(45 days)
Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by:
- . Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis.
- Primary or 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.
The Aequalis monobloc stem is cemented use. The Aequalis press-fit is for uncemented use. Glenoid component is for cemented use.
The Aequalis PerFORM+ Shoulder System is a modular system consisting of a metaphyseal humeral stem component, anatomic humeral heads and glenoid for a total shoulder athroplasty. Surgical instruments are designed to facilitate proper implantation of the system.
The provided text describes a 510(k) premarket notification for a medical device called the Aequalis PerFORM+ Shoulder System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring formal acceptance criteria and a study proving those criteria are met for a new, standalone device in the same way a novel AI or diagnostic might.
Therefore, the concept of "acceptance criteria and a study that proves the device meets the acceptance criteria" as it applies to an AI/diagnostic device does not directly translate here. Instead, the document discusses "Performance Data" to demonstrate substantial equivalence to a predicate device.
Regarding the Aequalis PerFORM+ Shoulder System:
- A table of acceptance criteria and the reported device performance:
| Validation and / or Verification Method | Acceptance Value / Criteria | Results |
|---|---|---|
| Dimensional comparison | The profile and anchorage of the Aequalis PerFORM+ to be the same as to the predicate device design. | Acceptable |
| Dimensional comparison | The geometric shape of the articular surface must be compatible with existing humeral heads. | Acceptable |
| Dimensional comparison | Posterior build up must be equivalent to the currently marketed devices. | Acceptable |
| Loosening Test | No Loosening detected at completion of test. | Acceptable |
| Shear testing | Comparable to the predicate device design. | Acceptable |
| Tensile (pull out) testing | Comparable to the predicate device design. | Acceptable |
| Simulated use of instrumentation | Successful preparation of cadaveric specimens. | Acceptable |
The following information cannot be extracted from the provided text, as it pertains to a different type of device evaluation (e.g., AI/diagnostic software) than the mechanical shoulder implant described:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
The document explicitly states: "Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device." This reinforces that the evaluation method for this orthopedic implant is based on engineering and mechanical testing to demonstrate equivalence, not clinical performance or expert interpretation as would be the case for an AI/diagnostic system.
§ 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.”