(203 days)
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 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.
In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.
The subject SMR Reverse HP Shoulder System is a line extension to the predicate SMR Shoulder System (K223876) consisting of Reverse HP crosslinked UHMWPE glenospheres and Co-Cr-Mo liners. The components are available in one diameter with various options to accommodate varying patient anatomy.
Based on the provided FDA 510(k) clearance letter for the SMR Reverse HP Shoulder System, here's an analysis of the acceptance criteria and the study proving the device meets them:
It's important to note that this document is a 510(k) clearance, which is primarily a declaration of substantial equivalence to a previously cleared predicate device, rather than a full, de novo approval that would detail extensive clinical performance studies with specific statistical acceptance criteria for novel claims. The focus here is on demonstrating that the new device (SMR Reverse HP Shoulder System) is as safe and effective as existing legally marketed devices, rather than proving a new level of clinical efficacy.
Therefore, many of the specific details you've asked for, such as precise quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or effect size for AI assistance), adjudication methods, or detailed expert qualifications for ground truth establishment, are typically not found in a 510(k) summary, as they are not generally required for demonstrating substantial equivalence for an orthopedic implant.
The "acceptance criteria" for a 510(k) device primarily revolve around demonstrating that the new device performs as intended and is as safe and effective as its predicate. This is primarily done through non-clinical (mechanical) testing and reference to the predicate's established clinical history.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SMR Reverse HP Shoulder System are implicit in the demonstration of substantial equivalence to its predicate devices. The performance testing aims to show that the new components function equivalently to, or better than, the predicate components within the intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Area | Acceptance Standard (Implicit from Substantial Equivalence and Standards) | Reported Device Performance (Summary from Document) |
|---|---|---|---|
| Mechanical Performance | Fatigue Test | Device must withstand anticipated physiological loads and cycles without failure or significant degradation over its intended lifespan, meeting relevant ISO/ASTM standards. | "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices." |
| Push-Out Test | Components must maintain adequate fixation strength against physiological forces. | "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices." | |
| Wear Test | Wear rates of bearing surfaces (UHMWPE, CoCrMo) must be within acceptable limits as defined by relevant ISO/ASTM standards and comparable to predicate devices. | "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices." | |
| Creep and Deformation Test | Materials must exhibit acceptable levels of creep and deformation under sustained loads. | "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices." | |
| Micromotion Test | Interface micromotion between implanted components and bone must be within limits conducive to bone ingrowth and long-term stability. | "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices." | |
| Clean and Abrasive Wear Test | Evaluation of wear under specific conditions, ensuring material integrity. | "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices." | |
| Particle Analysis | Assessment of wear debris generated by the bearing surfaces to evaluate potential biological reactivity and long-term effects. | "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices." | |
| Range of Motion | The system should allow satisfactory physiological range of motion. | "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices." | |
| Biocompatibility | Biological Safety Evaluation | Biocompatibility (cytotoxicity, sensitization, irritation, etc.) must be established according to ISO 10993-1. | "A biological safety evaluation was conducted per FDA Guidance and ISO 10993-1." (Implicitly met acceptance criteria) |
| Material Compliance | Material Standards (e.g., Ti6Al4V, CoCrMo, UHMWPE) | All materials must conform to specified international standards (ISO, ASTM) for medical implants. | "Ti6Al4V (ISO 5832-3 - ASTM F1472) – Ti6Al4V 3D printed (to meet the mechanical and chemical requirements of ISO 5832-3) - CoCrMo (ISO 5832-12 - ASTM F1537) – UHMWPE (ISO 5834-2 - ASTM F648) - LimaVit™ (Vitamin E highly crosslinked UHMWPE) (ISO 5834-2 - ASTM F648 - ASTM F2695 – ASTM F2565) - PoroTi Titanium Coating (ASTM F1580) - Ta (ISO13782 - ASTM F560)" (Confirmed compliance) |
| Sterility, Packaging, Shelf Life, Reprocessing | Validation against established standards. | Must be adequately validated. | "Previously completed sterility, packaging, shelf life and reprocessing validations from the predicate system were leveraged for the subject devices." (Implicitly met acceptance criteria by leveraging predicate data) |
| Clinical Performance (Substantial Equivalence) | Equivalence in safety and effectiveness to predicate device, as demonstrated through post-market data. | Clinical outcomes for the subject device (or its components) must be consistent with the known performance and safety profile of the predicate device. | "Post-market clinical data from outside the United States on the subject and predicate device were provided in this submission, including patient-level radiographs, outcome measures, and safety data. The data supported a determination of substantial equivalence." (Implicitly met acceptance criteria) |
Study Proving Device Meets Acceptance Criteria
The study described is primarily a non-clinical performance study combined with a post-market clinical data review for demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Non-clinical): The document states "Mechanical testing was performed on worst case components or constructs." This implies a limited sample size based on engineering principles (e.g., statistical power calculations for specific test types or industry standards for mechanical testing). Specific numbers are not provided, as is typical for 510(k) engineering tests.
