(135 days)
Cemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Uncemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
The Aegualis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.
Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to relieve pain. The reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.
The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
The present device modification consists in the addition of glenoid base plates with central threaded post and a new coating.
Here's an analysis of the provided text regarding the Aequalis Reversed Shoulder Prosthesis, focusing on acceptance criteria and supporting studies:
It's important to note that the provided document is a 510(k) Premarket Notification summary for a modification to an already cleared device ("Aequalis Reversed II glenoid base plate"). Therefore, the studies are primarily aimed at demonstrating substantial equivalence of the new components to the previously cleared ones, rather than establishing de novo safety and effectiveness for a completely new device.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission for a modification, the "acceptance criteria" are framed around demonstrating equivalence to previously cleared predicate devices, particularly concerns about the new glenoid base plate's anchorage.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Equivalence of Pull-out Resistance (Glenoid Anchorage): The new glenoid base plate must demonstrate equivalent resistance to pull-out forces compared to the cleared glenoid base plate, independently of post design. | Demonstrated Equivalence: Pull-out testing (E1586) was conducted and results showed that the new Aequalis Reversed base plates (with the modified post design and dimensions) were equivalent to the cleared models in terms of resistance in pull-out. The document explicitly states: "To demonstrate the equivalence between the new glenoid base plate and the cleared glenoid base plate the resistance in Pull-out has to be equivalent." and "The result shows that primary fixation has been achieved without scapular fracture or other major peri-operative complications." |
| Proper Use of Instruments and Implants (Surgical Feasibility): The new components and associated instruments must be able to be used effectively without major peri-operative complications. | Demonstrated Feasibility: Cadaver testing was performed to "ensure proper use of instruments and implants." The results indicated "primary fixation has been achieved without scapular fracture or other major peri-operative complications." |
| Risk of Glenoid Fracture: The new post dimensions and drilled hole diameter should not increase the risk of glenoid fracture compared to the predicate. | Equivalent Risk: The submission states, "In comparison of the recommended drilled hole diameter of the pending Aequalis Reversed base plate and the predicate, we can see that the pending Reversed base plate is equivalent with the predicates concerning the risk of glenoid's fracture." |
| Equivalent Intended Use | Met: The new glenoid base plate "have the same intended use as the cleared glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis." |
| Equivalent Technological Characteristics (General features, fixation, materials) | Met: Overall, it's stated that "Major technological characteristics are equivalent between the new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis and the predicate devices: Equivalence of general features - Equivalent means of fixation - Equivalent materials." |
2. Sample Size Used for the Test Set and Data Provenance
- Pull-out Testing (E1586):
- Sample Size: Not explicitly stated as a number. The text mentions "Posts of glenoid base plate (pending and cleared) are impacted in the same foam bloc in several configurations." This implies a comparative test with multiple specimens/configurations for both the new and cleared devices.
- Data Provenance: The study was "conducted on the new Aequalis Reversed II glenoid base plate and the cleared Aequalis Reversed II glenoid base plate." This indicates controlled laboratory testing, not human patient data.
- Cadaver Testing:
- Sample Size: Not explicitly stated (e.g., number of cadavers).
- Data Provenance: "Cadaver testing was performed." This is prospective testing on biological tissue from cadavers, likely conducted in a laboratory or simulated surgical environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the engineering tests (pull-out) and cadaver testing described, "ground truth" is typically established by objective physical measurements (e.g., force required for pull-out, visual inspection for fractures/complications) rather than expert consensus on interpretive data.
- No information is provided about the number or qualifications of experts for establishing ground truth in these non-clinical tests. This type of testing relies on engineering and biomechanical principles, not clinical interpretation.
4. Adjudication Method for the Test Set
Given the non-clinical, objective nature of the tests (pull-out force, observational findings during cadaver surgery), formal adjudication methods like 2+1 or 3+1 (common in diagnostic imaging studies) are not applicable or described. The results would be based on direct measurement and observation by the testing personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- This submission pertains to a medical implant (shoulder prosthesis modification), not a diagnostic device or a system involving human interpretation of data. Therefore, the concept of human readers or AI assistance in the context of an MRMC study does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm-only performance study was not done.
- This is an implantable medical device, not a software algorithm.
7. The Type of Ground Truth Used
- Pull-out Testing: The ground truth used was objective physical measurement of the force required to pull out the glenoid base plate from a foam block. The "truth" was the measured load/resistance.
- Cadaver Testing: The ground truth was based on direct observation and qualitative assessment of surgical outcomes, specifically whether "primary fixation has been achieved without scapular fracture or other major peri-operative complications." This involved visual inspection, palpation, and potentially other assessments during and after the simulated surgical procedure.
8. The Sample Size for the Training Set
- Not applicable. This is a medical implant, not a machine learning algorithm. There is no concept of a "training set" in this context. The device's design is based on engineering principles and previous device iterations, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 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.”