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The MedalOne Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;

• 2. inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. correction of functional deformity:

revision procedures where other treatments or devices have failed: and treatment of fractures 4) that are unmanageable using other techniques.

The MedalOne Total Knee System is for cemented use only.

The subject device, MedalOne Total Knee System, is intended for reduction or relief of pain and/or improved knee function. The subject device is a total knee replacement system composed of four different component types: MedalOne Femoral Component, MedalOne CS Tibial Insert, MedalOne Tibial Base and SoSuperior Patella.

The subject system is based on, and substantially equivalent to, the predicate EVOLUTION® MP Total Knee System in terms of size availability, geometry, nominal dimensions, manufacturing tolerances, overall device processing steps, and materials of construction. The articulation adheres to the same "Medial-Pivot" philosophy as the predicate device. The femoral components are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are offered in sizes 1-8 in left and right variants. The tibial inserts are made from standard UHMWPE conforming to ISO 5834-2 and are available in sizes 1-8 in standard and "extended" versions with thickness options of 10, 12, 14, 17, 20, and 24mm. The tibial bases are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are available in 8 standard sizes and 3 plus sizes to permit 1-up/1-down size interchangeability. The patellas are made from UHMWPE conforming to ISO 5834-2 and are offered in a tri-peg design in 4 sizes: 26, 29, 32, and 35mm. The system is intended to be used with bone cement for fixation.

The system also includes device-specific instrumentation to facilitate implantation of the subject devices. The instrument system includes new MedalOne instrumentation and is fully compatible with the predicate Evolution instrumentation.

This FDA 510(k) summary describes a new knee replacement system, the MedalOne Total Knee System, and compares it to a legally marketed predicate device. The document focuses on demonstrating substantial equivalence rather than presenting an acceptance criteria table with reported device performance against specific targets for a new AI/software device.

Here's an analysis based on the provided text, addressing your points where information is available:

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

The provided text does not contain a typical acceptance criteria table with specific performance metrics and reported values. This document is a 510(k) submission summary for a medical device (a knee replacement system), not an AI/software performance study. The "acceptance criteria" here are implicitly related to demonstrating "substantial equivalence" to a predicate device through various non-clinical tests.

Instead of a table of acceptance criteria and reported device performance in the context of an AI/software driven diagnostic, the document outlines the types of non-clinical tests performed to support the safety and effectiveness of the MedalOne Total Knee System. The "performance" is demonstrated by showing that these tests align with established standards (e.g., ISO, ASTM) and that the results are comparable to the predicate device.

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

This information is not applicable in the context of this document. The submission pertains to a physical knee implant, not a software or AI device that processes data. The "tests" mentioned are mechanical, materials, and biocompatibility evaluations of the physical components, not studies on a test set of data.

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)

This information is not applicable. Ground truth establishment by experts (like radiologists) is relevant for diagnostic AI/software, not for the physical and material testing of a knee implant.

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

This information is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth for diagnostic AI, neither of which is present in the context of this physical device's 510(k) summary.

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 information is not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human diagnostic performance. The document describes a physical knee implant, not an AI system.

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

This information is not applicable. This question assesses the standalone performance of an algorithm. The document is about a physical medical device, not an algorithm.

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

This information is not applicable in the sense of ground truth for a diagnostic AI system. For the physical device, "ground truth" implicitly refers to established biomechanical principles, material science standards (e.g., ISO 5832-4 for Cobalt Chrome alloy, ISO 5834-2 for UHMWPE), and biocompatibility guidelines (ISO 10993 series). The device's performance is compared against these engineering and biological standards and the performance of the predicate device.

8. The sample size for the training set

This information is not applicable. A training set is used for machine learning models. This document is for a physical medical implant.

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

This information is not applicable. As above, there is no training set mentioned or implied as this is not an AI/ML device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document's context):

The "study" in this context refers to the non-clinical testing performed and leveraged analyses to demonstrate substantial equivalence to the predicate device, the EVOLUTION® MP Total Knee System (K093552), and other reference devices.

• Acceptance Criteria (Implicit): The implicit acceptance criteria are that the MedalOne Total Knee System must perform as safely and effectively as the predicate device(s) and conform to relevant international standards for materials, biomechanics, and biocompatibility. The differences in technological characteristics should not raise new questions of safety and effectiveness.

