(301 days)
The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
· Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis
- · Rheumatoid and other inflammatory arthritis
- · Correction of functional deformity, including fracture malunion
- · Humeral head fracture
- · Revision of other devices if sufficient bone stock remains
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.
Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. Glenoid components are indicated for cemented use only.
This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers (Full-Wedge), as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.
This FDA 510(k) summary is for the AltiVate® Anatomic Shoulder AG e+™ with Markers. It is a premarket notification, not a study report. Therefore, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving device performance in the way a clinical trial report would.
However, based on the provided text, I can infer some aspects and directly state where information is not available.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in the sense of clinical metrics (e.g., pain reduction, range of motion improvement). Instead, it discusses the substantial equivalence to a predicate device based on material, design, and manufacturing standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition | The subject device, AltiVate® Anatomic Shoulder AG e+™ with Markers (Full-Wedge), is manufactured from ultra-high molecular weight polyethylene with vitamin E, identical to the primary predicate. |
| Design Characteristics | The articulating surface has a radius of curvature greater than compatible humeral heads, allowing translation. The back surface is spherical with four pegs for fixation. The central peg has three annular barbs, and peripheral pegs have machined Tri-lobes identical to the predicate device. |
| Manufacturing Process | Identical to the predicate device. |
| Sterilization Method | Identical to the predicate device. |
| Packaging | Identical to the predicate device. |
| Endotoxin Limits | Device testing assures pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing. |
| Dynamic Loosening (Glenoid) | Performed per ASTM F2028-17. (No specific performance metric or acceptance limit is reported in this document). |
| Indications for Use | Identical to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of the testing performed for this 510(k). The mechanical testing mentioned (ASTM F2028-17) would have a sample size of components, but it is not specified here. There was no clinical study.
- Data Provenance: Not applicable as a clinical test set. The mechanical testing would have been conducted in a lab.
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. No clinical test set with human interpretation requiring ground truth by experts was conducted or needed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was conducted.
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 a shoulder implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a shoulder implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's regulatory clearance is established through demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering principles, material science, and adherence to relevant ASTM standards for mechanical performance.
8. The sample size for the training set
Not applicable. The device is a mechanical implant; there is no "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.”