(224 days)
· Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
· Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection: fracture-dislocation of the hip; and correction of deformity.
REDAPT™ Augments are intended for single use only and are to be implanted with bone cement to the mating acetabular shell and without bone cement to the bone interface
Augments are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously.
Subject of this Traditional premarket notification are the REDAPT® Augments. The subject devices are acetabular augment hip components to be used to fill bone voids where significant bone loss is present and a cup alone cannot fill the void.
This document is a 510(k) Premarket Notification from the FDA regarding the "Smith & Nephew, Inc. REDAPT Augments." It describes the device, its intended use, and the pre-clinical testing performed to establish substantial equivalence to legally marketed predicate devices.
Summary of Acceptance Criteria and Study:
The document focuses on substantiating the equivalence of the REDAPT Augments to predicate devices, primarily through engineering analysis and mechanical testing, rather than an AI/ML-based study with specific acceptance criteria for algorithm performance. Therefore, many of the requested points related to AI/ML performance, ground truth, expert review, MRMC studies, and training data are not applicable to this 510(k) submission.
The "acceptance criteria" in this context are implicitly the successful completion of the described pre-clinical tests and the demonstration that the results are equivalent to or better than the predicate devices, thereby ensuring safety and effectiveness.
Here's a breakdown of the requested information based on the provided text, with "N/A" for sections not covered by this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implicit) | Specific Test/Analysis | Device Performance/Results |
|---|---|---|
| Mechanical Performance | Impaction Testing (Worst-Case Shell/Augment Constructs) | Successfully completed impaction testing. |
| Fatigue Testing (Worst-Case Shell/Augment Constructs) | Successfully completed fatigue testing. | |
| Lever Out Testing (Worst-Case Shell/Augment Constructs) | Similar lever-out values as the predicate (K070756). | |
| Post-Fatigue Microstructure Analysis | Microstructure was maintained post-fatigue. | |
| Run-out Fatigue Load Comparison | Higher run-out fatigue load compared to the primary predicate device (K962541). | |
| Screw Tab Strength: Static Pull Through Testing | Strength was shown to be greater than previously cleared devices. | |
| Screw Tab Strength: Cantilever Bending Testing | Strength was shown to be greater than previously cleared devices. | |
| Biocompatibility/Safety | Corrosion Testing | Not statistically significant compared to the predicate. Ions and ion amount generated do not pose a biological risk. |
| Chemical Extraction Testing | Residuals did not pose a biological risk. | |
| Bacterial Endotoxin Testing | Met the acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST-72. | |
| Packaging/Sterility | Packaging Verification Testing | Demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Test Set: The document refers to "worst-case products" and "representative samples" for testing. Specific numerical sample sizes for each mechanical or chemical test are not provided in this summary.
- Data Provenance: N/A for this type of testing (not clinical data or image data). The tests were conducted on manufactured device samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- N/A. This is pre-clinical engineering and laboratory testing, not a study requiring human expert interpretation of data for ground truth establishment in the context of AI/ML.
4. Adjudication Method for the Test Set:
- N/A.
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:
- N/A. This is not an AI/ML device, nor is it a clinical study comparing human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a medical implant device, not an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for these tests is based on established engineering principles, material science standards, and in vitro testing methodologies. For example, "successful completion" of fatigue testing means the device withstood the specified cyclical loads without failure or excessive deformation, as defined by the test protocol and industry standards. Comparison to predicate device performance also serves as a benchmark.
8. The Sample Size for the Training Set:
- N/A. This product does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set was Established:
- N/A.
Additional Context from the Document:
- Clinical Data: The summary explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."
- Substantial Equivalence: The overarching goal of this 510(k) submission is to demonstrate "substantial equivalence" to predicate devices based on intended use, indications, and performance characteristics, primarily through the pre-clinical engineering and laboratory testing described.
- Technological Characteristics: The augment devices use the same titanium alloy, sterilization method, porous structure, and manufacturing as previous cleared devices. Key differences identified are geometry, size offering, and additive manufacturing method (Ti-6Al-4V).
§ 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.