(30 days)
The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of:
- Severely painful and/or disabled joint: as a result of osteoarthritis, posttraumatic arthritis, rheumatoid arthritis or psoriatic 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.
The Mpact Extension components are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Extension acetabular components that are the subject of this 510(k) consist of a multi-hole or rim-hole shell (Ti-6Al-4V, ASTM F136 and Ti, ASTM F1580 porous coating), a fixed liner in sizes "J" and "K" that is made of ultra-high molecular weight polyethylene (UHMWPE ISO 5834-2 Type1) or HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE), and a cortical bone screw, flat head (Ti-6AJ-4V, ISO 5832-3).
The provided document describes the 510(k) submission for the Mpact Extension, a hip prosthesis system. It outlines the performance testing conducted to demonstrate substantial equivalence to predicate devices, but it does not include the detailed information requested regarding sample sizes, data provenance, expert qualifications, or comparative effectiveness studies in the context of an AI/algorithm-based device.
This document is for a traditional medical device (hip prosthesis), not an AI/ML-based medical device. Therefore, many of the requested categories (like "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Training set sample size," etc.) are not applicable to this type of submission.
However, I can extract the available information related to acceptance criteria and device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Pull-out stability (modular connection of fixed liner to metal shell) | (Implied: Meet established standards/predicate device performance for pull-out strength/resistance) | Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.) |
| Lever-out stability (modular connection of fixed liner to metal shell) | (Implied: Meet established standards/predicate device performance for lever-out resistance) | Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.) |
| Torsional stability (modular connection of fixed liner to metal shell) | (Implied: Meet established standards/predicate device performance for torsional resistance) | Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.) |
| Coating validation | (Implied: Meet established standards for coating adhesion, integrity, and biocompatibility) | Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.) |
| Metal shell deformation resistance during impaction | (Implied: Resist deformation during surgical impaction within acceptable limits as per standards/predicate device performance) | Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.) |
| Range of motion | (Implied: Demonstrate an acceptable range of motion, comparable to predicate devices or physiological norms) | Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.) |
| Wear | (Implied: Exhibit wear rates within acceptable limits as per standards/predicate device performance) | Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.) |
| Bone screw testing | (Implied: Meet established standards for bone screw performance, e.g., thread pull-out strength, torsional strength, fatigue) | Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.) |
Study Proving Acceptance Criteria Met:
The study was described as "Performance testing of the Mpact Extension," conducted "in accordance with various international standards and FDA guidance documents." The testing was part of "design verification to written protocols with pre-defined acceptance criteria."
Details on the Study (as much as available in the text):
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document states that testing was "conducted on the worst case component size and option/design." However, it does not specify the exact number of samples or units tested for each type of test (e.g., number of shells, liners, or screws).
- Data Provenance: Not specified. This type of physical device testing typically wouldn't have "country of origin of the data" in the same sense as patient data.
- Retrospective or Prospective: Not applicable in the context of physical product testing. It's prospective testing.
-
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 as this is performance testing of a physical medical device, not an AI/ML algorithm requiring expert interpretation for ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
-
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.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" or reference standard for this type of testing is established by the relevant "international standards and FDA guidance documents" specific to orthopedic implants. These standards define the benchmark performance requirements for pull-out strength, wear, deformation, etc.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.