• Reported Device Performance (Implicit): The non-clinical performance testing results demonstrate that the device is "as safe and effective and performs as well or better than the legally marketed predicate and reference devices." Specific numerical performance values are not given in this summary, but the types of tests performed are listed.

• Non-Clinical Tests Performed:

  • Tibial baseplate fatigue strength evaluation per ISO 14789-1:2000
  • MRI safety evaluation per ASTM F2182-19 and FDA guidance (including other ASTM standards like F2182-11a, F2181-11, F2052-15, F2213-17, F2119-07)
  • Biocompatibility testing per ISO 10993-1 (2018), ISO 10993-5 (2009), ISO 10993-10 (2014), ISO 10993-11 (2017), ISO/TS 21726 (2019), and FDA Guidance.
  • Endotoxin Testing

• Analyses Leveraged from Predicate Device (due to substantial equivalence):

  • Range of motion evaluation
  • Femorotibial and patellofemoral contact area and stability evaluation
  • Component lock detail evaluation
  • UHMWPE Material Property Characterization
  • Durability of the Patellofemoral Joint
  • UHMWPE Tibial Insert Endurance and Deformation Under High Flexion
  • Fatigue Strength of Knee Femoral Components

• Justification for Omissions: Justification was provided for not completing wear testing of the tibial bearing components.

• Clinical Data: No clinical data were provided, and the submitter stated they were "not necessary to support the substantial equivalence."

In essence, the "study" for this device involved a battery of engineering, materials, and biological tests to demonstrate that its physical properties and intended function are within acceptable limits defined by established standards and are equivalent to a device already cleared for market.

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The Evolution® Total Knee Systems can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for the following conditions:

• 1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• 2. inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. correction of functional deformity;

The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary Knee components or the Evolution® Stemmed CS Femur and Evolution® Revision Tibia Base.

The purpose of this submission is to seek clearance for the Evolution® Total Knematic Alignment Instrumentation and Technique. The instruments consist of resection and alignment guides, calipers, spacers, and trays that are used in conjunction with MicroPort's existing 510(k)-cleared knee instrumentation. The Kinematic Alignment technique is to duplicate the pre-arthritic native joint line. Unlike Mechanical Alignment where the focus is placed on making a perpendicular tibial resection, non-anatomic distal and posterior femoral cuts, and ligament releases if needed, Kinematic Alignment prioritizes the femoral cuts to replicate the native joint line. The Kinematic Alignment technique compensates for wear on the prearthritic joint line and strives for natural ligament tension.

The Evolution® Kinematic Alignment surgical technique is used with the following 510(k)-cleared knee components. No changes to the compatible Evolution® implants are being presented in this 510(k). The compatible implants are axactly the same as the previously cleared Evolution® implants.

• · Evolution® MP Total Knee System, K093552
• · Evolution® MP Total Knee System, K102380
• · Evolution® MP CS/CR Porous Femur, K140735
• · Evolution® Biofoam® Tibial Base and Evolution Biofoam Modular Keels, K152298
• · Evolution® Revision Tibia Base System, K162026
• · Evolution® Biofoam Tibial Base with Biofoam® Additive Manufacturing, K170288
• · Evolution® Stemmed CS Femur, K182125
• Evolution® NitrX™ Medial-Pivot Knee, K182251

The provided text is a 510(k) summary for the MicroPort Orthopedics Inc. "Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique." It outlines the regulatory clearance process for a new surgical technique and associated instrumentation, not an AI/ML-based medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study design for AI performance, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is not applicable to this document.

This document describes a medical device (surgical instrumentation for knee replacement) that falls under traditional medical device regulations, where clearance is typically based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through non-clinical testing and comparison of technological characteristics. There is no mention of software with AI/ML components requiring performance evaluation against specific metrics like sensitivity, specificity, or accuracy, nor is there any data related to how human readers improve with AI assistance.

