(87 days)
The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional all polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement shoulder system. The Nexa Total Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.
The Nexa Orthopedics Total Shoulder System is indicated for use as a replacement of shoulder joints disabled by the following:
- . Rheumatoid arthritis with pain
- . Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- . Correction of functional deformity
- . Fractures of the humeral head
- . Traumatic arthritis
- Revision of other devices if sufficient bone stock remains .
All components are single use. The humeral stem is intended for cementless use while the all polyethylene glenoid is intended for cemented use only.
The Nexa Orthopedics Total shoulder system is comprised of a line of humeral stems, humeral heads, and all polyethylene glenoid components. The humeral stems are sized and shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally filling shape, are designed to accommodate the natural humeral geometry and provide stable fixation, proximal bone loading, and proper head placement with 0 to 3 mm of head adjustment possible. The humeral heads are offered with both spherical and non-spherical articulating surfaces and allow both neutral and offset head positioning via offset taper. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the Nexa all polyethylene, cemented glenoid. The glenoid has two or three pegs, depending on size, and is designed to function with both the spherical and non-spherical heads of the Nexa system.
The provided text describes a 510(k) summary for the Nexa Orthopedics Total Shoulder System. However, it does not include detailed acceptance criteria or a study proving device performance against such criteria in the format requested.
The document lists various ASTM standards to which the device components have been evaluated. These standards define test methods and specifications, which imply certain performance requirements, but the specific acceptance criteria values and the results showing the device meets them are not provided in this summary.
Therefore, I cannot fully complete the table or answer all sub-questions based solely on the provided text. I will fill in what can be inferred and explicitly state where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM Standards) | Reported Device Performance |
|---|---|
| Mechanical/Physical Properties: | |
| ASTM F2009-00: Axial Disassembly Force of Taper Connections of Modular Prostheses | Evaluated as per standard, specific results not provided. |
| ASTM F2028-02: Dynamic Evaluation of Glenoid Loosening or Disassociation | Evaluated as per standard, specific results not provided. |
| ASTM F1378-05: Standard for Shoulder Implants | Evaluated as per standard, specific results not provided. |
| ASTM 1044-05: Shear Testing of Calcium Phosphate Coatings and Metal Coatings | Evaluated as per standard, specific results not provided. |
| ASTM F1147-05: Tension Testing of Calcium Phosphate and Metallic Coatings | Evaluated as per standard, specific results not provided. |
| Material Specifications: | |
| ASTM F-1537-00: Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants | Device components are composed of Ti-6Al-4V, CoCrMo, and Ultra High Molecular Weight Polyethylene. Implied to meet material specifications, specific test results not provided. |
| ASTM F 136 REV A: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications | Device components are composed of Ti-6Al-4V, CoCrMo, and Ultra High Molecular Weight Polyethylene. Implied to meet material specifications, specific test results not provided. |
| ASTM F648-04: Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | Device components are composed of Ti-6Al-4V, CoCrMo, and Ultra High Molecular Weight Polyethylene. Implied to meet material specifications, specific test results not provided. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The listed ASTM standards typically define test methodologies, including sample size recommendations, but the specific number of units tested for this device is not reported here.
- Data Provenance: Not specified. This would typically be from laboratory testing as per the ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is an orthopedic implant and its performance is evaluated through mechanical testing against established engineering standards (ASTM), not through expert clinical review of data for "ground truth" in the way a diagnostic AI might be.
4. Adjudication method for the test set
- Not applicable for mechanical testing of an orthopedic implant. Adjudication methods like "2+1" are relevant for clinical or imaging studies involving human interpretation or consensus.
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 is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/diagnostic device.
7. The type of ground truth used
- Not applicable in the typical sense of "ground truth" for clinical or diagnostic devices. The "ground truth" for this device's performance is defined by its adherence to established engineering specifications and material properties as outlined in the ASTM standards.
8. The sample size for the training set
- Not applicable. This is an orthopedic implant, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As noted above, there is no "training set" or "ground truth" in the context of training a model for this device.
§ 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.”