FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

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)

AI/ML Overview

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.

Acceptance Criteria (Implied for 510(k) Submission)	Reported Device Performance (Implied from Substantial Equivalence Basis)
Substantial Equivalence to Predicate Devices:
- Intended Use	Meets: Indications for Use are listed as substantially equivalent to cleared total shoulder systems (Table 1).
- Material	Meets: Stated as substantially equivalent to competitive devices.
- Type of Interface	Meets: Stated as substantially equivalent to competitive devices.
- Design Features	Meets: Stated as substantially equivalent to competitive devices.
Safety and Effectiveness	Meets: "Adequately supported by the substantial equivalence information, materials data, and testing results provided, within this Premarket Notification." (Detailed testing results are not 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:

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.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided.
The sample size for the training set: Not applicable/Not provided.
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.

Summary

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”