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The WMT Modular Shoulder is indicated for use in shoulder arthroplasty for reduction or relief of pain and/or improved shoulder function in skeletally mature patients with sufficient and satisfactory bone stock to support the prosthesis with the following conditions:

Indications for Use:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis or post-traumatic 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 ULTRA-FITTM Modular Shoulder System consists of three main components: humeral stem, humeral head, and glenoid implants. All heads will be interchangeable with all stems, and glenoids will be matched to humeral heads. The glenoids will be available in two designs: The 3M-like glenoids are identical in intended use, type of interface, material, and design features to the 3M glenoid component submitted under 3M Modular Shoulder System (Table 1: K920362, SE 07/22/1993) currently distributed by WMT; and the WMT ULTRA-FITTM Glenoids that are described below.

The WMT ULTRA-FIT™ Humeral Stems will be available in four options:

• Press-fit slotted stems (4): 10,12,14,16mm X 125mm
• Cemented or press-fit non-slotted stems (7): 6, 8, 10, 12, 14, 16mm X 125mm; . 6mm X110mm
• Standard revision stems (4): 6, 8, 10, 12mm X 175mm
• Long revision stems (4): 6, 8, 10, 12mm X 225mm

The WMT ULTRA-FITTM Humeral Heads will be available in:

• 5 radii of curvature: 20, 22, 24, 26, and 28mm
• 3 heights: standard (defined by 155° to 160° arc), +3mm, and -3mm

The WMT ULTRA-FIT™ Glenoids will be available in:

• 6 radii of curvature (Keeled)

This 510(k) summary for the WMT ULTRA-FIT™ Modular Shoulder System does not contain the kind of detailed information about acceptance criteria and study design that would be found in a study proving a device meets acceptance criteria, especially not for an AI/ML device.

Here's why and what information is missing:

This document is a 510(k) Summary of Safety and Effectiveness, which is a premarket submission to the FDA for medical devices. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device already legally marketed in the U.S., not to prove performance against specific acceptance criteria through a detailed clinical or performance study in the way an AI/ML device would.

The document primarily focuses on:

• Intended Use and Indications for Use: Stating what the device is for.
• Device Description: Explaining its components and variations.
• Substantial Equivalence Argument: Comparing it to legally marketed predicate devices (other modular shoulder systems) based on intended use, materials, type of interface, and design features.

Therefore, the requested information about acceptance criteria, study sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/ML context is not present in this document.

To answer your request, here's what we can infer and what is explicitly missing from the provided text:

Acceptance Criteria and Device Performance

Since this is a 510(k) for a traditional medical device (shoulder prosthesis), the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The "performance" is considered equivalent to those predicates based on design and material similarities, rather than through specific quantitative metrics presented in this summary.

Missing Information (as it pertains to an AI/ML device study)

The following information, relevant for evaluating an AI/ML device's performance against detailed acceptance criteria, is not available in this 510(k) summary because it's for a traditional device demonstrating substantial equivalence:

1. Sample size used for the test set and the data provenance: Not applicable/Not provided. The 510(k) doesn't describe a specific "test set" in the context of an AI/ML algorithm's performance evaluation. The data supporting substantial equivalence would likely come from design verification/validation testing for the physical device (e.g., mechanical testing, biocompatibility), not a clinical data set for algorithm evaluation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment is not described for this type of device submission.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
4. 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: Not applicable. This device is an implant, not an AI diagnostic or assistance tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided.
7. The sample size for the training set: Not applicable/Not provided.
8. How the ground truth for the training set was established: Not applicable/Not provided.

In essence, this document is a regulatory filing for a physical medical implant (a shoulder replacement system), and thus the framework for evaluating and describing an AI/ML diagnostic or assistive device's performance against acceptance criteria does not apply here. The "proof" for this device lies in its demonstrated equivalence to already approved predicate devices.

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