FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

· Severely painful and/or disabled joint: as a result of osteoarthritis, rheumatod arthritis or psoriactic 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.

• Dislocation risks

Device Description

The Mpact Double Mobility System acetabular shells are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Double Mobility System consists of acetabular shells (size 42mm to 66mm in 2mm increments) that have a TiGrowth porous coating (Ti, ASTM F1580) and hemispherical shape that is identical to the K103721 and K132879 predicate devices. The material of the shells (High Nitrogen StSt - ISO 5832-9) and the double mobility design is the same as the K083116 predicate device.

The shells are used with the Versafitcup Double Mobility Liners that are registered with K083116, K092265, and K131458 predicate devices in addition to one new size (22.2/DMA) of the Medacta Double Mobility liner in both UHMWPE (ISO 5834-2 Type 1) and HighCross highly crosslinked UHMWPE which are included in this submission. These liners are identical to the liners in the K083116, K092265, and K131458 submissions but have a smaller external diameter than the predicates. These new liners can only be coupled with a 22.2mm femoral head and have a minimum thickness of 5 mm.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device (Mpact Double Mobility System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through clinical studies as would typically be described for AI/software devices. Therefore, much of the requested information regarding clinical study specifics (sample size, ground truth, expert qualifications, etc.) is not applicable or cannot be extracted from this document.

However, I can extract the information related to performance testing which serves as the "study" demonstrating the device's substantial equivalence based on pre-defined acceptance criteria.

Acceptance Criteria and Device Performance for Mpact Double Mobility System

The "study" for this device is primarily a demonstration of substantial equivalence through performance testing rather than a clinical trial with human subjects. The acceptance criteria were based on established standards, FDA guidance, and comparison to predicate devices. The document indicates that the Mpact Double Mobility System's performance was found to be "not worst case" compared to the worst-case predicate device and had "similar performance testing as the predicates."

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Based On)	Reported Device Performance
Acetabular Shell:
Coating Adhesion	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.
Chemical Characterization (Coating)	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.
Friction Test	ASTM G115-04 and ASTM D4518-94	Evaluated, similar performance as predicates.
Ion Release and Corrosion Test	ASTM F746-04	Evaluated, similar performance as predicates.
Acetabular Shell and Liner:
Excessive Wear During Motion	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.
Limited ROM	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.
Dislocation Risk	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.
Acetabular Liner:
Instability Risk of Modular Connection	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in terms of number of devices or components. The testing would involve specific numbers of components/assemblies required by the cited ASTM standards and internal protocols for mechanical and material tests.
Data Provenance: The tests are likely performed in a laboratory setting by Medacta International, the device manufacturer. This is not patient-specific data, but rather device performance data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable in the context of this 510(k). This is pre-clinical engineering and materials testing, not a clinical study involving human judgment or expert consensus for "ground truth" derived from patient data. The "ground truth" here is the established performance characteristics and safety profiles of predicate devices and relevant industry standards.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical "test set" requiring adjudication by human experts in this document. Test results are compared against pre-defined acceptance criteria based on standards and predicate device performance.

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 document describes a hip prosthesis, not an AI or software-based medical device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware medical device (hip prosthesis), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the performance characteristics and safety profiles of the legally marketed predicate devices, as well as relevant international and national standards (e.g., ASTM F1580, ISO 5834-2 Type 1, ASTM G115-04, ASTM D4518-94, ASTM F746-04). This document aims to demonstrate that the new device is substantially equivalent to these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a 510(k) submission for a hip prosthesis. This term is specific to AI/machine learning models.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI/ML model, this question is not relevant to the provided document.

Summary

Regulation Number and Section

§ 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.