(90 days)
The ABG™ II Modular Hip Stem is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available compatible Howmedica Osteonics' acetabular components. Compatibility with the modular stems includes: V40 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40 CoCr Heads, V40 LFIT CoCr Heads, C-Taper Alumina Heads when used with the V40/C-taper Adaptor, C-Taper Delta Heads when used with C-taper Adaptor, UHR Universal Head, Unitrax Heads when used with the Unitrax V40 Modular Adapter.
The indications for use of total hip replacement prostheses include:
- Noninflammatory degenerative ioint disease including osteoarthritis and avascular 1) necrosis;
- Rheumatoid arthritis; 2)
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- Correction of functional deformity:
- Revision procedures where other treatments or devices have failed; and, 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur 5) with head involvement that is unmanageable using other techniques.
Stryker's ABGTM II Modular Hip Stem is intended for cementless use only.
Howmedica Osteonics is introducing a modular hip prosthesis. The basic design of the ABG™ II Modular Hip Stem, referred as the ABG™ II Modular, is similar to other total hip systems commercially distributed such as the Stryker Modular Hip System.
The subject hip stem is composed of a modular stem with a modular neck intended for cementless, press-fit application. It is designed for use with the currently available compatible Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.
This 510(k) summary describes a premarket notification for a hip prosthesis, not an AI/ML medical device. Therefore, many of the requested categories related to performance studies for AI/ML devices (e.g., sample size for training, ground truth establishment, MRMC studies, standalone performance) are not applicable.
The submission focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, operational principles, and mechanical testing.
Here's an analysis of the provided text in relation to your request, highlighting the applicable information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of quantitative performance metrics for a diagnostic or AI device. Instead, the main "acceptance criteria" for this hip stem are demonstrating substantial equivalence to predicate devices. The performance is assessed through mechanical testing.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (intended use, design materials, operational principles) | "The ABG™ II Modular Hip Stem...is substantially equivalent to other commercially available hip stems in regard to intended use, design materials and operational principles as a hip prosthesis." |
| Mechanical Performance Equivalent to Predicate Devices | "Based upon the mechanical testing the ABG™ II Modular Hip Stem is substantially equivalent for its intended use to other press-fit femoral replacement hip stems currently on the market." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as this is a mechanical device submission, not a study involving human data or AI algorithms. Mechanical testing usually involves a set number of physical prototypes or simulated models, but the specific "sample size" for these mechanical tests is not detailed in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic or image analysis AI/ML devices. For a hip prosthesis, the "ground truth" relates to its material properties and mechanical integrity, which are evaluated through standardized engineering tests, not expert interpretation of human data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for AI/ML devices.
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 is not applicable. MRMC studies are specific to evaluating diagnostic AI/ML tools used by human readers. This submission is for a physical medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. "Standalone performance" refers to the performance of an AI algorithm without human interaction. This document describes a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the concept of "ground truth" as typically applied to AI/ML studies is not applicable here. The "truth" for this device is its adherence to mechanical performance standards and material specifications, which are verified through engineering tests and comparison to predicate devices.
8. The sample size for the training set
This is not applicable. There is no AI model or "training set" described in this submission.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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.