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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

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.

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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 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 and Acetabular Shells are made from Ti-6A1-4V-ELI. Stem and shell coatings include CPTi Plasma Porous Spray with or without HA. The subject devices are identical to the predicate devices, with the exception that there has been an additional supplier qualified for coatings.

All system components are supplied sterile and are single use devices.

This looks like a 510(k) clearance letter and summary for a medical device, specifically the b-ONE Total Hip System. The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered device.

The document describes the b-ONE Total Hip System, its intended use, and a comparison to a predicate device. It lists several non-clinical bench tests that were performed to support substantial equivalence, such as "Endurance and Performance," "Fatigue Test," "Accelerated Wear," and "Biocompatibility." These tests are typical for orthopedic implants and assess the physical and mechanical properties of the device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: These are not provided for performance related to an AI/ML component.
2. Sample size used for the test set and the data provenance: Not applicable as there's no AI/ML component described.
3. Number of experts used to establish the ground truth... and their qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance (algorithm only): Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document is about a traditional orthopedic implant, not an AI/ML-powered device.

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The b-ONE MOBIO Total Knee System is intended for total knee arthroplasty due to the following conditions:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis.

· Post-traumatic loss of knee joint configuration and function.

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Revision of previous unsuccessful knee replacement or other procedure.

· Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture- management techniques.

Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components:

· Ligamentous instability requiring implant bearing surface geometries with increased constraint.

• · Absent or nonfunctioning posterior cruciate ligament.
  · Severe anteroposterior instability of the knee joint.

The b-ONE MOBIO Total Knee System is intended for implantation with bone cement only. b-ONE MOBIO Total Knee System components are not intended for use with other knee systems.

The b-ONE™ MOBIO™ Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.

The purpose of this submission is to add a line extension to the existing system to offer the Tibial Inserts and Patella components in UHMWPE Crosslinked with 0.1% tocopherol.

All system components are supplied sterile and are single use devices.

This is a 510(k) Premarket Notification for a medical device (a total knee replacement system), not for a diagnostic AI/ML device. Therefore, the provided text does not contain the information requested regarding acceptance criteria, study design for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, or ground truth establishment for an AI/ML algorithm.

The document discusses a traditional 510(k) submission for a physical medical device (knee implant), focusing on its materials, design features, and manufacturing processes, and demonstrating substantial equivalence to a predicate device. The "Performance Data" section refers to non-clinical studies (material characterization, wear testing, biocompatibility) for the physical implant material, not the performance of an AI/ML algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI device meets the acceptance criteria from this document.

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The b-ONE Total Knee System is intended for total knee arthroplasty due to the following conditions:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis,

· Post-traumatic loss of knee joint configuration and function.

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Revision of previous unsuccessful knee replacement or other procedure.

• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture- management techniques.
  Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components:

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.

• · Absent or nonfunctioning posterior cruciate ligament.

• · Severe anteroposterior instability of the knee joint.

The b-ONE Total Knee System is intended for implantation with bone cement only. b-ONE Total Knee System components are not intended for use with other knee systems.

The b-ONE Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device type and includes two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.

The System includes left and right femoral components manufactured from cast cobalt chrome. The system includes 30 sizes. Sizes 1-10 are provided in right and left versions. Sizes 3-7 are provided in both standard and narrow configurations, with the narrow sizes having a relatively smaller aspect ratio of the medial-lateral to anterior-posterior widths when compared to the standard sizes. Optional modular distal pegs are included in the system.

The system includes a Patella Component offered in seven sizes of variable diameter and thicknesses. The bone fixation surface incorporates three fixation pegs. The Patella Components are made from Conventional UHMWPE.

The system includes Tibial Inserts which are offered in 40 sizes, size A/1-4 through HJ/7-10 with 8 thicknesses and 48 sizes for PS+ inserts, size A1-2+ through HJ/7-10+ with 8 thicknesses. The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.

The system includes Tibial Baseplates offered in 9 sizes ranging from A-J. Tibial Baseplates are manufactured from forged titanium alloy.

All system components are supplied sterile and are single use devices.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the b-ONE Total Knee System. This type of document is used to demonstrate that a new device is "substantially equivalent" to an existing, legally marketed device (predicate device) and therefore does not require a full Pre-Market Approval (PMA).

It is important to understand that a 510(k) summary for a prosthetic joint like a knee replacement does NOT involve clinical studies or "acceptance criteria" related to diagnostic performance as would be found in AI/ML medical devices.

Instead, the "acceptance criteria" for a knee replacement relate to the performance of the physical components (e.g., strength, fatigue life) and their biocompatibility, demonstrating that the new device functions as safely and effectively as the predicate devices. The "study that proves the device meets the acceptance criteria" refers to non-clinical (bench) tests of the device's materials, design, and mechanical properties.

Therefore, the requested information elements related to AI/ML device evaluations (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

Here's a breakdown of the applicable information based on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This is a physical medical device (knee implant), not a diagnostic algorithm. The "test sets" refer to individual device components or representative samples subjected to specific engineering tests, not patient data sets. The data provenance would be laboratory testing results.

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)

• Not Applicable. "Ground truth" in this context refers to established engineering standards, material specifications, and mechanical performance criteria, not expert consensus on medical images or diagnoses. These tests are conducted by engineers and technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are relevant for subjective interpretations of data, typically in clinical evaluations or AI/ML ground truth establishment. These are objective engineering tests.

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

• No. This is a physical knee implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a physical knee implant, not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for the non-clinical tests is based on established engineering standards, material specifications, mechanical performance criteria, and comparison to the predicate devices' known performance and specifications.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing processes are developed through engineering and materials science principles.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" for the device's design and manufacturing is established through adherence to recognized industry standards, regulatory requirements, and engineering principles.

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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.

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.

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