(144 days)
The Aequalis PerFORM Reversed & Aequalis PerFORM+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and non-repairable rotator cuff-tear with pain disabled by:
- · Rheumatoid arthritis
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- · Correction of functional deformity
- · Fractures of the humeral head
- · Traumatic arthritis
- · Revision of the devices if sufficient bone stock remains.
The Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed Glenoid are intended to replace the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis. Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed glenoid component assembly must be used in association with a Tornier humeral component:
- Humeral implants Aequalis Reversed, Aequalis Reversed Fracture or Aequalis Adjustable ● Reversed Shoulder
- . or Humeral implants Aequalis Ascend Flex Shoulder System in reverse configuration
- or humeral implants Aequalis Reversed FX2 ●
The glenoid component assembly includes a modular system including a baseplate with central screw or press-fit post, peripheral anchoring screws and a glenosphere. The baseplates are available in various design configurations including: standard, lateralized, half-wedge augment and full-wedge augment. The glenospheres are available in various design configurations including: standard, lateralized and eccentric. The press-fit post may be used with the standard baseplate in lieu of the central anchoring screw. The baseplates and the press-fit posts are manufactured using additive manufacturing technology.
The document provided does not describe an acceptance criteria or study that proves the device meets specific performance metrics in the way a clinical or standalone study for an AI/algorithm-based device would.
Instead, this is an FDA 510(k) Premarket Notification for a medical device (Aequalis PerFORM Reversed and Aequalis PerFORM+ Reversed Glenoid – a shoulder prosthesis). The purpose of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to meet pre-defined performance acceptance criteria as would be typical for a diagnostic or AI device.
Here's how the information provided relates to your request, with an emphasis on what's not relevant for a typical AI/algorithm acceptance criteria study:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail numeric targets for performance metrics like sensitivity, specificity, or AUC, as these are not relevant for a mechanical prosthesis 510(k). The "acceptance criteria" here is that the device is "substantially equivalent" to predicate devices, meaning it is as safe and effective.
- Reported Device Performance: The document lists "Performance Data" which consists of a series of non-clinical bench tests (mechanical testing). These demonstrate the physical properties and durability of the prosthesis. Examples include:
- Compressive Strength and Elastic Modulus Testing of Titanium Porous Metal Verification
- Titanium Porous Structure Stereological Evaluation
- Titanium Porous Structure Mechanical Verification
- PerFORM Reversed Fixation Pull-out Test
- Fatigue Test
- Range of Motion Analysis
- PerFORM Reversed Taper Pull-Off Test
- Glenoid Loosening Test (100,000 cycles)
- PerFORM+ Reversed Augment Baseplate compared to the Exactech Equinoxe Reverse Augmented Baseplate Analysis
- PerFORM Reversed Lateralization Comparison
- PerFORM Reversed and PerFORM+ Reversed Peripheral Screw Angulation
- Direct Metal Laser Sintering (DMLS) Process Validation
- Endotoxin (
§ 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.”