(115 days)
The Arthrex Univers Apex is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.
The Univers Apex is the humeral stem component of a shoulder prosthesis system. It consists of a stem, a trunion, an inclination block and pins and screws. All of the components are comprised of titanium. The Short Stem is identical to the existing Univers II Stem, except for the overall length.
The provided text describes the Arthrex Univers Apex, a shoulder prosthesis. However, it does not contain information about acceptance criteria and a study proving that a device meets those criteria for software or AI.
The document is a 510(k) summary for a medical device (shoulder prosthesis) seeking clearance based on substantial equivalence to predicate devices, not on performance against specific acceptance criteria in a clinical study of AI/software. It details the device's components, intended use, and materials. The "study" mentioned is mechanical testing to demonstrate the fatigue strength of the proposed device as comparable to predicates, which is a common requirement for orthopedic implants.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria in the context of AI/software performance. The provided document is about a physical medical device (shoulder prosthesis) and its clearance process, which relies on demonstrating substantial equivalence, including material and mechanical property comparisons to existing legally marketed devices, rather than a clinical performance study with specific acceptance criteria as you would find for an AI/software product.
Here’s a breakdown of why I cannot answer your specific questions based on the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence to predicate devices through material and mechanical testing comparisons, not on fulfilling specific performance acceptance criteria for a software/AI system.
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/software test set. The "testing" mentioned is mechanical testing of the implant.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/software test set is not relevant here.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not about AI assistance or reader studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: Not applicable for AI/software. For the mechanical testing, the "ground truth" would be the measured mechanical properties of the device and comparator devices.
- The sample size for the training set: Not applicable. This is not an AI/software product.
- How the ground truth for the training set was established: Not applicable.
The "study" mentioned is:
- "The submitted mechanical testing data demonstrates that the fatigue strength of the proposed devices are comparable to that of the predicate device for the desired indications."
This is a mechanical performance study on a physical device, not a clinical or AI/software performance study.
§ 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.”