The document explicitly states: "Not applicable. Clinical data were not necessary for the subject device." and "The nonclinical analyses and validations demonstrate that the device is as safe and effective and performs as well or better than the legally marketed predicate and reference devices." This confirms that the clearance was based on non-clinical engineering and design validation, not clinical performance studies involving outcome data or expert consensus for AI/ML performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt's questions are tailored for AI/ML medical devices, which this document does not describe.

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The EVOLUTION® Hinge Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Hinge Knee System implants are for cemented use only.

GUARDIAN™ Limb Salvage Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/ or total femur is required with the following conditions: 1) patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment; 2) surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications. 3) metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors)

The GUARDIANTM Limb Salvage Knee Components: Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions: 1) patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment: 2) surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications. 3) metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors)

The DCW Modular Distal Femoral System is primarily indicated for procedures in which a variable resection length prosthesis is necessary to accommodate the condition of the femur, e.g. bone loss/removal in disease-related knee arthroplasty or a distally fractured femur. It is also indicated for revious total knee replacement where the femoral prosthesis has loosened, broken, or requires surgical removal for another medical reason. These indications are intended to provide relief of pain and restoration of knee function in skeletally mature patients.

Limb salvage surgery is indicated for cemented procedures where radical resection and replacement of the distal femur and/or proximal tibia is required with the following conditions: 1. patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2. surgical intervention for severe trauma. revision knee arthroplasties, and/or oncology indications. 3. metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors)

The EVOLUTION® MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. inflammatory degenerative joint disease including rheumatoid arthritis; 3. correction of functional deformity: 4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Total Knee System nonporous components are for cemented use only. The EVOLUTION® Total Knee System porous components are for use without bone cement.

The ADVANCE® Total Knee System components are indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity: 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The ADVANCE® Total Knee System is for single use. The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous components are for use with bone cement.

The Whiteside Condylar II™ Total Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis or traumatic arthritis, with or without moderate valgus, varus, or flexion deformities. The prosthesis is also indicated for revision of a failed prosthesis where the posterior cruciate and collateral ligaments are intact. The device is intended for cemented use only.

The Whiteside ORTHOLOC™ Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities, where posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. The prosthesis is also indicated for revision of a failed prosthesis where the cruciate ligaments are absent ligaments are intact. The device is intended for cemented use only.

The Whiteside ORTHOLOC® M.A. Total Knee System is indicated for use in conjunction with the metal tibial base of the Whiteside ORTHOLOC® II Total Knee System for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental or tricompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate and collateral ligaments are intact. The prosthesis is also indicated for revision of a failed prosthesis where the posterior cruciate and collateral ligaments are intact. The device is intended for cemented use only.

The AXIOM ACL Retaining Tibial Tray and Tibial Insert are used in total knee arthroplasty for replacement of the tibial plateau of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. AXIOM ACL Retaining Tibial Tray and Tibial Insert are for cemented use only.

The A/P Curved Tibial Insert is used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. The A/P Curved Tibial Insert is intended for cemented application only.

The Second Generation Knee System is used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. The Second Generation Knee System is intended for cemented application only.

The Whiteside ORTHOLOC® Modular Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities, where the posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. This prosthesis is also indicated for revision of a failed prosthesis. where the cruciate ligaments are absent. This device is intended for cemented use only.

The Modular Femoral Component and Constrained Tibial insert are used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. Additional indications specific to the Modular Femoral Component and Constrained Tibial Insert include use in patients with anterior/posterior, varus/valgus, and rotational joint instability resulting from inadequate or absent cruciate and collateral ligaments, or who's knee can not be stabilized by usual soft tissue management. This device is intended for single use in a cemented application only.

The ORTHOLOC® Tibial Plastic Insert, as part the ORTHOLOC® Total Knee System, is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate and collateral ligaments are intact. The system is also indicated for revision of failed prosthesis where the posterior cruciate and collateral ligaments are intended for cemented use only.

Total knee arthroplasty has been proved effective in reducing pain and in restoring functional knee motion. Such surgical procedures have been used in the management of: painful disabling bicompartmental joint disease secondary to osteoarthritis, theumatic arthritis; posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities. The device may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cemented use only.

The ORTHOLOC® ADVANTIM™ Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. This prosthesis is also indicated for revision of a failed prosthesis, where the cruciate ligaments are absent.

