(21 days)
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' BG trunnion.
Indications:
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur ● with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. ●
The existing Accolade™ TMZF® HA Hip System features femoral stems in neutral, press-fit versions consisting of a variety of lengths and two neck angles, 132° and 127°. The subject Accolade™ TMZF® Plus HA 127° Size 0 Hip Stem is an addition to the existing hip stems. It features a 127° neck angle and will be offered in an additional size (size 0). The Accolade™ TMZF® Plus HA Size 0 Hip Stem is intended for smaller size patient populations. The subject hip stem, like the predicate hip stems, is manufactured using TMZF® alloy and is also coated with a CP Titanium plasma spray coating and PureFix™ HA.
The provided text describes a Special 510(k) Premarket Notification for a hip stem, which is a physical medical device. It does not contain information about an AI/ML powered medical device, therefore, many of the typical acceptance criteria and study details relevant to AI/ML devices (like sensitivity, specificity, human reader performance, training set details, etc.) are not applicable.
However, I can extract the relevant information regarding the device's performance based on the provided text.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Proper strength requirements | "Testing demonstrated that this hip stem component successfully maintains the proper strength requirements." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or patient samples. The testing mentioned refers to mechanical or physical performance testing of the hip stem component itself. Therefore, sample size and data provenance are not applicable in the way they would be for an AI/ML device or a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for a physical device like a hip stem would be its measurable physical properties (e.g., strength, material composition) as determined by engineering and material science standards, not clinical expert consensus in the typical sense.
4. Adjudication Method for the Test Set
Not applicable, as the testing was for mechanical properties, not clinical assessment requiring 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 device is a physical hip stem, not an AI-powered system designed to assist human readers.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical hip stem, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device's performance would be engineering and material science standards for "proper strength requirements." This would involve objective measurements against predefined specifications.
8. The Sample Size for the Training Set
Not applicable. This refers to the development of a physical product, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This refers to the development of a physical product, not a machine learning model.
Summary of the Study:
The document briefly mentions a "Testing Summary" stating: "Testing was employed to evaluate the Accolade™ TMZF® Plus HA Size 0 Hip Stem component. Testing demonstrated that this hip stem component successfully maintains the proper strength requirements."
This indicates that mechanical and/or material testing was conducted to ensure the hip stem met predetermined strength specifications. The nature of these tests (e.g., fatigue testing, static load testing) and the specific standards applied are not detailed in the provided text. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, and the testing summary is provided to support that conclusion regarding the new size/variation of the hip stem.
§ 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.