(30 days)
The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional 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. The Ascend 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 Ascend Shoulder System is indicated for use as a replacement of shoulder joints disabled by:
- 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 Ascend Shoulder System consists of a humeral stem Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a mating humeral head and an optional all polyethylene glenoid. The stem and head may be used alone, as a hemiarthroplasty if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total shoulder replacement system.
The present device submission corresponds to changes made to the version of the device cleared in 510(k) K120794.
This is a 510(k) premarket notification for the Tornier Inc. Ascend Shoulder System, specifically highlighting changes made to a previously cleared version of the device. This document describes a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) are not applicable.
Below is a summary based on the provided text, focusing on the available information regarding the device itself.
Acceptance Criteria and Device Performance for the Tornier Inc. Ascend Shoulder System (K121493)
The document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device (Tornier Ascend Shoulder System: K120794) for regulatory approval. This typically means demonstrating that the modified device is as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Device (K120794) | The results of non-clinical tests (coating validation) allow the conclusion that the Ascend Shoulder System described in this submission is substantially equivalent and as safe and effective as the original device. |
| Material/Design Changes Validation | Modified Ascend Shoulder System was subjected to "non-clinical testing (coating validation)." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a premarket notification for a physical medical device (shoulder prosthesis), and the "test set" refers to non-clinical testing of the device itself (e.g., mechanical testing, coating validation), not a dataset for an AI/ML algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is not an AI/ML device where experts establish ground truth for a diagnostic output. The "ground truth" for a physical device is its material properties, mechanical performance, and biological compatibility, typically assessed through engineering standards and biological evaluations, not expert consensus on images.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for ambiguous cases in diagnostic studies, particularly with AI/ML. For a physical device, testing involves defined protocols and measurements.
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
No. This is not an AI/ML device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
For a physical orthopedic implant, the "ground truth" implicitly refers to:
- Engineering Standards and Specifications: Adherence to established mechanical, material, and performance standards for orthopedic implants.
- Biocompatibility Data: Evidence that the materials used are safe for implantation in the human body.
- Coating Validation Specifications: Specific criteria for the Titanium Plasma Spray (Ti PS) coating, such as adhesion strength, thickness, and morphology.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device, not an AI/ML algorithm.
Summary of Non-Clinical Testing:
The document explicitly states: "The modified Ascend Shoulder System was subjected to non-clinical testing (coating validation)." This indicates characterization and performance testing on the physical device, specifically focusing on the titanium plasma spray (Ti PS) coating. The results of these tests were deemed sufficient to conclude that the modified device is substantially equivalent to the predicate.
§ 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.”