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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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The ADVANCE® BIOFOAM® and EVOLUTION® BIOFOAM® tibial bases are indicated for use in knee athroplasty in skeletally mature patients with 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 treatment of fractures that are unmanageable using other techniques.
   The ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only.

The DYNASTY® BIOFOAM® Acetabular Shell is 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, ankyloses, protrusion 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.
   The DYNASTY® BIOFOAM® Acetabular Shell is for uncemented use only.

A process change is taking place to introduce BIOFOAM® Additive Manufacturing (BIOFOAM® AM) as an alternative to the currently manufactured BIOFOAM® material used as a porous coating. BIOFOAM® AM will be used as a porous coating for MicroPort Orthopedics' tibial bases and acetabular shells with the current BIOFOAM® material as a porous coating. The BIOFOAM® AM is a porous material manufactured from the same raw material as the predicate, Commercially Pure Titanium conforming to ASTM F67, The surface treatment of BIOFOAM® AM is identical to the predicate and helps to provide initial fixation. The structure and porosity of BIOFOAM® AM is designed to encourage bone apposition.

The provided documentation is a 510(k) Summary for a medical device and does not contain the detailed data or study design typically found in a clinical study report or a validation study for an AI/ML powered device. This document describes the "BIOFOAM® Additive Manufacturing (BIOFOAM® AM)" as an alternative porous coating material for existing orthopedic implants, not an AI/ML device.

Therefore, many of the requested sections about AI/ML device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and standalone performance metrics are not applicable to the information provided in this document. The document focuses on demonstrating substantial equivalence of a new manufacturing process for a material to existing predicate devices, primarily through non-clinical testing.

However, I can extract the relevant information regarding the acceptance criteria (or performance metrics) used for the material and the study that proves it meets those criteria based on the provided text:

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

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: Not applicable as this is a non-clinical material testing study, not a study involving human 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):

• Not applicable. Ground truth for material performance is established through recognized ASTM standards and engineering measurements, not expert consensus in a medical diagnostic context.

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

• Not applicable. This is a non-clinical material testing study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a non-clinical material testing study, not an AI/ML device.

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

• Not applicable. This is a non-clinical material testing study, not an AI/ML device.

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

• The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1854) and comparisons to the performance of the predicate device materials. FDA Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces also served as a benchmark.

8. The sample size for the training set:

• Not applicable. This is a new material/manufacturing process, not an AI/ML model that requires training data.

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

• Not applicable.

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