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The EVOLUTION® Revision 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® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

The EVOLUTION® Revision Tibial System is being introduced to supplement MicroPort Orthopedics' knee product lines to provide revision surgery options with a cemented tibial base. The design features are summarized below:

• Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought) .
• Available in 8 standard sizes, left and right ●
• . Available in 3 plus sizes, left and right
• Tibial base has holes for augment attachment screws
• System includes tibial base, modular keels, block augments, stem adapters (offset & extension), stem extensions (cemented & canal-filling cementless) and stem caps (metallic and poly)

The provided text is a 510(k) Summary for a medical device called the "EVOLUTION® Revision Tibial System." This document is a regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how training set ground truth was established) are not applicable or provided in this document as it pertains to a mechanical orthopedic implant, not an AI/software device that would involve such testing.

Here's a breakdown of the available information:

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

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

This information is not provided. The testing described is non-clinical (laboratory/mechanical testing of the implant itself) and does not involve human sample sizes or data provenance in the context of clinical trials or AI model evaluation.

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. The ground truth for mechanical device performance is established by engineering standards (e.g., ASTM F1800, ASTM F2009) and the physical properties of the materials and design, not by expert human interpretation in a medical imaging context.

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

Not applicable. Adjudication methods are relevant for human-interpreted medical data, not for mechanical device testing.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" for the non-clinical testing is based on established engineering standards and specifications (e.g., ASTM standards for fatigue and static evaluation), and the physical test results compared against those standards or the predicate device's established performance.

8. The sample size for the training set

Not applicable. This is a physical orthopedic implant, not a software/AI device that requires a training set.

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

Not applicable. There is no training set for this type of device.

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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.

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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.

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