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Joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis;
• avascular necrosis of the femoral condyle;
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• moderate valgus, varus or flexion deformities;
• treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia, and Porous Patella which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Revision VVC+, e+™ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:

• Absence or loss of both cruciate ligaments
• Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon
• Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

The EMPOWR Revision Knee™ system is intended for use in total knee arthroplasty. The system includes femoral components, tibial components, tibial inserts, cones, stems, stem extenders, and augments. Components are available in various sizes and configurations to accommodate a range of patient anatomies and surgeon preferences.

The purpose of this submission is to obtain clearance for using vaporized hydrogen peroxide (VHP) as a sterilization method for the EMPOWR VVC+, e+ Tibial Insert component. The subject device is identical in design, materials, and intended use to the predicate.

This FDA 510(k) clearance letter pertains to a medical device, the EMPOWR Revision Knee™ system, specifically focusing on the clearance for a new sterilization method (Vaporized Hydrogen Peroxide - VHP) for the EMPOWR Revision VVC+, e+ Tibial Insert component. The document explicitly states that no clinical data or animal studies were submitted for this clearance. Instead, the substantial equivalence to the predicate device is based on non-clinical performance data (verification and validation activities).

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for a clinical or AI-based study cannot be extracted from this document, as it is not relevant to the type of submission described.

The document discusses the following non-clinical performance data:

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

   • This information is not explicitly presented in a table format within the provided document. However, the document states that "Verification and validation activities demonstrate substantial equivalence between the subject and predicate devices." and lists the types of tests conducted. To fully answer this, one would typically need access to the actual verification and validation reports.

   Acceptance Criteria (Implied)	Reported Device Performance (Implied)
   Sterilization Efficacy	Validated for VHP
   Shelf-Life Stability	Demonstrated stability
   Packaging Integrity	Demonstrated integrity
   Biocompatibility (Cytotoxicity)	Met biocompatibility requirements
   Material Properties	Maintained material characteristics
   Wear Resistance	Comparable to predicate (Pin-on-disk)
   Fatigue Strength (Lock Detail)	Met strength requirements
   Fatigue Strength (Tibial Post)	Met strength requirements

2. Sample sizes used for the test set and the data provenance:

   • Sample sizes: Not specified in the provided text. These would be detailed in the individual test reports for each verification and validation activity.
   • Data provenance: Not specified. This would typically come from internal laboratory testing or contract research organizations. The document indicates these are "Verification and validation activities," implying laboratory-based testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in the traditional sense. The "ground truth" for non-clinical testing refers to established engineering or biological standards.

4. Adjudication method for the test set:

   • Not applicable. Adjudication is typically for clinical or interpretation-based studies. Non-clinical tests follow predefined protocols and acceptance limits.

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. The document explicitly states: "No clinical data submitted." This is not a study involving human readers or AI.

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

   • No. This is not an algorithm-based device.

7. The type of ground truth used:

   • For the non-clinical tests listed (Sterilization Validation, Shelf-Life Study, Packaging Testing, Cytotoxicity, Material Characterization, Pin-on-disk Wear, Lock Detail Fatigue, Tibial Post Fatigue), the "ground truth" would be established engineering standards, regulatory requirements, and validated testing methodologies.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable. This is not an AI/machine learning device requiring a training set.

In summary, the provided document is a 510(k) clearance letter for a medical device that highlights a change in sterilization method. The substantial equivalence argument is based entirely on non-clinical performance testing, not clinical trials or AI performance evaluations. Therefore, most of the requested information related to clinical studies, AI performance, expert ground truth, and sample sizes for such studies is not applicable to this specific submission.

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The Stryker Scorpio Total Knee system components are intended for the replacement of the bearing and/or articulating surfaces of the distal femur and proximal tibia to remove pain, instability, and restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma. The devices are intended for single-use only, and are intended for cemented fixation in patients indicated for total knee arthroplasty.

The devices included in this submission are tibial inserts, and all-polyethylene patellar components used in total knee arthroplasty procedures. All devices have been previously deemed substantially equivalent in prior premarket submissions and are commercially available.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA regarding a change in labeling for orthopedic knee implants (Scorpio Universal Dome Patella, Scorpio Total Stabilizer Insert, Scorpio-Flex Posterior Stabilized Tibial Insert, Scorpio-Flex Cruciate Retaining Tibial Insert, Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert, Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert).

