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

IN ANATOMIC:
The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The AEQUALIS™ FLEX REVIVE™ Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The AEQUALIS™ FLEX REVIVE™ Shoulder System 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 humeral head
· Traumatic arthritis
· Revision of other devices if sufficient bone stock remains

IN REVERSE:
The AEQUALIS™ FLEX REVIVE™ Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:

Rheumatoid arthritis
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
· Correction of functional deformity
· Fractures of the humeral head
· Traumatic arthritis
· Massive and non-repairable rotator cuff tear
· Revision of the devices if sufficient bone stock remains

The reversed tray and polyethylene insert are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision with a functional deltoid muscle.

Device Description

AEQUALIS™ FLEX REVIVE™ Shoulder System (AFR) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation. AFR includes a proximal body (metaphysis), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Ascend Flex Humeral Head and Ascend Flex reversed trays and poly inserts.

The AFR Shoulder System is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Flex humeral heads or Ascend Flex reversed trays and inserts. In addition, the AFR Shoulder System can be transformed from anatomic to reverse shoulder prosthesis without the removal of the humeral implant assembly during revision surgery.

The humeral length is measured to determine the overall humeral implant construct length. The length is assembled from 120 mm (using the short proximal body and stem) to 300 mm (using the standard proximal body, spacers, and stem) in 10 mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity.

The proximal body, stem, and spacers are made from Ti6A14V per ASTM F-136. The proximal body and stem have a Titanium plasma spray coating. The assembly screw and locking cap are made of CoCr per ISO 5832-12. All implant parts are single use and packaged sterile, using gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10-6.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the AEQUALIS™ FLEX REVIVE™ Shoulder System. This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study or a clinical trial to establish the device's performance against specific acceptance criteria for diagnostic output.

Therefore, the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating the performance of an AI/diagnostic device, is not applicable to this document.

Here's why and what information can be extracted from the document:

Type of Device: The AEQUALIS™ FLEX REVIVE™ Shoulder System is a shoulder joint prosthesis, not a diagnostic device, AI software, or a device that produces a measurable output requiring a performance study against specific acceptance criteria like sensitivity, specificity, or accuracy.
Regulatory Pathway: The document is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves performance bench testing, biocompatibility, and sometimes design verification, but rarely requires large-scale clinical studies proving diagnostic or AI performance with clearly defined acceptance criteria in the way you've described.
"Non-clinical Performance Testing" Section: This section explicitly states the types of tests performed:
- Packaging Validation Testing
- Biocompatibility Evaluation
- Press-Fit Analysis
- Simulated Use Test
  These are engineering, material, and mechanical tests, not diagnostic performance evaluations.
"Clinical Testing" Section: This section explicitly states: "No clinical studies were performed." This is crucial as it directly answers point 5 and 6 of your prompt, indicating that no studies were done to assess human reader improvement with AI or standalone algorithm performance.

Based on the provided text, none of the specific details about acceptance criteria for AI/diagnostic performance studies, sample sizes for those studies, expert involvement, adjudication methods, MRMC studies, or specific ground truth for such studies can be extracted because they are not relevant to this type of device submission.

However, if we interpret "acceptance criteria" broadly in the context of this 510(k) submission, it refers to passing the non-clinical performance tests and demonstrating substantial equivalence to the predicate device.

Information that can be extracted or inferred from the document related to its regulatory acceptance is presented below, though it does not align with your specific questions about AI/diagnostic performance studies.

Acceptance Criteria and Device Performance (in the context of a 510(k) for a prosthesis):

Acceptance Criteria Category (as per 510(k) for a prosthesis)	Reported Device Performance / Assessment
Substantial Equivalence:	Demonstrated to be substantially equivalent to the predicate device (K181420).
Intended Use:	Identical to the predicate device.
Principles of Operation:	Identical to the predicate device.
Conditions for Use:	Identical to the predicate device.
Design Differences:	Differences (new distal stem components in additional lengths and a partially coated format) do not raise new issues of safety or effectiveness.
Material Composition:	Proximal body, stem, spacers: Ti6A14V per ASTM F-136. Assembly screw, locking cap: CoCr per ISO 5832-12. (Compared to predicate, implied to be acceptable).
Sterilization:	Gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10^-6. (Standard acceptance, implied).
Packaging Validation Testing:	Device passed all testing.
Biocompatibility Evaluation:	Device passed all testing.
Press-Fit Analysis:	Device passed all testing.
Simulated Use Test:	Device passed all testing.

Study Details (as they pertain to this 510(k) submission, not an AI/diagnostic study):

Sample sizes used for the test set and the data provenance: Not applicable in the context of AI/diagnostic performance. The document describes "non-clinical bench testing" and "process validations" for which specific sample sizes (e.g., number of components tested for strength, wear, etc.) are performed but not detailed in this summary document. There is no "test set" of patient data for diagnostic performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an implant, not a diagnostic tool requiring expert interpretation of images or data for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no "test set" of patient cases or diagnostic interpretations for adjudication.
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: No MRMC study was done. The document explicitly states: "No clinical studies were performed." This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithmic performance study was done. This is not an AI/algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/diagnostic context. For the device itself, the "ground truth" for its performance would be engineering specifications, material standards, and mechanical test results (e.g., passing pre-defined load limits, wear rates, etc.).
The sample size for the training set: Not applicable. This device does not use a training set for an AI model.
How the ground truth for the training set was established: Not applicable. This device does not have a training set.

In summary, the provided document is a regulatory communication for a medical device (a shoulder prosthesis) seeking 510(k) clearance based on substantial equivalence, not a study evaluating the performance of an AI or diagnostic device against specific clinical or imaging acceptance criteria.

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.”