(116 days)
Advanced destruction of the shoulder joint resulting from:
- Omarthrosis.
- Rheumatoid arthritis
- Post-traumatic arthritis
- Avascular necrosis of the humeral head.
- Cuff-tear arthropathy (BF heads with heights of 27mm or greater)
- Conditions following earlier operations (including revision shoulder arthroplasty).
The Anatomical Shoulder Combined System is intended for cemented or cementless use. When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use:
- Anatomical Shoulder Standard Cemented Humeral Stem.
- Anatomical Shoulder Revision Stem.
When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use:
- Anatomical Shoulder Standard Uncemented Stem.
When used with the following humeral stems the Anatomical Shoulder Combined 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 Shoulder Combined System is intended for cemented use:
- Bigliani/Flatow Glenoid (pegged and keeled).
- Trabecular Metal Glenoid.
The Anatomical Shoulder (AS) Combined System consists of the following:
- AS Humeral Stem (cemented or uncemented)
- AS Fracture Humeral Stem
- Bigliani/Flatow Head
- Bigliani/Flatow Gleniod
- Trabecular Metal (TM) Glenoid
- AS Bigliani/Flatow (AS B/F) Adaptor
The AS B/F Adaptor is a new product designed to be used with the humeral stems of the Anatomical Shoulder System and Anatomical Shoulder Fracture System and with any humeral head of the Bigliani/Flatow (BF) System in a conventional hemi or total shoulder arthroplasty procedure. The B/F humeral heads are used with existing UHMWPE B/F glenoids and TM glenoids manufactured from Trabecular Metal and UHMWPE. AS cemented humeral stems are manufactured from Protasul -1 (Co-Cr-Mo); the uncemented and fracture stems from Protasul-100 (titanium alloy). The B/F heads are manufactured from Zimaloy® (Co-Cr-Mo). Collectively, these components are identified as the Anatomical Shoulder Combined System.
The Adaptor features two taper interfaces, one connecting to the Anatomical Shoulder humeral stems and the other connecting to the Bigliani/Flatow humeral heads. The proximal taper of the adaptor (connecting to the Bigliani/Flatow heads) is identical to the male taper geometry from the predicate Bigliani/Flatow humeral stems. The distal taper of the adaptor (connecting to the Anatomical Shoulder humeral stem) is a male oval taper, identical to the oval taper of the predicate Anatomical Shoulder Ball-Taper component. Both the AS B/F Adaptor and the predicate AS Ball-Taper component are manufactured from Protasul-100, a forged titanium alloy.
The Zimmer Anatomical Shoulder™ Combined System is a medical device and, as such, the "acceptance criteria" and "device performance" are typically assessed through non-clinical (laboratory) testing to demonstrate substantial equivalence to predicate devices, rather than through sensitivity, specificity, or AUC as might be seen for diagnostic AI/ML devices.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: For medical devices like shoulder prostheses, "acceptance criteria" are usually based on meeting established engineering standards and demonstrating equivalent or superior performance to existing predicate devices through various mechanical and material tests. The specific numerical acceptance criteria for each test (e.g., minimum load for fatigue, maximum corrosion rate) are not detailed in this summary but are implied to have been met.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Demonstrates safety and effectiveness (as per predicate devices). | The results of non-clinical (lab) performance testing and/or analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. |
| Similar performance characteristics to predicate devices. | The proposed system has similar performance characteristics to the predicate devices. |
| Manufactured from similar materials using similar processes to predicate devices. | The proposed system is manufactured from similar materials using similar processes to the predicate devices. |
| Mechanical integrity under simulated physiological loads. | Performance testing and/or analyses included: Evaluation of Loading Conditions, Fatigue Analysis, Fretting Corrosion, Assembly Strength Test. (The specific results demonstrate acceptable performance based on these tests, implying mechanical integrity and durability comparable to, or better than, predicate devices). |
| Biocompatibility and material stability (implied by material selection). | Components are manufactured from Protasul-1 (Co-Cr-Mo), Protasul-100 (titanium alloy), and Zimaloy® (Co-Cr-Mo), which are standard biocompatible materials for such implants. Fretting Corrosion testing would also address material stability. |
| Maintained intended use characteristics. | The proposed system has the same intended use as the predicate devices. |
| Taper interface compatibility and strength. | The AS B/F Adaptor has identical proximal taper geometry to the predicate Bigliani/Flatow humeral stem and identical distal taper geometry to the predicate Anatomical Shoulder Ball-Taper component. This implies successful testing of these interfaces. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This device underwent non-clinical (lab) performance testing and/or analyses. The document does not specify a "sample size" in the context of a clinical test set with patient data. Instead, it refers to mechanical and material tests performed on various components of the device. The "sample size" would relate to the number of physical components tested for each specific non-clinical test (e.g., number of stems tested for fatigue, number of adaptors for strength testing). These specific numbers are not provided in this summary.
- Data Provenance: The data is from non-clinical (lab) performance testing. No country of origin for this testing is explicitly stated, but the sponsor is Zimmer GmbH in Switzerland, and the contact person is in Indiana, USA. This is not retrospective or prospective patient data, but rather engineering test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This is a mechanical device, and "ground truth" for a test set typically refers to clinical diagnosis or outcome, which is not relevant here. Ground truth would be defined by engineering standards and specifications.
4. Adjudication Method for the Test Set
- Not applicable. This refers to consensus among clinical experts for diagnostic decisions, not for mechanical device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. Such studies are typically for diagnostic devices or AI/ML tools where human readers interpret medical images.
- Effect size of human reader improvement: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a shoulder prosthesis, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For this device, the "ground truth" is established through industry-standard engineering specifications, material properties, and biomechanical principles. Performance is benchmarked against the known characteristics and successful clinical history of the predicate devices. This includes adherence to standards for loading conditions, fatigue life, fretting corrosion resistance, and assembly strength.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and prior successful device designs (predicates).
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this type of medical device.
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”