The key takeaway from the document regarding the submission is:

• Reason for 510(k) Submission: "The purpose of this "Change Being Effected" bundled submission is to add a contraindication to the labeling of the subject Scorpio Total Knee System." (Page 7)
• Non-Clinical and Clinical Testing: "Non-Clinical testing was not required as a basis for substantial equivalence." and "Clinical testing was not required as a basis for substantial equivalence." (Page 10)

This means the submission is primarily administrative (a labeling change) and does not involve new performance testing or studies. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document.

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The Unity Knee™ PS-C Tibial Insert is intended for use in the Unity Total Knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The General total knee arthroplasty indications include:

· Painful, disabling joint disease of the knee resulting from: degenerative arthritis, 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
• · Revision of previous unsuccessful knee replacement or other soft tissue stability is adequate
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques
• · The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface with
• increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament

The Unity Total Knee System is intended for cemented use, single use only.

The Unity Total Knee System is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, an ultra-high molecular weight polyethylene (UHMWPE) tibial insert, a CoCr tibial tray with a titanium alloy keel extension and all-polyethylene patellar component for use in primary and revision total knee arthroplasty. The Unity Total Knee System femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilised (PS).

• The CR femoral component is intended for use in conjunction with the CR tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Condylar Stabilised (CS) tibial insert where the PCL is present but is lax or non-functioning or when the PCL is absent.
• . The PS femoral component is intended for use in conjunction with the PS tibial insert where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability, or in conjunction with the constrained posterior-stabilized (PS-C) tibial insert where is instability of the lateral collateral ligament and/or medial collateral ligament (LCL/MCL).

The Unity Total Knee System patellar component is optional and for use with either the CR or PS femoral variants and is intended for use where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments, tibial augments, stem extensions and offset adapters.

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

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

The document does not explicitly present a table of acceptance criteria. Instead, it describes various non-clinical tests performed and states that the "results of the specific mechanical testing performed on the Unity Knee PS-C Tibial Insert show that the device is substantially equivalent to the predicate devices." This implies that the acceptance criteria are met if the new device performs comparably to the predicate devices in these tests.

However, we can infer the tested parameters and the general outcome:

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

The document describes non-clinical (mechanical) testing only. Therefore, the concept of a "test set" in the context of patient data (retrospective/prospective, country of origin) is not applicable. The sample size for mechanical tests is not explicitly stated but would refer to the number of physical samples of the device components subjected to testing. This information is typically detailed in the full test reports, which are not provided here.

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)

Since this is a submission for a mechanical medical device (a knee implant component), the concept of "ground truth" established by medical experts for a "test set" (e.g., image-based diagnosis) is not applicable. The ground truth for mechanical performance is established by the specifications of the predicate devices and the performance standards (ASTM, ISO). The "experts" involved would be engineers and testing technicians who design and execute the tests and analyze the results against these standards. Their qualifications are not specified in this summary.

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

Not applicable as this is not a study involving human readers or image interpretation.

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 document pertains to the clearance of a mechanical orthopedic implant, not an AI-assisted diagnostic device.

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

Not applicable. As noted above, this is about a mechanical implant, not an algorithm.

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

The ground truth for the non-clinical tests is based on established engineering standards and specifications (ASTM F1223-20, ISO 21536:2023, ASTM F2083-21) and the performance characteristics of the legally marketed predicate devices (Apex PS Knee System, PS-C Insert K111184; Unity Total Knee System K113060). The new device's performance is compared against these benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable, as this is a mechanical device, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for a mechanical device.

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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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The Balanced Knee System TriMax PS Plus Tibial Inset is in cemented total knee arthroplasty procedures with the following indications:

1. Loss of knee joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

The Balanced Knee® System (BKS) TriMax PS Plus Tibial Insert is a line extension of the TriMax PS Tibial Insert (K131337) that offers slightly more constraint than the original PS Insert. The PS post geometry is the only design difference between the previously cleared predicate device and the subject device. The change slightly modifies the post's shape to provide additional internal/external and varus/valgus constraint if the surgeon determines the need exists. The balance of the design is identical including the articulating surface, locking mechanism, as well as the PS post location and height. The PS Plus inserts are intended for use in primary and revision knee surgeries with the same indications for use as the predicate. This implant is used with existing BKS and BKS Revision (BKSR) tibial travs. TriMax femoral components and the BKSR modular femoral components. The material is identical as well as all manufacturing processes, cleaning, sterilization and packaging that were cleared under K131337.

