Search Results

The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.

Hip replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• 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.

The AMIStem and Quadra - Line Extension is comprised of the following femoral stems:

• Quadra H STD #00 Short neck
• Quadra S STD #00 Short neck
• AMIStem H STD Stem #00
• AMIStem H LAT Stem #0
• AMIStem H Collared STD and LAT, multiple sizes

The subject devices have the same material as the predicate devices (titanium alloy, according to ISO 5832-11, 1994, Implants for surgery - Metallic materials - part 11: Wrought titanium 6-aluminum 7-niobium alloy).

The AMIStem H and Quadra H have the same coating as the predicate devices: Hydroxyapatite coating, material according to ASTM F1185.

The Quadra H STD #00 Short neck, Quadra S STD #00 Short neck, AMIStem H STD Stem #00, and AMIStem H LAT Stem #0 are a smaller size than the predicate devices and are intended for patients with a smaller bone structure.

The AMIStem H Collared differs from the AMIStem H (KQ93944) only for the presence of the collar. The collar of the stem is designed to achieve contact only with the medial femoral cortex and to provide a path for direct axial stress transfer from the prosthesis to the proximal femur avoiding the over-insertion of the stem in case of subsidence.

The provided text describes a 510(k) premarket notification for a medical device, the AMIStem and Quadra - Line Extension, which are femoral stems for hip prostheses. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness through extensive clinical trials with acceptance criteria for a new device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for training/test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance does not apply directly to this 510(k) summary.

However, I can extract the information that is relevant to the substantial equivalence determination.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The concept of "acceptance criteria" for a new, novel device is not explicitly stated as this is a line extension demonstrating substantial equivalence to predicate devices. The primary "acceptance criterion" in this context is demonstrating that the new devices perform the same as the predicate devices and do not raise new safety or effectiveness concerns.

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. This submission relies on performance testing against established standards and comparison to predicate devices, not on a clinical "test set" of patient data for algorithm evaluation.
• Data Provenance: Not applicable. The focus is on mechanical testing and material compatibility, not clinical data provenance in the typical sense of a diagnostic or AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This is not a study requiring expert ground truth for a diagnostic outcome. The "ground truth" for the device's acceptable performance is defined by adherence to international standards (ISO, ASTM) and comparison to legally marketed predicate devices.

4. Adjudication method for the test set

• Not applicable. This is not a study involving human adjudication of results.

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 passive implant; it does not involve AI or human readers for diagnostic interpretation.

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

• Not applicable. This device is a mechanical implant; it does not involve algorithms or AI.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence is based on:

• Engineering Standards: Compliance with international standards such as ISO 7206-4, ISO 7206-6 (for mechanical performance), and ISO 5832-11, ASTM F1185 (for materials).
• Predicate Device Performance: The established safety and effectiveness track record of the legally marketed predicate devices. The subject devices are shown to perform similarly and use the same materials and coating as these predicates.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-based device.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/algorithm-based device.

Ask a specific question about this device