(186 days)
The Aequalis Ascend Flex Shoulder System is intended for use as:
- 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 Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.
IN ANATOMIC: The stem and head 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; Noninflammatory degenerative joint disease (i.e. osteoarthritis 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 Shoulder System total shoulder replacement and for transformation of the Aequalis Assend Flex 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 arthropatly is associated with a massive and non-repairable rotator cuff-tear.
The Aequalis Ascend Flex Shoulder System consists of:
- In a Anatomic configuration: A titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (COCr) 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 with compatible Aequalis Reversed glenoid implants.
The reversed adapter is comprised of two components: a titanium tray and a UHMWPE reversed insert.
The Aequalis Reversed glenoid implants is comprised of four components: Baseplate: made from Titanium; Glenoid sphere; made from of CoCr; Screw (baseplate/to glenoid sphere): made from CoCr and Fixation screws: made from Titanium.
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. This submission corresponds to the addition of Titanium Humeral Heads in anatomic to the Aequalis™ Ascend™ Flex Shoulder System.
The provided document is a 510(k) Summary for the Aequalis™ Ascend™ Flex Shoulder System, focusing on the addition of Titanium Humeral Heads. This type of regulatory submission demonstrates substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a comprehensive study in the way an AI/ML device would be evaluated.
Therefore, the requested information, which is typically relevant for AI/ML device evaluations involving clinical performance studies and ground truth establishment, is largely not applicable to this document. The document describes non-clinical (bench) testing to demonstrate mechanical equivalence, not clinical performance or diagnostic accuracy.
However, I can extract the relevant information the document does provide and indicate where the requested information is not present or not applicable.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define "acceptance criteria" in a quantitative manner as one would for diagnostic accuracy metrics (e.g., sensitivity, specificity thresholds). Instead, "device performance" is demonstrated through non-clinical (bench) testing, showing equivalence to predicate devices under simulated conditions.
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Wear Test | Titanium humeral head remains intact during its lifetime. Wear of new Ti/UHMWPE frictional couple is equivalent to predicate CoCr/UHMWPE frictional couple. | Equivalent results between Ti/UHMWPE and CoCr/UHMWPE in terms of: weight loss, wear rate, and shape/size of generated particles. |
| Anatomical Fatigue Test | Aequalis™ Ascend Flex Shoulder System (anatomical configuration with Titanium humeral head) remains intact during its lifetime, resisting load for 5M cycles without fracture or damage. | No fracture or damage observed after applying a load for 5 million cycles. Validated with titanium humeral head, similar to CoCr humeral head (predicate). |
| Reversed Fatigue Test | Aequalis™ Ascend Flex Shoulder System (reversed configuration after revision from anatomical to reversed, with Titanium humeral head) remains intact during its lifetime after 5M cycles without fracture or damage. | No fracture or damage observed after applying a load for 5 million cycles. Validated with titanium humeral head, similar to CoCr humeral head (predicate). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable in the context of clinical studies for diagnostic AI/ML. The tests mentioned are bench tests on physical devices/components. The sample size would refer to the number of physical samples tested, which is not specified in the summary document but would be detailed in the full test reports.
- Data provenance: Not applicable. The data comes from non-clinical bench testing, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in this context is established by the physical testing and material properties, not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This refers to expert consensus for clinical image interpretation, not mechanical testing.
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. This is for AI/ML diagnostic devices, not shoulder prosthetics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for AI/ML diagnostic devices, not shoulder prosthetics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests are the material properties and mechanical performance under specified conditions, determined by standardized test methodologies (e.g., ISO standards, and documented internal test protocols). The assessment is based on physical observation (e.g., absence of fracture, damage) and quantitative measurements (e.g., wear rate, weight loss), not clinical outcomes or pathology.
8. The sample size for the training set
Not applicable. There is no AI/ML algorithm being trained here.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML algorithm being trained here.
In summary, this 510(k) submission demonstrates the safety and effectiveness of a medical device (shoulder prosthesis component) through non-clinical (bench) testing, showing its equivalence to legally marketed predicate devices. The framework for describing acceptance criteria and studies for AI/ML devices is not directly applicable to this type of traditional medical device submission.
§ 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.”