(90 days)
The SMR Revision Stems are indicated for the treatment of fractures or revision of a failed primary component in total or hemi-shoulder replacement.
The components are intended for use in cemented applications according to their labeled indication.
Total or hemi-shoulder replacement is indicated for 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
- Cuff tear arthropathy; .
- Revision of a failed primary component. .
The SMR Revision Stems are made from Ti6Al4V (ISO 5832-3 / ASTM F1472). They are available in two versions: cemented and uncemented.
SMR Revision cemented stems are characterized by a cylindrical shape in the distal region while the proximal part is tapered and fluted. The whole surface of the stem is polished.
SMR Revision uncemented stems are characterized by a cylindrical shape in the distal region while the proximal part is tapered and finned. The whole surface of the stem is sand-blasted.
Both the stems are provided with a male taper for the coupling with the humeral bodies and a safety screw is used to help initially seat the body on the stem taper. SMR Revision Stems can be used for anatomical (when coupled with trauma and election humeral bodies, cleared via K100858 and K101263) shoulder replacements.
SMR Revision cemented stems are intended to be used with bone cement: SMR Revision uncemented stems are intended for press-fit applications.
This document describes a medical device, the SMR Revision Stems, and its substantial equivalence to predicate devices, focusing on non-clinical testing. It explicitly states that clinical testing was not necessary. Therefore, many of the requested elements pertaining to acceptance criteria and clinical study performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from the provided text.
Here is the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength of Humeral Stem | Demonstrated ability to perform under expected clinical conditions |
| Post-Fatigue Strength of Modular Connections | Demonstrated ability to perform under expected clinical conditions |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No clinical test set.
- Data Provenance: Not applicable. Non-clinical testing was conducted, but details on data provenance (e.g., country of origin, retrospective/prospective) for this type of testing are not typically included in these summaries, nor are they provided here.
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. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set.
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 clinical testing, and this device is a physical implant, not an AI-assisted diagnostic tool.
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)
For non-clinical testing, the "ground truth" would be established by engineering standards and validated testing protocols. The text states: "Where possible, standard test methods were used to allow comparison to testing of the predicate devices."
8. The sample size for the training set
Not applicable. No training set for an AI/algorithm is mentioned. For the non-clinical mechanical testing, "worst case components or constructs" were used, but a specific "sample size" in terms of number of units tested is not provided.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/algorithm. For non-clinical testing, the "ground truth" would be the expected performance based on relevant engineering standards and predicate device performance.
§ 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.”