This document describes a 510(k) premarket notification for a medical device called the "Balanced Knee® System TriMax PS Plus Tibial Insert." The submission is a "Special 510(k)" because it is a line extension of a previously cleared predicate device (K131337).

Since this is a Special 510(k) for a line extension of an existing device, and the primary change is a slight modification to the PS post geometry, the provided document does not contain information about a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to the predicate device through engineering analysis and verification testing.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance (in the context of a clinical study or AI performance evaluation)
2. Sample size used for a test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method for a test set
5. MRMC comparative effectiveness study results or effect size
6. Standalone (algorithm-only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document describes the engineering and material performance evaluations conducted to demonstrate that the new device's design outputs meet the design inputs, similar to the predicate. The "performance data" section refers to:

• Sterilization: Stated adherence to ISO 11135-1 with a Sterilization Assurance Level (SAL) of 10-6.
• Shelf Life: Validation according to ASTM D4169:2016.
• Biocompatibility: Suitability for implantation verified per ISO 10993.

The comparison of technological characteristics mentions evaluations in the following areas, indicating what was assessed, but not specific acceptance criteria or performance numbers:

• Geometric Analysis
• Contact Area and Pressure
• Constraint
• Wear
• Range of Motion
• PS Post Fatigue

It concludes that "The results showed similar or identical performance indicating that the design outputs of the PS Plus Tibial Insert meet the design inputs." This is a general statement of engineering conformance, not a specific performance metric from a study as typically requested for AI/diagnostic device approvals.

In summary, this document is a 510(k) premarket notification for a mechanical orthopedic implant, not a software or AI-driven medical device. Therefore, the types of studies and acceptance criteria typically associated with AI/software performance evaluations (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable to the content of this FDA letter.

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The Klassic® Knee System is intended for prosthetic replacement in treatment of the following:

• Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
• Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
• Patients with failed previous surgery where pain, deformity, or dysfunction persists
• Correctable varus-valgus deformity and moderate flexion contracture
• Revision of a previously failed knee arthroplasty
• Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.

The Klassic® Knee System is being updated with additional thicknesses of Tibial Inserts, PS-Post and Additional All Poly Tibia PS-Post implants. Both proposed geometries are fabricated from both Standard Poly and Vitamin E UHMWPE (E-Link).

This document is a 510(k) Pre-Market Notification from the FDA regarding the Klassic® Tibial Insert, PS-Post, and Klassic All Poly Tibia, PS-Post. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study of a novel AI-powered medical device.

Therefore, the requested information regarding acceptance criteria and a study proving a device (implying an AI or software as a medical device) meets these criteria cannot be fully extracted from the provided text. The document describes non-clinical testing and engineering analyses for mechanical components (tibial inserts), not a software or AI device.

However, I can extract the information that is present and explain why other requested information is not applicable to this document.

Information Extracted from the Document (Pertaining to Mechanical Device Evaluation):

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

   The document states: "Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities, demonstrating that the subject components perform as safe and effective compared to the predicate components, and is substantially equivalent to the predicate."

   It lists the types of non-clinical tests performed:

   • Femoral/Tibial Constraint Testing (ASTM F1223)
   • Contact Area/Contact Stress (ASTM F2083)
   • Post Fatigue Testing
   • Range of Motion Evaluation
   • Wear (ISO 14243-3)
   • Tibial Insert Modular Disassembly Strength (ASTM F1814)

   While the types of tests and the conclusion that criteria were met are stated, the specific quantitative acceptance criteria (e.g., minimum load for post fatigue, maximum wear rate) and the measured performance values are not provided in this summary document. This information would typically be in the full submission, not the public summary.

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

   This document describes testing of physical components (tibial inserts), not an AI algorithm. Therefore, "sample size" would refer to the number of physical components tested, which is not specified. "Data provenance" such as country of origin or retrospective/prospective is not applicable in the context of mechanical engineering testing on manufactured parts.

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 the context of an AI device, refers to expertly labeled data. Here, the "ground truth" (or standard) for mechanical performance is established by engineering standards (e.g., ASTM, ISO), not human experts labeling data.

