(577 days)
Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patient's quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty and other disorders in which arthrodesis is not an acceptable solution.
The press fit Æqualis® Shoulder Prosthesis is made from titanium alloy (TA6V4, titanium alloy in accordance with standard ISO 5832-3) and is used with humeral heads made of cobalt chromium alloy steel. This provides material compatibility with the existing line of Equalis® Shoulder implant humeral heads.
The provided text is a 510(k) premarket notification for a medical device, the Æqualis® Shoulder Prosthesis. It does not describe a study that proves the device meets acceptance criteria. Instead, it demonstrates substantial equivalence to previously marketed devices.
Here's how to break down the information based on your request, highlighting what's not present:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria or reported device performance in the context of a new study proving safety and effectiveness. The "acceptance criteria" here are met by demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed equivalent to those predicate devices based on shared characteristics.
| Acceptance Criteria | Reported Device Performance (as demonstrated by Substantial Equivalence) |
|---|---|
| Indications for Use: Hemi and total shoulder replacement | Same as predicate devices (Aqualis® Shoulder System, Biomet Biomodular®, Neer II®) |
| Materials (Stem, Humeral Heads, Glenoid): Ti6Al4V, CoCr, UHMWPE | Same as predicate devices (Ti, 6AI,4V, Ti, CrCo for stem; CrCo for humeral heads; UHMWPE for glenoid) |
| Sizes (Stem, Humeral Head, Glenoid): 7-15mm, 12 sizes, 3 sizes | Comparable to predicate devices (e.g., 6-13mm diameter for stem, 6.3-12.7mm for stem) |
| Standards/Specifications (Titanium, Cobalt-chromium, UHMWPE): ISO 5832-3, ISO 5832-4, ISO 5834-2 | Comparable to predicate devices (e.g., ASTM F136, ASTM F90-87, ASTM F648) |
| Method of Fixation: Uncemented or Cemented (with qualification for glenoid) | Uncemented or Cemented (same as predicate devices, with restriction that glenoid component can only be labeled for cemented use per FDA letter) |
| Clinical Performance: | Implicitly equivalent to predicate devices due to shared materials, design, and intended use. No specific clinical performance data from a new study is presented. |
Important Note: The FDA's letter explicitly states a conditional acceptance for the glenoid component: it "may not be labeled or promoted for non-cemented use" and "must prominently state that the glenoid component is intended for cemented use only." Any non-cemented use is considered investigational. This is a critical distinction from full equivalence for all fixation methods.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This document is a 510(k) submission based on substantial equivalence to predicate devices, not a clinical trial with a "test set" of patients for the device itself.
- Data Provenance: Not applicable. There is no specific patient data from a test set presented. The data is largely derived from material specifications, design comparisons, and the regulatory history of predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. As above, there is no "test set" in the context of a clinical performance study. The "ground truth" for substantial equivalence is established by regulatory review based on engineering, material, and design comparisons with existing devices.
4. Adjudication Method for the Test Set
- Not applicable. There is no test set or adjudication process for clinical outcomes described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This document focuses on the physical and functional equivalence of the device to existing ones, not on human reader performance, with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study was not done. This device is a physical shoulder prosthesis, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" used for demonstrating substantial equivalence is based on:
- Regulatory definitions: Classification of devices (Class II, Class III).
- Industry standards: ISO and ASTM standards for materials.
- Technical specifications: Material composition, dimensions, method of fixation.
- Clinical experience of predicate devices: Implicit assumption that if the new device is sufficiently similar to legally marketed predicate devices, it will also be safe and effective for the stated indications.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "training set."
In Summary:
The provided document details a 510(k) submission for the Æqualis® Shoulder Prosthesis. The core "study" and "proof" presented is a comparison of the new device's features (materials, design, intended use, fixation methods, and compliance with standards) to legally marketed predicate devices to demonstrate substantial equivalence. It is not a clinical trial or performance study with acceptance criteria and results from a new patient cohort. The FDA's letter confirms substantial equivalence, with a significant caveat regarding the cemented-only use of the glenoid component.
§ 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.”