(169 days)
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy. 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 components are intended for use in cemented and uncemented applications, as specified in the following table:
| COMPONENT | USE | |
|---|---|---|
| Cemented | Uncemented | |
| Cemented stems | X | |
| Cementless Finned stems | X | |
| Reverse Humeral Bodies | X | X |
| Reverse Liners | X | X |
| Glenospheres | X | |
| Connectors | X | |
| Metal Back Glenoid | X | |
| Bone Screws | X |
The SMR Reverse Shoulder System consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenoid, a glenosphere and a connector with screw. Bone screws are used for the fixation of the metal-back glenoid to the scapula. Humeral stems are provided for both cemented (cleared via 510(k): K100858) and cementless (cleared via 510(k): K101263) fixation as well as reverse humeral bodies (object of this submission). The SMR Reverse Shoulder System metal back glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation. Two designs of humeral stems are available: the first one (cleared via 510(k): K100858) is intended for cemented use only while the second one (cleared via 510(k): K101263) is intended for uncemented use. The stems are provided with a male Morse taper to allow coupling with the reverse humeral bodies. All reverse humeral bodies for SMR Reverse Shoulder Systems are made from Ti6Al4V (ASTM F1472 - ISO 5832-3). They are intended to be coupled by means of a Morse taper with the humeral stem; further stabilization is achieved with a screw that joins the humeral body to the stem. SMR reverse humeral bodies have a fixed cervico-diaphyseal angle of 150° to provide the correct varus-valgus alignment of the joint. The humeral body has a female taper for coupling with the reverse liner. Two versions of the SMR reverse liners are available: standard (available in Standard and Short sizes) and finned for trauma applications (fins with holes for tuberosities reconstruction provided). Reverse liners are made from standard ultra-high molecular weight polycthylene (ASTM F648 - ISO 5834-2); they are coupled via the internal tapcr of the reverse humeral bodies. Two designs of reverse liners are available: standard and retentive (characterized by deeper spherical concavity, higher lateral rim to provide a larger articulating surface and greater congruency between the liner and the glenosphere than the standard liners). Three thicknesses are available: STD, +3mm and +6mm. As reported for standard liners, the choice of the thickness is made by the surgeon to ensure the appropriate tension and prevent laxity in the joint. Metal-backed glenoids are made from Ti6Al4V (ASTM F1472 - ISO 5832-3). The surface of the metal-backed glenoid which comes in contact with bone is coated with Ti plasma spray coating. These devices are intended to be press-fitted into a hole drilled into the glenoid cavity during surgery; the peg surface has several wings to aid in fixation. Metal backed glenoids are available in four sizes (small-R, Small, Standard and Large). The plate has curved surfaces to adapt to the spherical shape of the glenoid cavity. The plate is provided with holes to allow the insertion of screws to fix the device in the glenoid cavity: Small-R, Small and Standard glenoids have two holes while the Large size has four holes. Glenospheres are made from CoCrMo alloy that conforms to ASTM F1537 - ISO 5832-12. Two different designs are available: a standard glenosphere that can be centered with respect to the glenoid component or eccentrical glenosphere to provide offset. Both designs have a spherical shape of 36mm diameter and articulate with the standard UHMWPE liners of the humeral body. Glenospheres are intended to be coupled to the metal-back glenoid through the use of a connector manufactured of Ti6Al4V (ASTM F1472 - ISO 5832-3). It incorporates a double male taper: one side is connected to the glenosphere while the other is coupled with the glenoid component. To increase the solidity of the system, a screw is used to link the glenosphere to the glenoid component. The screw is inserted through a hole on the surface of the glenosphere, passing through the internal cavity of the connector and then screwed to the metal-backed liner. Two types of connectors are used depending on the metal backed glenoid component: Small-STD and Small-R.
This document describes the SMR Reverse Shoulder System, a medical device for shoulder replacement. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-based medical device.
The provided text is a 510(k) premarket notification summary for a physical medical device (a shoulder implant system). It focuses on:
- Device Description: The components and materials of the SMR Reverse Shoulder System.
- Intended Use: The medical conditions and patient types for which the device is indicated.
- Predicate Devices: Other similar devices already on the market that establish substantial equivalence.
- Non-Clinical Testing: Mechanical and wear testing performed on the physical components (e.g., fatigue strength, wear of liners and glenospheres). This testing is to ensure the physical components meet performance requirements, not an AI algorithm.
- Clinical Testing: Explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Reverse Shoulder System to the predicate device(s)."
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The document pertains to a traditional orthopedic implant, not an AI-powered diagnostic or assistive tool.
§ 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.”