(286 days)
The AETOS Shoulder System is intended for:
• Replacement of shoulder joints in primary anatomic or primary reverse arthroplasty.
• Replacement of shoulder joint devices in revision cases if sufficient bone stock is present.
• The AETOS Shoulder System also allows for conversions from anatomic to reverse in case of revision.
Indications for Use
In Anatomic:
The stem and 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 AETOS Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:
• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains
The coated humeral component is intended for uncemented use. The glenoid component is intended for cemented use only.
In Reverse:
The AETOS Shoulder System 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:
• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of devices if sufficient bone stock remains
The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.
The coated humeral stem is indicated for uncemented use. The coated glenoid baseplate is intended for cementless application with the addition of screws for fixation.
Note: All implant components are single use.
The AETOS Shoulder System consists of:
In an anatomic configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible humeral head (CoCr) with a compatible glenoid (UHMWPE). The AETOS Shoulder System stem and head may be used by themselves for hemiarthroplasty.
In a reverse configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible liner (UHMWPE), glenoid baseplate (Titanium with Titanium plasma spray), glenosphere (CoCr with Titanium retaining component), peripheral screws (Titanium), center screw (Titanium), and optional post extension (Titanium with Titanium plasma spray).
The provided text is a 510(k) Summary for the AETOS Shoulder System. It details the device's description, indications for use, and a summary of nonclinical performance data. However, it explicitly states that "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device."
Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets these criteria in the context of clinical performance, as no such clinical study was deemed necessary or performed for this 510(k) submission.
The document focuses on nonclinical performance data to establish substantial equivalence to predicate devices. Here's what can be extracted regarding the nonclinical evaluation:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table with explicit acceptance criteria (e.g., "Must withstand X N of force") and specific reported device performance values (e.g., "Device withstood Y N of force"). Instead, it lists the types of nonclinical testing performed to demonstrate substantial equivalence. The implication is that the performance in these tests was considered acceptable compared to the predicate devices and relevant standards.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Full Construct Fatigue Testing (Anatomic and Reverse Configurations) | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Taper Axial Testing (Humeral Head, Glenosphere) | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Taper Torsional Testing (Humeral Head, Glenosphere) | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Anatomic Glenoid Pull-out Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Anatomic Glenoid Loosening Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Humeral Liner Axial Disassembly Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Humeral Liner Torsional Disassembly Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Humeral Liner Lever-out Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Screw Testing (Torsional Properties, Axial Pullout) | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Reverse Glenoid Dynamic Loosening Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Post Extension Corrosion Testing | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Scapular Notching Risk Evaluation | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Range of Motion Evaluation | Not explicitly detailed; deemed acceptable for substantial equivalence. |
| Wear Assessment | Not explicitly detailed; deemed acceptable for substantial equivalence. |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the provided text for any of the nonclinical tests.
- Data Provenance: The tests are nonclinical (bench testing) and were performed by the manufacturer, Smith & Nephew, Inc. No country of origin for the data or whether it was retrospective/prospective is given, as these are typically not relevant for bench testing in the same way they are for clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there was no clinical study, and thus no "ground truth" established by experts in a diagnostic context. The "ground truth" for the nonclinical tests would be the measurement results against engineering specifications or established standards.
4. Adjudication method for the test set:
This information is not applicable as there was no clinical study requiring adjudication of expert interpretations.
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. The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the AETOS Shoulder System is a physical orthopedic implant, not an AI algorithm or software device.
7. The type of ground truth used:
For the nonclinical (bench) testing, the "ground truth" would be the engineering specifications, material science properties, and performance standards relevant to orthopedic implants, against which the device's performance in mechanical and material tests was evaluated for substantial equivalence to predicates.
8. The sample size for the training set:
This information is not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason 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.”