(88 days)
The Alumina Ceramic Femoral Heads are modular components designed for use 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 Alumina Ceramic Femoral Heads are single-use devices manufactured from Al 2 O 3 . Both 28 and 32 mm diameter heads are available in three neck lengths each. The 12/14 bore of the ceramic ball mates with Zimmer titanium and cobalt-chromium alloy femoral stems having a corresponding 12/14 neck taper.
This document is a 510(k) summary for a medical device called "Alumina Ceramic Femoral Heads, 28 and 32 mm" manufactured by Zimmer, Inc. The purpose of this summary is to demonstrate substantial equivalence to previously cleared predicate devices.
Based on the provided text, the device primarily relies on mechanical testing to establish equivalence rather than a study with acceptance criteria related to a specific performance metric like sensitivity or specificity often seen in AI/diagnostic device submissions.
Here's a breakdown of the requested information, where available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that mechanical testing was performed. The acceptance criteria are implicitly tied to the ability to withstand in vivo loading and equivalence to existing devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Withstand in vivo loading (as per FDA Draft Guidance) | "Test results indicate that the Alumina Ceramic Femoral Heads are capable of withstanding in vivo loading." |
| Equivalent to devices currently on the market (mechanically) | "Test results indicate that the Alumina Ceramic Femoral Heads are equivalent to devices currently on the market..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "mechanical testing." This type of testing typically involves physical samples of the device, not a "test set" in the sense of patient data.
- Sample Size for Test Set: Not specified, but it would refer to the number of physical femoral heads tested, not patient data.
- Data Provenance: Not applicable in the context of mechanical testing. This is not a study using patient data from a specific country or collected retrospectively/prospectively. It's laboratory-based engineering performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. "Ground truth" in the context of this device's evaluation refers to the objective physical properties and performance under mechanical stress, not expert interpretation of patient data. The evaluation is against engineering standards and a comparison to predicate devices, not expert consensus on medical conditions.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of data, which is not relevant for mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is not a diagnostic device or an AI-assisted device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or performed for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is based on engineering standards and specifications for strength, durability, and other mechanical properties under simulated in vivo loading conditions, as outlined in the "FDA Draft Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems." The ultimate "truth" is whether the device physically performs as safely and effectively as the predicate devices under these conditions.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" as it is not an algorithm or an AI system that learns from data.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As explained above, there is no "training set" for this 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.