(268 days)
The Anato™ Hip Stem is a sterile, single-use device intended for use in primary and revision total and hemi-hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' V40™ femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40130 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40™ CoCr Heads, V40™ LFITM CoCr Heads, C-Taper Alumina Heads when used with the V40TM /C-taper Adapter, 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 for total hip arthroplasty include:
- noninflammatory degenerative joint disease, including osteoarthritis . and avascular necrosis;
- rheumatoid arthritis; .
- correction of functional deformity; .
- revision procedures where other treatments or devices have failed; and, ●
- nonunions, femoral neck fractures, and trochanteric fractures of the . proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Anato™ Hip Stem with compatible Howmedica Osteonics Constrained Liners:
- When the stem is to be used with compatible Howmedica Osteonics . Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
The Anato™ Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.
Howmedica Osteonics is introducing a monolithic, non-porous coated femoral hip prosthesis, which is intended for cementless, press-fit application. The basic design of the Anato™ Hip Stem is similar to two other commerically distributed total hip systems, which are Howmedica Osteonics' ABG® II Monolithic and Accolade® II Hip Stems.
The Anato™ and the Accolade® II stem are both made from the same material combinations. The subject device is similar in design to the ABG® II Monolithic stem as they are both anatomic stems with a 130 degree neck angle. There are normalization patterns (scales) on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission. Based on 3-Dimensional simulations, these normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.
The subject stem is manufactured from titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium coating, and PureFix® hydroxylapatite (HA) coating identical to the previously cleared Accolade® II Hip Stem.
The Anato™ Hip Stem has a shot peened neck and will be available in 8 sizes ranging from size 1 through 8 with two different neck versions (neutral and anteverted). As the stem is anatomic, there will be a right and left component for each size. The stem is designed only for use with compatible Howmedica Osteonics' femoral heads and acetabular components.
Here's the breakdown of the acceptance criteria and the study information based on the provided text, categorized as you requested.
The provided document describes a 510(k) premarket notification for a hip stem, which primarily relies on substantial equivalence to predicate devices rather than independent clinical efficacy studies. Therefore, many of the typical elements of AI/software device evaluation (like ground truth, expert consensus, MRMC studies, training set details) are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | Identical material combinations to predicate device (Accolade® II Hip Stem). | Made from titanium (Ti-6Al-4V) alloy, CP titanium coating, and PureFix® hydroxylapatite (HA) coating, identical to the previously cleared Accolade® II Hip Stem. |
| Design Characteristics | Similar design to ABG® II Monolithic stem (anatomic, 130-degree neck angle, normalization patterns). | Similar in design to ABG® II Monolithic stem; anatomic stem with a 130-degree neck angle and normalization patterns for press-fit stability and load transmission. |
| Mechanical Performance | Pass distal stem fatigue testing per ISO 7206-4. | Met compliance. |
| Mechanical Performance | Pass neck fatigue testing per ISO 7206-6. | Met compliance. |
| Intended Use | Consistent with predicate devices. | Alleviate pain and restore function in primary and revision total/hemi-hip arthroplasty; consistent with predicate indications. |
| Substantial Equivalence | Demonstrably equivalent in intended use, materials, and performance characteristics to predicate devices. | Device comparison and mechanical testing showed substantial equivalence to predicate devices (ABG® II Monolithic Hip Stem K110807, Accolade® II Hip Stem K103479, K120578). |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The evaluation was based on non-clinical testing (mechanical fatigue) and comparison to predicate devices, not on a "test set" of clinical data.
- Data Provenance: Not applicable for clinical data. For non-clinical testing, it would refer to the testing facilities and methods as described by ISO standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device relies on mechanical testing standards and comparison to predicate devices, not on expert consensus or ground truth derived from expert review of individual cases. Decisions on substantial equivalence are made by regulatory bodies based on submitted documentation.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" in the sense of clinical cases requiring adjudication. Mechanical test results are objective measurements against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This is a medical device (hip stem), not an AI or imaging diagnostic tool that would typically involve human readers.
- Effect size of human readers with/without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a physical hip stem, not an algorithm or software. Its performance is evaluated through mechanical testing and material properties.
7. Type of Ground Truth Used
- Mechanical Testing Standards and Predicate Device Performance Data: Performance was established against recognized international standards (ISO 7206-4 and ISO 7206-6) for mechanical fatigue, and by demonstrating identical material compositions and similar design characteristics to legally marketed predicate devices. The "ground truth" for substantial equivalence is the proven safety and effectiveness of the predicates and compliance with relevant engineering standards.
8. Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI model that requires a training set.
9. How Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth for it.
§ 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.