The ULTRACK™ Total Knee System is intended for bicompartmental replacement of the knee joint for reduction of pain or increased function for the following conditions: 1) Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity: 4) Revision procedures where other treatments or devices have failed; and 5) Treatment of fractures that are unmanageable using other techniques. This device is intended for cemented use only.

The subject devices include the following affected components: Tibial spacers manufactured from UHMWPE; Tibial hinge base with stop pins manufactured from UHMWPE, titanium alloy, and cobalt chromium alloys; Hinge bushings manufactured from UHMWPE; Tibial inserts manufactured from UHMWPE with locking screws and posts manufactured from titanium alloy, cobalt chromium tungsten allov, and cobalt chromium molybdenum alloy; Femoral axial pins manufactured from combination UHMWPE and cobalt chromium molybdenum alloy and combination high density polyethylene (HDPE) and cobalt chromium alloy; Yoke extension stops manufactured from UHMWPE; Patellae manufactured from UHMWPE and cobalt chromium tungsten alloy. The subject materials conform to the following standards: GUR 1050 UHMWPE conforming to ASTM F648; GUR 1020 UHMWPE conforming to ASTM F648; High-density polyethylene; Titanium-6Aluminum-4Vanadium Extra Low Interstitial Alloy conforming to ASTM F136; Cobalt-28 Chromium-6 Molybdenum Alloy conforming to ASTM F75; Cobalt-28 Chromium-6 Molybdenum Alloy conforming to ASTM F799; GUR 1020 5 MRad Cross-linked Polyethylene conforming to ASTM F648; Cobalt-20Chromium-15Tungsten-10Nickel Alloy conforming to ASTM F90.

The provided text is a compilation of FDA 510(k) clearance letters and summaries for various knee and limb salvage systems manufactured by MicroPort Orthopedics Inc. These documents primarily address administrative changes related to sterilization suppliers and parameters and assert substantial equivalence to previously cleared devices.

Crucially, the documents explicitly state that "No bench testing, animal testing, or clinical testing was performed to support this submission" ([28]D, [37]D) and "Clinical data were not submitted or relied on for a determination of substantial equivalence" ([29]E, [37]E).

Therefore, based solely on the provided text, it's not possible to describe acceptance criteria or a study that "proves the device meets the acceptance criteria" in the traditional sense of a clinical or performance study for a newly designed medical device.

The "study" referenced in these documents is limited to:

• Validation of sterilization parameters (Ethylene Oxide Sterilization Validation Report) according to ISO standards (ISO 11135:2014, ISO/TS 21387, and ISO 10993-7:2008) to demonstrate the new supplier can achieve a Sterility Assurance Level (SAL) of 10⁻⁶.
• Biocompatibility assessment of the materials, concluding no impact on biological safety due to the change in sterilization supplier/parameters.

The acceptance criteria here are related to the maintenance of sterility and biocompatibility following a change in the manufacturing process (specifically, the sterilization supplier and parameters) for devices that have already established substantial equivalence through previous 510(k) submissions.

Given this context, I will address the questions to the best of my ability based on the information provided, explicitly stating where information is "Not Applicable" or "Not Provided" due to the nature of this particular 510(k) submission (change in sterilization process for already cleared devices, not a new device performance study).

Acceptance Criteria and Study for Sterilization Process Change (based on the provided document)

The core "study" described in the provided text is the validation of a change in Ethylene Oxide (EO) sterilization supplier and parameters for a range of existing knee and limb salvage system implants. The device performance being "proven" here is the continued sterility and biocompatibility of these devices after this change, asserting they remain as safe and effective as their predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the exact sample size (number of devices) used for the sterilization validation or biocompatibility assessment. It states that the "subject sterilization process underwent sterilization" and that "biocompatibility assessment... was assessed" ([28]D, [37]D). Regulatory requirements for sterilization validation (e.g., ISO 11135) dictate specific sample sizes for sterility testing (e.g., bioburden, sterility tests). However, these specific numbers are not provided in this summary.
• Data Provenance: The data comes from internal validation studies conducted by MicroPort Orthopedics Inc. (or their contracted sterilization supplier) to support the change. The country of origin for the data is not explicitly stated, but MicroPort Orthopedics Inc. is based in Arlington, Tennessee, USA ([24] Submitted by, [30] Submitted by). The studies are prospective in the sense that they were conducted specifically to validate the new sterilization process before seeking 510(k) clearance for the change.

