(84 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 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 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 Connectors are used to couple the glenosphere to the metal-backed glenoid. Connectors are made from Ti6Al4V alloy (ASTM F1472 - ISO 5832-3) and are characterized by a double male taper. To increase the solidity of the system, a screw is used to link the glenosphere to the glenoid component. No.5 additional sizes (Lateralized connectors) are available in both Small-STD and Small-R configuration to allow lateralization of Center of Rotation.
The provided document is a 510(k) premarket notification for a medical device called "SMR Lateralized Connectors with screws". This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than proving efficacy or safety through extensive clinical trials. Therefore, much of the information requested about acceptance criteria and detailed study designs (especially relating to AI or expert adjudication) is not applicable or present in this document.
However, I can extract the relevant information regarding the non-clinical testing performed to establish substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of numerical acceptance criteria or reported device performance in the format typically seen for novel device performance claims. Instead, it states that mechanical tests "demonstrated device performances fulfill the intended use and are substantially equivalent to the predicate devices." This implies that the performance met predefined internal criteria for equivalence, but these criteria are not explicitly detailed.
2. Sample sized used for the test set and the data provenance
The document mentions "Mechanical testing was performed on worst case components or constructs." It does not specify the exact sample size for these mechanical tests. The data provenance is internal to Limacorporate S.p.A. and the tests are non-clinical (experimental/lab-based), not derived from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the study described is non-clinical mechanical testing, not a study involving human interpretation or ground truth establishment by experts for diagnostic or prognostic purposes.
4. Adjudication method for the test set
This is not applicable for the same reason as point 3.
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
No, an MRMC study was not done. The device is a mechanical implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone AI algorithm performance study was not done. The device is a mechanical implant.
7. The type of ground truth used
For the non-clinical mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks derived from the predicate devices and relevant ASTM/ISO standards (e.g., ASTM F2028-18). The device's performance was compared against these established standards and predicate device characteristics to demonstrate substantial equivalence.
8. The sample size for the training set
This is not applicable as there is no AI algorithm being trained.
9. How the ground truth for the training set was established
This is not applicable as there is no AI algorithm being trained.
Summary of Relevant Information from the Document:
While the document doesn't fit the typical structure for AI/diagnostic device evaluation, it does provide clear information about the type of acceptance criteria and study performed for this medical device:
- Acceptance Criteria (Implied): Substantial equivalence to predicate devices, fulfilling intended use, and meeting relevant mechanical testing standards (e.g., ASTM F2028-18 for dynamic evaluation of glenoid loosening and dissociation, and standards for fatigue-fretting behavior and endurance stability of taper connections).
- Study Type: Non-clinical mechanical testing.
- Specific Tests Mentioned:
- Dynamic evaluation of glenoid loosening and dissociation per ASTM F2028-18.
- Fatigue-fretting behavior.
- Endurance stability of the taper connection, followed by evaluation for corrosion.
- Sample Size for Testing: "worst case components or constructs" (specific number not provided).
- Data Provenance: Laboratory testing (non-clinical).
- Ground Truth for Testing: Engineering specifications, performance benchmarks of predicate devices, and relevant international standards (ASTM, ISO).
- Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of SMR Connectors to the predicate devices."
The document primarily focuses on demonstrating that the new SMR Lateralized Connectors with screws are safe and effective because their design, materials, and mechanical performance are equivalent to predicate devices already cleared for market, negating the need for novel clinical data.
§ 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.”