(259 days)
The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented applications.
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 component. Components are offered for cemented use for hemi or total shoulder joint arthroplasty, in primary trauma surgery.
Humeral stems are designed for cemented use and are characterized by an outline with a triple conicity to provide optimal fixation and fit independent of canal morphology. The stems are made from Ti6Al4V (ISO 5832-3, ASTM F1472). The surface in contact with cement is polished to reduce shear stresses on the cement mantle and avoid abrasion resulting from micromovements at the stem-cement interface. The distal part of the stems is characterized by a cylindrical cross-section while the proximal part is fluted to prevent rotation of the component relative to bone. The stems are provided with a male Morse taper in the proximal part for coupling with the humeral body.
Humeral bodies are made from Ti6Al4V and 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 the Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morsetaper 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 Morsetaper and the axis of the stem gives the correct varus-valgus alignment to the joint. A system of holes on the external surface allows anatomical attachment of tuberosities using sutures or wires in trauma applications.
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 joint 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 Shoulder System:
The provided document, K100858 for the SMR Shoulder System, is a Traditional 510(k) premarket notification. Traditional 510(k)s typically demonstrate substantial equivalence to a predicate device through non-clinical performance data. They generally do not require extensive clinical studies with specified acceptance criteria in the same way a PMA (Pre-Market Approval) or certain De Novo applications might.
Based on the provided text, the "acceptance criteria" are implicitly met by demonstrating that the device performs comparably to the predicate devices and meets established performance standards for orthopedic implants.
Here's a breakdown of the information requested, based solely on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|
| Static pull-out strength of modular connections | "All mechanical testing was done on worst case components or constructs... The testing results demonstrated the device's ability to perform under expected clinical conditions." |
| Torsional testing of modular connections | "All mechanical testing was done on worst case components or constructs... The testing results demonstrated the device's ability to perform under expected clinical conditions." |
| Fatigue strength of humeral stem | "All mechanical testing was done on worst case components or constructs... The testing results demonstrated the device's ability to perform under expected clinical conditions." |
| Post-fatigue strength of modular connections | "All mechanical testing was done on worst case components or constructs... The testing results demonstrated the device's ability to perform under expected clinical conditions." |
| Static shear strength of glenoid component | "All mechanical testing was done on worst case components or constructs... The testing results demonstrated the device's ability to perform under expected clinical conditions." |
| Torsional strength of glenoid component | "All mechanical testing was done on worst case components or constructs... The testing results demonstrated the device's ability to perform under expected clinical conditions." |
| Fatigue strength of glenoid component | "All mechanical testing was done on worst case components or constructs... The testing results demonstrated the device's ability to perform under expected clinical conditions." |
| Material Properties (e.g., Ti6Al4V, CoCrMo, UHMWPE conforming to ISO/ASTM standards) | Components are manufactured from specified materials (Ti6Al4V, CoCrMo, UHMWPE) conforming to ISO and ASTM standards (e.g., ISO 5832-3, ASTM F1472 for stems; ISO 5832-12, ASTM F1537 for heads; ISO 5834-2, ASTM F648 for glenoids). This implicitly means they meet the properties defined by those standards. |
| Clinical performance (implied by substantial equivalence to predicates) | "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Shoulder System to the predicate device(s)." The device is deemed substantially equivalent based on intended use, indications, design, and materials. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document only mentions "worst case components or constructs" were used for non-clinical (mechanical) testing. It does not specify the exact number of samples for each test.
- Data Provenance: The document does not explicitly state the country of origin for the non-clinical test data. The manufacturer is Lima-Lto S.p.A. in Italy, suggesting the testing may have been conducted in Italy or by a contracted lab. The testing is prospective in nature, as it involves physical testing of newly manufactured components.
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. This information is relevant for studies involving human interpretation (e.g., image analysis, diagnostic algorithms). The provided document describes non-clinical mechanical testing of an orthopedic implant. Ground truth for mechanical tests is established by physical measurement against engineering specifications and industry standards, not by expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As explained above, this document describes non-clinical mechanical testing, not a study requiring human adjudication of results.
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 describes a medical device (shoulder implant), not an AI-assisted diagnostic tool. No MRMC study was performed, and thus no effect size related to AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This document describes a medical device (shoulder implant), not an algorithm or AI system. Therefore, no standalone algorithm performance study was relevant or conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical testing appears to be engineering specifications, established industry standards (ISO, ASTM), and historical performance data of predicate devices. The tests (static pull-out, torsional, fatigue, shear) are designed to assess physical properties and durability against these benchmarks.
8. The sample size for the training set
- Not Applicable. This document describes a device, not an AI or machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no training set for an AI/ML model described in this document.
§ 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.”