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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. The device type (knee and limb salvage system implants) is a physical implant, not an AI-assisted diagnostic tool.

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The EVOLUTION® Tibial Cones are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis

2. Inflammatory degenerative joint disease, including rheumatoid arthritis;

3. Correction of functional deformity

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

The EVOLUTION® Tibial Cones are for uncemented use only.

The EVOLUTION® Tibial Cones are hollow, cone shaped accessory implants made of a Titanium Alloy substrate conforming to ASTM F136 and has a diffusion-bonded porous coating on the inner and out surface made Titanium conforming to ASTM F67 (OsteoSync™ Ti). These cones are to be used in knee arthroplasty in skeletally mature patients as part of the tibial implant construct. The subject device is press-fit into a reamed tibial void and then filled with bone cement to provide a reinforced cement mantle for the compatible tibial construct.

The EVOLUTION® Tibial Cones consist of 6 sizes of porous cones to be used particularly for complex knee replacement cases where there is severe defect where the bone will not provide appropriate fixation for the EVOLUTION® implants. The subject device is stackable to a construct of maximum 3 compatible sizes.

Overall functionality and indications for use of the device are identical to the predicate device, Regenerex™ Porous Titanium Sleeve Augments (K072336). The subject device possesses similar design characteristics being a tapered cone implant of similar dimension with a porous coating to promote greater bone adhesion.

The subject EVOLUTION® Tibial Cones are compatible with the EVOLUTION® Revision Tibia components (K162026, K231947) and the EVOLUTION® Hinge Knee System modular tibial bases (K230563). This 510(k) also seeks to expand the compatibility of the cement keel (K231947) to also be used with the EVOLUTION® Hinge Modular Tibial Base (K230563) as they are used in conjunction with the subject EVOLUTION® Tibia Cones. The EVOLUTION® Hinge Modular Tibia Base possesses the same identical modular stem taper as the currently compatible EVOLUTION® Revision Tibia (K162026). Therefore, assessments presented in K231947 are sufficient to support the compatibility with EVOLUTION® Hinge Modular Tibia Base.

The provided document is a 510(k) summary for the Microport Orthopedics EVOLUTION® Tibial Cones. This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML device.

Instead, this document details the substantial equivalence of a physical medical device (tibial cones used in knee arthroplasty) to legally marketed predicate devices. The "testing" mentioned is non-clinical bench testing for material properties and an MRI safety evaluation, not clinical studies or performance evaluations against acceptance criteria for an AI/ML algorithm.

Therefore, I cannot provide the requested information because the provided text does not describe an AI/ML device or its performance study.

Here's a breakdown of why this information is not present in the provided text:

• No AI/ML Device: The document describes "EVOLUTION® Tibial Cones" which are hollow, cone-shaped accessory implants made of titanium alloy with a porous coating. This is a physical orthopedic implant.
• No Acceptance Criteria for AI/ML Performance: The document does not mention any AI/ML model, its output, or any performance metrics like sensitivity, specificity, AUC, or accuracy which would be subject to acceptance criteria in an AI/ML study.
• No Study Proving AI/ML Performance: The "Nonclinical Testing" Section D lists tests related to the physical properties of the implant (e.g., porous coating evaluation, abrasion resistance, tensile strength, MRI safety). These are standard for physical medical devices and are not AI/ML performance studies.
• No Clinical Testing: Section E explicitly states, "Clinical data was not submitted or relied on for a determination of substantial equivalence." This further confirms that no studies involving human data (which would be central to an AI/ML medical device's evaluation) were performed or relied upon for this submission.

If you have a document describing an AI/ML medical device and its performance study, please provide that, and I would be happy to help.

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The EVOLUTION® Cement Keel is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis

2. Inflammatory degenerative joint disease, including rheumatoid arthritis;

3. Correction of functional deformity

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

The EVOLUTION® Cement Keels are for cemented use only.

