(192 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 rheumatoid 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 KOSMO™ HA coated stems are intended for cementless use only. The b-ONETM Total Hip System KOSMOTM stainless steel stems are intended for cemented use only.
b-ONETM 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; optional acetabular bone screws. 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.
This 510(k) premarket notification is being submitted as a line extension to the current b-ONE Total Hip System by adding a bone compacting Femoral Stem component. The KOSMO™ Femoral Stem is compatible with the b-ONE™ Primary Acetabular components. The KOSMO™ Cementless Femoral Stem components are compatible with the b-ONE™ 12/14 Taper CoCr or Ceramic Femoral Heads. The KOSMO™ Cemented Femoral Stem components are compatible with the b-ONE™ 12/14 Taper Ceramic Femoral Heads only.
b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The KOSMO Femoral Stem is composed of HA coated titanium alloy Ti-6Al-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stem. All system components are supplied sterile and are single use devices.
This is a 510(k) premarket notification for a medical device (KOSMO Femoral Stem, a hip joint prosthesis), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth for an AI/ML model is not applicable.
The provided text describes a submission for a traditional medical device and focuses on establishing substantial equivalence to legally marketed predicate devices through material properties, design features, manufacturing processes, sterilization methods, and bench performance testing.
However, to directly answer your request based only on the provided text, and assuming the question is about the acceptance criteria and supporting studies for the medical device itself (not an AI/ML component lacking in this document), here is what can be inferred:
Acceptance Criteria and Study Information for the KOSMO Femoral Stem (Medical Device)
The document does not explicitly state quantitative "acceptance criteria" in the format one might expect for an AI/ML performance study (e.g., minimum sensitivity, specificity, or AUC). Instead, for this traditional medical device, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices through various non-clinical studies. The "performance" being assessed is the physical and mechanical integrity and biological compatibility of the implant.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implicit) | Reported Device Performance (as demonstrated by studies) |
|---|---|
| Substantial Equivalence to Predicate Devices | Demonstrated through comparison of materials, design, manufacturing, sizes, coatings, and sterilization methods. |
| Mechanical Strength and Durability | Endurance and Performance testing conducted. (Specific values not provided in this summary, but presumed to meet standards for hip stems). |
| Biocompatibility | Biocompatibility testing conducted. (Presumed to meet ISO 10993 or equivalent standards for implantable devices). |
| Range of Motion | Range of Motion Study conducted. (Presumed to demonstrate functionality comparable to predicate devices). |
| Impingement | Impingement Testing conducted. (Presumed to demonstrate acceptable mechanical interaction within the joint). |
| Sterility & Safety | Bacterial Endotoxin Testing conducted. (Presumed to meet limits for sterile implants). |
| Shelf Life | Shelf Life Studies conducted. (Presumed to demonstrate stability over the intended storage period). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in this 510(k) summary. For bench testing of medical devices, sample sizes are typically determined by relevant ISO standards (e.g., ISO 7206 for hip implants) but are not detailed in this high-level summary.
- Data Provenance: The studies are "Non-Clinical Studies," meaning they are bench tests (mechanical, chemical, biological) performed in a lab setting, not on human patients. Therefore, country of origin of data or retrospective/prospective clinical data are not applicable here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable as this is not an AI/ML application or a clinical study requiring expert ground truth for interpretation of complex clinical data. The "ground truth" for a mechanical device is based on engineering specifications, material science, and established test methods.
4. Adjudication Method for the Test Set
- Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for bench testing of a traditional medical device.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Not applicable. MRMC studies are used to assess the impact of an AI algorithm on human reader performance, which is not relevant for this traditional medical device.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This is for an AI/ML algorithm. This device is a physical implant. The "standalone performance" refers to its mechanical and material properties as assessed by bench tests. The summary indicates that "Performance Testing - Bench" was done.
7. Type of Ground Truth Used
- For the non-clinical studies mentioned (Endurance, Impingement, Biocompatibility, etc.), the "ground truth" is derived from:
- Engineering Specifications: Design tolerances, material properties, and mechanical performance requirements derived from national and international standards (e.g., ISO, ASTM) for hip implants.
- Pre-defined Pass/Fail Criteria: Established by industry standards and regulatory expectations for the safety and effectiveness of such devices.
8. Sample Size for the Training Set
- Not applicable. This refers to AI/ML model training data. For a traditional medical device, there is no "training set" in this context. Device design and manufacturing processes are refined through engineering, prototyping, and testing, but not in the sense of training an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the device's development and validation relies on established biomechanical principles, material science, regulatory standards for medical device safety and effectiveness, and comparisons to legally marketed predicate devices.
§ 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.