(87 days)
General indications: The LINK Embrace Shoulder System - Anatomic Configuration is intended for anatomic total or hemi shoulder arthroplasty.
Indications:
• A severely painful and/or disabled shoulder joint resulting from osteoarthritis or theumatoid arthritis
- · Avascular necrosis of the humeral head
- · Deformity and/or limited motion
· Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
· Revision of a failed primary component - · Ununited humeral head fractures
- · Cuff tear arthropathy (CTA Heads only)
The All Poly Glenoid Components are intended for cemented use.
The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation.
The Humeral Stems Standard without CaP (HX) and Short without CaP (HX) are intended for cementless fixation.
The Humeral Fracture Stems are intended for cementless fixation.
The LINK Embrace Shoulder System offers diverse fixation options suitable for the majority of patient populations and indications. A wide range of stems in different configurations allows for cemented and cementless fixation.
Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature a proximal modular taper connection for assembly to head adapters. The monoblock Humeral Stems are available in Standard Stems and Short Stems with a broad size spectrum, and in non-coated and Calcium Phosphate coated versions. Humeral Fracture Stems are also available. The Humeral Stems have been previously cleared for use with the LINK Embrace Shoulder System – Reverse [K200368].
Humeral Heads (CoCrMo) are available in several sizes with a female taper for connection to the Head Adapters.
CTA Heads (CoCrMo) are available in neutral and different offset versions and feature a male taper for connection to Humeral Stems.
The Cemented All Poly Glenoids are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur).
The LINK Embrace Shoulder System is supported by a streamlined, lightweight and ergonomic instrument set.
Here's a breakdown of the acceptance criteria and study information, based on the provided text:
Important Note: The provided document is an FDA 510(k) clearance letter and a 510(k) Summary for a medical device (LINK Embrace Shoulder System - Anatomical Configuration). This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria for a novel AI/software function. Therefore, the questions related to AI/software performance metrics, ground truth, experts, and reader studies are not applicable to this document, as it describes a physical shoulder implant, not an AI-powered diagnostic or therapeutic tool.
The "acceptance criteria" in this context refer to the successful completion of non-clinical performance tests and analyses to demonstrate the device's safety and effectiveness compared to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Range of Motion analysis (ASTM F1378) | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Glenoid loosening (ASTM F2028) | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Fatigue testing with Fretting/Corrosion assessment | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Static and post-fatigue evaluation of component Locking Mechanisms (ASTM F2009) | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Wear Rationale | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Characterization of UHMWPE sterilized EO (reference K200368) | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Biocompatibility evaluation | Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion. |
| Overall Substantial Equivalence | The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicates. |
Regarding the other questions related to AI/Software Performance:
Since this document describes a physical medical implant (shoulder prosthesis) and not an AI/software device, the following questions are not applicable (N/A). The concept of "test set," "training set," "ground truth experts," and "reader studies for AI" do not apply in this context.
- Sample size used for the test set and the data provenance: N/A (Not an AI/software device)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/software device)
- Adjudication method for the test set: N/A (Not an AI/software device)
- 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: N/A (Not an AI/software device)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/software device)
- The type of ground truth used: N/A (Not an AI/software device)
- The sample size for the training set: N/A (Not an AI/software device)
- How the ground truth for the training set was established: N/A (Not an AI/software device)
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”