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

IN ANATOMIC:
The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty. if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Aequalis Fx2 is indicated for use as a replacement of shoulder joints disabled by:

Rheumatoid arthritis with pain
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
Correction of functional deformity
Fractures of the proximal humerus
Traumatic arthritis
Revision of other devices if sufficient bone stock remains

IN REVERSE:
The Aequalis Fx2 is indicated for use as a replacement of shoulder joints with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

Rheumatoid arthritis
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
Correction of functional deformity
Fractures of the proximal humerus
Traumatic arthritis
Revision of the devices if sufficient bone stock remains.

The reversed insert is permitted to be used in the transformation to reverse Aequalis Fx2 without the removal of the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle.

Device Description

The Aequalis Fx2 is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.

The Aequalis Fx2 consists of:
in an anatomic configuration, a humeral stem compatible with Flex Shoulder System humeral heads ; Or

in a reversed configuration, a humeral stem and a reversed insert, compatible with Aequalis Reversed/Aequalis Reversed II glenoid implants.
The Aequalis Fx2 is intended for use as:
traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures,
in case of bone defect in the proximal part of the humerus,
a replacement of shoulder joints in primary anatomic or in primary reverse,
a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. -

The Aequalis Fx2 also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called Aequalis Fx2, a shoulder prosthesis. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo acceptance criteria and proving performance through a clinical study with a test set, ground truth, and expert evaluation as would be common for AI/ML-based devices.

Therefore, the specific information requested in the prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable to this type of regulatory submission for a traditional medical device (implant) like the Aequalis Fx2.

Instead, the document details physical and mechanical testing and a comparison of materials, design, and intended use to existing, cleared devices.

Here's a breakdown of what is provided, and why the requested information isn't present:

1. A table of acceptance criteria and the reported device performance:

Not Applicable in the traditional sense. For this device, "acceptance criteria" are related to mechanical and material properties meeting established standards and demonstrating equivalence to predicate devices, not diagnostic performance metrics (like sensitivity, specificity, accuracy).
What is provided: Table 1 on page 6 compares "Main features or system characteristics" of the Aequalis Fx2 to several predicate devices, including materials, standards, stem fixation, stem length, and diameter of reversed insert. This comparison aims to show technological equivalence.
Device Performance: The document states:
- "The results of these tests [pull out, torque, and fatigue testing] demonstrate the equivalence between the Aequalis Fx2 and the predicate devices." (Page 7)
- This implies that the Aequalis Fx2 performed comparably to the predicate devices in these mechanical tests, thus meeting the "acceptance criteria" for demonstrating substantial equivalence on a technical level. Specific numerical performance values are not provided as they would be for a software device.

2. Sample sized used for the test set and the data provenance:

Not Applicable. This device is a physical implant, not an AI/ML diagnostic or therapeutic device that would use a test set of data (e.g., images, patient records). The testing described (pull-out, torque, fatigue) are physical tests on the device itself.
What is provided: The document mentions "pull out, torque testing, and fatigue testing were performed." (Page 7). The sample size for these engineering tests is not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth, in the context of diagnostic AI/ML, refers to a definitive correct answer established by experts or other definitive means. This concept does not apply to the mechanical testing of a physical implant.

4. Adjudication method for the test set:

Not Applicable. As no test set of data is used in the AI/ML sense, there is no need for an adjudication method.

5. 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. MRMC studies are used to evaluate the impact of a diagnostic tool (often AI) on human performance (e.g., radiologists reading images). This device is a surgical implant and does not involve human readers interpreting data.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. This device is solely a physical implant. There is no algorithm to evaluate in a standalone manner.

7. The type of ground truth used:

Not Applicable. As explained in point 3, the concept of "ground truth" for diagnostic evaluation is not relevant here. The "truth" for this device lies in its physical properties and mechanical performance meeting established engineering standards and showing equivalence to legally marketed devices.

8. The sample size for the training set:

Not Applicable. This device does not involve machine learning; therefore, there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set for machine learning, this question is not relevant.

In summary: The provided document is a 510(k) submission for a non-AI medical device (a shoulder prosthesis). It demonstrates "substantial equivalence" to predicate devices through comparisons of design, materials, and mechanical testing results (pull-out, torque, and fatigue). The requested information primarily pertains to the evaluation of AI/ML-based diagnostic devices and is therefore not found within this type of regulatory submission.

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.”