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

• Not Applicable in this context. This 510(k) submission is about validating a manufacturing process change (sterilization), not evaluating clinical performance or diagnostic accuracy. Therefore, there is no "ground truth" established by clinical experts for a test set in the sense of image interpretation or medical diagnosis. The "ground truth" for sterilization is defined by established international standards (ISO series) for achieving a specific SAL, and for biocompatibility, by biological safety assessments.

4. Adjudication Method for the Test Set

• Not Applicable. As no clinical or diagnostic test set requiring expert interpretation or consensus was performed, no adjudication method was used. The assessment relied on adherence to scientific and engineering standards for sterilization and material biocompatibility.

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 MRMC study was done. The device type (knee and limb salvage system implants) is a physical implant, not an AI-assisted diagnostic tool.

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

• Not Applicable. The devices are physical implants, not algorithms.

7. The Type of Ground Truth Used

• The "ground truth" for this submission revolves around compliance with established international standards for sterilization and biocompatibility:
  • Sterilization: The ground truth is the achievement of a Sterility Assurance Level (SAL) of 10⁻⁶ as defined by ISO 11135:2014 and ISO/TS 21387.
  • Biocompatibility: The ground truth is the absence of adverse biological reactions as demonstrated by assessment against ISO 10993-7:2008 and other relevant biocompatibility standards, ensuring material properties and device characteristics are unaffected.

8. The Sample Size for the Training Set

• Not Applicable. This submission is not for a new device development involving a "training set" for an algorithm. The "training" in this context refers to manufacturing process validation.

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

• Not Applicable. As above, no training set for an algorithm exists here. The "ground truth" for the overall device's safety and effectiveness was previously established by the predicate devices which had undergone their own respective regulatory clearances, covering aspects like design, materials, and clinical performance (if applicable). This 510(k) only addresses the impact of a change in sterilization supplier on these already established devices.

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SkyWalker Total Knee System is intended to assist the surgeon to perform Total Knee Arthroplasty (TKA) procedures by providing software-defined spatial boundaries for orientation and reference information to anatomical structures for the accurate placement of compatible knee implant components.

It is indicated for use in TKA procedures in which the selection of stereotactic surgery is appropriate and the anatomical bony structures can be identified with a CT based model.

SkyWalker Total Knee System includes surgical console (a robotic arm platform), navigation console (an optical tracking navigation platform), software system (including preoperative planning software), cables, surgical instruments and accessories. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a preoperative plan derived from imported CT images.

The targeted population as well as indications have the same characteristics as those suitable for the following implants compatible with SkyWalker Total Knee System: EVOLUTION® MP TOTAL KNEE SYSTEM, EVOLUTION® MP TOTAL KNEE SYSTEM, ADVANCE® STATURE FEMORAL COMPONENT, ADVANCE® TIBIAL COMPONENT, and ADVANCE® KNEE SYSTEM.

SkyWalker Total Knee System consists of a navigation console, a surgical console, cables, software system, surgical instruments and disposables. The navigation console includes a navigation trolley, an optical tracking device, a primary monitor and a surgeon monitor. The surgical console includes a robotic arm, a robotic arm trolley and a foot pedal.

The TKA surgery workflow under the guidance of SkyWalker Total Knee System can be divided into preoperative procedure and intraoperative procedure. The preoperative procedure is to assist the user with preoperative planning by using patient CT image data and providing reference information to anatomical structures to make a surgical plan for the TKA surgery. In the intraoperative procedure, Skywalker Total Knee System can provide stereotactic guidance for real-time orientation of the cutting block to a target position with a target pose. When the robotic arm reaches the target position, the cutting block is being held in an expected pose, then the surgeon could be able to accurately perform knee resection.

The provided text describes the MicroPort NaviBot International LLC's "SkyWalker Total Knee System" and its 510(k) summary for FDA clearance. However, it does NOT contain information about specific acceptance criteria for AI/ML performance, nor a study proving the device meets such criteria.

