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The WMT Modular Shoulder System, humeral head and stem, is intended to be used for total or hemi-arthroplasty. When used for total shoulder arthroplasty, the subject components are to be used with shoulder artill oplaar glenoid components cleared in K920362 or with 3M Neer IITM Shoulder (K895226, SE 11/3/89) compatible glenoid components.

Indications for Use:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Revision where other devices or treatments have failed;
• Correction of functional deformity;
• Treatment of acute fracture of the humeral-head unmanageable using other treatment methods; and
• Cuff tear arthroplasty.

Hemi-shoulder replacement is also indicated for:

• Ununited humeral head fractures; and
• Avascular necrosis of the humeral head.

The humeral stem may be implanted by press-fit or cement fixation.

The WMT Modular Shoulder System includes humeral heads in five sizes. A regular length and long length humeral stem are available in identical diameters. Both humeral stems have four proximal flanges: one lateral, two anterior/posterior and one medial. The lateral flange has three suture holes and the anterior/posterior fins have one suture hole each. Both the regular and long stems are manufactured from titanium alloy (ASTM F 136). The heads are manufactured from cobalt chrome (ASTM F 1537, warm worked or ASTM F 799).

The provided text is a 510(k) summary for the WMT Modular Shoulder System. It describes the device, its intended use, indications for use, and a summary of testing. However, it does not contain information about acceptance criteria, detailed study designs, or specific performance metrics that would be used to prove a device meets acceptance criteria in the context of an AI/ML medical device.

The "Testing Summary" section states: "The WMT Modular Shoulder System was declared substantially equivalent to the predicate device. Mechanical test data demonstrated that the material and subject device design meet the strength requirements of the predicate device."

This statement indicates that mechanical testing was performed to demonstrate that the physical and design properties of the shoulder system are comparable to a previously cleared predicate device. It doesn't present a clinical study with quantifiable performance metrics, acceptance criteria, or ground truth as would be expected for an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies in the context of an AI/ML device from this document.

If this were an AI/ML device submission, the document would typically include:

• Acceptance Criteria Table: Specific thresholds for metrics like sensitivity, specificity, AUC, F1-score, accuracy, etc.
• Reported Device Performance: The actual measured values from the study for those metrics.
• Sample Size and Data Provenance: Details about the test set, including its size, origin (e.g., country), and whether it was retrospective or prospective.
• Ground Truth Experts: Number and qualifications of experts who established the ground truth.
• Adjudication Method: How disagreements among experts were resolved.
• MRMC Study: Information on comparative effectiveness studies, including effect sizes.
• Standalone Performance: If the algorithm was evaluated without human intervention.
• Type of Ground Truth: Whether pathology, consensus, or other methods were used.
• Training Set Details: Sample size and how ground truth was established for the training data.

Since this is a submission for a mechanical orthopedic implant, these types of details are not present.

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