. The evidence presented is for a physical orthopedic implant.
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)
Not applicable/Not provided within this 510(k) submission. Ground truth establishment for an AI/ML test set is not relevant to this submission for a physical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided within this 510(k) submission. Adjudication methods for AI/ML test sets are not relevant here.
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
Not applicable/Not provided within this 510(k) submission. This device is an orthopedic implant, not an AI/ML diagnostic tool meant to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided within this 510(k) submission. This document describes a physical medical device (hip implant), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided within this 510(k) submission. Ground truth for an AI/ML algorithm is not applicable to this submission. The "truth" for this device's safety and effectiveness is established through engineering principles, material science, and prior clinical use of substantially equivalent predicate devices.
8. The sample size for the training set
Not applicable/Not provided within this 510(k) submission. There is no "training set" for an AI/ML algorithm described.
9. How the ground truth for the training set was established
Not applicable/Not provided within this 510(k) submission. Ground truth establishment for an AI/ML training set is not applicable here.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.