(28 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).
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 Shoulder System in Anatomic configuration usually consists of a humeral stem, a humeral body, an adaptor taper, a humeral head and a glenoid component. Components are offered for hemi or total shoulder joint arthroplasty, in primary trauma surgery. SMR Shoulder System components are provided in different designs and are intended for cemented or cementless use.
Humeral stems are connected with humeral bodies trough taper coupling. The humeral body is then coupled with the humeral heads, directly (only for some sizes of the heads) or through adaptor tapers. Adaptor tapers are made of Ti6A14V. They are neutral or with eccentricities and in different offsets to allow the adjustment of the centre of rotation of the joint, to provide the required offset to the humeral head and to achieve the correct balancing to the soft tissues, optimizing joint stability. The humeral heads are made of CoCrMo. They are intended to articulate with the glenoid bone in hemi-arthroplasty or with the glenoid component in total shoulder joint arthroplasty.
The current submission is for the extension of the available heights for each diameter of the humeral heads and for the introduction of a new eccentricity (+6 mm) for the adaptor tapers.
This document is a 510(k) Pre-Market Notification from the FDA regarding the "SMR Shoulder System". It's a regulatory approval document for a medical device, specifically shoulder joint prostheses.
Based on the provided text, the device is the "SMR Shoulder System". This document is a "Special 510(k) - Device Modification" focusing on the extension of available heights for humeral heads and the introduction of a new eccentricity (+6 mm) for adaptor tapers for the shoulder system.
The core of the request is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets acceptance criteria through a new study. Therefore, the information you're asking for regarding acceptance criteria and a study to prove it is largely not present in this document for the specific modifications.
Here's a breakdown of why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail criteria in this document for the specific modifications. The FDA's acceptance is based on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves showing that the device has the same intended use, similar technological characteristics, and does not raise different questions of safety and effectiveness.
- Reported Device Performance: The document states that the new components (Variable-Height Humeral Heads and 6mm Eccentricity Adaptor Tapers) do not represent worst cases for mechanical testing. Therefore, the performance is assumed to be equivalent to the predicate device in terms of mechanical properties.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided for the current modification. The submission states "no additional testing was required to demonstrate substantial equivalency" for these modifications. This implies that no new test set was generated or analyzed for these specific changes.
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 / Not provided. Since no new testing was conducted for these modifications, there's no mention of experts establishing a ground truth for a test set. This type of information would be relevant for studies involving diagnostic accuracy or clinical outcomes, which are not the focus of this particular 510(k) modification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set for ground truth establishment.
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. This document is for a shoulder prosthesis, not an AI-powered diagnostic tool. Therefore, MRMC studies ("human readers improve with AI") are entirely irrelevant and not mentioned.
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):
- Not applicable. For this specific 510(k) modification, the "ground truth" to establishing substantial equivalence relies on the established safety and effectiveness of the predicate device (K100858) and the argument that the changes do not introduce new safety or effectiveness concerns. There isn't a "ground truth" in the sense of clinical outcomes or expert labels being evaluated for the modified device itself in this submission.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of available information related to "acceptance criteria" and "study" for this specific 510(k) modification:
The "study" performed here is a demonstration of substantial equivalence to a predicate device already on the market (SMR Shoulder System cleared via K100858).
Table of "Acceptance Criteria" and "Reported Device Performance" (as interpreted from the document):
| Acceptance Criterion (Implicit for "Substantial Equivalence") | Reported Device "Performance" (for these modifications) |
|---|---|
| Mechanical Performance: Do new components (Variable-Height Humeral Heads, 6mm Eccentricity Adaptor Tapers) meet established mechanical safety profiles? | "The Variable-Height Humeral Heads and 6mm Eccentricity Adaptor Tapers do not represent worst cases for mechanical testing. Therefore, the results of the tests performed on the SMR Shoulder System in K100858 are applicable to the Variable-Height Humeral Heads and the 6mm Eccentricity Adaptor Tapers and no additional testing was required to demonstrate substantial equivalency." (This indicates "performance" is considered equivalent to the already cleared predicate for mechanical properties.) |
| Material Composition: Are the materials of the new components consistent with predicate and recognized standards? | "The new heights of the Humeral Heads and the new Adaptor Taper... are identical to the Humeral Heads and Adaptor Tapers cleared via K100858 for design diameters, material, intended use, indications for use." |
| (Materials are listed in tables: Ti6Al4V, CoCrMo, UHMWPE, PoroTi, Titanium Coating, conforming to ISO/ASTM standards). | |
| Intended Use/Indications: Do the new components maintain the same intended use and indications as the predicate? | "The indications for use for the devices submitted are the same of the heads and adaptor tapers of the SMR Shoulder System used in anatomic configuration cleared via previous 510(k)s." (This confirms the intended use and indications match the predicate, fulfilling a key "performance" aspect for substantial equivalence.) |
In essence, for this specific 510(k) submission, the "study" demonstrating the device meets "acceptance criteria" is a determination by the manufacturer (and accepted by the FDA) that the modified components are substantially equivalent to a previously cleared device (K100858) through a comparison of technological characteristics and a rationale for why new mechanical or clinical testing is not necessary due to the nature of the modification.
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”