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1. The TITAN Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
   Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid
   arthritis.Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted,
   separated from its blood supply or where the surgeon's experience indicates that alternative methods
   of treatment are unsatisfactory.Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not
   acceptable (e.g., revision of a failed primary component).Shoulder Hemiarthroplasty is also indicated for:
   Ununited humeral head fractures.Avascular necrosis of the humeral head.Rotator cuff arthropathy.Deformity and/or limited motion.The humeral component is intended for cemented or uncemented use. The glenoid component is intended for
   cemented use only.
2. The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe
   arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint
   must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is
   necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures including
   proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to
   gross rotator cuff deficiency. The glenoid baseplate is intended for cementless application with the addition of
   screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body
   component is intended for cementless use.
3. The Ascension HRA System is intended for resurfacing of the humeral head due to:
   Patients disabled by either non-inflammatory or inflammatory arthritis (i.e., rheumatoid arthritis,
   osteoarthritis and avascular necrosis)Mild or moderate humeral head deformity and/or limited motionPost-traumatic arthritisMalunions of the humeral headAcute fractures of the humeral headPatients with an intact or reparable rotator cuffContraindications:
   Infection, sepsis, and osteomyelitisOsteoporosisMetabolic disorders which may impair bone formationOsteomalaciaRapid joint destruction, marked bone loss or bone resorption apparent on roentgenogramRevision procedures where other devices or treatments have failed4. The Ascension Modular Radial Head is intended for:
   Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain,
   crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

• joint destruction or subluxation visible on x-ray
• resistance to conservative treatmentPrimary replacement after fracture of the radial headSymptomatic sequelae after radial head resectionRevision following failed radial head arthroplasty5. The Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty.
  Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone
  stock inadequate.

The purpose of this submission is the addition of MR Conditional information to the labeling of the predicate devices.
There are no other changes proposed in this submission. The following aspects of the devices are not impacted by
the additional labeling and remain identical to the predicate devices as cleared in their respective 510(k)s.
• Intended Use/Indications for Use
• Contraindications
• Design and Dimensions
• Performance Specifications
• Materials
• Biocompatibility

The provided document is a 510(k) summary for the Smith & Nephew TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), and Katalyst Bipolar Radial Head System (Katalyst).

However, the document does not contain information about an AI/ML-based medical device or any study demonstrating its performance against acceptance criteria. Instead, it focuses on the addition of MR Conditional information to the labeling of existing predicate devices. The "Non-Clinical Performance Data" section describes the testing performed to ensure MR compatibility, which is a different type of performance testing than what would be expected for an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML-based medical device from this document. The document describes a traditional medical device submission for orthopedic implants.

To answer your request, if this were a document about an AI/ML device, I would look for sections describing:

• Clinical Performance Study: Details about how the AI/ML model's output was evaluated, often involving a comparison to a ground truth or human expert readings.
• Performance Metrics: Specific metrics like sensitivity, specificity, AUC, F1-score, accuracy.
• Acceptance Criteria: Predetermined thresholds for these metrics that the device must meet to be considered effective.
• Test Set Description: Information on the size, source, and characteristics of the data used for testing.
• Ground Truth Establishment: How the definitive diagnosis or finding for the test data was determined (e.g., expert consensus, pathology, long-term follow-up).
• Reader Study Information: If applicable, details about human reader performance with and without AI assistance.

Since the provided document does not contain this type of information, I must state that it is not possible to fulfill the request based on the given input.

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