(268 days)
The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented and uncemented applications, as specified in the following table:
| COMPONENT | USE | |
|---|---|---|
| Cemented | Uncemented | |
| Cemented stems | X | |
| Cementless Finned stems | X | |
| Trauma Humeral Bodies | X | X |
| Finned Humeral Bodies | X | X |
| Humeral Heads | X | X |
| Adaptor Tapers | X | X |
| Cemented Glenoids | X |
Total or hemi-shoulder replacement is indicated for 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
The SMR Shoulder System consists of a humeral stem, a humeral body, an adaptor taper, a humeral head and a glenoid components are offered for hemi or total shoulder joint arthroplasty, in primary trauma surgery. Humeral components are provided in different designs and are intended for cementless use while glenoid components are intended for cemented use only.
Two designs of humeral stems are available: the first one (object of this submission) is intended for uncemented use while the second one (submitted in 510(k): K100858) is intended for cemented use only.
Two lengths of uncemented humeral stems are available: 60 and 80 mm. The 60 mm stems are characterized by an outline with a double conicity and they are finned to provide optimal proximal fixation. The stem is sand-blasted. The 80 mm stems are characterized by an outline with a triple conicity and are also finned to provide optimal fixation. The proximal part is sand-blasted while the distal part is polished. All stems are made from Ti6Al4V (ISO 5832-3, ASTM F1472). The stems are provided with a male Morse taper (identical to that described in K100858) to allow coupling with the humeral bodies.
Humeral bodies are available in two designs. The first one (submitted in 510(k): K100858) is characterized by holes for humeral bone reconstruction as a consequence of trauma while the second one (object of this 510(k)) is finned to allow proximal press-fit fixation of the humeral system. Both designs of humeral bodies can be used in cemented (with cemented stems submitted in 510(k): K100858) and in uncemented applications (with uncemented stems submitted in this 510(k). Humeral bodies are made from Ti6Al4V (ISO 5832-3, ASTM F1472).
They are coupled with the humeral stem via a female Morse-taper connection; a locking screw is provided to aid in initial mating of the stem / body assembly.. Cylindrical marks are designed at the base of this Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morse-taper connection is designed for the coupling between the humeral body and the humeral head by means of specific adaptor tapers: an angle of 45° between the axis of this Morse-taper and the axis of the stem gives the correct varus-valgus alignment to the joint.
The device descriptions for the adaptor tapers, humeral heads and glenoid components submitted in K100858 are repeated here in italic typing for a better understanding of the complete system.
Adaptor tapers (neutral and eccentrical with different heights), are made from Ti6Al4V. They allow coupling between the humeral body and the humeral head. These devices are designed to adjust the centre of rotation of the joint and provide the required offset to the humeral head to achieve the correct tensioning to the soft tissues, optimizing joint stability.
The humeral heads are made from CoCrMo (ISO 5832-12, ASTM F1537). They are intended to articulate with the glenoid bone in hemi-arthroplasty or with the glenoid component in total shoulder arthroplasty. The surface is polished to aid in the reduction of wear.
The glenoid components are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head, which allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SMR Uncemented Shoulder System:
Based on the document K101263, the SMR Uncemented Shoulder System is a medical device (shoulder prosthesis). The submission is a 510(k) premarket notification, which means the manufacturer is asserting substantial equivalence to existing legally marketed predicate devices, rather than proving safety and effectiveness through extensive clinical trials.
The provided document does not describe a study involving a particular "device" that makes predictions against a "ground truth" using metrics, nor does it provide acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or F1-score. This type of information is typically associated with AI/ML-driven or diagnostic devices.
Instead, this document describes a traditional medical device (implantable prosthesis) and its premarket submission. The "acceptance criteria" and "study" are interpreted here in the context of device design verification and validation, demonstrating substantial equivalence to predicate devices, focusing on mechanical performance and material compatibility.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a mechanical device submission and not an AI/ML or diagnostic device, the "acceptance criteria" relate to mechanical performance and material compatibility, demonstrated through non-clinical testing. The document states that a detailed table or specific quantitative acceptance criteria and their corresponding results are not provided in this summary. Instead, a general statement of compliance is made.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Mechanical Performance | The document states: "All mechanical testing was done on worst case components or constructs. Where possible, standard test methods were used to allow comparison to testing of the predicate devices. The testing results demonstrated the device's ability to perform under expected clinical conditions." | |
| Static Pull-out Testing | Passed | Performed on all modular connections. Specific quantitative values are not provided in this summary. |
| Torsional Testing | Passed | Performed on all modular connections. Specific quantitative values are not provided in this summary. |
| Fatigue Testing | Passed | Demonstrated strength of humeral stem and post-fatigue strength of modular connections. Specific quantitative values are not provided in this summary. |
| Static Shear Testing | Passed | Performed on the glenoid component. Specific quantitative values are not provided in this summary. |
| Torsional Testing | Passed | Performed on the glenoid component. Specific quantitative values are not provided in this summary. |
| Passed | Performed on the glenoid component. Specific quantitative values are not provided in this summary. | |
| Material Compatibility | Matched/Similar | Components manufactured from the same or similar materials as predicate devices (e.g., Ti6Al4V, CoCrMo, UHMWPE). |
| Intended Use / Indications | Similar to Predicates | The SMR Shoulder System's intended use and indications are similar to those of predicate devices, with the exception of not being indicated for revision procedures. |
| Design | Similar to Predicates | Modular design elements are similar to predicate devices, though some variations exist (e.g., presence/absence of adaptor tapers). |
Regarding the other requested points (2-9), these are typically relevant for AI/ML or diagnostic device studies, and are not applicable to this traditional mechanical medical device submission.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This refers to non-clinical mechanical testing, not a data-driven test set.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on diagnostic images or clinical outcomes.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is an implant, not a diagnostic tool or an AI-assisted device for human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, the "ground truth" is defined by established engineering principles, material science, and physical measurement standards (e.g., ASTM, ISO).
- 8. The sample size for the training set: Not applicable. There is no "training set" in the context of this traditional device submission.
- 9. How the ground truth for the training set was established: Not applicable.
Study that proves the device meets the acceptance criteria:
The study proving the device meets the acceptance criteria is detailed in the "Non-Clinical Testing" section of the document.
- Type of Study: Non-Clinical Mechanical Testing.
- Tests Performed:
- Static pull-out testing of all modular connections.
- Torsional testing of all modular connections.
- Fatigue testing to demonstrate humeral stem strength and post-fatigue strength of modular connections.
- Static shear testing of the glenoid component.
- Torsional testing of the glenoid component.
- Fatigue testing of the glenoid component.
- Test Conditions: Testing was performed on "worst case components or constructs."
- Methodology: "Where possible, standard test methods were used to allow comparison to testing of the predicate devices." (Specific standards like ISO or ASTM are not explicitly named in this summary but are commonly used for such tests).
- Results/Conclusion: "The testing results demonstrated the device's ability to perform under expected clinical conditions."
- Clinical Testing: The document explicitly states: "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Shoulder System to the predicate device(s)." This reinforces that the primary evidence for this 510(k) submission comes from non-clinical mechanical testing and comparison to predicate devices, rather than human trials for safety and effectiveness.
§ 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.”