MicroPort Orthopedics Inc. is seeking clearance to introduce the subject device, the EVOLUTION® Cement Keel, a line extension to the predicate EVOLUTION® Revision Tibial System cleared in K162026. It is a smaller, lower-profile size compared to the existing predicate Modular Keels, is manufactured from Ti6Al4V alloy conforming to ASTM F136, and is compatible with the same tapers as the predicate. The intended use of the subject modular keel is identical to the predicate, which is to provide optional rotational stability and added fixation to the compatible tibial bases.

The provided text is a U.S. FDA 510(k) summary for a medical device called the "EVOLUTION® Cement Keel." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study typically associated with AI/software devices.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable (N/A) because this submission is for a physical orthopedic implant seeking equivalence based on design, materials, and non-clinical testing, not a de novo or AI/ML-based device that requires extensive clinical validation against specific performance metrics using human experts and large datasets.

Here's the breakdown of the information provided in the context of your questions:

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

• Acceptance Criteria: The core "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to the predicate device (EVOLUTION® Revision Tibial System, K162026) regarding indicators for use, technological characteristics, and safety/effectiveness. There are no quantitative performance metrics for the device itself listed as acceptance criteria in the way you might see for a diagnostic AI.
• Reported Device Performance: The "performance" is demonstrated through:
  • Dimensional comparison analysis: The subject device is a smaller, lower-profile size compared to the predicate modular keels.
  • Leveraging predicate test data: Axial and rotational distraction testing data from the predicate (K162026) were leveraged due to dimensional equivalency.
  • Material equivalency: Manufactured from Ti6Al4V alloy conforming to ASTM F136, which is equivalent to the predicate.
  • MRI safety evaluation: Per various ASTM standards and FDA guidances (ASTM F2182-19, F2182-11a, F2181-11, F2052-15, F2213-17, F2119-07, and FDA guidances on MR environment safety).
  • Biocompatibility, sterility, and shelf life: Justified based on equivalency to the predicate, as the subject implant materials are identical, and overall geometry/site of application are the same.

Table (Conceptual - as actual metrics are not provided in this type of submission):

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

• Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing (dimensional analysis) and leveraging previous test data from the predicate device, not a distinct "test set" of patient data or a clinical study for the new device.
• Data Provenance: Not applicable for a new clinical data set. The data leveraged is from non-clinical mechanical testing and material evaluations of previous iterations or the predicate device.

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 as understood in the context of AI/ML or diagnostic device validation (e.g., expert consensus on medical images) is not relevant for this type of implant submission, which relies on engineering and materials science principles, and equivalency to previously cleared devices.

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

• Not applicable. There is no clinical "test set" requiring adjudication of findings.

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 is relevant for AI-assisted diagnostic tools, not for a knee implant.

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

• Not applicable. This is a physical orthopedic implant, not an algorithm.

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

• Not applicable in the context of clinical ground truth for diagnostic purposes. The "ground truth" for this device's acceptance is its compliance with engineering standards, material specifications, and its demonstrated substantial equivalence through non-clinical testing and comparison to the predicate device.

8. The sample size for the training set

• Not applicable. No training set is involved as this is not an AI/ML or data-driven device.

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

• Not applicable.

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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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MicroPort hip instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Hip Systems in their cleared indications for use.

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative ioint disease such as rheumatoid arthritis:
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed

Rough grit blast surfaces and the hydroxyapatite and titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty. LINEAGE® and DYNASTY® modular shells with porous metal bead coating are intended only for uncemented arthroplasty.

PRIME shells are intended only for uncemented arthroplasty.

The device modification consists of an alteration to the sterilization instructions for FDAcleared MicroPort Orthopedics' (MPO) non-sterile hip orthopedic joint replacement instruments. The subject instruments are part of MicroPort Orthopedics' hip product lines and are required to facilitate total hip arthroplasty procedures. The modification will allow the option to sterilize the subject instruments using an FDA-cleared containment device. The subject devices will be placed in an FDA-cleared containment device, which will be wrapped in an FDA-cleared CSR wrap or similar type nonwoven, medical grade wrapping material, and then steam sterilized.

