(28 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 device modifications to the Medacta Total Hip Prosthesis System which are the subject of this special 510(k) are as follows:
Line Extension to include CoCrMo Femoral ball heads of 22 mm diameter: These CoCrMo femoral ball heads would be used with Quadra® S femoral stems from the Medacta Total Hip Prosthesis System (K072857) and the Ortho Development's Triplus® Acetabular cups and liners.
Line Extension to include CoCrMo Femoral ball heads of 36 mm diameter: These CoCrMo femoral ball heads would be used with Quadra® S femoral stems from the Medacta Total Hip Prosthesis System and the Ortho Development's Triplus® Acetabular cups and liners.
Labeling to allow the use of Medacta Quadra® S stems from Medacta Total Hip Prosthesis system and Medacta CoCrMo Femoral ball heads of sizes 22 and 28 mm with Ortho Development's Pivot Bipolar heads. The Ortho Development's Pivot Bipolar heads were previously cleared under K050966.
This document is a 510(k) premarket notification for a medical device modification, specifically a "Line Extension" to the Medacta Total Hip Prosthesis System. The core purpose of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive new performance studies. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving their fulfillment is largely not applicable in the context of this specific document.
Here's why and what information can be extracted:
- Type of Submission: This is a Special 510(k) for a "Line Extension," which means the manufacturer is a modifying an already cleared device (K072857) with minor changes (new femoral ball head diameters and allowing use with previously cleared bipolar heads). The modifications are considered to not raise new questions of safety and effectiveness.
- Focus on Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is demonstrating "substantial equivalence" to a predicate device. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate, or that any differences do not raise new questions of safety or effectiveness.
- "Performance Testing" Section: The document explicitly states: "No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act." It also notes, "Risk analysis was conducted on the impact of these changes and appropriate design verification and validation was conducted under the company's design controls." This implies that the 'study' to prove acceptance criteria was primarily focused on internal design controls and risk analysis related to the specific modifications, rather than a large-scale clinical or comparative performance study.
Given the nature of this document, I cannot fill out the table and detailed sections as you might expect for a de novo submission or a PMA where new performance data is central. However, I can explain why these sections are not present and provide what little relevant information exists.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy > X%) | Reported Device Performance |
|---|---|
| Not applicable. The primary "acceptance criterion" for a 510(k) is demonstrating Substantial Equivalence to a predicate device (K072857). This is a regulatory threshold, not a specific performance metric like sensitivity or accuracy. | The device (Medacta Total Hip Prosthesis System - Line Extension) was determined to be substantially equivalent to its predicate device (Medacta Total Hip Prosthesis System, K072857) with respect to indications for use and technological characteristics. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for external large-scale test sets. The document describes modifications to an existing device. The "performance testing" mentioned refers to internal design verification and validation activities conducted under the company's design controls and risk analysis. These would typically involve testing of materials, components, and assemblies against design specifications, rather than a "test set" of patients or images as might be seen for diagnostic AI. The document does not provide details on sample sizes or data provenance for these internal tests.
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. There is no mention of a "test set" requiring expert ground truth in the context of this 510(k) submission. The evaluation is mechanical and regulatory, focused on the safety and performance changes of the physical device components.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. As there is no external "test set" or diagnostic performance evaluation, adjudication methods are not relevant.
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 is for a hip prosthesis system, not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a hip prosthesis system, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For this type of device modification, "ground truth" would be established through engineering specifications, material testing standards, and risk analyses (e.g., ensuring new components meet strength requirements, wear characteristics, biocompatibility standards, etc.). These are typically internal verification and validation activities.
8. The sample size for the training set
- Not applicable. As this is for a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set," this question is not relevant.
In summary, this 510(k) pertains to a physical medical device (hip prosthesis system) undergoing a minor modification. The "study" mentioned for acceptance is primarily focused on internal design controls, risk analysis, and demonstrating "substantial equivalence" to a predicate device, as opposed to generating new clinical or performance data against specific acceptance criteria for a new feature or algorithm.
§ 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.