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

IN ANATOMIC : The stem and 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 Ascend Flex 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 stability and to relieve pain.

The Aequalis Ascend Flex 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 Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients 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. ostoorthritis and avascular necrosis
Correction of functional deformity
Fractures of the humeral head
Traumatic arthritis
Revision of the devices if sufficient bone stock remains

The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into a reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cuff-tear.

Notes:

All components are single use.
The coated humeral stem is intended for cemented or cementless use
The non-coated humeral stem is for cemented use only.
The all-poly glenoid components are intended for cemented use only
The glenoid sphere implant is anchored to the bone with screws and is for non-cernented fixation.
Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Indications For Use: Device Name: Aequalis Reversed Shoulder Prosthesis

Cemented Aequalis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Uncemented Aequalis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cufftear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cufftear. The humeral components are for uncemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis.

When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Note:

Titanium glenoid spheres are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium glenoid sphere is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Device Description

The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear.

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. It is a semi-constrained system composed of a humeral and a glenoid parts.

The Aequalis Ascend Flex Shoulder System consists of:

In an Anatomic configuration: A titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (CoCr or titanium) with a compatible UHMWPE Aequalis glenoid; or UHMWPE Affiniti Anatomic glenoid.
The Aequalis Ascend Flex Shoulder System stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total shoulder joint replacement.
In a Reversed configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a reversed adapter compatible with Aequalis Reversed glenoid implants (consisting of a sphere, a baseplate and screws). The reversed adapter consists of two components: a titanium tray and a UHMWPE reversed insert which includes a titanium locking ring.

This submission corresponds to the addition of new reversed inserts Aequalis Ascend Flex and glenoid spheres Aequalis Reversed II in diameter 33 mm and 39 mm compatible with each other. The indications for use, the materials, the manufacturing principle, the method of fixation, the packaging and the sterilization process of the pending reversed insert and glenoid spheres are identical or equivalent to the predicate devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for shoulder prosthesis devices, specifically the "Aequalis™ Ascend™ Flex Shoulder System" and "Aequalis Reversed Shoulder Prosthesis." This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical performance studies with specific acceptance criteria and ground truth establishment as is common for novel diagnostic or AI-driven devices.

Therefore, the information you've requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for device performance in the context of a new clinical study is not present in this document. This document focuses on demonstrating that the new devices are essentially the same as previously approved devices.

Here's an analysis of the provided text based on your request, highlighting what is (and isn't) present:

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

Not present in the traditional sense. For a 510(k) submission, the "acceptance criteria" are typically met by demonstrating that the new device has "substantially equivalent" technological characteristics and uses as the predicate devices. The "reported device performance" is not from a new clinical study with specific metrics, but rather inferred from the known performance of the predicate devices.
The document presents tables comparing the "Main features or system characteristics" of the pending devices to their predicates (pages 8-9). This is the closest equivalent to "performance comparison" in this context.

Table of Comparative Characteristics (from document, indicating "performance" by equivalence):

Feature/Characteristic	Aequalis Ascend Flex Shoulder System Reversed Inserts (Pending)	Aequalis Ascend Flex Shoulder System Reversed Inserts (Cleared Predicate)	Aequalis Reversed Shoulder Prosthesis (Reversed Inserts - Predicate)	Surgical Reverse Shoulder Prosthesis (RSP - Predicate)
Material	Polyethylene + titanium (locking ring)	Polyethylene + titanium (locking ring)	Polyethylene	Polyethylene
Reversed insert diameters	33mm, 39 mm	36 mm, 42 mm	36 mm, 42 mm	32 mm, 36 mm, 40 mm
Method of fixation (Glenoid components)	Uncemented	Uncemented	Uncemented	Unknown
Terminal sterilization	Gamma	Gamma	Gamma	Unknown
Manufacturer	Tornier	Tornier	Tornier	DJO

Feature/Characteristic	Aequalis Reversed II (Pending Glenoid Spheres)	Aequalis Reversed II (Cleared Glenoid Spheres - Predicate)	Surgical Reverse Shoulder Prosthesis (RSP Spheres - Predicate)
Material	Titanium, CoCr	Titanium, CoCr	CoCr
Glenoid sphere diameters	33mm, 39mm	36mm, 42mm	32 mm, 36mm, 40 mm
Method of fixation with base plate	Taper + Glenoid sphere Screw	Taper + Glenoid sphere Screw	Taper + Glenoid sphere Screw
Method of fixation (glenoid components)	Uncemented	Uncemented	Unknown
Terminal sterilization	Gamma	Gamma	Unknown
Manufacturer	Tornier	Tornier	DJO

"Acceptance Criteria" for a 510(k) in this context: The device is considered to meet "acceptance criteria" if the FDA determines it is "substantially equivalent" to predicate devices. This is based on:
* Same intended use.
* Similar indications for use.
* Equivalent major technological characteristics (materials, biomechanical features, fixation means, prosthetic dimensions).

2. Sample size used for the test set and the data provenance

Not applicable/Not present. This document does not describe a clinical performance study with a test set of data. The submission is based on engineering design, material specifications, and comparison to existing devices.

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

Not applicable/Not present. No ground truth establishment from expert review is described for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not present.

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/Not present. This device is a physical shoulder prosthesis, not an AI-driven diagnostic tool.

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

Not applicable/Not present. This device is a physical shoulder prosthesis, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not present.

8. The sample size for the training set

Not applicable/Not present.

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

Not applicable/Not present.

In summary, the provided document is a 510(k) summary for a medical device (shoulder prosthesis), which focuses on demonstrating substantial equivalence to predicate devices through technical comparisons rather than clinical performance studies involving test sets, expert ground truth, or AI performance metrics.

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.”