(63 days)
The Anatomical Shoulder Inverse /Reverse system is 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 and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Anatomical Shoulder primary humeral stem is intended for cemented or cementless use. The Anatomical Shoulder revision humeral stem is intended for cemented use only. The Anatomical Shoulder Inverse /Reverse glenoid fixation is intended for cementless, press-fit use. It requires screws for initial fixation.
The Anatomical Shoulder Inverse / Reverse system is a reverse shoulder prosthesis that allows an intra-operative change from a conventional shoulder arthroplasty to a reverse shoulder arthroplasty. The components of the system include a glenoid fixation baseplate, a glenoid head, a humeral cup and a humeral inlay. These components are intended for use with previously submitted polyaxial screws and previously cleared humeral stems.
The provided document (K053274) is a 510(k) premarket notification for a medical device called the "Anatomical Shoulder Inverse / Reverse" system. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML algorithm.
This document pertains to a traditional orthopedic implant, not an AI-powered diagnostic or therapeutic device. As such, the standard information requested for AI/ML device evaluations (such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) is not applicable or present in this filing.
The document states:
- "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device." This confirms that a clinical study with human subjects, which would typically involve performance metrics and acceptance criteria, was not required for its clearance.
- "Non-Clinical Performance and Conclusions: Analysis of the glenoid components, the glenoid taper connection, glenoid fixation screw stability, the humeral taper connection, the humeral cup and the connection between the humeral cup and the humeral inlay indicate that all components are adequate for their intended use." This refers to mechanical and material testing of the components, which are common for orthopedic implants, but these are not the "acceptance criteria" in the context of an AI/ML study.
Therefore, I cannot provide the requested table and information, as it is not present in the given 510(k) summary for this type of device.
§ 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.”