(88 days)
The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint :
- in case of 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, or
- in case of bone defect in proximal humerus. .
The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.
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 hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed Fracture Shoulder humeral stem, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.
The Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.
The Aequalis Reversed Fracture Shoulder Prosthesis is intended to relieve pain or significant disability following massive 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 surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Fracture Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm and its Aequalis Fracture Shoulder humeral stem-like design allows to facilitate the bone reconstruction and improve the tuberosity healing and fixation.
The Aequalis Reversed Fracture Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
This document is a 510(k) premarket notification for the "Aequalis Reversed Fracture Shoulder Prosthesis." It outlines the device's indications for use, materials, and provides a comparative analysis to predicate devices to establish substantial equivalence.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
This document describes a medical device (Aequalis Reversed Fracture Shoulder Prosthesis) and its substantial equivalence to predicate devices, rather than an AI/software device. Therefore, the concept of "acceptance criteria" as typically applied to performance metrics like sensitivity, specificity, or accuracy for an AI system is not directly applicable here.
Instead, the "acceptance criteria" implicitly referred to are the regulatory requirements for showing substantial equivalence to legally marketed predicate devices, as defined by the FDA's 510(k) process. This involves demonstrating that the new device is as safe and effective as the predicate device(s). The document indicates that the device meets these criteria as the FDA issued a "substantially equivalent letter."
The "reported device performance" is not quantified in terms of clinical outcomes or performance metrics in this document, but rather in terms of its design, materials, and intended use being comparable to existing devices already deemed safe and effective.
| Acceptance Criteria (Implied for 510(k) Clearance) | Reported Device Performance (as per document) |
|---|---|
| Substantial Equivalence to Legally Marketed Predicate Devices | The FDA has determined the device is substantially equivalent for the stated indications for use to legally marketed predicate devices. This implies that the Tornier Aequalis Reversed Fracture Shoulder Prosthesis is considered as safe and effective as the predicate devices. This assessment is based on comparisons in design, materials, and intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document is a regulatory submission for a medical implant (a shoulder prosthesis), not a study evaluating an AI device's performance. Therefore, there is no test set, sample size, or data provenance information related to an AI algorithm's evaluation. The evaluation is based on a comparison to predicate devices, materials testing, and design specifications.
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)
Not applicable, as this is a medical device submission, not an AI study requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a medical device submission.
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
Not applicable, as this is a medical device submission, not an AI or software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a medical device submission, not an AI or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this medical device, the "ground truth" for regulatory clearance is the established safety and effectiveness of the legally marketed predicate devices. The new device demonstrates substantial equivalence by showing similar technological characteristics, materials, and intended use, supported by engineering testing and clinical experience with similar devices, rather than a specific "ground truth" derived from patient data in the context of an AI algorithm validation.
8. The sample size for the training set
Not applicable, as this is a physical medical device submission, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a physical medical device submission.
§ 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.”