(34 days)
AEQUALIS Shoulder Range (except AEQUALIS for Fracture): Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary and secondary necrosis of the humeral head - Displaced 4-part upper humeral fracture . - Humeral head fracture , - Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable - Revision surgery when other treatments or devices have failed. - AEQUALIS for Fracture: 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. Revision surgery when other treatments or devices have failed.
The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemiarthrosplasty to a total shoulder replacement. The present submission corresponds to the following modifications: - addition of two large glenoid components to the four existing sizes of glenoid both for the Aegualis shoulder Fracture System and the Aequalis shoulder System, - addition of a model of Fracture Stem covered with hydroxylapatite to the Aequalis shoulder Fracture -System, the new stem is strictly identical to the previously cleared device except for the coating.
The provided text is a summary of a 510(k) premarket notification for the Aequalis Shoulder Fracture System and Aequalis Shoulder System. It focuses on the device description, materials, indications for use, and regulatory classification.
There is no information in the provided document about:
- Acceptance criteria: The document does not specify any performance-based acceptance criteria for the device beyond the general goal of restoring the shoulder joint and reducing pain.
- Studies or performance data: The document states that the FDA determined the device is "substantially equivalent" to legally marketed predicate devices, but it does not provide any specific studies, test results, or performance metrics (like sensitivity, specificity, accuracy, or effect size) for the Aequalis Shoulder systems themselves. The substantial equivalence determination is often based on design similarities, material biocompatibility, and similar indications for use to already approved devices, rather than new extensive clinical performance studies for 510(k) applications.
Therefore, I cannot populate the table or answer most of your detailed questions based on the input text.
Here's what I can extract and state explicitly about the lack of information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | No specific performance metrics (e.g., success rates, pain reduction scores, range of motion improvements, fracture healing rates) are reported in the provided document. The document states the "usual goal...is to restore the shoulder joint to its best working condition and to reduce or eliminate pain." |
Additional Information (based on the lack of data in the provided document):
- Sample size used for the test set and the data provenance: Not provided. The submission is a 510(k), which typically relies on substantial equivalence to predicate devices rather than new clinical outcome studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no specific test set or ground truth establishment is described for the Aequalis devices' performance.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no specific test set or ground truth establishment is described.
- 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. This device is a surgical implant, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical implant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance studies are described. The regulatory approval is based on substantial equivalence to predicate devices for mechanical and material properties and intended use.
- The sample size for the training set: Not applicable, as no development of an AI algorithm or similar data-driven model is described.
- How the ground truth for the training set was established: Not applicable.
Summary of available information from the document:
- Device Name: Aequalis Shoulder Fracture System & Aequalis Shoulder System
- Predicate Devices: K952928, K041339, K043077 (Aequalis Shoulder system); K994392, K003728, K032679, K043077 (Aequalis Shoulder Fracture system)
- Regulatory Mechanism: 510(k) Premarket Notification based on substantial equivalence.
- Modifications in current submission: Addition of two large glenoid components and a fracture stem covered with hydroxylapatite (which is strictly identical to a previously cleared device except for the coating).
- Materials: Humeral implant: titanium alloy (Ti6Al4V) or chromium-cobalt alloy (CrCo). Glenoid component: ultra-high molecular weight polyethylene (UHMWPE). Hydroxylapatite coating.
- Indications for Use: Detailed for both the Aequalis Shoulder Range (except for Fracture) and Aequalis for Fracture, covering degenerative pathologies, necrosis, various humeral fractures, and revision surgeries.
§ 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.”