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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 and Grit-Blasted stems are intended for cementless use only.

The b-ONE® Total Hip System KOSMO™ Stainless Steel stems are intended for cemented use only.

The b-ONE® Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.

b-ONE® Total Hip System components are not intended for use with other total hip systems.

b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The b-ONE KOSMO Femoral Stems Sizes are offered in 12 femoral stem sizes ranging from size 0 to 10 with half size of 4.5 for Cementless Collared Standard, High, and Proportional Offset families and 11 femoral stem sizes ranging from size 1 to 10 with half size of 4.5 for Cementless Collarless/Collared Coxa Vara families and Cemented Standard and Proportional Offset families.

The subject stems are laser marked with the catalog number, company logo, size, and material. The KOSMO Femoral Stem is composed of titanium alloy Ti-6A1-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stems. The cementless stems are offered as either HA coated or Grit-blasted.

The b-ONE Cement Restrictor is made from UHMWPE (ASTM F648/ISO 5834-1). The restrictor is offered in 7 different sizes with a major diameter of 9, 11, 13, 15, 17, 20, and 23mm and have a total length of 17mm. The cement restrictor is to be used for cement implantation. This b-One Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the b-ONE® Total Hip System, which primarily discusses the substantial equivalence of the subject device to legally marketed predicate devices.

The content focuses on:

• The FDA's decision regarding the 510(k) submission (K240528).
• Regulatory information, classifications, and requirements for the device.
• Indications for Use for the b-ONE® Total Hip System.
• A comparison of technological characteristics with predicate devices.
• A list of non-clinical performance tests conducted, but not the acceptance criteria for these tests, nor the detailed results proving they were met.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or describe the study details (sample size, ground truth, expert qualifications, adjudication, MRMC, or standalone performance) because that information is not present in the provided text.

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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 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 MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial tray, 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. This submission is to add a Stemmed Baseplate with modular Stem Extension options. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies. The b-ONE MOBIO Total Knee System Stemmed Tibial Baseplates are manufactured from forged titanium alloy. The baseplates are offered in 9 sizes with medial lateral dimensional range from 58-85mm and anterior posterior dimensional range from 58-85mm and anterior posterior dimensional range from 38-59mm. The baseplate is intended for cemented fixation. The Stemmed Baseplates mate with stem extensions through a threaded junction. The Tibial Stems are manufactured from forged titanium alloy. The Tibial Stems are offered in 3 diameters (12, 14, and 16mm) with various lengths ranging from 20-120mm. The stems are intended for cemented fixation. All system components are supplied sterile and are single use devices.

The provided text describes a 510(k) premarket notification for a medical device, the MOBIO Total Knee System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or reporting results from a study proving the device meets those criteria in the way one might expect for an AI algorithm or a diagnostic tool.

The "acceptance criteria" in this context refer to the requirements for demonstrating substantial equivalence for a new or modified medical device. The "study" proving the device meets these criteria is the collection of non-clinical tests and comparisons presented in the 510(k) submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't present a table with explicit "acceptance criteria" and "reported device performance" in the quantitative sense typical for a diagnostic or AI device. Instead, the acceptance criteria are implicitly met by demonstrating that the new device's performance, materials, and design are substantially equivalent to those of legally marketed predicate devices.

The "reported device performance" is essentially that the MOBIO Total Knee System is as safe and effective as the predicate devices based on the non-clinical tests performed.

2. Sample Size Used for the Test Set and the Data Provenance

For a medical implant like a total knee system, studies are typically non-clinical (bench testing, mechanical testing) rather than involving patient test data sets in the way an AI algorithm would.

• Sample Size: Not explicitly stated in terms of "test set" size. The "samples" would be the individual components or assemblies tested for fatigue, torque, etc. The document does not specify the number of units tested for each non-clinical study.
• Data Provenance: The studies are non-clinical (bench testing), so there's no patient data involved in this 510(k) summary. These tests would have been conducted in a laboratory setting by the manufacturer or a contract research organization.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable in the context of this 510(k) submission.

• Ground Truth for Non-Clinical Tests: For mechanical and material tests, the "ground truth" is established by adherence to recognized standards (e.g., ISO, ASTM) and engineering principles, not by expert consensus on clinical images or diagnoses. The "experts" would be the engineers and scientists performing and interpreting these tests.
• The document implies that the internal experts of b-ONE ORTHO, Corp. and potentially external labs were involved in conducting and evaluating these non-clinical tests, following established regulatory and scientific guidelines.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies, not for non-clinical mechanical testing of medical 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 question is not applicable. This 510(k) is for a total knee replacement system, which is a physical implant, not an AI-assisted diagnostic tool or an imaging modality. There are no "human readers" or "AI assistance" involved in its direct function.

