(122 days)
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 components of the Medacta Total Hip Prosthesis System are intended for single, cementless use, only, and are described below:
a) Quadra® S Femoral Stem: The Quadra® S Femoral Stem is intended for cementless use, and is available in four versions, standard or lateral stem, both in regular or short neck version. The Quadra® S Femoral Stem is intended, as a component of the Mcdacta Total Hip Prosthesis System, for use in total or partial hip arthroplasty and in primary or revision surgery. The Quadra® S Femoral Stem is manufactured from a titanium alloy, according to ISO 5832-11, 1994, Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6aluminium 7-niobium alloy. The stem is sandblasted and the neck has a mirror-polished finish. The Quadra® S Femoral Stem may be used with the Tri-Plus™ Cup System and CoCrMo Femoral Ball Heads.
b) Cobalt Chromium Molybdenum (CoCrMo) Femoral Ball Head: The CoCrMo femoral ball head is intended for mechanical fixation to a mating hip stem such as the Quadra® S Femoral Stem and for use in total or partial hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery. The CoCrMo femoral ball heads are manufactured from Cobalt Chromium Molybdenum, according to ISO 5832-12, 2007, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy. The CoCrMo femoral balls heads range in diamcter from 28 mm to 32 mm and may be used with the Quadra® S Femoral Stem and Tri-Plus™ Cup System.
c) Tri-plus™ Cup System: The Tri-plus™ Acetabular shell is a true hemispherical design featuring plasma spray coating which allows the substrate to retain its fatigue strength characteristics. The shell and liner utilize a secure locking mechanism designed to decrease the potential for polyethylenc wear debris. The liner is manufactured from direct-compression molded polyethylene and incorporates anti-rotation features. The locking mechanism allows for secure fixation between the shell and liner. Superior surface tabs designed into liner provides anti-rotation stability and proper liner indexing. The shell is a true hemisphere design available in No-hole, Cluster hole, and Multi-hole options. The liners are available in Neutral and Hooded (10°) options. The Tri-plus™ liners are manufactured from DCM polyethylene. The Tri-plus™ Cup System may be used with the Quadra® S Femoral Stem and CoCrMo femoral ball heads.
This document describes the Medacta Total Hip Prosthesis System, a medical device. The information provided focuses on its substantial equivalence to predicate devices and adherence to relevant standards rather than a study demonstrating its performance against specific acceptance criteria in the way one might expect for a diagnostic or AI-driven device.
Here's an analysis of the provided text in the context of your request for acceptance criteria and a study proving their fulfillment:
The document does not describe a study in the sense of a clinical trial or performance evaluation with specific acceptance criteria and outcome data for the device itself. Instead, it's a 510(k) premarket notification summary, which aims to demonstrate substantial equivalence to already legally marketed predicate devices.
Therefore, for many of your requested points, the answer will be "Not applicable" or "Not provided in this document" as the nature of the submission is different from proving novel performance.
Here's how to break down your request based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: Adherence to FDA recognized standards for mechanical testing for hip prostheses. | Design verification and design validation, including bench testing, was performed according to FDA's Design Control Requirements (21 CFR Part 820.30) and FDA recognized standards for mechanical testing. (Specific quantitative results or individual acceptance criteria are not detailed in this summary.) |
| Material Composition: Conformance to specified ISO standards for titanium alloy and cobalt-chromium-molybdenum alloy. | Quadra® S Femoral Stem: Conforms to ISO 5832-11, 1994. |
| CoCrMo Femoral Ball Head: Conforms to ISO 5832-12, 2007. | |
| Sterility: Conformance to specified ISO standards for radiation sterilization. | Conforms to ISO 11137-1:2006 and ISO 11137-2:2006. |
| Substantial Equivalence: Device has similar indications for use and technological characteristics to predicate devices. | The Medacta Total Hip Prosthesis System is substantially equivalent to the predicate devices (K001942, K021178, K063278, K042565) regarding indications for use/intended use and technical characteristics. |
Explanation: The "acceptance criteria" here are primarily the established standards and regulations that a new medical device must meet to be considered safe and effective, or substantially equivalent to existing devices. The "reported device performance" refers to the declaration that these standards and regulations were met through design verification, validation, and material conformity. Specific quantitative performance metrics are not given in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable/Not provided. This document describes bench testing, material conformity, and substantial equivalence, not a clinical study with a "test set" of patients in the typical sense. Bench testing would involve samples of the device components, but the sample size for these tests is not specified.
- Data provenance: Not applicable/Not provided. The "data" primarily refers to internal design control documentation and adherence to international standards.
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. This is not a study requiring expert-established ground truth. The "ground truth" for this type of submission is adherence to recognized standards and established engineering principles for mechanical performance and material compatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving expert adjudication.
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 a diagnostic imaging device or an AI-assisted tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a hip prosthesis, not an algorithm. Bench testing of the physical components can be considered "standalone" performance for the device itself, but not in the context of an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's submission is primarily based on recognized international standards (ISO standards for materials and sterilization) and FDA's Design Control Requirements for demonstrating the safety and effectiveness of a medical implant through mechanical testing and material properties. It also relies on the established safety and effectiveness of the predicate devices to which it claims substantial equivalence.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.