The document primarily focuses on:

• Indications for Use of the robotic surgical system.
• Comparison of its technological characteristics with a predicate device (ROSA Knee System).
• General performance data, including biocompatibility, electrical safety, device performance testing (bench, accelerated aging, reprocessing, human factor, cadaveric validation), and software verification.

Specifically, the document states:

• The subject device provides robot position repeatability ≤ 0.5mm, robot orientation repeatability ≤ 1.0°, navigation accuracy with mean of errors ≤ 0.5mm, and subsequently suffices for the system accuracy of cutting position accuracy ≤ 1.5mm and cutting orientation accuracy ≤ 2.0°.
• "Cadaveric Validation Test, to validate SkyWalker Total Knee System is safe and effective by orthopedic surgeons' simulated uses on cadaveric specimens, and provide evidence that the performances of SkyWalker Total Knee System satisfy the intended use."

This indicates that the focus of the performance testing was on the accuracy and repeatability of the robotic system itself for surgical procedures, rather than on an AI/ML algorithm's diagnostic or predictive performance that would require a test set, ground truth experts, and specific metrics like sensitivity, specificity, or AUC. The "software system" mentioned is for preoperative planning and real-time guidance, not for AI-driven image analysis or decision support in the context of an AI/ML device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, as this document does not describe such a device or study.

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MicroPort Total Knee Systems are in knee arthroplasty in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis:

2. inflammatory degenerative joint disease including rheumatoid arthritis;

3. correction of functional deformity:

4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

Non-porous MicroPort total knee replacement implants are for cemented use only.

The EVOLUTION® Stemmed CS Femur is a line extension of the EVOLUTION® revision knee system product line. The device is a stemmed distal femoral knee joint replacement implant design to address bone-on-bone bearing conditions in a patient's knee where there is also a lack of bone stock or quality, but intact and sufficient collateral ligaments. An optional polyethylene stem cap designed to obstruct bone cement migration into the trunnion is packaged with the subject femoral component in the event no stem extension or adapter is used. The design features are summarized below:

• o Manufactured from Cobalt Chrome Alloy
• o CS design, sizes 1-8, left and right
• Compatible with 510(k) cleared EVOLUTION® Revision Stem Extensions, ● EVOLUTION® Revision Offset Adapters, EVOLUTION® Stem Adapters, EVOLUTION® Revision Femoral Augments, EVOLUTION® MP CS Tibial Inserts, EVOLUTION® Adaptive CS Tibial Inserts, and ADVANCE® Patella Components.

The provided document (K182125) is a 510(k) Premarket Notification for a medical device called the "EVOLUTION® Stemmed CS Femur," which is a component of a knee replacement system. This document does not describe acceptance criteria for an AI/ML medical device, nor does it detail a study proving such a device meets acceptance criteria.

The document discusses the substantial equivalence of a physical medical implant (a stemmed femoral component for knee arthroplasty) to existing predicate devices. It relies on non-clinical testing (e.g., range of motion, stress analysis) of the predicate devices and material equivalence to demonstrate safety and effectiveness.

Therefore, I cannot provide the requested information for acceptance criteria and study proof for an AI/ML medical device based on the given input. The categories in the request (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth) are relevant to the evaluation of AI/ML software as a medical device (SaMD), but they are not applicable to the premarket notification for a physical knee implant as described in K182125.

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The EVOLUTION® Revision CCK System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

EVOLUTION® Revision CCK (Constrained Condylar Knee) is being introduced to supplement MicroPort Orthopedics' knee product lines to provide options in the case of revision or complex primary total knee replacements. The design features are summarized below:

• Components manufactured from cobalt chrome alloy, titanium alloy, and UHMWPE conforming to ASTM F75, F136, and F648, respectively
• . Available in 8 standard sizes, left and right
• Available in 2 plus sizes, left and right
• . System includes femoral component, augments, stem offset adapters, tibial insert and stem cap

The provided text describes the MicroPort Orthopedics EVOLUTION® Revision CCK System, a knee joint prosthesis. However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the typical format of a diagnostic or AI/software device.