- Data Provenance (Clinical): "Post-market clinical data from outside the United States on the subject and predicate device were provided in this submission." This indicates a retrospective collection of data from clinical use, not a prospective, controlled clinical trial specifically designed for this submission. The exact country of origin within "outside the United States" is not specified, nor is the specific sample size, though it is described as "patient-level radiographs, outcome measures, and safety data."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Non-clinical: Ground truth is established by engineering standards and specifications (e.g., ISO, ASTM). The "experts" would be the engineers and technicians performing and assessing the mechanical tests against these predefined standards. Their qualifications are implicit in their ability to conduct and interpret these tests, but not explicitly stated in terms terms like "mechanical engineer with 10 years experience."
- Clinical: For the post-market clinical data, the "ground truth" refers to patient outcomes and safety information. This data is observed in real-world clinical practice, typically by treating physicians. There is no mention of a separate panel of experts specifically adjudicating this post-market data for "ground truth" purposes in the context described.
4. Adjudication Method for the Test Set:
- Non-clinical: The "adjudication" is against the pre-defined engineering standards and performance specifications for each mechanical test. This is typically a pass/fail determination based on quantitative measurements. No human-expert consensus "adjudication method" (like 2+1, 3+1) is described or typically applicable to component mechanical testing.
- Clinical: For the post-market clinical data, there's no mention of an adjudication method by external experts. The data would have been collected as part of routine clinical care or existing registries, and then compiled and analyzed by the manufacturer for the submission.
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 MRMC study was done. This device is an orthopedic implant, not a diagnostic imaging AI algorithm. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not applicable to the SMR Reverse HP Shoulder System.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated above, this is an orthopedic implant, not an AI algorithm.
7. The Type of Ground Truth Used:
- Non-clinical: The ground truth for mechanical testing is based on established engineering principles and international standards (ISO, ASTM) for orthopedic implants. These standards define the expected performance and limits for various mechanical properties.
- Clinical: The "ground truth" for the clinical data is real-world patient outcomes, safety events, and radiographic assessments collected during post-market use of the predicate device and the subject device (where applicable) outside the US. These are actual clinical observations rather than expert consensus on a test set.
8. The Sample Size for the Training Set:
- Not applicable for a 510(k) orthopedic implant. Training sets are relevant for machine learning algorithms. The design and validation of this mechanical implant do not involve "training sets" in this context. The "training" for the device would be the iterative design and development process, informed by biomechanical principles and material science, leading up to the final testing.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
In summary, the FDA 510(k) clearance for the SMR Reverse HP Shoulder System relies heavily on demonstrating engineering equivalence and material compliance through non-clinical testing, supplemented by a review of existing post-market clinical data for the predicate and related devices. It is a process focused on showing that the new device is "substantially equivalent" to an already cleared device, rather than a de novo approval process that would require extensive novel clinical efficacy studies with sophisticated statistical methodologies often seen for new drug or AI algorithm approvals.
§ 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.”