(116 days)
In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.
The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain. The PERFORM Humeral System – Stem is indicated for use as a replacement of shoulder joints disabled by:
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis .
- Correction of functional deformity
- Post-traumatic arthritis 0
- o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.
All components are single use. The humeral stems are intended for cementless use.
The PERFORM Humeral System – Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty.
In Reverse:
The PERFORM™ Humeral System - Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:
- o Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- Pseudoparalysis or anterior superior escape ●
- Rotator cuff tear arthropathy
- Correction of functional deformity
- Post-traumatic arthritis
- o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.
All components are single use. The humeral stems are intended for cemented or cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
The PERFORM Humeral System - Stem is an inlay convertible humeral system intended for anatomic, reverse, and hemiarthroplasty of the shoulder system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The PERFORM Humeral System - Stem is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty.
The PERFORM Humeral System – Stem includes titanium humeral stems, cobalt chrome and titanium humeral heads, titanium humeral head couplers, conventional and Vitamin E UHMWPE reversed inserts, and titanium humeral spacers. The system also includes reusable instruments used to implant the shoulder prosthesis.
This FDA 510(k) summary describes the Tornier PERFORM™ Humeral System - Stem, a shoulder prosthesis. The document does not describe an AI/ML powered device, therefore, the requested information cannot be fully provided.
However, based on the provided text, here is what can be extracted regarding the device (a physical medical implant) and its non-clinical performance testing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or reported device performance values in a comparative format. Instead, it lists the types of non-clinical performance testing conducted to support substantial equivalence to a predicate device.
| Test Type | Purpose/Standard(s) | Relationship to Acceptance Criteria/Performance |
|---|---|---|
| Fatigue testing | Not explicitly stated, but typically assesses the device's ability to withstand repeated stress without failure. | "Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the device met fatigue requirements comparable to the predicate. Specific acceptance criteria (e.g., number of cycles at a certain load) and reported performance are not detailed. |
| Static taper evaluation | ASTM F2009 | "Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies compliance with the standard for static taper evaluation. Specific acceptance criteria and reported performance (e.g., pull-off strength, torque values) are not detailed. |
| Static Reversed Insert testing | Not explicitly stated what standard or specific aspects are tested, but likely related to the mechanical integrity and stability of the reversed insert. | "Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies meeting performance criteria for static reversed insert properties, comparable to the predicate. Specific acceptance criteria and reported performance (e.g., displacement, load-to-failure) are not detailed. |
| Wear and range of motion evaluations | Not explicitly stated what standard or specific aspects are tested, but typically assesses the wear rate of bearing surfaces and the range of motion provided by the implant. | "Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the device exhibited wear and range of motion characteristics comparable to or better than the predicate. Specific acceptance criteria (e.g., wear rate limits, degrees of motion) and reported performance are not detailed. |
| Vitamin E material characterization testing | Not explicitly stated, but likely involves testing physical and chemical properties of the Vitamin E UHMWPE material used in the reversed inserts. | "Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the Vitamin E material met specified characteristics (e.g., mechanical properties, stability). Specific acceptance criteria and reported performance (e.g., tensile strength, oxidative stability) are not detailed. |
| MRI compatibility evaluation | Not explicitly stated what standard, but usually ensures the device is safe for use in an MRI environment (e.g., heating, artifact, force). | "Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the device exhibited MRI compatibility comparable to the predicate. Specific acceptance criteria and reported performance (e.g., Mr conditional labeling, temperature rise, artifact size) are not detailed. |
| Biocompatibility evaluation | ISO 10993-1 | "Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the device materials passed biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993-1. Specific acceptance criteria (e.g., pass/fail for each biological effect) and reported performance are not detailed. |
| Packaging and shelf life evaluations | ISO 11607-1, ISO 11607-2, ASTM F1980 | "Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the packaging system maintained sterility and integrity over the claimed shelf life according to these standards. Specific acceptance criteria and reported performance (e.g., seal strength, burst strength, microbial ingress) are not detailed. |
| Distribution testing | ISTA Procedure 3A, ASTM D4169, ASTM F2096 | "Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the packaged product safely withstood typical shipping and handling stresses, maintaining package integrity and device functionality. Specific acceptance criteria (e.g., no damage or breach of sterile barrier after testing) and reported performance are not detailed. |
| Sterilization evaluation | ISO 11137-1, ISO 11137-2 | "Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the sterilization process successfully rendered the device sterile to the specified sterility assurance level (SAL). Specific acceptance criteria (e.g., SAL of 10^-6) and reported performance (e.g., dosimetric release, bioburden reduction) are not detailed. |
| Endotoxin testing | AAMI ST72 | "Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device." Implies that the device met endotoxin limits (e.g., |
§ 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.”