(83 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 if bone stock is adequate.
• Avascular necrosis.
• Conditions consequent to earlier operations.
• Optional use in revision: in some medical conditions (e.g. early revision when adequate bone stock exits), the surgeon may opt to use primary implants in a revision procedure).
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 Anaverse Anatomical Shoulder Pegged Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System
• The Anatomical Shoulder Reverse System and the ASHCOM Shoulder system are 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 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 4-part 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 use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented are intended for cemented use only.
Anatomical Shoulder Combined System
Advanced destruction of the shoulder joint resulting from:
• Omarthrosis
• Rheumatoid arthritis
• Post-traumatic arthritis
• Avascular necrosis of the humeral head
• Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)
• Conditions following earlier operations
The Anatomical Shoulder Combined System is intended for cemented or cementless use.
When used with the following humeral stems the Anatomical System is intended for cemented use.
• Anatomical Shoulder Standard Cemented Humeral Stem
• Anatomical Shoulder Long Stem
When used with the following humeral stem the Anatomical System is intended for cementless use:
• Anatomical Shoulder Standard Uncemented Stem.
When used with the following humeral stems the Anatomical System is intended for cemented or cementless use:
• Anatomical Shoulder Fracture Stem.
• Anatomical Shoulder Fracture Long Stem.
When used with the following glenoids the Anatomical System is intended for cemented use:
• Bigliani/Flatow Glenoid (pegged and keeled).
• Trabecular Metal™ Glenoid.
The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision (Reverse Shoulder Arthroplasty), 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.
The proposed Anatomical Shoulder System is comprised of the following families of products:
Anatomical Shoulder Humeral Stems (Cemented, Uncemented)
Anatomical Shoulder Reverse System (Cups, PE-inlays, Glenoid Fixation, Screws, Glenospheres)
Anatomical Shoulder Fracture System (Stems, Heads)
Anatomical Shoulder Combined system (Bigliani / Flatow® Adaptors)
Anaverse™ Anatomical Shoulder Pegged Glenoid
Anatomical Shoulder Domelock® System (Heads, Dome Centric, T-Domes)
Anatomical Shoulder ASHCOM® Shoulder System (ASHCOM Shoulder AC-Connector)
This document is a 510(k) premarket notification for the Zimmer GmbH Anatomical Shoulder System. It details the device, its indications for use, and its substantial equivalence to previously cleared predicate devices.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present explicit "acceptance criteria" in a quantitative table for a new device's diagnostic performance, as this is a medical device (shoulder prosthesis) rather than an AI/diagnostic software. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various non-clinical performance tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (General) | Non-clinical performance testing and analyses demonstrate that the Anatomical Shoulder System is safe and effective and substantially equivalent to the predicate devices. Differences do not raise new questions of safety and effectiveness. |
| MR Compatibility | MR compatibility evaluation on the Anatomical Shoulder™ System. No new MRI performance testing or simulations were completed for the Anatomical Shoulder™ System implant devices. The existing reports were reviewed to ensure appropriate labeling harmonized with the Zimmer Biomet shoulder portfolio, without changing compatibility/final scanning recommendations. |
| Mechanical Integrity and Resistance (for instruments) | Mechanical integrity and resistance testing was performed for instrument groups of mechanically loaded devices (in response to correction of instrument classification from Class I to Class II). |
| Packaging Configuration & Sterile Barrier System Integrity | Packaging performance testing was performed to verify that the packaging configuration maintains integrity of the sterile barrier system up to the point of use and provides adequate protection to the product through hazards of sterilization, handling, distribution, and storage according to ISO 11607-1:2006 and ISO 11607-2:2006. Testing was conducted using representative worst-case products. |
| Intended Use & Indications for Use | The subject devices have the same intended use and similar indications for use as the predicate devices. Changes involve merging IFU, removing redundant indications, reworded existing indications for clarity (especially for revision cases), and clarification of MR verbiage. These changes limit the use of the devices within currently cleared indications and do not change compatibility/scanning recommendations. |
| Operating Principle, Design, Manufacturing, Sterilization | The subject devices use the same operating principle, incorporate the same basic design and labeling, and are manufactured and sterilized using the same materials and processes as the predicate devices. |
2. Sample size used for the test set and the data provenance:
- Test Set (Non-clinical Performance Data): The document does not specify a "sample size" in the context of patients or clinical cases for a test set. The tests performed are non-clinical (MR compatibility, mechanical integrity of instruments, packaging performance).
- For MR compatibility, it states "MR compatibility evaluation on the Anatomical Shoulder™ System," but no specific number of implants or tests is given. It clarifies that no new MRI performance testing or simulations were completed for the implant devices, but existing reports were reviewed.
- For Mechanical integrity and resistance, it states testing was performed "for instrument groups of mechanically loaded devices." No specific number of instruments or tests is provided.
- For Packaging performance, it states "Packaging Configuration testing was conducted by representative worst-case products." No specific number of packages or products is provided.
- Data Provenance: Not applicable in the traditional sense of patient data. The provenance for the non-clinical tests would be Zimmer GmbH's internal testing facilities or contracted labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert readers to establish ground truth from medical images or clinical data. The "ground truth" for non-clinical tests is established by objective engineering and material science standards (e.g., ISO standards for packaging, mechanical test specifications).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert readings.
5. 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:
- Not applicable. This is an application for a shoulder prosthesis, not an AI-assisted diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (shoulder prosthesis), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance tests, the "ground truth" is defined by established engineering and material science standards (e.g., ISO 11607-1:2006, ISO 11607-2:2006 for packaging, relevant mechanical testing standards for device integrity, and MRI compatibility standards).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm was used.
§ 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.”