(99 days)
IN ANATOMIC:
The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral 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 Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The Aequalis Ex2 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 proximal humerus except for size 50mm(1)
- Traumatic arthritis
- Revision of other devices if sufficient bone stock remains except for size 50mm(1)
IN REVERSE:
The Aequalis Fx2 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:
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Rheumatoid arthritis
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Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
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Correction of functional deformity
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Fractures of the proximal humerus except for size 50mm(1
-
Traumatic arthritis
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Revision of the devices if sufficient bone stock remains except for size 50mm( ).. The reversed insert is permitted to be used in the transformation from anatomic to reverse Aequalis Fx2 without the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle.
The Aequalis Fx2 is a non-constrained prosthesis intended for the total or partial replacement of the gleno-humeral articulation.
The Aequalis Fx2 consists of:
- in an anatomic configuration, a humeral stem compatible with Flex Shoulder System humeral heads (K122698 ; K140082);
or
- in a reversed configuration, a humeral stem and a reversed insert, compatible with Aequalis Reversed/Aequalis Reversed II glenoid implants (K081059; K140478).
The Aequalis Fx2 is intended for use as:
- traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint,
including humeral head fracture and displaced 3-or 4-part proximal humeral fractures,
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in case of bone defect in the proximal part of the humerus,
-
a replacement of shoulder joints in primary anatomic or in primary reverse,
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a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.
The Aequalis Fx2 also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.
This submission corresponds to the design modification related to the Aequalis Fx2 assembly zone (humeral stems and reversed inserts) compatible only with each other. This design modification does not affect the intended use of the device or alter the fundamental scientific technology of the device. The pending humeral stems are compatible with the cleared Flex Shoulder humeral heads and the pending reversed inserts are compatible with the cleared Aequalis Reversed II glenoid implants. There is no change regarding the material of the pending Aequalis Fx2 humeral stems. The design change related to the pending Aequalis Fx2 reversed inserts does not include a titanium locking ring in contrast to the previously cleared Aequalis Fx2 reversed inserts.
Here's a breakdown of the acceptance criteria and the study information for the Aequalis Fx2 device based on the provided document:
This document is a 510(k) premarket notification for a medical device (Aequalis Fx2), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study on human-in-the-loop performance or diagnostic accuracy. Therefore, many of your requested points related to AI/algorithm performance (standalone performance, MRMC studies, ground truth establishment for training/test sets, expert qualifications) are not applicable to this type of submission.
The "study" described here consists of various engineering and physical tests to demonstrate that the modified device's performance is acceptable and comparable to its predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Validation and / or Verification Method | Acceptance Value / Criteria | Reported Device Performance |
|---|---|---|
| Dimensional comparison | The geometric shape of the reversed insert articular surface must be compatible with the existing range of Aequalis Reversed/Reversed II glenoid spheres | Acceptable |
| Assembly method | Assembly method between pending Aequalis Fx2 (reversed insert and humeral stems) must be equivalent to the assembly method between cleared Aequalis Fx2 (reversed insert and humeral stems) | Acceptable |
| Convertibility | The assembly geometry of the humeral stem must allow the conversion from the anatomical configuration to the reversed configuration of the prosthesis | Acceptable |
| Dimensional comparison | The external geometric shape of the pending Aequalis Fx2 humeral stem must be the same as the cleared Aequalis Fx2 humeral stem | Acceptable |
| Fatigue testing | No failure after the test | Acceptable |
| Pull out pre-fatigue testing | Equivalent to the predicate (K030941) | Acceptable |
| Torque testing | Equivalent to the predicate (K141345) | Acceptable |
| Pull out post fatigue testing | Equivalent to the predicate (K030941) before fatigue | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size in terms of units tested for each validation method. It refers to "the design modification" and "the pending Aequalis Fx2 humeral stem and reversed insert," implying that these tests were conducted on representative samples of the device components.
- Data Provenance: The tests are described as physical/bench tests conducted by the manufacturer, Tornier S.A.S., which is based in Montbonnot Saint-Martin, France. This is not patient-derived data; it's engineering test data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The "ground truth" for these engineering tests is established by industry standards, engineering specifications, and predicate device performance, not by medical experts interpreting data like in a diagnostic study.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations, which is not relevant to the physical testing described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
This information is not applicable. This document is for a shoulder prosthesis and does not involve AI or human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
This information is not applicable. This document is for a physical medical device (shoulder prosthesis) and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these performance tests is based on:
- Engineering Specifications and Design Requirements: For dimensional comparisons, assembly methods, and convertibility.
- Predicate Device Performance: For tests like Pull-out and Torque testing, where the modified device's performance is compared for equivalence to previously cleared devices (K030941 and K141345).
- Failure Criteria: For fatigue testing ("No failure after the test").
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of an engineering evaluation for a mechanical implant.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
§ 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.”