The modified sterilization process of the subject instruments was successfully challenged and validated through worst-case load configurations using an FDA-cleared containment device. The intended use and sterilization parameters, such as cycle, temperature, and exposure time, remain identical to the predicate devices.

The review document provides details on the 510(k) submission for MicroPort Orthopedics Inc.'s MPO Hip Instruments, focusing on a modification to their sterilization instructions.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes (number of instruments) used for the sterilization validation or vibration testing. It refers to "worst-case load configurations" for the sterilization validation, implying that a representative selection of instruments was tested under challenging conditions. The data provenance is not specified, but it would typically be generated from internal testing conducted by MicroPort Orthopedics, Inc.

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

This information is not provided. The evaluations for sterilization validation and vibration testing rely on established standards (AAMI ST77, AAMI ST79, ISTA 2A), where "ground truth" is determined by meeting the specified physical and biological parameters within the standards, not by expert consensus in the typical sense of clinical image interpretation.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are compliance-based (meeting standards) rather than requiring adjudication of subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done. This device is an orthopedic instrument, and its effectiveness is not assessed through human interpretation of cases. The study focuses on the safety and efficacy of its reprocessing (sterilization).

6. Standalone Performance:

Standalone performance was implicitly assessed through the non-clinical testing. The instruments themselves, within the specified containment devices and sterilization cycles, directly underwent the validation tests to demonstrate their ability to achieve sterility and withstand integrity challenges. There is no "algorithm only without human-in-the-loop performance" as this is not an AI/software device.

7. Type of Ground Truth Used:

The ground truth used for these tests is based on accepted industry standards and scientific principles for sterilization and product integrity:

• Sterility: Achieved by demonstrating a Sterility Assurance Level (SAL) through biological indicators and physical parameters outlined in AAMI ST77 and AAMI ST79.
• Physical Integrity: Maintained by demonstrating the instrument's ability to withstand vibration during transit as per ISTA 2A.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of the reported studies. The modification is related to the reprocessing of physical instruments.

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

Not applicable, as there is no training set.

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MicroPort knee instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Total Knee Systems in their cleared Indications for Use as provided below:

MicroPort Total Knee Systems are 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.

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

Porous coated MicroPort total knee replacement implants, including ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants, are for use without bone cement.

MicroPort's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in quiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with MicroPort's ADVANCE® and EVOLUTION® Total Knee Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for single use only.

The device modification consists of an alteration to the sterilization instructions for FDAcleared MicroPort Orthopedics' (MPO) non-sterile knee orthopedic joint replacement instruments. The subject instruments are part of MicroPort Orthopedics' 510(k)-cleared knee product lines and are required to facilitate total knee arthroplasty procedures. The modification will allow the option to sterilize the subject instruments using an FDA-cleared containment device. The subject devices will be placed in an FDA-cleared containment device, which will be double-wrapped in an FDA-cleared CSR wrap or similar type nonwoven, medical grade wrapping material, and then steam sterilized.

The modified sterilization process of the subject instruments was successfully challenged and validated through worst-case load configurations using an FDA-cleared containment device. The intended use and sterilization parameters, such as cycle, temperature, and exposure time, remain identical to the predicate devices.

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

Acceptance Criteria and Device Performance Study for MPO Knee Instruments Reprocessing Change (K213817)

This submission (K213817) focuses on a modification to the sterilization instructions for existing, FDA-cleared MicroPort Orthopedics' non-sterile knee instruments. The device itself (the instruments) remains unchanged in its design or intended use. The study specifically validates the modified sterilization process.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a sterilization process change rather than a new diagnostic or AI-driven device, the acceptance criteria are related to the effectiveness of the sterilization and the integrity of the instruments after the new process.

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

The document does not explicitly state a numerical "sample size" in terms of how many individual instruments were tested or how many sterilization cycles were run. However, the testing was conducted under "worst-case load configurations," implying a robust validation approach.

