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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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Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

• Osteoarthritis
• Post-traumatic arthrosis
• Focal avascular necrosis of the humeral head
• Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Fractures of the humeral head (with Short Humeral Stems).
• Fractures of the humeral head and proximal humerus, where other methods of treatments are deemed inadequate (with Standard or Long Stems).
• Difficult clinical management problems where other methods of treatment may not be inadequate.

Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

• A severely painful, disabling, arthritic joint
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
• Revisions of previously failed shoulder joint replacements

The INHANCE™ Convertible Glenoid system consists of a Baseplate with minor modifications compared to the previously cleared Baseplate in K212737 and a poly insert that locks atop the Baseplate to allow for an anatomic procedure. The Convertible Glenoid Insert implants are offered in four sizes: Small (24.0mm), Medium (26.5mm), Large (29.0mm), and X-Large (31.5mm). The Convertible Glenoid Insert implants consist of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) articulation surface and an interrupted fixation ring along with a finned central fixation post to facilitate poly locking to the Convertible Glenoid Baseplate.

The INHANCETM Convertible Glenoid Insert Implants have a lateral surface that is concave and designed to articulate with the Humeral Heads from the INHANCE Anatomic Stemmed and Stemless Shoulder Systems that are indicated for use in total shoulder arthroplasty.

The INHANCE™ Convertible Glenoid Baseplates, previously cleared in K212737, were modified to provide for a means of mechanical fixation between the Convertible Glenoid Inserts and Baseplates.

The INHANCE Convertible Glenoid implants are compatible with the implants and instruments previously cleared for use in the INHANCE Anatomic Shoulder System (K202716), the INHANCE Stemless Anatomic Shoulder System (K203108), and the INHANCE Reverse Shoulder System (K212737).

This document describes the regulatory approval for the INHANCE™ Convertible Glenoid device. It is a medical device, specifically a component of a shoulder arthroplasty system. Therefore, the "acceptance criteria" and "device performance" refer to the successful completion of specific non-clinical (mechanical, material, and biocompatibility) tests according to established standards, rather than the performance of an AI algorithm based on clinical data.

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

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes the regulatory approval for a medical device (orthopedic implant), not an AI algorithm. Therefore, the concepts of "test set" and "data provenance" specifically for AI evaluation are not applicable in this context. The "test sets" here refer to the samples of the physical device or its materials subjected to various non-clinical (mechanical, material, biological) tests as outlined above. The provenance of these test articles would be the manufacturing process of the INHANCE™ Convertible Glenoid components.

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

This information is not applicable. For physical medical devices, "ground truth" is established by adherence to recognized engineering standards (e.g., ASTM, ISO), which dictate testing methodologies and performance thresholds. These standards are developed and maintained by expert committees in relevant engineering and medical fields, but there isn't a "number of experts" establishing ground truth for a specific test set in the same way clinical data is evaluated for AI.

4. Adjudication Method for the Test Set

This information is not applicable. "Adjudication method" usually refers to resolving disagreements among human reviewers (e.g., radiologists) in AI or clinical studies. In the context of device testing, results are typically objective measurements against a standard, which are then analyzed and interpreted by qualified engineers/scientists.

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

This information is not applicable. An MRMC study is relevant to AI/diagnostic imaging devices. This document concerns the mechanical and material performance of an orthopedic implant.

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

This information is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this medical device, the "ground truth" is based on:

• Adherence to established international and national standards (e.g., ASTM F1378, ISO 10993-1, ASTM F2028, ASTM F1829, ASTM F2695, ISO 11607-1, ISO 11607-2, ISO 11137-1, ISO 11137-2).
• Engineering justifications and characterizations demonstrating equivalence to predicate devices and acceptable performance (e.g., non-worst-case for wear, identical material properties).
• Quantitative data derived from physical testing.

8. The Sample Size for the Training Set

This information is not applicable. There is no AI algorithm and thus no training set.

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

This information is not applicable. There is no AI algorithm and thus no training set or ground truth for it.

Summary of Device-Specific Information:

The INHANCE™ Convertible Glenoid is a shoulder arthroplasty component. Its acceptance for market (substantial equivalence to predicate devices) was based on a comprehensive series of non-clinical tests and evaluations covering:

• Range of Motion
• Biocompatibility
• Porous Structure Characterization
• AO-HXLPE Material Characterization
• Glenoid Wear Rate Evaluation
• Dynamic Evaluation of Loosening/Disassociation
• Static Evaluation of Locking Mechanism
• Glenoid Fatigue Resistance
• MRI Compatibility
• Shelf-Life
• Sterilization Validation

All these tests met their respective acceptance criteria as defined by national and international standards (ASTM, ISO) and FDA guidance, ensuring the device's safety and effectiveness. Clinical testing was explicitly stated as "not necessary to demonstrate substantial equivalence."

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