(145 days)
The Delta 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 and hip dysplasia;
- Rheumatoid arthritis;
- · Post-traumatic arthritis,
- · Correction of functional deformity;
- · Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
- · Revisions in cases of good remaining bone stock.
The Delta Acetabular System is intended for cementless use.
The Delta TT Pro is an acetabular system, intended for total hip replacement in cementless applications. The system consists of a Delta TT Pro acetabular cup (Ti6Al4V) and LimaVit liners (cross-linked UHMWPE with Vitamin E), available in three different design: neutral, protruded and high-wall. The LimaVit liners articulate with the Biolox®Delta and CoCrMo femoral heads, which are coupled to LimaCorporate femoral stems. Bone screws may be used to give further stability to the cup.
This FDA 510(k) summary is for the Delta TT Pro, a total hip prosthesis. As such, it describes a physical medical device and not a software algorithm or AI model. Therefore, many of the requested categories related to acceptance criteria for AI/software, expert review, and ground truth are not applicable.
Here's the information that can be extracted or deduced from the provided text, primarily focusing on the physical device's performance and regulatory pathway rather than AI-specific criteria.
1. A table of acceptance criteria and the reported device performance
The document does not provide specific numerical acceptance criteria or performance metrics for the device. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Performance | "All verification and validation testing confirms that the product specifications are met, in support of the substantial equivalence of the intended use and technological characteristic as the predicate devices." |
| Stress Testing | "The Delta TT Pro has been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use and in a manner substantially equivalent to the predicate devices." |
| Mechanical Tests | Various tests performed to confirm substantial equivalence, including "Push out, lever out and torque out disassembly test," "Stiffness test," "Impingement test," and "Wear test." |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The document refers to "extensive verification and validation testing" but does not quantify the number of devices or components tested for each type of test.
- Data provenance: Not explicitly stated, but as a physical device, the data would originate from laboratory testing of the manufactured components. The manufacturer, Limacorporate S.p.A., is located in Italy, so the testing would likely have occurred there or at a certified lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable as this is a physical medical device, not an AI/software device that requires ground truth established by experts for performance evaluation. The "ground truth" for mechanical testing would be the physical properties and performance characteristics measured against established engineering standards.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human readers and AI for agreement on findings, which is not relevant for the mechanical testing of a hip prosthesis.
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. This is a physical device, and MRMC studies are not relevant. This type of study focuses on the diagnostic performance of human readers, typically aided by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Delta TT Pro is a physical hip prosthesis, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As it is a physical device, the "ground truth" for its performance is based on established engineering and biomechanical principles and standards. The tests mentioned (push out, lever out, torque out, stiffness, impingement, wear) would have their results compared against these industry-accepted benchmarks and the performance of the predicate devices. The document states that the testing "confirms that the product specifications are met" and that the device operates "in a manner substantially equivalent to the predicate devices."
8. The sample size for the training set
Not applicable. There is no "training set" for a physical device in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical device.
§ 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.