(28 days)
This device is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; revision procedures where other treatment or devices have failed arthroplasty or other procedure.
"UNITED" 36 mm Ceramic Femoral Head – Delta is an additional size extension to the previously cleared "UNITED" Ceramic Femoral Head (K103497). The materials, design, safety and effectiveness of this subject are identical to the previously cleared Ceramic Femoral Head - Delta Components (available in sizes 28 mm and 32 mm), except for its larger diameter (available in sizes 36 mm). 36 mm Ceramic Femoral Head - Delta manufactured from zirconia-toughened alumina ceramic is available in -3, +1, +5 and +9 mm of neck length. This device is intended to articulate against XPE cup liners (K111546) and can be used in conjunction with U2 Acetabular Cups and U2 Hip Stem made of titanium. U2 Acetabular Cups include U2 HA/Ti Plasma Spray Cup (K050262). U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Cup (K111546), while U2 Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), Ti Plasma Spray Revision Stem (K062978), Ti Press-fit Stem (K111546) and UTF Stem (K110245). The size extension does not affect the intended use of the device or alter the fundamental scientific technology of the device.
This document describes the acceptance criteria and the study conducted for the "36 mm Ceramic Femoral Head, Delta" device (K112463).
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly detail specific quantitative acceptance criteria or a performance table for the "36 mm Ceramic Femoral Head, Delta" device in terms of clinical outcomes or specific thresholds for mechanical tests. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.
The performance data section states: "This 510(k) was prepared in accordance with 'Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems'. Burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test. completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device."
This implies that the acceptance criteria for each of these tests were met by comparing the results to those of the predicate devices or to established industry standards outlined in the referenced guidance document. Without the specific guidance document or detailed test reports, the precise numerical acceptance criteria and the exact reported performance cannot be extracted from the provided text.
However, based on the text, the following can be inferred:
| Test Performed | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Burst Test | Demonstrated performance comparable to or exceeding the predicate device, and/or meeting standards outlined in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" to ensure structural integrity and resistance to sudden failure. | "demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." (Specific values are not provided, but the device met the criteria for substantial equivalence.) |
| Fatigue Test | Demonstrated performance comparable to or exceeding the predicate device, and/or meeting standards outlined in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" to ensure durability and resistance to failure under prolonged or cyclical loading. | "demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." (Specific values are not provided, but the device met the criteria for substantial equivalence.) |
| Burst Test for Post-Fatigue | Demonstrated structural integrity after undergoing fatigue testing, comparable to or exceeding the predicate device, and/or meeting standards outlined in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems." | "demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." (Specific values are not provided, but the device met the criteria for substantial equivalence.) |
| Rotational Resistance Test | Demonstrated rotational stability comparable to or exceeding the predicate device, and/or meeting standards outlined in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" to prevent unwanted rotation between components. | "demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." (Specific values are not provided, but the device met the criteria for substantial equivalence.) |
| Pull-off Test | Demonstrated pull-off strength comparable to or exceeding the predicate device, and/or meeting standards outlined in the "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems" to ensure secure attachment of the femoral head. | "demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." (Specific values are not provided, but the device met the criteria for substantial equivalence.) |
2. Sample Size Used for the Test Set and Data Provenance
The text does not specify the exact sample sizes used for each of the "burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test." The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being "completed as part of the design assurance process." Given the nature of these tests for an orthopedic implant, they would typically be laboratory-based mechanical tests performed on newly manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The study described is a mechanical performance study, not one requiring expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. The study described is a mechanical performance study, not one requiring adjudication by human experts.
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
This information is not applicable and not provided in the document. The device is a physical orthopedic implant, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided in the document. The device is a physical orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical performance tests (burst, fatigue, rotational resistance, pull-off) would be the objective, quantitative measurements derived from the tests themselves, as compared against established engineering standards and performance of legally marketed predicate devices. It is based on objective physical properties and not on expert consensus, pathology, or outcomes data in the context of this specific 510(k) submission for mechanical properties.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. The described study is a mechanical performance evaluation of an orthopedic implant, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided in the document, as there is no training set mentioned.
§ 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.