• Sample Size: Not explicitly stated as a numerical count of individual instruments or cycles. Testing was performed under "worst-case load configurations" and for "MicroPort orthopedic joint replacement instruments."
• Data Provenance: The studies were non-clinical validation tests performed by MicroPort Orthopedics Inc. There is no mention of country of origin for data or whether it was retrospective or prospective, as it pertains to laboratory validation of a manufacturing process change.

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

This section is not applicable to this submission. The device is a set of surgical instruments, and the study is a non-clinical validation of a sterilization process. There is no "ground truth" to be established by human experts in the way that would apply to diagnostic imaging or AI devices. The conformity to sterilization standards (AAMI ST77:2013 and AAMI ST79:2017) and vibration testing (ISTA 2A) serves as the "ground truth" for the performance of the modified process.

4. Adjudication Method for the Test Set

This section is not applicable. Since there are no human experts establishing a ground truth for a diagnostic outcome, there is no adjudication method. The test results are objective measurements against established engineering and sterilization standards.

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

No. A MRMC comparative effectiveness study is designed for evaluating human performance, often with and without AI assistance, typically in diagnostic tasks. This submission is for surgical instruments and a sterilization process change, so such a study is not relevant or required.

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

No. This question typically applies to AI algorithms. The device being discussed is physical surgical instrumentation, and the study is evaluating a sterilization process, not an algorithm's performance.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established by adherence to recognized industry standards and validated testing protocols for sterilization and material integrity:

• Sterility: Demonstrated by successful validation according to AAMI ST77:2013 and AAMI ST79:2017, likely involving biological indicator testing and sterility assurance level (SAL).
• Physical Integrity/Durability: Demonstrated by successful vibration testing according to ISTA 2A.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of validating a sterilization process for physical surgical instruments. Training sets are relevant for machine learning algorithms.

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

This section is not applicable, as there is no training set for this type of submission.

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The Prime Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

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.

Shells with BIOFOAM® coating are intended only for uncemented arthroplasty.

MicroPort is introducing the Prime BIOFOAM® Multi-Hole Shells as a line extension of its existing Prime Acetabular System (K170444, K171181, K180798, and K181598). The subject implants are single use only, are provided sterile, and are to be implanted only by orthopedic specialists in an operating room setting. Associated instrumentation is reusable, provided nonsterile, and are to be used only by orthopedic specialists in an operating room setting.

The Prime BIOFOAM® Multi-Hole Shell includes 10, 12, or 14 screw hole variations. The subject acetabular shells can be used with existing MicroPort devices listed in Section G, Table 3 to form a complete total hip system.

• Multi-Hole Acetabular Shells
  • Material: Ti alloy conforming to ASTM F620 O
  • Coating: Commercially Pure Ti Foam conforming to ASTM F67 O (BIOFOAM®)
  • Outer diameters: 42mm to 68mm with 2 mm increments O
  • Variants: 10, 12, or 14 screw holes O
  • Sterilized using Gamma Radiation O

This FDA 510(k) summary (K201157) is for the Prime BIOFOAM® Multi-Hole Shells, an acetabular shell used in total hip arthroplasty. The document asserts substantial equivalence to existing predicate devices based on design features, materials, and nonclinical bench testing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results against such criteria. Instead, it relies on demonstrating equivalence to predicate devices through design similarity and standard mechanical testing.

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

• Sample Size: Not specified. The document states "bench testing was performed" for mechanical tests, but doesn't quantify the number of units tested. For MR conditionality, predicate test results were leveraged, so no new test set was used for the subject device in this regard.
• Data Provenance: The document implies the mechanical bench testing was conducted by MicroPort Orthopedics Inc. The general provenance is regulatory submission data. The studies are non-clinical (bench) studies, not human subject studies, so concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply in the same way they would for clinical trials. The data is generated ex vivo.

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

This section is not applicable as the studies described are non-clinical bench tests. "Ground truth" in this context typically refers to clinical diagnosis or outcomes for human subjects. For mechanical and material testing, the "ground truth" is defined by the physical properties measured against established standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

This section is not applicable as the studies described are non-clinical bench tests. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where expert consensus is needed to establish ground truth from patient data.