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

   Not applicable. Adjudication methods are relevant for human interpretation of complex data (e.g., medical images) to establish ground truth for AI training/testing. This document is about mechanical testing.

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. An MRMC study assesses the impact of an AI algorithm on human diagnostic performance. This document concerns the substantial equivalence of a physical medical implant.

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

   Not applicable. Standalone performance refers to the performance of an AI algorithm without human involvement. This evaluation is of a mechanical device.

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

   The "ground truth" for the mechanical components is defined by established engineering and biological safety standards (e.g., ASTM F1223, ASTM F2083, ISO 14243-3, ASTM F1814, and LAL testing for orthopedic implants). These are quantitative, objective measurements against pre-defined engineering and material science criteria.

8. The sample size for the training set:

   Not applicable. There is no "training set" as this is not an AI/machine learning device. The design and testing are based on engineering principles and material science.

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

   Not applicable (no training set).

Summary of Applicable (and Not Applicable) Information from the Provided Text:

• Femoral/Tibial Constraint Testing (ASTM F1223)
• Contact Area/Contact Stress (ASTM F2083)
• Post Fatigue Testing
• Range of Motion Evaluation
• Wear (ISO 14243-3)
• Tibial Insert Modular Disassembly Strength (ASTM F1814)
• LAL testing requirements for orthopedic implants.

Reported Performance: "Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities, demonstrating that the subject components perform as safe and effective compared to the predicate components, and is substantially equivalent to the predicate." | The document confirms that specific mechanical tests were performed against pre-determined acceptance criteria, and the device met these criteria. However, the quantitative values of the acceptance criteria (e.g., "must withstand X N without deformation") and the specific measured results from each test are not detailed in this summary. This is typical for a 510(k) summary, as the full detailed test reports are part of the confidential submission. The "reported device performance" is given as a qualitative statement of meeting the criteria. |
| 2. Sample Size & Data Provenance (for test set) | Not disclosed. | This relates to mechanical testing of physical parts, not a data-driven AI model. The number of physical components tested is not provided. Data provenance (e.g., country, retrospective/prospective) is not relevant for this type of non-clinical, in-vitro testing. |
| 3. Number & Qualifications of Experts for Ground Truth | Not applicable. | Ground truth in this context is established by objective engineering standards and measurements (e.g., ASTM, ISO), not by human expert consensus or labeling of data. |
| 4. Adjudication Method (for test set) | Not applicable. | Adjudication is relevant for resolving discrepancies in human interpretation to establish ground truth for AI algorithms. This is mechanical testing. |
| 5. MRMC Comparative Effectiveness Study | Not applicable. | This type of study evaluates the impact of AI on human reader performance for diagnostic tasks. The device in question is a physical knee implant. |
| 6. Standalone (Algorithm Only) Performance | Not applicable. | This refers to the performance of an AI algorithm independent of human interaction. The device is a physical implant, not an algorithm. |
| 7. Type of Ground Truth Used | Established engineering and material science standards (e.g., ASTM, ISO) and LAL testing. | The "ground truth" for evaluating the performance of the physical device components is based on well-defined and quantitative performance specifications derived from these industry-standard test methods to ensure mechanical integrity, biocompatibility, and safety. |
| 8. Sample Size for Training Set | Not applicable. | This refers to data used to train an AI model. This device is a physical implant, not an AI. |
| 9. How Ground Truth for Training Set was Established (If any) | Not applicable. | As there is no training set for an AI model, this question is not applicable. |

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The TRULIANT E-PX Tibial Inserts and Patellas are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The TRULIANT E-PX Patellas are intended for cemented use only.

The TRULIANT Knee System is a system of orthopedic implants intended for total knee replacement. The system includes Femoral components, Tibial Trays, Tibial Inserts, and Patellas. The Tibial Inserts and Patellas used in the TRULIANT Knee system currently are constructed of compression molded UHMWPE and extruded UHMWPE respectively. This submission proposes TRULIANT Tibial Inserts and Patellas made from UHMWPE containing vitamin E. This submission additionally proposes minor geometric change(s) to all Tibial Insert devices as well as additional intermediate TRULIANT CC Tibial Insert size options.

The provided text is a 510(k) summary for the TRULIANT® E-PX Tibial Inserts and Patellas. It describes the device, its intended use, and comparative testing to demonstrate substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria, reported device performance metrics (numerical results), or information about a clinical study with a test set, ground truth establishers, or adjudication methods.