Instead, this 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices based on design features, materials, and non-clinical performance testing. The information provided is primarily related to mechanical and material performance rather than diagnostic accuracy or human performance with or without AI.

Therefore, I cannot fulfill all parts of your request as posed because the document is not an "acceptance criteria study" in the sense you are asking for. It is a regulatory submission demonstrating substantial equivalence.

Based on the provided text, I can extract information relevant to non-clinical performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for each test in a pass/fail format alongside numerical performance values. Instead, it describes comparative performance against a predicate device. The general "acceptance criteria" can be inferred as performing "as well as" or "greater than" the predicate device for various mechanical properties to demonstrate substantial equivalence.

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The EVOLUTION® BIOFOAM® Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION® BIOFOAM® Tibial System is for use without bone cement.

The ADVANCE® BIOFOAM® Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The ADVANCE® BIOFOAM® Tibial System is for use without bone cement and is intended for use with EVOLUTION® and ADVANCE® modular keels.

The EVOLUTION® BIOFOAM® Tibial System is a line extension of the EVOLUTION® MP Total Knee System product line. The device is an asymmetrical tibial base with a BIOFOAM® coating on the distal surface. The design features are summarized below:
. Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought)
. Available in 11 sizes, left and right
Tibial base is available with and without holes for bone screws ●
. System includes 3 options of modular keels consisting of a two fin bullet-tip, a four fin bullet-tip and a four fin stem-accepting keel
Compatible with 510(k) cleared EVOLUTION® Tibial Inserts, ADVANCE® . Keels and ADVANTIM® Stems

The keel compatibility for the ADVANCE® BIOFOAM® Tibia is being expanded to include all keels subject to this 510(k). The subject design and indications remain identical according to K063128.

The provided text is a 510(k) Summary of Safety and Effectiveness for the EVOLUTION® BIOFOAM® Tibial System and ADVANCE® BIOFOAM® Tibial System. This document focuses on demonstrating substantial equivalence to existing predicate devices, not on providing the results of a primary study proving a device meets specific acceptance criteria in a clinical context.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it states:

• Clinical Testing: "Clinical data was not provided for the subject devices."
• Acceptance Criteria/Performance: The document discusses non-clinical testing for fatigue strength against a predicate device, but this is not presented as "acceptance criteria" with reported "device performance" in the clinical sense you've outlined.

The non-clinical testing section (D) does mention.

• Nonclinical Testing: "The subject EVOLUTION® BIOFOAM® Tibial System was evaluated for fatigue strength per ASTM F1800 and 3-point stem fatigue. Results concluded that the subject tibial base is expected to perform as well or better than the predicate device in fatigue loading."

While this indicates some engineering performance evaluation, it does not fulfill the requirements of your prompt for clinical acceptance criteria and related study details.

To answer your prompt directly based on the provided text:

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

   • Not available. The document states "Clinical data was not provided for the subject devices." Non-clinical testing for fatigue strength was performed, concluding "the subject tibial base is expected to perform as well or better than the predicate device in fatigue loading," but specific acceptance criteria and detailed performance metrics are not given for this non-clinical test.

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

   • Not available. No clinical test set information is provided. For the non-clinical fatigue testing, the sample size is not mentioned, and given it's a mechanical test, country of origin or retrospective/prospective status is not applicable in the human data sense.

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. No clinical test set was used, therefore no experts were used to establish clinical ground truth.

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

   • Not applicable. No clinical test set was used.

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. This device is a knee implant, not an AI diagnostic tool. No MRMC study was performed.

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

   • Not applicable. Not an algorithm/AI device.

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

   • Not applicable for clinical ground truth. For the non-clinical fatigue testing, the "ground truth" would be engineering standards (ASTM F1800) and mechanical measurements.

8. The sample size for the training set

   • Not applicable. This device is a physical implant, not an AI model requiring a training set.

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

   • Not applicable. Not an AI model.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (knee implant), not an AI/diagnostic device. Consequently, it does not contain the information you requested about clinical acceptance criteria and associated studies.

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The EVOLUTION® MP Revision Femoral System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® MP Revision Femoral System is for cemented use only.