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 section is not applicable. The device described is a physical orthopedic implant (acetabular shell), not an AI/software device that assists human readers in interpreting medical images. Therefore, an MRMC study is outside the scope of this device's evaluation.

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

This section is not applicable. The device is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is established by:

• Standardized Test Methods: Adherence to recognized international and national standards such as ISO 7206 series and ASTM F series (F620, F67, F3090, F1820, F2068, F2052, F2119, F2503, F2182). These standards define how performance characteristics (like fatigue, frictional torque, material properties) are measured and evaluated.
• Material Specifications: Compliance with ASTM standards for material composition (e.g., ASTM F620 for Ti alloy, ASTM F67 for Commercially Pure Ti Foam).

8. The Sample Size for the Training Set

This section is not applicable. As a physical orthopedic implant (not an AI/ML device), there is no "training set" in the context of machine learning. The design and manufacturing process are subject to engineering design principles and quality control, not algorithmic training.

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

This section is not applicable for the same reason as point 8.

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The Prime and DYNASTY® Additive Manufacturing Shells are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

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.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

MicroPort Orthopedics Inc. is introducing the Prime and DYNASTY® Additive Manufacturing (AM) Shells as a line extension of its existing Prime and DYNASTY® Acetabular Systems. The Prime and DYNASTY® AM Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and are designed for cementless use on the bone interfacing surface. The device design is identical to its corresponding predicate devices. The design features of the Prime and DYNASTY® AM Shells are summarized below.

• Prime AM Shells: ●
  • Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
  • Available in the following configurations and their respective sizes: -
    • Solid (46mm-68mm outer diameter)
    • Quad (42mm- 68mm outer diameter) .
  • Sterilization: Gamma Sterilization -
• DYNASTY® AM Shells: ●
  • Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
  • Available in the following configurations and their respective sizes:
    • o Standard (46mm- 76mm outer diameter)
    • Primary (46mm-68mm outer diameter) o
    • Revision (46mm-76mm outer diameter) o
  • Sterilization: Gamma Sterilization -

The subject implants are single-use only, are provided sterile, and are prescription only devices, intended to be implanted only by orthopedic specialists in an operating room setting.

The provided text does not contain information about an AI/ML-based medical device. Instead, it describes a traditional medical device, specifically Prime and DYNASTY® Additive Manufacturing Shells, which are hip implants.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI/ML device meets those criteria. The document details the substantial equivalence of the hip implants to legally marketed predicate devices based on non-clinical bench testing, material properties, and design similarity, not performance metrics for an AI algorithm.

Here's why the requested information cannot be provided from the given text:

• No AI/ML Component: The device described is a physical orthopedic implant. There is no mention of any AI or machine learning algorithm.
• No "Performance" in the AI/ML Sense: The "performance" discussed in the document relates to mechanical properties (tensile strength, fatigue, deformation, corrosion, shear strength, etc.) and biocompatibility of the implant, not the diagnostic or predictive performance of an algorithm.
• No Test Set/Training Set: These concepts are specific to AI/ML model development and evaluation. The document discusses "worst-case constructs" for physical testing and "predicate nonclinical test results," which are entirely different.
• No Experts for Ground Truth/Adjudication: Ground truth establishment and adjudication by experts are crucial for evaluating AI/ML models in medical imaging, but this is irrelevant for a physical implant.
• No MRMC Study: A Multi-Reader Multi-Case study is for evaluating human performance, often with or without AI assistance, in interpreting medical data. This device is not an interpretation tool.
• No Standalone Algorithm: This phrase applies to an AI algorithm operating without human intervention for diagnostic or predictive tasks.

In summary, the provided document does not describe an AI/ML device, and thus, the questions posed (which are relevant to AI/ML device evaluation) cannot be answered from this text.