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

This question is not applicable. The MOBIO Total Knee System is a physical medical device (an implant), not an algorithm.

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

As this is a non-clinical 510(k) submission for a physical implant, the "ground truth" for the performance studies refers to:

• Adherence to validated test methods and standards: For example, fatigue testing would be evaluated against established standards for implant longevity.
• Material specifications: Conformance to established material properties for the titanium alloy.
• Design specifications: Proof that the device meets its design intent, often through dimensional verification and mechanical simulation/testing.
• Biocompatibility standards: Compliance with ISO 10993 series for biological evaluation of medical devices.

8. The sample size for the training set

This question is not applicable. As this device is a physical implant and not an AI algorithm, there is no "training set" in the machine learning sense. The "training" for such a device comes from engineering design, material science, and prior knowledge from predicate devices.

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

This question is not applicable, as there is no "training set" for this type of medical device submission.

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The 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 the PS and PS+:

• Ligamentous instability requiring implant bearing surface geometries with increased constraint
• Absent or nonfunctioning posterior cruciate ligament
• Severe anteroposterior instability of the knee joint

The MOBIO Total Knee System is intended for implantation with bone cement only.

MOBIO Total Knee System components are not intended for use with other knee systems.

The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial tray, 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 purpose of this submission is to introduce a line extension to the b-ONE™ MOBIO™ Total Knee System CR/CR PLUS Tibial Insert components and PS/PS PLUS Tibial Insert Components. Compatibility with the b-ONE™ MOBIO™ Total Knee System tibial baseplate and femoral components remains the same. There is no allowed interchangeability with systems manufactured by other companies.

The subject b-ONE™ MOBIO™ Tibial Inserts are made from UHMWPE GUR® 1020-E Crosslinked with .1% tocopherol and conventional UHMWPE GUR® 1020. This material is the same as that used in the reference and predicate devices. The pre-assembled locking wire is the same locking wire used in the existing Tibial Inserts and is manufactured from Cobalt Chrome conforming to ASTM F90.

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

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "MOBIO Total Knee System." It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to previously cleared devices.

However, the document does not contain any information regarding the acceptance criteria or a study that proves the device meets specific performance criteria in terms of an AI/algorithm's performance. This device is a total knee replacement system, which is a physical implant, not an AI or algorithm-based diagnostic or assistive technology. Therefore, the questions posed in the prompt regarding acceptance criteria for AI performance, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, or training sets are not applicable to the content of this document.

The "Performance Data" section lists non-clinical studies such as "Locking Mechanism Strength," "Range of Constraint," "Contact Area and Contact Stress," "Tibiofemoral Range of Motion," "Characterization of UHMWPE Insert Material," "Bacterial Endotoxin Testing," "Shelf Life Studies," "Biocompatibility," and "Wear Testing." These are all tests related to the physical and material properties of the knee implant, not the performance of an AI or algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided document pertains to a physical medical device (knee implant) and not an AI/algorithm.

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The OneFix Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor Cuff Repair, Bankart Repair, BLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The OneFix Biocomposite Small Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot. ankle, knee, hand, wrist, elbow, shoulder, and hip. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral repair

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OneFix All Suture Anchor may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In con junction with appropriate postoperative immobilization throughout the suture anchor systems stabilize the damaged soft tissue.

The OneFix Biocomposite Interference Screws are indicated for fixation of bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

The OneFix Cannula System is introduction of instrumentation through a portal for surgical procedure.

The OneFix Biocomposite Anchors consist of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 96 model codes over 4 families. The anchors widths range from 3.0mm through 6.5mm and lengths of 11.9mm through 16.8mm.

The OneFix Biocomposite Small Anchors consist of cannulated anchors with an eyelet. They are preloaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 9 model codes corresponding to variations of sutures with anchor dimensions (11.9mm x 2.4mm x 3.0mm).

The OneFix All Suture Anchors consist of one "fixed suture" and 2 or 3 non-absorbable sutures. The non-absorbable suture is manufactured from UHMWPE and PET fibers. The OneFix All Suture Anchor is implanted using its self-punching option and are pre-loaded on a handled insertion device. They come in 14 various model codes.

The OneFix Biocomposite Interference Screws are inserted into the bone tissue and the external thread is screw shaped and the inside of the screw is start shaped. The screws are manufactured from PLGA copolymer and ß-TCP. There are 36 model codes with outside diameter ranging from 7-12mm and 20-35mm lengths.

