(301 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 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; in case of SMR Short Stems only if sufficient bone stock remains);
- . 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 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.
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) made of Ti6Al4V, coupled to a peg made of Trabecular Titanium; the metal back glenoid is fixed to the glenoid bone by means of bone screws made of Ti6Al4V. The glenoid component is intended for uncemented use. With this 510(k) new sizes of the SMR TT Augmented 360 Baseplate (7°X, 10°X, 15°X, 19°X, 19°) and bone screws (dia. 4,5mm and length ranging between 16 to 24 mm) are introduced.
The provided document is a 510(k) premarket notification for a medical device, the SMR TT Augmented Glenoid System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a comprehensive study demonstrating independent device performance against those criteria.
Therefore, the document does not contain the acceptance criteria and study details in the format requested. It clearly states:
- Clinical testing was not necessary to demonstrate substantial equivalence of the SMR TT Augmented Glenoid System to the predicate devices.
Instead, the document focuses on non-clinical (mechanical) testing to compare the device to its predicates.
However, I can extract the information that is present and note where the requested information is absent.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly stated in document) | Reported Device Performance (as stated or implied) |
|---|---|
| Non-clinical: | Non-clinical (implied equivalence to predicates): |
| Ability to perform substantially equivalent to predicate devices in: | |
| - Pull-out strength for bone screws | Demonstrated ability to perform substantially equivalent.* |
| - Dynamic Evaluation of Glenoid Loosening or Disassociation | Demonstrated ability to perform substantially equivalent.* |
| - Fatigue Fretting on Glenoid Baseplate in reverse shoulder configuration | Demonstrated ability to perform substantially equivalent.* |
| Clinical: | Not applicable; clinical testing was not performed for substantial equivalence. |
| (No explicit clinical acceptance criteria provided) |
Note: The document states "Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices" for these aspects. Specific quantitative acceptance criteria (e.g., "pull-out strength > X N") and their numerical results are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document. Mechanical tests typically use a certain number of samples, but the exact count isn't detailed here.
- Data Provenance: Not explicitly stated. Non-clinical mechanical testing data would typically be generated in a lab setting. The manufacturer, Limacorporate S.p.A., is based in Italy.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications of Experts
- This information is not applicable and not provided in the document. The study described is a non-clinical, mechanical testing study, not one requiring expert human interpretation or ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided in the document. Adjudication methods (like 2+1) are typically used in clinical studies involving multiple expert readers to resolve discrepancies in diagnoses or assessments, which is not the nature of the mechanical testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR TT Augmented Glenoid System to the predicate devices." Therefore, there is no information on the effect size of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone performance study was not done. This device is a physical shoulder implant system, not a software algorithm that would have "standalone performance" in the way AI or diagnostic algorithms do. The "study" here refers to mechanical testing of the physical components.
7. Type of Ground Truth Used
- The concept of "ground truth" as typically used in studies involving diagnostic accuracy (e.g., pathology, outcomes data, expert consensus) is not applicable to the mechanical testing described. For mechanical tests, the "ground truth" would be the measured physical properties or failure points under specified conditions, typically compared against pre-defined engineering standards or predicate device performance.
8. Sample Size for the Training Set
- This information is not applicable and not provided. The device is a physical implant, not an AI/ML algorithm that requires a "training set."
9. How Ground Truth for the Training Set Was Established
- This information is not applicable and not provided, as there is no training set for a physical implant device.
§ 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.”