(167 days)
The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40 mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty.
The provided text is a 510(k) summary for a medical device called the "BIOLOX® delta* Ceramic Femoral Head." This document outlines the device's summary of safety and effectiveness to gain market clearance via substantial equivalence to predicate devices, rather than a study typically associated with AI/ML-based diagnostic devices. Therefore, many of the requested categories related to AI/ML study design (e.g., test set, training set, ground truth, expert adjudication, MRMC studies) are not applicable.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate Devices) | Reported Device Performance |
|---|---|
| Mechanical Equivalence: Capable of withstanding in vivo loading similar to predicate devices. | Non-Clinical Performance: "Mechanical testing was performed and results indicate that the BIOLOX delta Ceramic Femoral Heads are equivalent to devices currently on the market and capable of withstanding in vivo loading." This indicates the device passed mechanical performance tests, demonstrating its ability to endure forces encountered in the human body, similar to already approved devices. The specific acceptance criteria (e.g., force thresholds, cycles) for these mechanical tests are not detailed in this summary, but the conclusion states equivalence to currently marketed devices. |
| Material Equivalence: Manufactured from the same materials as predicate devices. | Comparison to Predicate Device(s): "Both the proposed and predicate designs are intended to function as a modular femoral head component in total hip arthroplasty and are manufactured from the same materials." Specifically, it states the device is "fabricated from an alumina matrix composite." This confirms material equivalence. |
| Intended Use Equivalence: Same indications for use as predicate devices. | Intended Use: The provided indications for use are comprehensive and consistent with typical indications for ceramic femoral heads in total hip arthroplasty, and the submission states the device is "substantially equivalent to the femoral heads listed above as predicate devices." |
Explanation of the "Study" (510(k) Equivalence):
For this type of device (a Class II orthopedic implant), the "study" is a demonstration of substantial equivalence to legally marketed predicate devices. This is a regulatory pathway where the new device does not need to prove efficacy and safety from scratch in a de novo clinical trial if it can show it is as safe and effective as a device already on the market.
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable (N/A): This is not an AI/ML diagnostic device with a "test set" in the traditional sense. The equivalence was primarily demonstrated through non-clinical mechanical testing and comparison of design, materials, and intended use to predicate devices.
- The "data" for equivalence is derived from:
- Non-clinical mechanical testing: Performed on the BIOLOX delta Ceramic Femoral Head. Details on the number of samples tested are not provided, but it would typically involve a sufficient number to meet testing standards for orthopedic implants (e.g., ISO standards).
- Comparison to predicate devices: This involves reviewing the design, materials, manufacturing processes, and indications for use of previously cleared devices (Biomet K061312, DePuy K062748, Howmedica Osteonics K052718).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable (N/A): No "ground truth" was established by experts in the context of interpreting medical images or clinical outcomes for this device. The assessment for substantial equivalence is performed by FDA reviewers based on the submitted technical documentation and regulatory guidelines.
4. Adjudication Method for the Test Set
- Not Applicable (N/A): There was no "test set" requiring adjudication in the context of an AI/ML 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 (N/A): No MRMC study was conducted. This device is a passive implant, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A): This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- Engineering/Material Standards and Predicate Device Performance: The "ground truth" for this submission is based on established engineering and material science standards for orthopedic implants, and the regulatory acceptance of existing predicate devices. The device's performance (primarily mechanical in this case) is compared against these benchmarks and the performance of devices already deemed safe and effective by the FDA.
8. The Sample Size for the Training Set
- Not Applicable (N/A): There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable (N/A): There is no "training set" or corresponding ground truth establishment process in this context.
§ 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.