The OneFix Cannula Systems is intended to puncture through tissue to make a pathway for surgical instruments during surgery. It consists of a cannula and a trocar made of polycarbonate. There are 3 types of this product: threaded, smooth and all smooth and comes in 72 model codes with inside diameter of 4.3mm through 8.1mm and lengths of 84mm through 130mm.

All implant components are provided sterile and are designated as single use. The system also includes the reusable surgical instruments required for implantation.

The provided document is a 510(k) summary for medical devices, specifically orthopedic bone fixation appliances. It does not contain information about acceptance criteria for a study, nor does it describe a study that proves a device meets acceptance criteria in the way typically associated with AI/ML-driven devices (e.g., performance metrics like sensitivity, specificity, or reader studies).

This document is for a traditional medical device (anchors, screws, and cannulas) used in orthopedic surgery. The "study" referenced here is the comparison to predicate devices to demonstrate substantial equivalence, which is a regulatory pathway for market clearance for certain types of medical devices.

Therefore, many of the requested categories in your prompt are not applicable to the content of this FDA 510(k) summary for a physical orthopedic device.

Here's an explanation based on the provided text and why certain sections of your request cannot be fulfilled:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not provided. This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on setting and meeting specific performance acceptance criteria from a clinical trial or algorithm test for a new technology like AI/ML. The "performance" described is in terms of material properties, design features, and intended use being similar to predicates.

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

• Not applicable / Not provided. There is no "test set" in the context of an AI/ML algorithm or clinical study described. The "test" in a 510(k) often refers to bench testing (e.g., mechanical strength) which is not detailed in this 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)

• Not applicable / Not provided. No ground truth establishment for a diagnostic or prognostic task is mentioned.

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

• Not applicable / Not provided.

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

• Not applicable / Not provided. This device is a physical surgical implant/tool, not an AI-based diagnostic or assistive device.

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

• Not applicable / Not provided. The device is not an algorithm.

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

• Not applicable / Not provided.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" as this is not an AI/ML device.

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

• Not applicable / Not provided. There is no "training set."

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" in a 510(k) context for a traditional device largely revolve around demonstrating substantial equivalence to predicate devices. This is achieved by comparing technological characteristics, intended use, and materials.

The "study" or evidence provided to meet this "acceptance criteria" (substantial equivalence) is a qualitative comparison of the new device (OneFix product line) to several predicate devices.

Comparison of Technological Characteristics (as described in the document):

The document explicitly states:
"The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The OneFix Biocomposite/All Suture Anchors and Interference Screws and Cannula Systems and the predicate devices share the following characteristics:

• Materials of construction
• Manufacturing processes
• Sizes offered
• Product design for shape and macrostructures
• Sterilization methods"

Predicate Devices Used for Comparison:

The devices for which substantial equivalence is claimed are:

• Fixone Biocomposite Anchors; K192484
• Fixone Biocomposite Small Anchors; K192032
• Fixone All Suture Anchors; K192709
• Fixone Interference Screws; K193497
• JOINIX Cannula System; K162070

In conclusion, this document demonstrates that the OneFix product line is substantially equivalent to already cleared predicate devices based on a comparison of their intended use, technological characteristics (materials, manufacturing, size, design, sterilization), and performance (implied to be similar because of the equivalence in characteristics and materials). No specific quantitative performance metrics or studies in the context of AI/ML are presented.

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The 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 standard fracture- management techniques

Additional Indications for the Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+):

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint
• · Absent or nonfunctioning posterior cruciate ligament
• · Severe anteroposterior instability of the knee joint

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

The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial trav, 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. This submission is to add a condylar stabilizing (CR+) Tibial Insert device type to the system. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies.

The CR PLUS Tibial Inserts are offered in a total of 50 sizes, size A/1-3 through HJ/8-10, with 10 thicknesses ranging from 9 to 25mm. 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.

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

Acceptance Criteria and Study Proving Device Meets Criteria: MOBIO Total Knee System (K210483)

Based on the provided FDA 510(k) summary, the device in question is a Total Knee System, not an AI/software medical device. Therefore, the traditional acceptance criteria and study design for AI/software (e.g., MRMC studies, ground truth establishment for images, training/test sets) do not apply to this submission.

The FDA 510(k) process for a physical medical device like a knee replacement focuses on substantial equivalence to a previously cleared predicate device. This is demonstrated through a comparison of technological characteristics and performance data from non-clinical studies (bench testing) rather than clinical studies with human subjects or AI model validation.

