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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® 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 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.

The EVOLUTION® Hinge Knee System is a hinged, constrained cemented total knee system being introduced as a line extension to MicroPort Orthopedics Inc.'s EVOLUTION® Revision knee portfolio. The system is composed of:

• a femoral component offered in 7 sizes (sizes 2-8) with femoral yoke fixation screw for ● attachment to the yoke assembly
• a hinge yoke assembly offered in 9 sizes based on femur size (size 2-3, 4-6, and 7-8) and tibial insert thickness (small, medium, large)
• a yoke extension stop offered in 3 options (0°, 5°, 10°)
• a tibial insert offered in 8 sizes (sizes 1-8) and in 5 thickness options (12, 14, 17, 20, 24mm)
• a tibial base offered in two variants:
  • modular (8 sizes, 1-8) with tibia locking screw for attachment to stem extensions o and stem extension adapters
  • monolithic (3 sizes, 1-3) with fixed small keel o
• . Offset adapters (2 sizes, 4mm x 25mm and 8mm x 25mm) and valgus stem adapters (2 sizes, 1° x 25mm and 2° x 25mm)
• Universal femoral augments
  • distal augments offered in 7 sizes (sizes B-H) in 4, 8, 12, 16, and 20mm o thicknesses
  • posterior femoral augments in 7 sizes (sizes B-H) in 4, 8, and 12mm thicknesses, O
• Medial and lateral tibial augments offered in 8 sizes (sizes 1-8) in 5, 10, and 15mm thicknesses

Components are manufactured from cobalt chrome alloy, titanium alloy, UHMWPE and crosslinked UHMWPE, and PEEK conforming to ASTM F75, F1537 - Alloy 1, F136, F648, F2026, respectively.

The system includes new and existing instrumentation from K140735, K162026, and K171389 to facilitate device implantation.

The subject femoral offset adapters and femoral valgus adapters are not for use with the EVOLUTION® Hinge tibial bases. The subject system is compatible with previously cleared stem extensions, stem extension adapters, and modular keels cleared in K162026 and patellae from K953439 and K122218. Furthermore, the subject universal femoral augments introduced in this 510(k) are backwards compatible with the EVOLUTION® Femurs cleared in K142550, K171389, and K182125.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) premarket notification for a knee system, primarily discussing its substantial equivalence to previously marketed devices based on non-clinical testing, design features, and materials.

It explicitly states:

• "Clinical data were not provided for the subject device." (Page 7, Section E. Clinical Testing)

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used and their qualifications for ground truth.
4. Adjudication method for the test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on mechanical and material testing, and substantial equivalence, not a clinical study involving an AI or diagnostic device with acceptance criteria for performance metrics like sensitivity or specificity.

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The PROFEMUR® RENAISSANCE® Classic Stems are 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; and,
4. revision procedures where other treatments or devices have failed.
   The PROFEMUR® RENAISSANCE® Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

The PROFEMUR® RENAISSANCE® Classic Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® RENAISSANCE® Classic Stems offer both reduced flare stems (7 sizes, 10-16), and standard flare stems (9 sizes, 10 - 18) and are coated with titanium plasma spray conforming to ASTM F1580. The subject device offers two neck offset options, Standard (neutral) and Extended (varus), as well as two proximal flare options, Standard and Reduced. The stem geometry, neck length, and neck offset are designed to create options identical to those available with the predicate modular device. The subject devices feature one minor additional change in that they have an impaction slot that is oriented 90 degrees from the impaction feature of the predicate device.

This document describes a 510(k) submission for the PROFEMUR® RENAISSANCE® Classic Stems. The provided text is a summary for a medical device and does not pertain to an AI device or a study involving human readers or AI assistance. Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided information, focusing on the available details from a medical device submission rather than an AI study:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical implant (femoral hip stem), and its performance is evaluated through mechanical testing, not through metrics like sensitivity, specificity, or AUC typically used for AI diagnostics.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in terms of number of devices tested, but the tests were mechanical fatigue and range of motion tests on the physical device. This is not a "test set" in the context of AI or clinical studies with patient data.
• Data Provenance: The data comes from nonclinical laboratory testing of the device itself (mechanical tests). There is no patient data or geographical provenance described.

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

Not applicable. Ground truth for mechanical tests is established by meeting predefined engineering specifications and international standards (e.g., ISO). There are no "experts" establishing ground truth in the sense of medical diagnoses or image interpretations.

4. Adjudication method for the test set

Not applicable. This concept pertains to methods for resolving discrepancies in expert opinions, which isn't relevant for 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. This is not an AI device, and no MRMC study was conducted.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

For mechanical testing, the "ground truth" is defined by compliance with established international standards (ISO 7206-4, 6, 8, and 21535) and internal company specifications for material properties and design.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Summary of the Study:

The study conducted was a series of nonclinical mechanical tests designed to demonstrate the safety and effectiveness of the PROFEMUR® RENAISSANCE® Classic Stems. These tests were performed on the device itself and were in accordance with recognized international standards for orthopedic implants (ISO 7206 and ISO 21535). The key finding was that the device satisfied the acceptance criteria for all specified tests, including proximal and distal fatigue and range of motion. The titanium plasma spray coating was also confirmed to be identical to that of the predicate device and applied according to specifications. No clinical data was provided. The submission states that the device's substantial equivalence is supported by the nonclinical testing data, materials information, and design features being similar to predicate devices.

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