(136 days)
The ADVANCE® BIOFOAM® and EVOLUTION® BIOFOAM® tibial bases are indicated for use in knee athroplasty in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;
- Inflammatory degenerative joint disease, including rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only.
The DYNASTY® BIOFOAM® Acetabular Shell is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed.
The DYNASTY® BIOFOAM® Acetabular Shell is for uncemented use only.
A process change is taking place to introduce BIOFOAM® Additive Manufacturing (BIOFOAM® AM) as an alternative to the currently manufactured BIOFOAM® material used as a porous coating. BIOFOAM® AM will be used as a porous coating for MicroPort Orthopedics' tibial bases and acetabular shells with the current BIOFOAM® material as a porous coating. The BIOFOAM® AM is a porous material manufactured from the same raw material as the predicate, Commercially Pure Titanium conforming to ASTM F67, The surface treatment of BIOFOAM® AM is identical to the predicate and helps to provide initial fixation. The structure and porosity of BIOFOAM® AM is designed to encourage bone apposition.
The provided documentation is a 510(k) Summary for a medical device and does not contain the detailed data or study design typically found in a clinical study report or a validation study for an AI/ML powered device. This document describes the "BIOFOAM® Additive Manufacturing (BIOFOAM® AM)" as an alternative porous coating material for existing orthopedic implants, not an AI/ML device.
Therefore, many of the requested sections about AI/ML device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and standalone performance metrics are not applicable to the information provided in this document. The document focuses on demonstrating substantial equivalence of a new manufacturing process for a material to existing predicate devices, primarily through non-clinical testing.
However, I can extract the relevant information regarding the acceptance criteria (or performance metrics) used for the material and the study that proves it meets those criteria based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Performance Metric | Acceptance Criteria (Implied by FDA Guidance/Predicate Equivalence) | Reported Device Performance (BIOFOAM® AM) |
|---|---|---|
| Static Shear Strength | Greater than required by FDA Guidance Document and substantially equivalent to predicate. | Achieved static shear strength greater than required by FDA Guidance and substantially equivalent to predicate. |
| Static Tensile Strength | Greater than required by FDA Guidance Document and substantially equivalent to predicate. | Achieved static tensile strength greater than required by FDA Guidance and substantially equivalent to predicate. |
| Shear Fatigue Strength | Substantially equivalent to predicate. | Substantially equivalent to predicate. |
| Abrasion Resistance | Performs as well as predicate. | Performs as well as predicate, expected to resist abrasive in vivo forces. |
| Material Purity | Commercially Pure Titanium conforming to ASTM F67. | Manufactured from Commercially Pure Titanium conforming to ASTM F67. |
| Stereological Evaluation | (Not explicitly stated, but implies meeting established material characteristics). | Completed per ASTM F1854. (Specific results not detailed, but implied to be acceptable for substantial equivalence). |
| Build Parameters Validation | (Successful validation) | Performed and validated. |
| Print Chamber Validation | (Successful validation - orientation, location) | Performed and validated. |
| Powder Recycle Validation | (Successful validation) | Performed and validated. |
| Residual Powder Removal | (Successful demonstration) | Performed and demonstrated. |
| Bacterial Endotoxin Testing | (Acceptable levels) | Performed. (Implied to be acceptable, as substantial equivalence was granted). |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not applicable as this is a non-clinical material testing study, not a study involving human 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 for material performance is established through recognized ASTM standards and engineering measurements, not expert consensus in a medical diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a non-clinical material testing study.
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 a non-clinical material testing study, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a non-clinical material testing study, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1854) and comparisons to the performance of the predicate device materials. FDA Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces also served as a benchmark.
8. The sample size for the training set:
- Not applicable. This is a new material/manufacturing process, not an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
- Not applicable.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.