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PROFEMUR® GLADIATOR® Cemented Classic Stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

The PROFEMUR® GLADIATOR® Cemented Classic Stems present a tapered-wedge design and a reduced distal stem tip, identical to the legally marketed modular PROFEMUR® GLADIATOR® Cemented Stem (K111910, SE 10/14/2011) with PROFEMUR® Cobalt Chrome Modular Necks (K091423, SE 08/25/2009; K100866, SE 04/28/2010). The subject stems are intended to be cemented and have a glass-beaded body, medial collar, proximal shoulder and neck region with a surface roughness identical to the legally marketed modular PROFEMUR® GLADIATOR® Cemented Stem (K111910, SE 10/14/2011) with PROFEMUR® Cobalt Chrome Modular Necks (K091423. SE 08/25/2009; K100866. SE 04/28/2010). The subject stems possess a proximal medial collar designed to assist rotational stability and offer protection against subsidence, identical to the cleared predicate PROFEMUR® GLADIATOR® Cemented Stem (K111910, SE 10/14/2011) with PROFEMUR® Cobalt Chrome Modular Necks (K091423, SE 08/25/2009; K100866, SE 04/28/2010). The trunnion is a MicroPort 12/14 SLT taper, with an as-machined geometry to form a taper lock with a mating femoral head implant. The trunnion is identical to the MicroPort femoral stem tapers of the predicate and reference devices. The subject stems possess an oval impaction feature on the proximal shoulder for proper femoral stem insertion into the femoral canal, identical to the cleared reference PROFEMUR® GLADIATOR® Thin HA Classic Stem w/ Collar (K200007, SE 04/25/2020). The subject PROFEMUR® GLADIATOR® Cemented Classic Stems are manufactured from forged cobalt chromium alloy (ASTM F799). The PROFEMUR® GLADIATOR® Cemented Classic Stems were designed to accommodate a wide range of patient anatomy and to provide an optimized fit to adequately restore the biomechanics of the respective hip (including restoration of the natural leg length and head center offset). The subject PROFEMUR® GLADIATOR® Cemented Classic Stems are offered in sizes 4, 6, 8, 10, and 12 with the stem length ranging from 125mm to 170mm, identical to the cleared reference PROFEMUR® GLADIATOR® Cemented Stems (K111910, SE 10/14/2011). The subject classic stem possesses two different neck options: standard (with a CCD neck angle of 135°) and extended/Varus 8° (with a CCD angle of 127°).

This document describes a 510(k) premarket notification for the "PROFEMUR® GLADIATOR® Cemented Classic Stem," a hip joint prosthesis. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence through mechanical testing and engineering analyses. The acceptance criteria are implicitly that the subject device performs equivalently to the predicate devices under standardized tests.

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

The document states that "worst-case constructs" were used for mechanical testing. However, it does not specify the exact sample size (e.g., number of stems tested per condition) for the mechanical tests.

The data provenance is not explicitly mentioned as "country of origin" or "retrospective/prospective." Given this is a 510(k) submission for a medical device (hip stem), the testing data is typically generated in a controlled laboratory environment by the manufacturer (MicroPort Orthopedics Inc., located in Arlington, Tennessee, USA). It is not clinical data but rather benchtop mechanical testing.

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

This information is not applicable to this document. The "ground truth" for the test set is established by industrial standards (e.g., ASTM, ISO) and engineering analysis, not by human expert consensus or clinical observation for this type of device submission. The performance is objectively measured against predefined criteria in these standards.

4. Adjudication Method for the Test Set:

This information is not applicable. As the evaluation is based on objective mechanical testing against engineering standards, an adjudication method for human interpretation is not relevant.

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. This submission is for a hip replacement implant (a physical medical device) and does not involve AI, human readers, or image interpretation.

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

This information is not applicable. This submission is for a hip replacement implant and does not involve an algorithm.

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

The "ground truth" for the performance evaluation in this context is based on standardized mechanical testing protocols and design specifications compliant with recognized industry standards (ASTM, ISO). The performance is measured directly and objectively against these standards.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is a physical medical device and not an AI/machine learning model.

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

This information is not applicable for the same reason as point 8.

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