(144 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 cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically 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 graft is needed.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs are intended for cemented and uncemented use as specified in the following table.
The SMR TT Augmented Glenoid System 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. The glenoid component consists of a metal back glenoid (named SMR TT Augmented 360 Baseplate), coupled to a peg made of Trabecular Titanium. The glenoid component is intended for uncemented use with the addition of bone screws for fixation to the bone.
The provided text is related to a 510(k) premarket notification for the "SMR TT Augmented Glenoid System," a medical device for shoulder joint replacement. This document primarily focuses on demonstrating substantial equivalence to predicate devices through design, materials, intended use, and non-clinical mechanical testing.
Crucially, the document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR TT Augmented Glenoid System to the predicate devices."
This means that the device's acceptance criteria were not proven through a clinical study involving human patients, nor through a performance study that would typically involve test sets, expert ground truth, or MRMC studies for an AI/CAD type of device. The acceptance criteria and proof of their fulfillment are based on equivalence to predicate devices and mechanical testing of the device components.
Therefore, for the specific questions you've asked, the information is largely not applicable or not present in the provided text, as this device's clearance was based on non-clinical data.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since clinical testing for device performance in the context of AI/CAD (e.g., diagnostic accuracy) was not conducted or deemed necessary, the acceptance criteria and performance relate to mechanical integrity and material properties.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Torsional strength for bone screws (ASTM F543) | Device performed substantially equivalent to predicate devices. |
| Driving torque for bone screws (ASTM F543) | Device performed substantially equivalent to predicate devices. |
| Pull-out strength for bone screws (ASTM F543) | Device performed substantially equivalent to predicate devices. |
| Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028) | Device performed substantially equivalent to predicate devices. |
| Fatigue Fretting test on Glenoid Baseplate in reverse shoulder configuration | Device performed substantially equivalent to predicate devices. |
| Range of Motion (ASTM F1378) | Device performed substantially equivalent to predicate devices. |
| Material Standards: | |
| Ti6Al4V (ISO 5832-3 - ASTM F1472) | Conforms to standard. |
| CoCrMo (ISO 5832-12 - ASTM F1537) | Conforms to standard. |
| UHMWPE (ISO 5834-2 - ASTM F648) | Conforms to standard. |
| PoroTi Titanium Coating (ASTM F1580) | Conforms to standard. |
| Ta (ISO13782 - ASTM F560) | Conforms to standard. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical test set involving human data was used for performance evaluation as "Clinical testing was not necessary." The evaluation was based on mechanical testing of the device components. The specifics of the mechanical test samples are not detailed beyond referencing ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As no clinical "test set" in the context of diagnostic accuracy was used, no human experts were involved in establishing ground truth for such a purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Since no test set requiring expert interpretation was used, no adjudication method was employed.
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. No MRMC study was conducted. This device is a surgically implanted prosthetic, not an AI/CAD system assisting human readers with interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device, in terms of demonstrating safety and effectiveness, was established through adherence to material standards and performance against specified mechanical testing standards (e.g., ASTM F543, ASTM F2028, ASTM F1378). The comparative aspect was based on substantial equivalence to legally marketed predicate devices in terms of intended use, design, and materials.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device, so there is no "training set" or associated ground truth for a training set.
§ 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.”