The document outlines a series of non-clinical tests and engineering analyses that were performed. These tests, listed under "Non-Clinical and/or Clinical Tests Summary & Conclusions" (although it explicitly states "non-clinical testing"), are:

• Material Characterization
• Wear
• Fatigue
• Range of Motion
• Tibial-femoral stability characteristics
• Tibial modular disassembly characteristics
• Biocompatibility
• Bacterial endotoxins

The document concludes that "The differences in raw material and geometry do not change the intended use, safety, or performance requirements of the proposed devices, nor do they adversely affect their safety or effectiveness. This conclusion is based on consideration of the preclinical testing and analysis including material characterization, biocompatibility assessment and testing and mechanical testing and analysis completed to establish substantial equivalence of the proposed devices to the predicate devices."

Therefore, I cannot populate the table or answer most of the questions you've asked because the information is not present in the provided text. The text describes a pre-market notification (510(k)) for a medical device which relies on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing and engineering analysis, rather than a clinical study with human patients, a test set, or human expert evaluations in the way you've described.

Here's what I can provide based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical engineering and material tests, not a clinical study with a "test set" of patients or data provenance in that context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical study with human expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical study with adjudication of expert opinions is described.

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 document pertains to a knee implant, not an AI-assisted diagnostic device, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document pertains to a knee implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for demonstrating substantial equivalence for this device is based on the performance of the predicate devices and the outcomes of the non-clinical tests described (material characterization, wear, fatigue, etc.) designed to show comparable safety and effectiveness.

8. The sample size for the training set: Not applicable. No machine learning training set is described.

9. How the ground truth for the training set was established: Not applicable. No machine learning training set is described.

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Joint replacement is indicated for patients suffering from disability due to:

• · degenerative, post-traumatic or rheumatoid arthritis;
• · avascular necrosis of the femoral condyle;
• · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• · moderate valgus, varus or flexion deformities;
• · treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, and EMPOWR POROUS Tibia which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Revision VVC+, e+ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:

· absence or loss of both cruciate ligaments

• · moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgement of the surgeon
• · bone loss that requires supplemental fixation in the clinical judgement of the surgeon

The EMPOWR Revision VVC+ (Varus / Valgus Constrained) e+ Tibial Insert Implant is a line extension that offers an increased level of femoral / tibial constraint over the EMPOWR VVC Tibial Insert. This tibial insert implant provides additional internal / external and varus / valgus rotational stability.

The sizing architecture for the insert includes 14 sizes (2-11, 4BU, 5BU, 6BD, 7BD) and thicknesses of 10mm, 12mm, 14mm, 16mm, 19mm, 22mm and 25mm with post medial/lateral width of 0.5520 inches for sizes 2-5 and 0.7080 inches for sizes 6 - 11. Along with the post width, the articulating geometry of the proximal side of the tibial insert accommodates an additional amount of internal / external (I/E), varus / valgus (V/V) constraint, and tibial post / femoral cam jump height when interfacing with the EMPOWR Revision Femoral implant. The material (highly crosslinked 75kGy UHMWPE with vitamin E per ASTM F2695/F2565) and distal locking mechanism geometry with the mating tibial baseplate are identical to the predicate.

All tibial insert thickness options are configured to interface with a reinforcement pin accessory made of Wrought CoCr per ASTM F1537. This accessory is configured with a taper interface on the distal end to mate with the EMPOWR UNIVERSAL TIBIAL BASEPLATE, has a diameter and length configured to reinforce the post and thickness for the EMPOWR Revision VVC+ e+ tibial insert, and contains barbs to prevent the pin from backout when fully seated within the post of the EMPOWR Revision VVC+, e+ tibial insert.

This document is a marketing clearance letter from the FDA for a medical device, specifically a knee joint prosthesis. It does not contain information about the acceptance criteria and study proving the device meets those criteria in the context of an AI/ML medical device.

