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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 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 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 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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