(267 days)
Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries.
Mpact 3D Metal Augments are indicated in cases of:
- Acetabular dysplasia;
- Acetabular fractures;
- Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.
The Mpact 3D Metal Augment II is an acetabular implant intended to be used in Total Hip Arthroplasty cemented to its Medacta compatible Acetabular Shell. It is provided sterile and individually packaged to the end user.
The devices subject of this submission are:
- Mpact 3D Metal Augments II from size Ø46 to Ø80, made of Ti6Al4V according to ASTM F2924;
- Double Augment Technique Screw, made of Ti6Al4V according to ISO 5832-3.
The Mpact 3D Metal Augments II represent the second generation of the Mpact 3D Metal Augments cleared within K171966.
This FDA 510(k) clearance letter pertains to a medical device, specifically the Mpact 3D Metal Augments II, which are implants for hip replacement surgeries. The document focuses on establishing substantial equivalence to existing predicate devices based on design and performance testing. However, it does not describe a clinical study in the traditional sense, especially not one that involves human subjects or assesses AI performance.
The provided text details non-clinical performance data and validations to support the device's substantial equivalence to its predicate. It does not contain information about acceptance criteria for AI performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
Therefore, many of the requested sections (including specific tables for acceptance criteria and device performance based on AI metrics, details about test sets, ground truth establishment for AI, MRMC studies, and standalone performance) cannot be filled from the provided document.
Here's a breakdown of the information that is available:
1. A table of acceptance criteria and the reported device performance
The document describes performance testing as "Fatigue testing in single and double augment configurations" and "Rationale of comparison – EBM Additive Manufacturing Technology." It also mentions "Design Validation on Mpact 3D metal Augments II." However, it does not disclose specific acceptance criteria or quantitative performance results for these tests. It only states that "testing activities were conducted to written protocols" and these validations are "provided in support of the substantial equivalence determination." This is typical for a 510(k) summary, which generally summarizes the data rather than providing all raw or detailed results.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | - Fatigue testing results in single and double augment configurations (details not provided) |
| Not specified in document | - Design Validation on Mpact 3D metal Augments II (details not provided) |
| Pyrogenicity control (using LAL test per ISO11737-3 and EP §2.6.14, and in-vivo evaluation in rabbit per USP ) | Pyrogenicity is controlled and validated, meeting standards (specific quantitative results not provided) |
| Biocompatibility | Biocompatibility assessed (details not provided) |
| Shelf-life | Shelf-life evaluated (details not provided) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "tests" here refer to non-clinical laboratory and material tests, not clinical studies involving 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)
This is not applicable to the type of device and study described. There's no "ground truth" to be established by experts in the context of material fatigue or design validation for an orthopedic implant as presented here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the type of device and study described. Adjudication methods are typically used in clinical trials or studies involving expert review of medical images or outcomes.
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
There is no MRMC or comparative effectiveness study mentioned, as this is a physical medical device (hip augments), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the sense of medical diagnosis or AI performance. The "truth" for these non-clinical tests would be the physical properties and performance characteristics determined by established engineering and materials testing standards.
8. The sample size for the training set
This is not applicable, as there is no "training set" for an AI algorithm mentioned in this document.
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set" or "ground truth" for it in the context of AI.
Summary of what the document does provide regarding the study/testing:
The document describes non-clinical testing and validations performed to demonstrate the substantial equivalence of the Mpact 3D Metal Augments II to its predicate devices. These tests include:
- Design Validation: Performed on Mpact 3D Metal Augments II (details not provided).
- Performance Testing:
- Fatigue testing in single and double augment configurations.
- Rationale of comparison – EBM Additive Manufacturing Technology.
- Pyrogenicity: Control validated using bacterial endotoxin test (LAL test) per ISO11737-3 and European Pharmacopoeia §2.6.14, and in-vivo evaluation in rabbits per USP .
- Biocompatibility assessment.
- Shelf-life evaluation.
The document states that Medacta International S.A., based in Switzerland, submitted this 510(k). The tests are non-clinical, so data provenance regarding country of origin or retrospective/prospective does not apply in the same way as for clinical data. The studies are laboratory-based and conducted according to written protocols to ensure materials and design meet safety and performance standards for orthopedic implants.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.