The provided text discusses:

• The FDA's decision regarding substantial equivalence for the EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert.
• Regulatory information about the device (product code, regulation number, class).
• General controls provisions and additional controls that may apply.
• Indications for Use for the device, which describe the patient conditions for which the device is intended.
• A brief description of the device as a line extension offering increased constraint.
• Comparison of technological characteristics with a predicate device.
• Performance testing: This section lists types of performance tests conducted (e.g., CAD Based Range of Motion (ROM), Femoral – Tibial Contact Area Assessment, Femur - Tibial Intrinsic Stability, Femur - Tibial Varus / Valgus Constraint Testing, MR Conditional Labeling), but it does not provide acceptance criteria or the reported results of these tests. It merely states that "The following testing was performed to FDA recognized standards and internal protocols."
• Absence of animal or clinical studies: The document explicitly states "No animal data submitted" and "No clinical data submitted." This indicates that the substantial equivalence determination was based on non-clinical data, likely bench testing and comparisons to the predicate device.

Therefore, based solely on the provided text, it is not possible to answer the detailed questions about acceptance criteria, study methodologies, sample sizes, expert involvement, and ground truth establishment, as these pertain to performance studies that would typically be conducted for AI/ML medical devices or devices requiring clinical evidence for efficacy/safety.

The provided document is a 510(k) clearance letter, which often relies on demonstrating substantial equivalence to a predicate device through non-clinical performance and material characterization, rather than extensive clinical trials or AI/ML specific performance studies. This specific device is a mechanical implant, not an AI/ML-driven diagnostic or therapeutic device.

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For Tibial baseplate, CMA, #0
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in sketetally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surfaction or prior patellectorny, moderate valgus, varus, or flexion contraction. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device system is designed for cemented use only.

For Tibial insert, #0
The device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in sketally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cemented use only.

The U2 Total Knee System consists of Femoral components, patella components, Tibial baseplate components and Tibial inserts components which are designed to be used together to achieve total replacement of the knee joint. This system includes Cruciate Retained (CR) type, Ultracongruent (UC) type, and Posterior Stabilized (PS) type.

The U2 Total Knee System, Tibial baseplate, CMA, #0 (Subject device) is a size extension of the cleared "UNITED" U2 Total Knee System, Tibial baseplate, CMA, #1 to #7 (K131864). The materials, indications, sterilization of this subject are identical to the cleared "UNITED" U2 Total Knee System, Tibial baseplate, CMA, #1 to #7 (K131864).

The U2 Total Knee System, Tibial insert, #0 (Subject device) is a size extension of the cleared "UNITED" U2 Total Knee System, Tibial insert, #1 to #7 (K051640, K103733, K131864, K132752, K150829 and K161705). The materials, indications, sterilization of this subject are identical to the cleared "UNITED" U2 Total Knee System, Tibial insert, #1 to #7 (K051640, K103733, K131864, K132752, K150829 and K161705). The Subject Tibial insert, CR, #0 and Tibial insert, PS, #0 have a more concave sagittal plane design while comparing to the marketed predicate devices

Surgical procedures with the use of the Subject device shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. All the surgical instruments have been cleared as part of the predicate devices.

This is a medical device clearance, not an AI/ML device. Therefore, the questions regarding AI/ML device evaluations (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment for training set, etc.) are not applicable.

The document describes the acceptance criteria and study for a Tibial baseplate and Tibial insert, which are components of a knee replacement system. This is a traditional medical device, not an AI/ML powered device. Therefore, the concepts related to AI/ML device performance such as ground truth, expert adjudication, train/test sets, effect size of AI assistance, etc., are not relevant to this document.

However, I can extract the information provided regarding the device's performance analysis and acceptance criteria, based on the non-clinical tests conducted.

Here's the summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly list 'acceptance criteria' with numerical targets and then 'reported device performance' side-by-side in a table format. Instead, it states that "the following non-clinical tests were conducted to evaluate the safety and effectiveness of the subjected device, and the test results indicated that this device is safe and effective." This implies that the device met the internal acceptance criteria for each test.

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

The document does not specify the sample sizes (number of devices tested) for the non-clinical tests. It also does not provide information about data provenance as these are laboratory-based mechanical tests, not clinical data sets.

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. This is a mechanical device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. This is a mechanical device. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or AI/ML ground truth establishment.

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 is a mechanical device, not an AI/ML device.

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

Not applicable. This is a mechanical device, not an AI/ML device.

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

Not applicable. For mechanical devices, "ground truth" is typically defined by engineering specifications, material properties, and mechanical test standards (e.g., ISO or ASTM standards) that define acceptable performance limits. The document states that the "non-clinical tests were conducted to evaluate the safety and effectiveness," implying adherence to established engineering and material science principles, but specific ground truth definition is not explicitly detailed in this summary.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a mechanical device, not an AI/ML device.