The EVOLUTION® MP Revision Femoral System is a line extension of the EVOLUTION® MP Total Knee System product line. The device is a stemmed distal femoral knee joint replacement implant for use in revision or a complicated primary total knee arthroplasty. The design features are summarized below:

• Manufactured from Cobalt Chrome Alloy
• Available in CS and PS design, sizes 3-7, left and right
• Compatible with 510(k) cleared EVOLUTION® Tibial Inserts, EVOLUTION® Adaptive Tibial Inserts, ADVANCE® Patellae and ADVANCE® Stem Extensions
• System includes 4, 8 and 12 mm augments to fill bone voids in distal and/or posterior bone geometry

This document is a 510(k) Pre-Market Notification from the FDA for the EVOLUTION® MP Revision Femoral System. It is a regulatory approval document and, as such, does not contain the information requested in your prompt regarding acceptance criteria and study particulars for an AI/device performance study.

The device detailed in this document is a knee joint replacement implant. The document focuses on demonstrating substantial equivalence to a predicate device based on design features, materials, and nonclinical (mechanical) testing, not on the performance of a diagnostic AI algorithm.

Specifically, the document states:

• "E. Clinical Testing: Clinical data was not provided for the subject devices." This explicitly indicates that no clinical performance study, let alone one involving AI or diagnostic accuracy, was conducted or submitted.

Therefore, I cannot provide an answer to your detailed questions (acceptance criteria, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) because this document does not describe the kind of study you are asking about.

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The EVOLUTION® MP Adaptive CS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. Inflammatory degenerative joint disease including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION® Total Knee System is for cemented use only.

The purpose of this submission is to introduce a new EVOLUTION® Adaptive CS Tibial Insert that allows use of a femoral component from the EVOLUTION® Total Knee System with a tibial base from the ADVANCE® Knee System. The design features of the EVOLUTION® Adaptive CS Insert are summarized below:
. Tibial inserts manufactured from UHMWPE
. Available in 11 sizes, left and right
. Tibial insert thickness: 10 - 20mm
The EVOLUTION® Adaptive CS Insert was evaluated via mechanical testing and engineering analyses; including static stability, contact area, and range of motion testing. A review of these results indicates that the subject device is equivalent to predicate devices and is capable of withstanding expected in vivo loading without failure.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

The provided text, a 510(k) summary for the EVOLUTION® MP Adaptive CS Insert, describes a medical device, specifically a tibial insert for a knee replacement system. It does not describe an AI/ML powered device, an imaging device, or anything that would involve performance metrics like sensitivity, specificity, or AUC, or a study with human readers or ground truth established by experts/pathology.

Instead, the "acceptance criteria" and "study" are related to mechanical and engineering performance to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested fields are not applicable to this type of device and study.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a "sample size" in the context of typical clinical or AI/imaging studies. The "test set" here refers to the tested components of the device. The document mentions the insert is "Available in 11 sizes, left and right," implying these variations would be considered in testing.
• Data Provenance: The testing was conducted internally by Wright Medical Technology, Inc. (manufacturer). It's an engineering and mechanical evaluation, not a clinical study involving human patients or existing medical data.

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

• Not Applicable. This is an engineering/mechanical evaluation of a physical device, not an AI/imaging study requiring expert ground truth or diagnoses.

4. Adjudication Method for the Test Set

• Not Applicable. No expert adjudication process like 2+1 or 3+1 is mentioned or relevant for this type of device testing. The "adjudication" is based on engineering principles and comparison to predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This is not an AI/imaging device. No MRMC study involving human readers was conducted.

6. If a Standalone Study Was Done

• Yes, in concept. The "study" (mechanical testing and engineering analyses) evaluates the device itself (the EVOLUTION® MP Adaptive CS Insert) in a standalone fashion to determine if it meets physical performance criteria and is substantially equivalent to predicate devices. It's not "standalone" in the AI sense of algorithm-only performance, but rather the device's inherent mechanical properties.

7. The Type of Ground Truth Used

• The "ground truth" here is the established mechanical performance characteristics and design parameters of the predicate devices, as well as the engineering specifications and test methods (e.g., for static stability, contact area, range of motion) that are deemed acceptable for such implants. The performance of the subject device is compared against these benchmarks.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a "training set" of data.

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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