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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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Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, theumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.

The New Zimmer Shoulder features modular and monoblock cobalt-chrome alloy humeral stems intended for use with or without cement in total shoulder arthroplasty. The cobaltchrome alloy humeral heads feature female Morse-type tapers which facilitate assembly with the modular humeral stems. The keeled glenoid component is manufactured from UHMWPE. It is intended for cemented use only.

The provided text describes a 510(k) submission for the "New Zimmer Shoulder System." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics for the New Zimmer Shoulder System. Instead, it states:

2. Sample Size for the Test Set and Data Provenance

The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Performance Testing" section states that "Testing performed on the taper and the glenoid component demonstrated that the New Zimmer Shoulder System is safe and effective and substantially equivalent to predicate devices," but it does not specify what type of testing or how many samples were involved.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth or their qualifications. The testing described appears to be device-specific mechanical or functional testing rather than clinical evaluation requiring expert consensus on patient data.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as there is no indication of human-reviewed test sets or expert evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through component testing, not direct comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a physical shoulder joint prosthesis, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device would be based on engineering specifications, material science standards, and biomechanical parameters that define the safety and effectiveness of the components (taper and glenoid). The summary indicates that the testing demonstrated "safe and effective and substantially equivalent to predicate devices," implying that the performance was measured against established standards for shoulder prostheses.

8. Sample Size for the Training Set

This is not applicable as the device is a physical shoulder prosthesis, not an AI algorithm requiring a training set.

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

This is not applicable as the device is a physical shoulder prosthesis, not an AI algorithm.

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