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The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.

The patient's need for knee replacement should be due to one or more of the following conditions:

• · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
• · Inflammatory degenerative joint disease including rheumatoid arthritis.
• · Functional deformity such as varus, valgus or flexion deformities.
• · Revision procedures where other treatments or devices have failed.
• · Fractures that are unmanageable using other techniques.

Signature Orthopaedic's World Knee replacement components may be intended for cemented or cementless use. Please verify whether the particular component is intented for cementless use by checking the package label.

The World Knee Total Knee System is a modular knee system consisting of a femoral component, meniscal insert, a patella and a tibial baseplate or all polyethylene tibia. The femoral component and meniscal inserts are available as posterior Stabilized or cruciate retaining variants. Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. The tibial baseplate components covered in this 510(k) is made of Titanium as part of the cemented version. The patella components are available in a spherical or non-symmetrical designs.

The primary purpose of this Special 510(k) Device Modification to the World Knee System is to notify the FDA of the change in materials used to manufacture the tibial inserts (all variants (CR, PS and UC) of modular meniscal insert and all-poly tibial baseplate components) to Vitamin-E Stabilized, 100 kGy crosslinked UHMWPE (Vit-E HXLPE). This 510(k) also notifies the FDA of minor design updates to the implants and reusable instruments.

Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (ASTM F1537-11) for the femoral component, Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) for the tibial baseplate components, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) for all variants of the patellar implants, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the Allpoly tibial baseplate components and modular meniscal tibial inserts.

This document is a 510(k) premarket notification from the FDA, approving the "World Knee Total Knee System". It primarily discusses the substantial equivalence of a modified device (incorporating Vitamin-E Stabilized, crosslinked UHMWPE for tibial inserts) to its previously cleared predicate devices.

Crucially, this document focuses on mechanical and material engineering evaluations, not on clinical performance studies involving human subjects or AI algorithms. Therefore, it does not contain information related to the acceptance criteria and study designs that would be relevant for devices that perform functions like image analysis or diagnostic assistance (e.g., AI-powered medical devices).

The acceptance criteria mentioned in this document are entirely related to the physical and material properties of the knee implant. The "study" proving the device meets these criteria is a series of engineering evaluations and material testing, performed in a lab setting, not a clinical trial with human subjects.

Therefore, many of the requested categories for AI/clinical study information (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, effect size, training set details) are not applicable to this type of device submission.

Here's an attempt to fill in the table and address the questions based solely on the provided text, recognizing that most of the requested information (especially for AI/clinical studies) is absent:

Acceptance Criteria and Device Performance (Based on Engineering Evaluations)

Study Details and Ground Truth Establishment

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of human clinical data or images. The "test set" here refers to material samples or components tested in a lab for physical and mechanical properties. The specific number of samples tested for each engineering evaluation (e.g., number of fatigue specimens, wear resistance samples) is not provided in this summary.
   • Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective clinical data collection. The data comes from laboratory testing and engineering evaluations performed by the manufacturer (Signature Orthopaedics Pty Ltd, Australia and Ireland).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth for material and mechanical properties is established through adherence to international and industry standards (e.g., ASTM, ISO) and the results of validated engineering tests. This is not a diagnostic device where human experts establish ground truth.

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

   • Not applicable. This is not a study requiring adjudication of expert opinions. The "results" are quantitative measurements from standardized laboratory tests.

4. 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. An MRMC study is completely irrelevant for this device. This is a knee implant, not a diagnostic imaging device or an AI application.

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

   • No. This is not an algorithm or AI device. "Performance" here refers to the device's physical and material integrity, not its diagnostic accuracy.

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

   • The "ground truth" for this device's performance is established by validated engineering and material testing standards (e.g., ASTM, ISO standards). These standards define the methodologies and acceptable ranges for properties like density, mechanical strength, wear resistance, and oxidation. The goal is to demonstrate that the new material/design is "substantially equivalent" or superior to existing, legally marketed predicates in terms of these physical characteristics.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

In summary, this FDA 510(k) approval document is focused on demonstrating the physical and mechanical equivalence of a new knee implant material and minor design updates to a previously cleared device, based on established engineering and material science principles, not on clinical performance or AI/diagnostic evaluation.

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