(57 days)
The Aequalis Adjustable Reversed Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non repairable rotator cuff tear as a replacement of Shoulder joints disabled by:
- Rheumatoid arthritis with pain
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the humeral head
- Traumatic arthritis
- Revision of the devices if sufficient bone stock remains
The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis AscendTM Modular Reverse Shoulder System K110599.
The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty.
The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options:
- Uncoated,
- Hydroxylapatite (HAP) coated,
- HAP over titanium plasma spray (HAP/Ti PS) coated.
The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120):
The purpose of this 510(k) is to add an additional stem configuration that does not have HAP Coating and that has plasma titanium spray coating on a portion of the stem (20mm proximal portion of stem), and has a fluted surface on a portion of the stem instead of the full length of the stem (i.e., the HAP coating and fluted surface on 20mm proximal portion of stem. In addition, an alternate plasma titanium spray coating supplier has been validated to perform this manufacturing operation.
The provided text from the FDA 510(k) summary (K141029) describes a medical device, the Aequalis Adjustable Reversed Shoulder System, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.
The document discusses:
- Device: Aequalis Adjustable Reversed Shoulder System (a shoulder joint prosthesis).
- Predicate Device: Tornier Aequalis Adjustable Reverse Shoulder System, K120739.
- Purpose of this 510(k): To add an additional stem configuration (without HAP Coating, with plasma titanium spray coating on a portion, and a fluted surface on a portion) and validate an alternate plasma titanium spray coating supplier.
- Non-clinical Tests: Performed to evaluate device performance per design requirements and risk analysis. These included:
- Demonstration of design equivalence
- Fatigue testing
- Shear fatigue strength
- Static shear strength per ASTM F1044
- Static tensile strength per ASTM F1147
- Abrasion resistance per ASTM F1978
- Thickness per ASTM F1854
- Mean void intercept length per ASTM F1854
- Mean volume percent of void per ASTM F1854
- Conclusion: "All testing results met pre-established acceptance criteria." and "the Tornier Aequalis Adjustable Reverse Shoulder System was found to be substantially equivalent to the predicate device."
Based on the provided text, I cannot answer your questions because the document describes a mechanical orthopedic implant, not an AI or algorithm-based medical device. Your questions are tailored for evaluating the performance of an AI/algorithm.
Therefore, for each of your specific questions, the answer is that the information is not available in the provided document.
Here's why:
- AI/Algorithm Focus: The core of your questions (e.g., test set, ground truth, experts, MRMC studies, standalone performance, training set) directly pertains to the evaluation of AI/machine learning algorithms. The Aequalis Adjustable Reversed Shoulder System is a physical implant, and its evaluation focuses on mechanical and material properties.
I can only extract information that is present in the document.
§ 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.”