Search Results

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The femoral stem is for cementless use only.

The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is a modular, wedge-shaped stem that is coated with Ti-6A1-4V titanium alloy plasma spray.

The provided text describes a 510(k) premarket notification for a hip prosthesis, not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable or mentioned in this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance as these are not relevant to this type of device submission based on the provided information.

However, I can extract the information that is relevant to the "acceptance criteria" and "study" for this particular device submission:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. This submission relies on non-clinical testing of the device itself, not patient data in the context of an AI/ML test set.
• Data Provenance: Not applicable. The "data" refers to the results of non-clinical device testing, not patient data.

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. Ground truth as typically defined for AI/ML algorithms is not relevant here. Device performance is assessed through engineering and biocompatibility testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

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 not an AI/ML device that assists human readers.

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

• Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable in the context of AI/ML. The "ground truth" for this device's performance is established by recognized engineering standards and biocompatibility requirements for hip prostheses.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

Ask a specific question about this device

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

This femoral stem is for cementless use only.

The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is a modular, wedge-shaped stem that is coated with commercially pure titanium alloy plasma spray.

The modular neck options allow for soft tissue balancing and easier restoration of the hip joint center of rotation. The modularity feature will allow surgeons to independently equalize leg length and optimize offset while, at the same time, maximizing joint stability for a variety of patient anatomies.

The provided document describes a 510(k) premarket notification for the "Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System." This is a medical device submission for a hip prosthesis, and as such, the acceptance criteria and study data provided are related to the physical and mechanical performance of the device, not diagnostic or AI performance.

Therefore, many of the typical questions for AI/diagnostic devices regarding sample size, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of submission.

Here's the breakdown of the information that is applicable and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System met performance requirements and is as safe and effective as its predicate." The specific numerical or qualitative acceptance criteria for "performance requirements" are not detailed in this summary document. These would typically be established through recognized standards (e.g., ISO for implant materials and mechanical testing) and internal company specifications for the similar predicate device.

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

• Sample Size: Not specified. For non-clinical testing of a hip prosthesis, "samples" would refer to the physical devices or components subjected to laboratory tests (e.g., fatigue testing, wear testing).
• Data Provenance: Not specified, but inherently "non-clinical" (i.e., laboratory testing). The country of origin for the data is Zimmer, Inc. (Warsaw, IN, USA). The studies are prospective in the sense that they are conducted specifically for this submission, but they are not clinical studies on human subjects.

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

• Not applicable. For mechanical testing of medical devices like a hip prosthesis, "ground truth" is established by physical measurements, engineering principles, and adherence to recognized standards, rather than expert human interpretation.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review contexts, typically in diagnostic studies. This is a non-clinical device performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is for evaluating the impact of a diagnostic tool (often AI) on human reader performance, which is not relevant for a hip prosthesis itself. The comparison here is between the new device and its predicate device based on manufacturing, materials, and intended use, and non-clinical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This question pertains to AI algorithms. The Zimmer M/L Taper Hip Prosthesis with Kinectiv™ Technology System is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

• Engineering and Materials Standards / Predicate Device Performance: The "ground truth" for non-clinical testing of this device would be established by conforming to relevant industry standards (e.g., ISO standards for orthopedic implants), internal Zimmer specifications, and demonstrating equivalence to the performance of the legally marketed predicate device (Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology).

8. The Sample Size for the Training Set

• Not applicable. This question refers to machine learning models. This document describes a physical medical device.

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

• Not applicable. This question refers to machine learning models.

Ask a specific question about this device