(304 days)
The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions:
Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis and congenital dysplasia: treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip.
The b-ONE® Total Hip System is intended for cementless use only.
b-ONE® Total Hip System components are not intended for use with other total hip systems.
The b-ONE® Total Hip System is an artificial hip replacement system comprised of femoral stems and mating femoral heads; acetabular shells and mating acetabular liners; and, optional 6.5mm acetabular screws. Acetabular Shell options include no-hole and multiple hole configurations.
The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. Compatibility of the femoral head to the stem is only claimed for the b-ONE® Total Hip System. There is no allowed interchangeability with systems manufactured by other companies.
The Tapered Wedge Stem, Acetabular Shells, and Acetabular Bone Screws are made from Ti-6AI-4V-ELI. Stem and shell coatings include CPTi Plasma Porous Spray with or without HA. Femoral heads are made from CoCr or Ceram Tec Biolox® delta. Acetabular Shell Liners are made from conventional UHMWPE and UHMWPE with Vitamin E.
All system components are supplied sterile and are single use devices.
This FDA 510(k) summary describes the b-ONE® Total Hip System, a total hip replacement device. It does not contain information about a study based on AI/ML. There is no mention of acceptance criteria or details of a study proving the device meets said criteria in the context of AI/ML performance.
The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through bench testing and comparison of technological characteristics.
Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document. I cannot fill in the table or provide answers to the specific questions as they relate to AI/ML performance.
However, I can extract the information provided about the device's performance testing for its substantial equivalence claim, which is based on traditional engineering and biocompatibility testing:
Device Performance Information from the Provided Document (Not AI/ML related):
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the way one might expect for an AI/ML product (e.g., sensitivity, specificity, AUC). Instead, it lists various non-clinical performance tests conducted to demonstrate the device's safety and effectiveness compared to predicate devices. The implicit "acceptance criterion" for each test is that the b-ONE® Total Hip System performs comparably to or within acceptable limits for a device of its kind, thereby not raising new questions of safety or effectiveness relative to the predicates. The "reported device performance" is the successful completion of these tests.
| Test Category | Specific Test | Implied Performance/Outcome |
|---|---|---|
| Mechanical/Biological Performance | Endurance and Performance | Demonstrated acceptable mechanical endurance and overall performance. |
| Sustained Endurance | Demonstrated acceptable sustained endurance. | |
| Burst Test | Demonstrated acceptable resistance to bursting forces. | |
| Fatigue Test | Demonstrated acceptable resistance to fatigue. | |
| Post Fatigue Burst Test | Demonstrated acceptable resistance to bursting after fatigue. | |
| Axial Pull-off | Demonstrated acceptable resistance to axial pull-off forces. | |
| Rotational Stability | Demonstrated acceptable rotational stability. | |
| Acetabular liner/shell disassembly | Demonstrated acceptable resistance to disassembly. | |
| Impingement Test | Demonstrated acceptable performance under impingement conditions. | |
| Range of Motion Studies | Demonstrated acceptable range of motion. | |
| Accelerated Wear | Demonstrated acceptable wear characteristics. | |
| Torsional Strength | Demonstrated acceptable torsional strength. | |
| Axial Pull-out | Demonstrated acceptable resistance to axial pull-out. | |
| Bacterial Endotoxin Testing | Demonstrated acceptable endotoxin levels (biocompatibility). | |
| Shelf Life Studies | Demonstrated acceptable shelf life. | |
| Biocompatibility | Demonstrated acceptable biocompatibility. | |
| Characterization of Vitamin E | Vitamin E material characterized (for UHMWPE with Vitamin E liners). | |
| Characterization of Conventional Polyethylene Liner Material | Conventional polyethylene liner material characterized. | |
| Coating Characterization Study | Coatings (CPTi Plasma Porous Spray, HA) characterized. |
2. Sample Size for the Test Set and Data Provenance:
Not applicable. The tests listed are non-clinical, bench-top tests, and material characterization studies, not studies involving patient data or AI/ML test sets.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This information is relevant for AI/ML performance evaluation based on expert-labeled data, which is not described in this document.
4. Adjudication Method:
Not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for the type of bench testing described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. An MRMC study is not mentioned as this document describes a traditional medical device (hip implant), not an AI/ML device or software for interpretation.
6. Standalone (Algorithm Only) Performance:
Not applicable. There is no algorithm or software component mentioned that would have standalone performance.
7. Type of Ground Truth Used:
For the mechanical and material tests, the "ground truth" is defined by established industry standards (e.g., ASTM, ISO guidelines) and regulatory requirements for orthopedic implants, ensuring the device meets specific physical and chemical properties and performs as intended under simulated physiological conditions. Biocompatibility is assessed against recognized standards.
8. Sample Size for the Training Set:
Not applicable. There is no AI/ML training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no AI/ML training set.
In summary, the provided document is a 510(k) summary for a physical medical device (an orthopedic implant) and does not describe an AI/ML-driven device or study. Therefore, most of the questions related to AI/ML acceptance criteria and study design are not relevant to this content.
§ 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.