Here's a breakdown of the acceptance criteria and study information as it pertains to this orthopedic implant:

1. Table of Acceptance Criteria and Reported Device Performance

For an orthopedic implant seeking 510(k) clearance, the "acceptance criteria" are generally met by demonstrating that the new device's performance is equivalent to, or better than, the predicate device across relevant performance metrics. These metrics are often derived from recognized consensus standards and ensure the device is safe and effective for its intended use.

Note: The FDA 510(k) summary typically lists the types of studies performed, but the detailed results and specific numerical acceptance thresholds are part of the full submission, not the public summary. The "Reported Device Performance" here refers to the fact that supporting data was submitted and found acceptable by the FDA to demonstrate equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of human "test sets" as this is a non-clinical (bench) study for a physical device. The "sample size" would refer to the number of devices or components tested for each specific non-clinical study (e.g., how many locking mechanisms were tested for strength). This specific number is not provided in the 510(k) summary.
• Data Provenance: The data is generated from bench testing in a laboratory setting, not from human subjects or clinical data in a specific country. The studies are typically conducted by the manufacturer or a contract research organization following recognized standards (e.g., ISO, ASTM).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This concept is not applicable to a physical medical device bench study. "Ground truth" in this context is established by:

• Engineering specifications and design requirements.
• International and national consensus standards (e.g., ISO 21536 for Knee joint prostheses, ASTM standards for material testing).
• Validated test methods and equipment.

The "experts" involved would be qualified engineers, material scientists, and biomechanical experts who design the device, perform the tests, and interpret the data against established engineering principles and standards. Their qualifications are inherent in their professional roles and adherence to Good Manufacturing Practices (GMP) and quality system regulations (21 CFR 820).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for consensus in subjective human assessments, often in image interpretation. For a physical device, testing involves objective measurements (e.g., force, stress, range of motion) performed according to validated protocols, not subjective interpretation. Any outliers or discrepancies in test results would be investigated through root cause analysis, not adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. MRMC studies are used to assess the impact of AI algorithms on human reader performance, typically in diagnostic imaging. This 510(k) is for a physical orthopedic implant. Clinical studies, if performed, would typically be for PMA (Premarket Approval) applications or for higher-risk devices, not typically for 510(k) clearances that rely on substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is for a physical knee implant, not a software algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for performance is defined by:

• Engineering Specifications: The design parameters and expected performance characteristics set by the manufacturer.
• Consensus Standards: Performance criteria defined by recognized standards organizations (e.g., ISO, ASTM) for mechanical properties, material properties, wear, and biocompatibility of orthopedic implants.
• Predicate Device Performance: The demonstrated safe and effective performance of the legally marketed predicate device (MOBIO Total Knee System; K202429, and reference devices K063423, K071071, K180446). The new device must meet or exceed these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train an AI algorithm. For a physical device, the equivalent would be the R&D and design verification process, where prototypes are developed and tested, and design iterations are guided by engineering principles and previous test results. There isn't a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As explained above, "ground truth" for a physical device is established through engineering design, recognized standards, and performance of predicate devices. There is no AI model "training" in this context.

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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 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 standard fracture- management techniques

Additional Indications for the Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+):

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint
• · Absent or nonfunctioning posterior cruciate ligament
• · Severe anteroposterior instability of the knee joint

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

The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial trav, 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. This submission is to add a cruciate retaining (CR) device type to the system, including the CR femoral component and corresponding CR Tibial inserts. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies.

The MOBIO Total Knee System includes left and right femoral components for the Cruciate Retaining (CR) system. These components are manufactured from cast cobalt chrome conforming to ASTM F75. 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. Fixed femoral pegs on the femoral components provide additional medio-lateral fixation.

The CR Tibial Inserts are offered in a total of 50 sizes, size A/1-4 through HJ/7-10, with 10 thicknesses ranging from 9 to 25mm (total thickness with Tibial Baseplate is 9 to 25mm). 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.

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

The provided text is a 510(k) premarket notification for the MOBIO Total Knee System. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria or reporting on the performance of an AI/ML powered medical device.

Therefore, the information required to answer your questions about acceptance criteria for an AI/ML device and its study is not present in the provided text. The document describes a traditional medical device (knee replacement system) and addresses its physical properties, materials, manufacturing, and intended use, comparing them to existing devices.

The "Performance Data" section in the document refers to non-clinical studies for the physical knee replacement components (e.g., locking mechanism strength, contact stress, range of motion, material characterization, biocompatibility, shelf life, bacterial endotoxin testing). These are for the mechanical device itself, not for an AI/ML algorithm's performance.

To answer your request, I would need a document detailing the performance evaluation of an AI/ML medical device, which would typically involve clinical validation studies, metrics like sensitivity, specificity, AUC, and details on ground truth establishment and expert adjudication.

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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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