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510(k) Data Aggregation
(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.
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(279 days)
Hemiarthoplasty/Conventional Total Application:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Correction of functional deformity.
- · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
· Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Reverse Application:
Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.
The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).
The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres not recommended for patients who lack suspected material sensitivity to cobalt alloy.
The Identity Shoulder System is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty.
The Identity Shoulder System in the anatomic configuration is comprises of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head Adapter, and Humeral Head. This configuration can be used as a hemiarthroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component.
The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing. This constructed is intended to be used with a compatible glenospheres/baseplate component.
This FDA 510(k) summary for the "Identity Shoulder System" does not contain any information about acceptance criteria or a study proving the device meets said criteria.
The document is a premarket notification for a medical device seeking substantial equivalence to previously cleared devices. It primarily focuses on:
- Indications for Use: What the device is intended for (e.g., non-inflammatory degenerative joint disease, rheumatoid arthritis, fractures).
- Device Description: A high-level overview of the components and configurations (hemiarthroplasty, total shoulder replacement, reverse configuration).
- Technological Characteristics: How the device is similar to predicate devices in terms of intended use, indications for use, materials, design features, and sterilization.
- Non-Clinical Tests/Justifications: A list of non-clinical tests performed (e.g., FEA, Axial Pull Off, Fatigue, Corrosion) to support substantial equivalence, but no results or acceptance criteria are provided for these tests in this summary document.
- Clinical Tests: Explicitly states "None provided."
Therefore, based solely on the provided text, I cannot answer the requested questions regarding acceptance criteria and studies proving the device meets them because this information is not present. This type of detail is typically found in the full 510(k) submission, not in the public summary.
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(234 days)
Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:
- Osteoarthritis
- Post-traumatic arthrosis
- Focal avascular necrosis of the humeral head
- Previous surgeries of the shoulder that do not compromise the fixation
The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Fractures of the humeral head (with Short Humeral Stems)
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems)
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
Fixation Methods
The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.
Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.
- A severely painful, disabling, arthritic joint
- Fractures of the humeral head (with Short Humeral Stems)
- Fractures of the proximal humerus (with Standard or Long Stems)
- Revisions of previously failed shoulder joint replacements
Fixation Methods
The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.
The INHANCE™ SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.
The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures.
The Anatomic Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem or humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt-chromium) in combination with a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) glenoid.
The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).
The Anatomic Hemi-Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy) an offset taper adapter (titanium alloy), a humeral head (cobaltchromium) (no glenoid component associated).
The provided text describes the regulatory clearance of a medical device, the INHANCE™ Reverse Shoulder System, and does not contain information about the performance of an AI/ML device. Therefore, it is not possible to answer the requested questions about acceptance criteria, study details, and AI performance.
The document focuses on demonstrating "substantial equivalence" of the device to previously cleared predicate devices through non-clinical testing. It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Shoulder System to the predicate devices."
The non-clinical testing performed includes:
- Range of Motion (RoM) Evaluation: Met established specifications per ASTM F1378.
- Construct Fatigue Testing: Met acceptance criteria per ASTM F1378.
- Construct Loosening and Disassociation: Met acceptance criteria per ASTM F2028-17.
- Biocompatibility Assessments: Found to be biocompatible per ISO 10993-1 and FDA Guidance.
- Porous Structure Characterization: Identical to previously cleared devices.
- Characterization of VE-UHMWPE: Fully characterized in a previous submission (K202716).
- Evaluation of Wear Rate: Wear rate was lower than a predicate device, meeting acceptance criteria.
- MRI Compatibility: Quantitative data obtained per ASTM standards (F2052-15, F2213-17, F2182-19e2, F2119-07).
- Shelf Life Evaluation: A five-year shelf life established per ISO 11607-1 and ISO 11607-2.
- Sterilization Validation: Sterility Assurance Level (SAL) of 10^-9 found per ISO 11137-1 and ISO 11137-2.
These are all engineering and material performance tests for a physical implant, not an AI/ML algorithm or software.
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