(357 days)
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 and structurally suited to receive the implants.
The Reverse Baseplate 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 or cementless fixation.
The Humeral Fracture Stems are intended for cementless fixation.
Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature a proximal modular taper connection for assembly to reverse tray components for rTSA configurations. The monoblock Humeral Stems are available in Standard Stems and Short Stems with a broad size spectrum, and in non-coated and Calcium Phospate coated versions. Humeral fracture stems are also available.
The Reverse Glenoid Baseplate (Ti6Al4V) hosts a central Bone Screw and up to 4 peripheral Bone Screws. The system includes anglestable (locking screws), polyaxial anglestable and standard screw fixation with cortical and cancellous thread designs. The baseplate's backside and central peg feature a porous titanium surface for biologic fixation. The Reverse Glenoid Baseplate is assembled with a CoCrMo Glenosphere for rTSA.
The LINK Embrace Shoulder System - Reverse Configuration offers Glenospheres in several diameters. And neutral and eccentric designs. The Embrace Glenospheres are connected to the Reverse Baseplate by means of a taper and locking screw.
Reverse Trays (CoCrMo) are available in neutral, inclined and offset versions, which are combined with Reverse Inserts (polyethylene) in neutral and 10° & 20° inclined versions, enabling the surgeon to adjust the mechanical parameters in different spatial planes (e.g. retroversion and inclination) independently from each other. In addition, different Insert heights are available.
The reverse inserts are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur®).
The LINK Embrace Shoulder System – Reverse Configuration is supported by a streamlined, lightweight and ergonomic instrument set.
The provided text is an FDA 510(k) summary for a medical device called the "LINK Embrace Shoulder System - Reverse Configuration." This document focuses on demonstrating substantial equivalence to already legally marketed devices, rather than proving the device meets specific performance criteria through clinical studies, AI algorithm validation, or human-in-the-loop performance evaluation.
Therefore, I cannot provide a table of acceptance criteria and reported device performance using the information given, nor can I answer questions related to AI performance, sample sizes for test/training sets, expert consensus, or MRMC studies. The document explicitly states:
"Clinical Testing: Clinical performance testing was not required to demonstrate the substantial equivalence of this device."
Instead, the submission relies on non-clinical performance testing and analysis to demonstrate that the device is suitable for its intended purpose and substantially equivalent to predicate devices. These tests are primarily mechanical and material characterization tests, not studies assessing clinical outcomes or AI algorithm performance.
Here's what I can extract from the provided text regarding the non-clinical testing:
Summary of Non-Clinical Performance Testing (as provided in the document):
| Test Type | Relevant Standard (if mentioned) | Purpose as Stated in Document |
|---|---|---|
| Range of Motion analysis | ASTM F1378 | To assess the device's range of motion characteristics. |
| Fatigue testing with Fretting/Corrosion assessment | N/A | To evaluate the device's durability and resistance to wear and corrosion under cyclic loading. |
| Glenoid baseplate loosening | ASTM F2028 | To assess the stability of the glenoid baseplate fixation. |
| Reverse Baseplate/Glenosphere Component Disassociation/Taper Connection Test | ASTM F2028 | To ensure the robust connection and prevent disassociation of these components. |
| Reverse baseplate and insert disassembly (lever-out, push-out, torque-out) testing | ASTM F1820 | To evaluate the mechanical integrity and resistance to disassembly of the baseplate and insert. |
| Bone screw testing | ASTM F543 | To assess the strength and performance of the bone screws used for fixation. |
| Wear rationale | N/A | To analyze and justify the wear characteristics of the device materials. |
| Impingement Testing | ASTM F2582 | To assess potential impingement phenomena within the shoulder system. |
| Characterization of UHMWPE sterilized by EO | N/A | To ensure the properties of the Ultra-High Molecular Weight Polyethylene are maintained after ethylene oxide sterilization. |
| Characterization of TrabecuLink porous surfaces | N/A | To assess the features and properties of the porous titanium surfaces for biologic fixation. |
Study Details from the provided document (where applicable):
- Sample sizes: Not specified for any of the non-clinical tests. These would typically be determined by the specific ASTM standards or internal validation protocols.
- Data provenance: Not explicitly stated, but these are laboratory-based, non-clinical tests likely conducted by the manufacturer or a contracted testing facility.
- Experts and Ground Truth: Not applicable in the context of this 510(k) summary, as it describes non-clinical mechanical testing, not clinical studies or AI algorithm validation requiring human expert consensus.
- Adjudication method: Not applicable.
- MRMC Comparative Effectiveness Study: Not performed (as per "Clinical performance testing was not required").
- Standalone Performance (algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of Ground Truth Used: Not applicable for non-clinical, mechanical testing. The "ground truth" would be the measured physical properties and performance against specified engineering criteria.
- Training Set Sample Size & Ground Truth Establishment: Not applicable, as this document does not describe the development or validation of an AI algorithm.
Conclusion stated in the document: The results of the non-clinical performance testing demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicate devices.
§ 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.”