(124 days)
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:
- . non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
- inflammatory degenerative joint disease such as rheumatoid arthritis; ●
- . treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
- revision of a failed primary implant;
- . cuff tear arthropathy (CTA Heads only);
- . glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).
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 (disabled shoulder). 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 SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists or of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
Bone Screws are characterized by a 5,0 mm diameter (new device) and they are used in combination with SMR TT Augmented 360 Baseplate (K191746/K200171) to fix the baseplate to the glenoid bone.
The SMR TT Augmented 360 Baseplate is a metal back glenoid component coupled to a peg made of Trabecular Titanium, intended for uncemented use with the addition of bone screws for fixation to the bone. This glenoid component is part of the SMR TT Augmented Glenoid System (K191746/K200171) that is a modular system intended to be used in combination with previously cleared components of the SMR Reverse Shoulder System. The system consists of a modular glenoid component to be used in total shoulder replacement in a reverse shoulder configuration.
This document is a 510(k) premarket notification decision letter from the FDA regarding Bone Screws dia. 5,0 mm manufactured by LimaCorporate S.p.A. The letter states that the device is substantially equivalent to legally marketed predicate devices.
The information provided does not contain details about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as these elements are typically associated with the evaluation of AI/ML-driven medical devices or diagnostic tools. This document pertains to the substantial equivalence determination of a bone screw, which is a mechanical implant, and its evaluation relies on mechanical testing and comparison to predicate devices, not data-driven performance metrics for an algorithm.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text, as this information is not present. The document explicitly states:
- "Clinical testing was not necessary to demonstrate substantial equivalence of Bone Screws dia. 5,0 mm to the predicate device." This confirms that there was no clinical study with a test set of patient data, human readers, or ground truth as you described.
- The testing performed was "Mechanical testing" which demonstrated the device's ability to perform substantially equivalent to the predicate device in:
- Torsional test, driving torque test, pull-out test for bone screws (ASTM F543)
- Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028)
In summary, the provided document is for a mechanical orthopedic implant, not an AI/ML-driven device. Therefore, the questions regarding acceptance criteria, test sets, training sets, expert consensus, MRMC studies, and ground truth are not applicable to the content of this FDA 510(k) premarket notification.
§ 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.”