(131 days)
The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of:
.
- Severely painful and/or disabled joint: as a result of osteoarthritis, posttraumatic . arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck. ●
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, ● hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The Mpact Extension components are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Extension consists of the following components:
Revised dimensions and labeling of the acetabular shells (Ti-6AI-4V, ASTM F136 and Ti, ASTM F1580 porous coating) cleared under K103721 and K122641 to correlate to the actual external diameter including the porous coating.
Modified design of the hooded acetabular liners (UHMWPE ISO 5834-2 Type1 and HighCross® HXUHMWPE) cleared under K103721 and K122641. The modification of the hooded liner is specific to the external side of the anti-luxation shoulder, creating a chamfer in order to reduce the risk of psoas irritation.
Additional sizes of the cancellous bone screws (flat head, 6.5mm diameter, Ti-6Al-4V ISO 5832-3) cleared under K103721 with lengths of 50, 55, 60, 65, and 70mm.
The provided text describes a 510(k) premarket notification for the "Mpact Extension" hip prosthesis. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data a new device might require. Therefore, the information typically requested in your prompt (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) is largely not applicable or not provided in this specific document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that performance testing was conducted "in accordance with various international standards and FDA guidance documents" and "as part of design verification to written protocols with pre-defined acceptance criteria." However, it does not explicitly list the specific numerical acceptance criteria for each test or the detailed, quantitative results against those criteria. It only provides a high-level summary that the results "met the acceptance criteria."
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Pre-defined acceptance criteria for design verification | All tested components and designs met the acceptance criteria. |
| ASTM F543 for bone screws | Testing per ASTM F543 was completed on the bone screws, with the results meeting the acceptance criteria. |
| Coating validation | Conducted (implied met criteria). |
| Metal shell deformation resistance during impaction | Conducted (implied met criteria). |
| Range of motion | Conducted (implied met criteria). |
| Wear | Conducted (implied met criteria). |
| Pull-off stability of modular connection (fixed liner to shell) | Conducted (implied met criteria). |
| Lever-out stability of modular connection (fixed liner to shell) | Conducted (implied met criteria). |
| Torsional stability of modular connection (fixed liner to shell) | Conducted (implied met criteria). |
2. Sample size used for the test set and the data provenance
The document mentions that testing was conducted on the "worst case component size and option/design" for the Mpact Extension. It does not specify a numerical sample size for any of the tests, nor does it refer to a "test set" in the context of clinical data for a device performance study. The testing described is design verification, typically conducted on physical prototypes or simulations. Data provenance (country, retrospective/prospective) is not applicable here as it refers to a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device underwent design verification testing against established engineering standards and internal protocols, not a clinical study requiring expert ground truth for interpretation of patient data.
4. Adjudication method for the test set
Not applicable, as this refers to a clinical study with image or data interpretation, which is not described.
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 device is a hip prosthesis, not an AI-powered diagnostic tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This refers to AI algorithms, and this device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the design verification tests, the "ground truth" would be the engineering specifications, material properties, and performance requirements defined by relevant international standards (e.g., ASTM, ISO) and the manufacturer's internal design controls. The device was tested to ensure it met these pre-defined physical and mechanical properties.
8. The sample size for the training set
Not applicable. This refers to the training of an AI algorithm, which is not relevant to this device.
9. How the ground truth for the training set was established
Not applicable. This refers to the training of an AI algorithm, which is not relevant to this device.
In summary:
This 510(k) submission for the Mpact Extension focused on demonstrating substantial equivalence to predicate devices through design verification testing based on engineering standards and internal protocols. It does not include clinical trial data, AI performance metrics, or information typically associated with studies involving human data interpretation or AI algorithms. The "study" referenced is the series of design verification tests, which confirmed the device's physical and mechanical properties met established criteria.
§ 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.