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The Porous Coated Comprehensive® Fracture Stems are indicated for:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of functional deformity.
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
   Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.)
   Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).
   The Comprehensive® Fracture Stems are intended for use with the Bio-Modular Humeral Heads and glenoid components and Versa-Dial Humeral Heads.
   The Comprehensive™ Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive™ Fracture Stem.
   The Comprehensive™ Shoulder Stems (Fracture, Primary and Revision) are intended for use with the Bio-Modular™ Humeral Heads and glenoid components and Versa-Dial™ Humeral Heads.
   The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive™ Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular™ Shoulder Stems, the glenoid components of the Bio-Modular Shoulder System, and the glenoid components of the Comprehensive™ Shoulder System.
   When a humeral stem and/or Versa-Dial™ Taper Adapter is being used for a reverse shoulder application, the user should refer to the package insert (01-50-0903) continued with the reverse shoulder components for additional information, including alternate indications.

Biomet's Porous Coated Comprehensive® Fracture Stems consist of a humeral stem comprised of cast Co-Cr-Mo. The Proximal body of the stem contains 4 fins, three of which include suture holes to facilitate multiple attachment sites for the bone. The proximal body also contains a porous plasma-spray coating, which will allow for optimum fixation of the stem in the proximal humerus. The humeral stem contains a reverse taper which allows for the use of either a Bio-Modular® humeral head or glenoid component, a Versa-Dial® humeral head, or the Comprehensive® Reverse Shoulder humeral components.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "Porous Coated Comprehensive® Fracture Stems." It outlines the device's indications for use and compares it to predicate devices to establish substantial equivalence.

Based on the provided text, there is no acceptance criteria or study proving device performance in the context of an AI/ML medical device. The document is for a traditional medical device (shoulder replacement prosthesis) and does not describe an AI/ML algorithm. Therefore, I cannot provide the requested information.

The document discusses:

• Device Name: Porous Coated Comprehensive® Fracture Stems
• Indications for Use: various shoulder conditions including degenerative joint disease, rheumatoid arthritis, fractures of the proximal humerus, and revision surgeries.
• Predicate Devices: Comprehensive Humeral Fracture Stems (K023063), Comprehensive Primary Shoulder Stems (K060692), Kirschner® Neer-III™ Modular Proximal Humerus (K874643).
• Performance Data: "SUMMARY OF NON-CLINICAL TESTS - Median Fatigue Test" and explicitly states "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence."

Since this is for a traditional medical device and not an AI/ML device, the questions regarding acceptance criteria for an AI/ML algorithm, sample sizes, ground truth, expert adjudication, and MRMC studies are not applicable.

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