(89 days)
Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for
- · Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
- · Avascular necrosis.
- · Conditions consequent to earlier operations.
- · Omarthrosis.
- · Rheumatoid arthritis.
- Revision of shoulder prosthesis.
The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.
Reverse Application of the Anatomical Shoulder System
· The Anatomical Shoulder Inverse/Reverse System is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
· The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.
Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following: • Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment
• Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
• Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment
· Fracture instability after osteosynthesis of 3- and 4part fracture fragments of the proximal humerus
- · Posttraumatic necrosis of the humeral head
- Posttraumatic arthrosis after humeral head fracture
The Humeral Fracture Stems are intended for either cemented or uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.
The Anatomical Shoulder System is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi shoulder arthroplasty.
Anatomical Shoulder Humeral Stems are available as either cemented or uncemented designs. Cemented stems are available in longer designs to support revision cases. All Humeral Stems possess a female oval taper geometry, which is the basis for all modularity with compatible mating components. For a hemi or total arthroplasty application, the stems can be combined with the proposed Anatomical Shoulder Domelock System, the existing Anatomical Shoulder Ball-taper Humeral Head System or the existing Anatomical Shoulder Bigliani/Flatow Adaptor. For a reverse application the stems are combined with the existing Anatomical Shoulder Inverse/Reverse components.
The Anatomical Shoulder Domelock System consists of a Humeral Head which is connected to the Anatomical Shoulder Stems using either an adjustable Domelock Dome centric including a Ball-taper and Expansion-pin, or a series of fixed-angle T-Domes. The Domelock Dome and T-Domes are used to set the orientation of the Domelock Humeral Heads. The male oval cone taper of the Domelock component is compatible with all Humeral Stems of the Anatomical Shoulder System. The assembled humeral component may be used alone for hemiarthroplasty or combined with the existing glenoid component of the Anatomical Shoulder System for total arthroplasty.
The Anatomical Shoulder Fracture System consists of a Humeral Fracture Stem and a Humeral Head Fracture including a Fracture Baseplate and a Looking Screw. The Anatomical Shoulder Fracture Stem is available as a slim and standard version, with longer stems available for revision surgery. They may be used with or without bone cement where appropriate fixation using cement or via a press-fit is achieved using the correct choice of rasp size. The Anatomical Shoulder Humeral Head Fracture offers right and left side-specific versions. The assembled Anatomical Shoulder Fracture humeral component may be used alone for hemiarthroplasty or combined with the glenoid component of the Anatomical Shoulder System for total arthroplasty. The Anatomical Shoulder Fracture Stem is also designed to accept the existing Anatomical Shoulder Inverse/Reverse components and the existing Anatomical Shoulder Bigliani/Flatow Adaptor.
The Humeral Stems and Baseplates are made from Protasul-100 (Ti6Al7Nb. ASTM F1295-11). The Domelock Humeral Heads, the Fracture Heads and the Fracture Screw are made from Protasul-21WF (Co28Cr6Mo, ASTM F1537-11). The Domelock head locking mechanism is made from Protasul-100 and Protasul-64WF (Ti6A14V, ASTM F136-13). The materials are anticipated to have permanent contact. All components are provided sterile (gamma irradiated) for use implantation in a hospital.
The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the Anatomical Shoulder™ System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in numerical terms (e.g., minimum tensile strength of X MPa). Instead, it lists the types of performance data collected and implicitly assumes that the results of these tests demonstrate safety and effectiveness, and substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these various tests.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Literature Review | Demonstrated that the devices are safe and effective. |
| Morphological and Range of Motion Analysis (ASTM F1378-12) | Demonstrated that the devices are safe and effective. (Implied |
| to meet standard requirements) | |
| Finite Element Analysis and Fatigue testing (ASTM F1378-12) | Demonstrated that the devices are safe and effective. (Implied to meet standard requirements for fatigue life and stress distribution) |
| Connection Strength Testing (ASTM F2009-00) | Demonstrated that the devices are safe and effective. (Implied to meet standard requirements for connection integrity) |
| Humeral Stem Fixation Testing | Demonstrated that the devices are safe and effective. (Implied to meet requirements for stable fixation) |
| Joint Contact Stresses Analysis | Demonstrated that the devices are safe and effective. (Implied to show acceptable stress distribution and wear characteristics) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This information is not provided in the document. The studies listed are "non-clinical performance testing and analyses," which typically involve a limited number of physical prototypes or virtual models, rather than a large patient-specific test set.
- Data Provenance: Not applicable in the context of non-clinical, in-vitro/computational testing. These are laboratory-based tests of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. These are physical and mechanical tests/analyses, using engineering standards (ASTM F1378-12, ASTM F2009-00), not expert-derived ground truth based on clinical data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no human interpretation or subjective assessment of clinical data that would require adjudication. The tests likely follow predefined protocols and acceptance criteria within the referenced ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect Size of human reader improvement: Not applicable, as no MRMC study was conducted. The submission specifically states: "Clinical data and conclusions were not needed to demonstrate substantial equivalence."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Not applicable. This device is a total shoulder joint prosthesis (mechanical implant), not an algorithm or AI system. The "performance data" refers to the mechanical and material characteristics of the implant components.
7. Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the "ground truth" is defined by the objective physical and mechanical properties measured against established engineering standards (ASTM F1378-12, ASTM F2009-00) and design specifications. This is engineering/physical measurement data and compliance with established standards.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. As this is a mechanical medical device, there is no "training set" in the context of an AI or algorithm. The design and manufacturing processes are refined through engineering principles, material science, and iterative testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable. There is no "training set" with associated ground truth for this type of device submission. The design and development process for such an implant relies on established biomechanical principles, material science knowledge, manufacturing standards, and pre-clinical testing data to ensure safety and effectiveness.
§ 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.”