(73 days)
Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint. Including humeral head fracture and displaced 3 or 4 part proximal humeral fractures.
The Aequalis Shoulder Fracture System is a typical 3 part system consisting of interchangeable humeral heads, a humeral stem and, if used as a total shoulder, a glenoid component.
The Aequalis Shoulder Open stem for Fracture is available in 3 diameters (6.5, 9 and 12), with the same length. The geometry of the meaphyseal part has been designed to allow the filling by bone graft and to improve the knitting of the bones. The goal of the metaphyseal shape is to make a "bony bridge" between the tuberosities. In order to allow extraction of the prosthesis in case of revision, two slits have been designed to break the bony bridge. Anterior-posterior fins extending from diaphyseal portion form a convex bearing area allowing adequate positioning and synthesis of the greater tuberosity. The stem is used cemented in the diaphyseal part.
Various heads may be assembled to the stem in different configurations thus accommodating large variations in patient size and anatomy. The head is fixed on the stem on a Morse taper. It is impacted onto the stem on an impacting support. Subsequent revisions may be accomplished if necessary by reoparetion and separation of the head and the stem. The taper fit heads may be rotated about the axis of the Morse taper. The reverse surface of the heads has series of holes drilled around the female Morse taper every 45°. Because the female Morse taper of the head is eccentric, rotation of the head before fully seating the male and female tapers produces eight possible offset combinations for the orientation of the humeral head radius. The rotational adjustability of the humeral articulating surface expands the surgical flexibility of the system. The articulating surface of each head is designed to mate with either the natural glenoid (hemi-shoulder applications) or the available glenoid implants (total shoulder applications).
The Aequalis glenoid components are pear-like in shape, to avoid friction with the deep surface of the rotator cuff.
Open Stem for fracture: 3 dia. (6.5. 9 and 12 mm) with 1 length
Humeral Heads:
37mm x 13.5mm
39mm x 14mm
41mm x 15mm
43mm x 16mm
46mm x 17
48mm x 18mm
50mm x 16mm
50mm x 19mm
52mm x 19mm
52mm x 23mm
54mm x 23mm
54mm x 27mm
Glenoid: 3 sizes (small, medium, large)
Each component of the system is individually part coded for ease identification. The offered combinations of stem, head and glenoid sizes accommodate a wide range of anatomical variations and circumstances.
The provided text describes a 510(k) Premarket Notification for the Aequalis Shoulder Fracture System. This document focuses on establishing substantial equivalence to a predicate device and safety and effectiveness, rather than providing specific acceptance criteria and performance data for a new device's functional attributes in the way a clinical trial for an AI/medical device might.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially for AI or software-based devices) are not applicable to this type of regulatory submission for a shoulder fracture system.
However, I can extract information related to the device's classification, general standards it complies with, and the regulatory process.
Here's a breakdown of what can be inferred or is directly stated, and what is not applicable:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than setting specific performance acceptance criteria for a new, innovative function and then reporting against them.
2. Sample size used for the test set and the data provenance:
Not applicable. This device is a shoulder implant, and the submission does not detail "test sets" or data provenance in the context of performance studies for an AI/software device. The submission relies on a comparison to a predicate device and compliance with established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment with experts is not mentioned as part of this type of regulatory submission for a physical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are not mentioned.
5. 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 is a physical shoulder implant, not an AI-assisted diagnostic or treatment device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this is a physical medical device.
7. The type of ground truth used:
Not applicable in the context of AI/software performance. For a physical implant, the "ground truth" would be related to clinical outcomes, biomechanical testing, and material properties, which are generally not detailed as "ground truth" in this manner within a 510(k) summary. The submission focuses on substantial equivalence based on design, materials, and intended use.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
General summary of what the document does address regarding "safety and effectiveness":
The document states:
- "This summary contains information upon which a determination of substantial equivalence could be based. Selected device testing demonstrates the functional equivalence of the Aequalis Shoulder Fracture System."
- It highlights compliance with various standards and regulations:
- Tornier, S.A. Standard Operating Procedures (SOP)
- Vendor certifications and qualification procedures
- Quality System Regulations (QSR)
- ISO9001 & EN46001 specifications
- European CE Marking
- FDA requirements for labeling (21 CFR 801 and 809.10)
- Good Manufacturing Practice requirement (21 CFR Part 820)
- The sterilization method (gamma radiation, 2.5 Mrad, SAL of 10^-6) and its validation according to EN552 are described.
- The FDA letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the core "acceptance criteria" for a 510(k) submission. This determination is based on the information provided in the submission, including device description, intended use, and comparison to existing legally marketed devices.
§ 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.”