(97 days)
The Aequalis Reversed Adapter is indicated for use as a component of a total shoulder replacement and is designed to allow the transformation of Aequalis Anatomical (monobloc or press-fit) or Aequalis Fracture stems into components of a reverse shoulder prosthesis without removal during revision surgery. The Aequalis Reversed Adapter is for use only when the implanted humeral stem is well fixed along its entire length and when the patient has a functional deltoid muscle and when the arthropathy is associated with a massive and non repairable rotator cufftear.
The Aequalis Reversed Adapter is intended for uncemented use only.
The Aequalis Reversed Adapter is intended to be used with the Aequalis Reversed glenoid which is anchored to the bone with 4 screws and which is for uncemented fixation.
The Aequalis Reversed Adapter is intended to be used with a cemented (Aequalis monobloc or Aequalis Fracture) or uncemented (Aequalis press-fit) stem. The humeral component is not to be revised in the conversion to a reverse shoulder prosthesis and must be well fixed along its entire length.
The Aequalis Reversed Adapter offers the surgeons the possibility to convert a current implanted standard Aequalis shoulder stem into a component of a reverse prosthesis without removing the wellfixed humeral stem during revision surgery.
It appears the provided document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Aequalis Reversed Adapter," and related summary information. This type of document is for a medical implant (a shoulder prosthesis component), not an AI or software-as-a-medical-device (SaMD) product.
Therefore, the concepts of "acceptance criteria," "study proving device meets acceptance criteria," "sample size for test set," "data provenance," "experts to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set" in the context of AI/ML are not applicable to this document.
The document focuses on:
- Substantial Equivalence: The FDA's determination that the Aequalis Reversed Adapter is substantially equivalent to legally marketed predicate devices. This is the primary hurdle for 510(k) clearance, not performance against specific AI metrics.
- Device Description and Materials: Details about what the device is made of and how it functions.
- Indications for Use: The specific medical conditions and scenarios for which the device is intended.
For a medical device like this, "acceptance criteria" and "proof of meeting them" would typically refer to:
- Mechanical Testing: Demonstrating the device's strength, durability, and fatigue resistance according to relevant ISO or ASTM standards.
- Biocompatibility Testing: Ensuring the materials are safe for implantation in the human body.
- Sterilization Validation: Confirming the device can be effectively sterilized.
- Clinical Data (if required): Sometimes, clinical data is needed to demonstrate safety and effectiveness, especially if there are significant differences from predicate devices or if the indications for use are novel. However, for a 510(k), often substantial equivalence to existing devices based on design and materials is sufficient without new clinical trials.
The provided text does not contain any information about these types of tests or the results, as it is a regulatory clearance letter and a summary, not the full technical submission document.
In summary, the questions you've asked are designed for Artificial Intelligence/Machine Learning (AI/ML) powered medical devices. The provided document is for a traditional medical implant, and therefore, the requested information is not available within this text.
§ 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.”