(104 days)
The Aequalis Ascend Modular Reverse Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive 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 Reverse Metaphysis and Assembly Screw or the Reverse Metaphysis, Reverse Spacer, and Reverse Spacer Assembly Screw are indicated for use as components of the Aequalis Ascend Modular Reverse total shoulder replacement and for transformation of the Aequalis Ascend Anatomic shoulder into a reverse shoulder prosthesis without the removal of the Diaphyseal stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if: - The Diaphyseal stem is well fixed
- The patient has a functional deltoid muscle
- The arthronathy is associated with a massive and non-repairable rotator cuff-tear.
Notes: - All components are single use
- The humeral stem is intended for cemented or cementless use
- The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
The Aequalis Ascend Modular Reverse Shoulder system is a modular Reverse version of the Aequalis Ascend Modular Anatomic Shoulder System (K102924) with Reverse adapters. The Aequalis Ascend Modular Reverse Shoulder system is supplied in separate sterile packages which will be assembled in the operating room. The components provided will be:
- The Modular Reverse Metaphysis and Modular Reverse Assembly Screw.
- The Modular Reverse Inserts
- The Modular Reverse Angled Inserts
- An optional Modular Reverse Spacer and Modular Reverse Spacer Assembly Screw can be used when maximum insert thickness does not achieve sufficient tension.
- When the Modular Reverse Spacer is implanted, the Modular Reverse Spacer Assembly Screw will be used in place of the Modular Reverse Assembly Screw.
Primary Reverse Shoulder:
The Aequalis Ascend Modular Reverse Metaphysis and Aequalis Ascend Modular Reverse Assembly Screw will mate with the existing; FDA cleared Tornier Aequalis Ascend Modular Anatomic Distal Stem (K102924) which when assembled together with the Aequalis Ascend Modular Reverse Insert form complete reverse prostheses. The reverse assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants (K081059).
Conversion Reverse Shoulder:
The Aequalis Ascend Reverse Metaphysis and Aequalis Ascend Modular Reverse Assembly Screw are designed to allow the transformation of the Aequalis Ascend Anatomic shoulder (K102924) into an Aequalis Ascend Modular Reverse Shoulder without removal of the Diaphyseal Stem if the stem is well fixed during revision surgery. The Aequalis Ascend Reverse Metaphysis is a metal component aimed to articulate as a reverse prosthesis with a specific polyethylene insert. The metal metaphysis is impacted onto the taper of the Diaphyseal Stem and then secured with the Ascend Modular Reverse Assembly Screw. The screw is tightened until it is firmly seated on the Reverse Metaphysis. A Reverse Spacer can be used when the maximum insert thickness does not achieve sufficient tension. During these situations, after impaction of the Reverse Metaphysis on the Diaphyseal stem, the metal spacer is impacted on the taper of the Reverse Metaphysis and then secured with the Ascend Modular Reverse Spacer Assembly Screw. The screw is tightened until it is firmly seated on the Reverse Spacer.
This document is a 510(k) summary for the Aequalis® Ascend™ Modular Reverse Shoulder System. It does not describe an AI/ML powered device, but rather a medical implant. Therefore, the requested information about acceptance criteria and study details for an AI/ML device is not applicable or available in this document.
However, I can extract information related to the device's testing and safety from the provided text, which serves a similar purpose to demonstrating that the device meets certain criteria for market approval.
Here's an interpretation of the document in the context of device approval, where "acceptance criteria" can be broadly understood as the standards it needed to meet for FDA clearance:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria with numerical targets. Instead, the device's "performance" is assessed through non-clinical tests to demonstrate substantial equivalence to predicate devices, implying it meets the same safety and effectiveness standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical integrity under fatigue loading | Successfully underwent Fatigue Testing. The results allowed the conclusion that the device is substantially equivalent to predicate devices in terms of safety and effectiveness. |
| Resistance to fretting corrosion | Successfully underwent Fretting Corrosion testing. The results allowed the conclusion that the device is substantially equivalent to predicate devices in terms of safety and effectiveness. |
| Stability of assembled components | Successfully underwent Static Disassembly Testing of Reverse Insert. The results allowed the conclusion that the device is substantially equivalent to predicate devices in terms of safety and effectiveness. |
| Biocompatibility of materials | Materials conform to established ASTM and ISO standards (ASTM F 136, ASTM F-1537, ASTM F648, ISO-5834-2). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-clinical testing" (Fatigue Testing, Fretting Corrosion, Static Disassembly Testing) but does not specify sample sizes for these tests or their provenance.
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)
This information is not applicable to this type of device (a physical implant) and is not provided. "Ground truth" in this context would generally refer to expert-labeled data for AI models, which is not relevant here. The "experts" involved would be engineers and materials scientists performing and evaluating the non-clinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this type of device and is not provided. Adjudication methods are typically used for expert consensus on clinical or imaging data in AI/ML studies.
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
This information is not applicable as this is a physical medical implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable in the AI/ML sense. For this device, the "ground truth" for the non-clinical testing is based on established engineering principles, material science standards (ASTM, ISO), and comparisons to previously cleared predicate devices. The safety and effectiveness are inferred from these tests and the device's substantial equivalence to predicates.
8. The sample size for the training set
This information is not applicable as this is a physical medical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical implant, not an AI model.
In summary, the provided document describes the FDA 510(k) clearance for a physical medical device (shoulder prosthesis). The core of its approval lies in demonstrating "substantial equivalence" to predicate devices through non-clinical (mechanical and material) testing, rather than through AI/ML performance metrics and studies.
§ 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.”