(59 days)
General indications: The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.
Indications: Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically suited to receive the implants.
The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws.
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 and Proximal Bodies are intended for cementless fixation.
The Modular Stems 75mm are intended for cemented or cementless fixation.
The Modular Stems, fully corundum blasted, are intended for cementless fixation.
The Modular Stems, fully polished, are intended for cemented fixation.
This system adds modular humeral stem components to the LINK Embrace Shoulder System – Reverse Configuration, comprised of Proximal Bodies and Modular Stems. The modular Proximal Bodies (Ti6A4V) are available in several sizes and heights. The Proximal Bodies feature a spiked surface, and m-l and a-p holes for suture fixation. The Proximal Bodies feature a proximal modular taper connection for assembly to the existing Reverse Tray components. The Proximal Bodies feature a distal modular taper connection for assembly to a modular stem.
The modular stems (Ti6Al4V) are available in different diameters and lengths as well as different surface options for cemented or cementless fixation.
The provided text is a 510(k) summary for the LINK® Embrace Shoulder System - Reverse Configuration. This document describes a medical device, specifically a shoulder prosthesis, and its substantial equivalence to previously cleared devices. It does not contain information about an AI/ML (Artificial Intelligence/Machine Learning) device or any study that proves such a device meets acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets them, as this information is not present in the provided text.
The document focuses on:
- Device Description: A shoulder joint replacement system, specifically an update adding modular humeral stem components.
- Indications for Use: When and for whom the device is intended.
- Comparison to Predicate Devices: Demonstrating that the new device is "substantially equivalent" to existing, legally marketed devices, primarily by comparing materials,
sterilization, packaging, and general design principles. - Performance Testing: Mentioning non-clinical performance tests (Range of Motion analysis, Fatigue testing with Fretting/Corrosion assessment, and post-fatigue disassembly tests)
to show mechanical safety and performance, but these are for the physical implant, not an AI component. - No Clinical Testing: Explicitly states that clinical performance testing was not required to demonstrate substantial equivalence for this device.
In summary, the provided text describes a conventional physical medical implant, not an AI/ML-driven device.
§ 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.”