(46 days)
The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The glenoid is intended for cemented use only. Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from disability due to:
- . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- . Inflammatory degenerative joint discase such as rheumatoid arthritis;
- . Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
- . Cuff tear arthropathy.
The SMR CTA Humcral Heads (cleared via 510(k): K110847) are intended for use with a humcral body - humeral stem assembly in total or hemi-shoulder joint arthroplasty. The CTA heads are coupled with the humeral bodies by means of an adaptor taper. When used in total shoulder replacement, the SMR CTA Humeral Heads are coupled with glenoid components.
The SMR CTA Humeral Heads were cleared in K110847 for use with the humeral stems, humeral bodics, adaptor tapers and glenoid components cleared in K100858, K101263 and K113254.
This submission is to modify the labeling for the SMR CTA Humeral Heads to add the SMR Reverse Humeral Bodies, cleared via K110598, as additional compatible components. An adaptor for the reverse humeral body is being added to allow coupling between the SMR CTA Humeral Heads and the SMR Reverse humeral body. When used with the CTA Humeral Heads, the SMR Reverse Humeral Bodies are intended for anatomic shoulder replacement.
Acceptance Criteria and Device Performance Study for SMR CTA Humeral Heads
The provided document describes a 510(k) submission for a modification to the labeling of the SMR CTA Humeral Heads to include SMR Reverse Humeral Bodies as compatible components. This is a special 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device for a minor change, rather than proving primary effectiveness for a novel device. As such, the "acceptance criteria" here refer to demonstrating equivalence in critical physical characteristics, not clinical performance metrics like sensitivity or specificity.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Taper Dimensions and Tolerances | The adaptor tapers for coupling the SMR CTA Humeral Heads to the SMR Reverse Humeral Bodies must be equivalent in dimensions and tolerances to: |
- The taper coupling for the SMR reverse humeral bodies and liners cleared via K110598 (predicate)
- The taper coupling for the SMR CTA Humeral Heads and adaptors cleared via K110847 (predicate) | A print review was conducted. The comparisons indicate that the adaptor tapers for the coupling of the reverse humeral bodies and the CTA heads are equivalent in dimensions and tolerances to the predicates. |
| Fretting / Corrosion Risk | The SMR CTA Humeral Head / SMR Reverse Humeral Body adaptor must not introduce new risks of fretting or corrosion compared to the predicate devices. | A review of previously conducted fretting / corrosion testing was performed. This review indicates that the SMR CTA Humeral Head / SMR Reverse Humeral Body adaptor does not introduce new risks of fretting or corrosion. |
| Substantial Equivalence | Demonstrating that the modified SMR CTA Humeral Heads (with SMR Reverse Humeral Bodies as compatible components) are substantially equivalent to the predicate devices (SMR CTA Humeral Heads cleared in K110847 and SMR Reverse Shoulder System cleared in K110598) based on similarities in indications, intended use, design, materials, surface finishing, and method of manufacture. | Limacorporate believes that the devices are substantially equivalent based on similarities in indications, intended use, design, materials, surface finishing, method of manufacture, and the conducted print review comparing taper dimensions and tolerances. The FDA concluded that the device is substantially equivalent for the stated indications for use. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical or retrospective data set. The "test set" consisted of the design specifications (prints) for the new adaptor and the previously cleared components.
- Data Provenance: The data provenance is internal to the manufacturer (Limacorporate S.p.A.), based on their design documentation and previous testing records. It is retrospective in the sense that it relies on existing design data and prior test results. The country of origin for the manufacturing and design is Italy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated as a separate team of external experts. The "ground truth" for the design specifications and testing results would have been established by the engineering and quality assurance teams at Limacorporate S.p.A. who are responsible for device design, manufacturing, and regulatory compliance.
- Qualifications of Experts: Assumed to be qualified engineers and technical personnel with expertise in orthopedic implant design, material science, mechanical testing, and regulatory requirements for medical devices. Specific experience levels are not provided in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in a clinical context. The "adjudication" in this non-clinical submission would be the internal review and approval process by Limacorporate's technical and regulatory teams, followed by FDA's review for substantial equivalence. The print review and review of existing test data constitute the evidence presented for this "adjudication."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. Clinical testing was explicitly stated as "not necessary to demonstrate substantial equivalence" for this specific modification. This is common for special 510(k)s where changes are minor and do not impact clinical performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No standalone study was done. This is not an AI or algorithm-based device, but a mechanical orthopedic implant. Therefore, "standalone performance" in the context of an algorithm is not relevant. The performance evaluated was solely on the physical compatibility and predicted mechanical integrity of the component interface.
7. Type of Ground Truth Used
- The "ground truth" for this submission was based on engineering specifications and established mechanical testing protocols.
- For taper dimensions and tolerances: ground truth was the validated design prints and specifications for each component.
- For fretting/corrosion risk: ground truth was established by previously conducted and validated fretting/corrosion testing results from the predicate devices.
8. Sample Size for the Training Set
- Not applicable. This device is a mechanical implant, not a software algorithm that requires a "training set" in the machine learning sense. The engineering design and manufacturing processes are developed based on established biomechanical principles and material science, not statistical training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a mechanical device, there is no "training set" or "ground truth for a training set" as would be found in AI/ML applications. The design and validation are based on engineering standards, material properties, and mechanical test results.
§ 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.”