(154 days)
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthroplasty or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation.
The Glenoid Polyaxial Non-locking Screws are line extensions to the Medacta Shoulder Reverse System (K170452) and the Threaded Glenoid Baseplate (K171058); and provide compatibility with Short Humeral Stem (K180089).
The Glenoid Polyaxial Non-locking Screws implants subject of this submission are comprised of the following products: Glenoid Polyaxial non-locking screw, 10 sizes: from L14 mm to L50 mm with 4mm increment. The Glenoid Polyaxial Non-locking Screws implants are part of the Medacta Shoulder Reverse System. The Medacta Shoulder Reverse System consists of the following components: Humeral Diaphysis Cemented; Humeral Diaphysis Cementless; Humeral Reverse Metaphysis; Humeral Reverse HC Liner (also referred to as PE Liner); Glenoid Baseplate - Pegged; Glenoid Baseplate - Threaded; Glenoidsphere; Glenoid Polyaxial Locking Screw (predicate item); Glenoid Polyaxial Non-Locking Screw (subject item); Reverse Metaphysis Screw; and Glenoidsphere Screw.
The Glenoid Baseplate (pegged version and threaded version) is intended to be fixed on the glenoid bone by means of a central pressfit and with the help of Glenoid Polyaxial Screws. The purpose of this submission is to gain clearance for the new Medacta Glenoid Polyaxial Non-Locking Screws, thus providing to surgeons an alternative to Glenoid Polyaxial Locking Screws for the Glenoid Baseplate fixation process.
The Glenoid Polyaxial Non-Locking Screws are made of Ti-6Al-4V), enhanced with Type-II anodization, according to ISO 5832-3:1996 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.
The provided text describes a 510(k) premarket notification for a medical device, specifically Glenoid Polyaxial Non-locking Screws. This document focuses on demonstrating substantial equivalence to predicate devices through a comparison of physical characteristics and mechanical testing. It does not involve AI/ML components or clinical studies that would require the type of acceptance criteria and performance data typically associated with AI/ML devices (e.g., sensitivity, specificity, algorithm-only performance, human reader studies with AI assistance).
Therefore, the requested information regarding AI/ML acceptance criteria and performance (ground truth, expert adjudication, MRMC studies, training/test set details) is not applicable to this submission.
The "Performance Data" section (Section VII) only details non-clinical, mechanical tests.
Here's a summary of the available information relevant to acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." However, the specific quantitative acceptance criteria and the numerical reported device performance are not detailed in the provided text. It lists the types of tests performed and the relevant ASTM standards, implying that meeting these standards was the acceptance criterion.
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Design Validation Report | Meets design specifications | Not explicitly stated; implied by "demonstrated through comparison..." |
| Micromotions Assessment (ASTM F2028-14) | Conforms to standard requirements | Not explicitly stated |
| Static Fatigue Testing (ASTM F543-13) | Conforms to standard requirements | Not explicitly stated |
| Pull-Out Test (ASTM F543-17) | Conforms to standard requirements | Not explicitly stated |
| Bacterial Endotoxin Test (European Pharmacopoeia §2.6.14/USP chapter ) | Meets pyrogenicity standards | Not explicitly stated |
| Pyrogen Test (USP chapter ) | Meets pyrogenicity standards | Not explicitly stated |
2. Sample Size Used for the Test Set and Data Provenance
This is not an AI/ML study, so the concept of test sets for algorithm performance doesn't apply. The "sample size" would refer to the number of devices or components tested in the mechanical studies. This information is not provided in the text. The data provenance is implied to be from internal laboratory testing conducted by Medacta International SA.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth as typically understood in AI/ML (e.g., expert labels for images) is not relevant for this type of mechanical device submission.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a mechanical device, not an AI-assisted diagnostic tool. No human reader studies were conducted or are relevant to this type of submission.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
Not applicable in the context of AI/ML. For mechanical testing, the "ground truth" would be established by the physical properties and performance characteristics defined by the referenced ASTM and European Pharmacopoeia standards.
8. Sample Size for the Training Set
Not applicable. There is no AI/ML training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.”