Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The ELEOSTM Bipolar Acetabular System is indicated for the following conditions:

1. pathological fractures of the femoral neck
2. non-union of femoral neck fractures
3. aseptic necrosis of the femoral head and neck
4. primary pathology involving the femoral head or femur but with a non-deformed acetabulum.

ELEOS™ Bipolar Acetabular System is a bipolar hip implant design that features a cross-linked polyethylene bearing surface with a lock detail enhanced for strength. Historical concerns with traditional bipolar designs have included loosening of the insert, disassociation of the head from the shell, and osteolysis resulting from polyethylene wear. This system is designed to address these concerns to give surgeons greater confidence when using a bipolar implant.
There is an UHMWPE support ring inside the shell that is permanently fixed. There is also an UHMWPE locking ring that assembles above the support ring and locks into place once the head is inserted into the shell. Bipolar heads are available in a variety of diameters with corresponding internal diameters for 22, 28, 32 and 36mm femoral heads with skirts are not compatible with the bipolar shells.

The provided text is a 510(k) summary for the ELEOS™ Bipolar Acetabular System. It states that no performance data for the subject device (ELEOS™ Bipolar Acetabular System) is provided. Instead, the submission relies on the substantial equivalence principle, asserting that the subject device has the same materials, technology, and sterilization methods as the predicate device (GLADIATOR® Bipolar System, K062693).

Therefore, I cannot extract information about acceptance criteria and a study proving the device meets those criteria from this document. The document explicitly states:

"No performance data is provided. A copy of the full 510(k) for the predicate device (K062693) is provided because there are no technological differences between the subject and predicate devices."

As such, I cannot populate the table or answer the specific questions about sample size, provenance, experts, adjudication, MRMC studies, standalone performance, ground truth types, or training set details, as this information is related to performance data that is explicitly stated to be not provided for the subject device in this document.

Ask a specific question about this device

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

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

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

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

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

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

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

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

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

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

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

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

To answer your prompt directly based on the provided text:

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • Not applicable. No clinical test set was used, therefore no experts were used to establish clinical ground truth.

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

   • Not applicable. No clinical test set was used.

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

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

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

   • Not applicable. Not an algorithm/AI device.

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

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

8. The sample size for the training set

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

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

   • Not applicable. Not an AI model.

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

Ask a specific question about this device

The ADVANCE® Porous Coated Spiked Tibial Base is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

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

2. Inflammatory degenerative joint disease, including rheumatoid arthritis;

3. Correction of functional deformity

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

The ADVANCE® Porous Coated Spiked Tibial Base is for uncemented use only.

The subject device is a line extension of the ADVANCE® Total Knee System.

The ADVANCE® Porous Coated Spiked Tibial Base is a porous coated tibial component with spikes on the distal surface for additional fixation. The design features are summarized below:

• Manufactured from titanium alloy ●
• Titanium sintered bead porous coating .
• Offered in the same size ranges as the predicate device ●
• Compatible with all 510(k) cleared ADVANCE® II Tibial Inserts and . EVOLUTION® Adaptive Inserts

This document is a 510(k) Pre-Market Notification from the FDA regarding a medical device, the ADVANCE® Porous Coated Spiked Tibial Base. It does not describe an AI/ML device or a study involving such a device based on the prompt's request.

Therefore, none of the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details is present in the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval for a physical medical implant. It mentions:

• Device Name: ADVANCE® Porous Coated Spiked Tibial Base
• Regulation Number: 21 CFR 888.3565
• Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
• Class: Class II
• Product Code: MBH
• Indications for Use: (listed on page 2 and 4)
• Predicate Device: ADVANCE® HA Coated Spiked Tibial Base and HA Coated Modular Keel (K043083)
• Reference Devices: ADVANCE® II Porous Coated Modular Titanium Tibial Component (K061223) and EVOLUTION® CS/CR Porous Coated Femur (K140735)
• Nonclinical Testing: Rotational stability testing and fatigue evaluation per ASTM F1800 was performed on the primary predicate device. Porous coating characterization was done for the reference device. The subject device leveraged this data due to identical structural geometries and porous coatings.
• Clinical Testing: "Clinical data was not provided for the subject devices." (page 5)

Since no AI/ML component is mentioned or implied, the requested details for evaluating an AI/ML device are not applicable.

Ask a specific question about this device

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

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

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

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

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

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

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

Specifically, the document states:

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

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

Ask a specific question about this device