(28 days)
The Apex Modular™ Ceramic Femoral Heads are intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup or bipolar component. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:
• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- · Congenital dislocation;
- Revision procedures where other treatments or devices have failed
- · Femoral neck and trochanteric fractures of the proximal femur.
The Apex Modular Hip System BIOLOX® delta Femoral Head is composed of an alumina matrix composite, the femoral heads include diameters ranging from 28mm to 40mm with various offsets.
Here's a breakdown of the acceptance criteria and study information for the APEX Modular Hip System BIOLOX® delta Femoral Head, based on the provided document:
This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific, independent performance acceptance criteria through clinical studies. Therefore, the "acceptance criteria" here are implicitly linked to the performance characteristics of the legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a medical implant, the "acceptance criteria" are not explicit performance metrics in the way one might find for a diagnostic device (e.g., sensitivity, specificity). Instead, they are related to demonstrating that the new device is as safe and effective as the predicate devices, primarily through design, material, and mechanical property comparisons. There are no direct "reported device performance" metrics in terms of clinical outcomes, but rather a demonstration of comparable mechanical performance.
| Category | "Acceptance Criteria" (Implicit from Predicate Comparison) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | Must be identical or very similar to predicate devices for modular head, primary and revision THA, cementless. | Yes, cementless. (Matches predicate for modular head, primary and revision THA) |
| Design: Taper | Must be identical to predicate devices. | 12/14 (Matches predicate) |
| Design: Head Diameters & Offsets | Must cover similar ranges and specifications as predicate devices, with reasonable justification for any variations (e.g., expansion of available sizes). | 28-40mm (Wider range than K012918, K073150 which are 28-36mm, but includes 40mm which is available in K100555). Specific offsets are generally consistent or offer expanded options. |
| Materials | Must be biocompatible and possess mechanical properties comparable to or superior to predicate devices (e.g., alumina for ceramic heads, CoCr Alloy for non-ceramic heads, titanium alloy/CoCr alloy for stem trunion). Specific material composition must be documented. | BIOLOX delta (Alumina matrix composite, 72-75% Al2O3+, 24-26% Z2O3), Titanium alloy/CoCr alloy for Stem Trunion. (Comparable to BIOLOX forte (99.7% Al2O3) in predicate ceramic heads, and CoCr Alloy for another predicate head, with a specified alternative ceramic composition). |
| Packaging & Sterilization | Must be equivalent to predicate devices to ensure sterility and integrity. | Peelable Tyvek® pouches, double pouched, cardboard box with foam, tamper resistant labels; inner pouch polyethylene with peelable Tyvek® panel. Ethylene oxide sterilization to 10-6 SAL. (Matches predicate packaging and sterilization methods). |
| Mechanical Performance | Demonstrate equivalence in mechanical properties through non-clinical testing, particularly burst strength and taper locking integrity, referencing established ISO standards. | - Component testing of BIOLOX delta ball heads (28-12/14 L) on CoCr and titanium test tapers per CeramTec Procedure VA 02 04 4129, ISO-7606-10. |
- Influence of diameter and neck length on burst strength of BIOLOX delta ball heads with taper type 12/14, per ISO-7206-10 setup.
(These tests aimed to show comparable mechanical integrity and performance to the predicate BIOLOX forte heads.) |
| Biocompatibility | Residuals of sterilization agents must be within acceptable limits (e.g., ETO residuals). | ETO Residuals per ANSI/AAMI/ISO 10993-7. (Indicates compliance with biocompatibility standards for ETO sterilization). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There was no "test set" of patient data used. The testing was non-clinical, focusing on device components. The specific number of femoral heads or tapers tested in the mechanical studies is not provided, only the types of tests performed.
- Data Provenance: The data is from non-clinical bench testing (mechanical and material characterization). There is no patient data, so country of origin or retrospective/prospective status is not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There was no "ground truth" derived from human experts for a clinical test set. The ground truth for the non-clinical tests would be the established chemical, physical, and mechanical properties of the predicate materials and devices, as defined by relevant ISO standards and material specifications. The expertise would lie with the engineers and scientists conducting the testing and comparing the results against these established standards.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring expert adjudication.
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 hip implant device, not a diagnostic imaging device involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device does not involve algorithms or AI.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the performance and material specifications of legally marketed predicate devices and the adherence to recognized industry standards (e.g., ISO for mechanical testing, ANSI/AAMI/ISO for ETO residuals). The goal was to demonstrate that the new device meets or exceeds the performance characteristics of its predicates.
8. The Sample Size for the Training Set
- Not applicable. There was no "training set" in the context of machine learning or clinical trials. This is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there was no training set, there was no ground truth for one.
§ 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.