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510(k) Data Aggregation
(250 days)
AETOS Shoulder System Stemless Humeral Prosthesis
In Anatomic:
The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) 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 humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural dlenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:
- Rheumatoid arthritis
- · Non-inflammatory degenerative ioint disease
- · Correction of functional deformity
- · Fractures of the humeral head
- · Traumatic arthritis
- Revision of other devices if sufficient bone stock remains
The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff.
When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by:
- · Non-inflammatory degenerative joint disease
- · Traumatic arthritis
- Revision of other devices if sufficient bone stock remains
The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only.
In Reverse:
The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, 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 stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation.
Note: All implant components are single use.
The AETOS Stemless Humeral Prosthesis subject to this submission is a humeral anchor intended for press-fit fixation as part of an implant construct in anatomic total shoulder arthroplasty for the treatment of skeletally mature individuals with degenerative diseases of the glenohumeral joint.
This FDA submission (K240716) for the AETOS Shoulder System Stemless Humeral Prosthesis does not describe an AI/ML medical device. Therefore, it does not include information on acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies that are typically associated with the evaluation of AI/ML software.
The submission focuses on the substantial equivalence of a new medical implant (a stemless humeral prosthesis) to previously cleared predicate devices. The evaluation criteria for this type of device are primarily based on non-clinical performance data, such as:
- Construct fatigue and corrosion resistance assessment
- Post-fatigue stability
- Static disengagement
- Dynamic stability / loosening
- Bone volume and contact analysis
The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device." This confirms that a clinical study, which would typically involve human readers or an AI algorithm, was not conducted or required for this submission.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it pertains to an AI/ML medical device, because this submission is for a physical orthopedic implant and does not involve AI/ML.
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(98 days)
AETOS Shoulder System
In Anatomic:
The stem and head may be used by themselves, as a hemiathroplasty, 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 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 uncement is intended for cement 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), optional humeral spacer (Titanium), and optional post extension (Titanium with Titanium plasma spray).
This document is a 510(k) Premarket Notification from the FDA regarding the AETOS Shoulder System. It is primarily concerned with establishing substantial equivalence to previously cleared devices based on non-clinical performance data and technological similarities/differences.
Therefore, a study proving the device meets acceptance criteria related to AI/algorithm performance (as described in your prompt, e.g., sensitivity, specificity, human reader improvement) was not performed nor is it relevant to this specific FDA submission.
The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device."
Instead, the acceptance criteria for this device are established through engineering and mechanical testing, ensuring the physical device components meet design specifications and performance standards comparable to legally marketed predicate devices.
Here's how to interpret the available information in the context of your request:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implied by the non-clinical performance data testing listed, which assess the mechanical integrity and function of the shoulder system components. The "reported device performance" is that the device met these standards, demonstrating substantial equivalence to the predicate devices. This type of submission relies on the device performing as well as the predicate in relevant mechanical and material property tests to prove safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Construct fatigue | Met standards |
| Dynamic glenoid loosening / dissociation per ASTM F2028 | Met standards |
| Range of motion evaluation | Met standards |
| Scapular notching evaluation | Met standards |
| Construct disassembly evaluation | Met standards |
| Total humeral offset evaluation | Met standards |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of patient data. The "test set" here refers to the physical components of the shoulder system subjected to mechanical testing. The sample size for these engineering tests would typically be a specific number of manufactured components.
- Data Provenance: This is not patient- or human-read data. It's likely from internal laboratory testing conducted by the manufacturer (Smith & Nephew, Inc. at Cordova, Tennessee). It's not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The "ground truth" for mechanical performance of an orthopedic implant is established through standardized engineering tests (e.g., ASTM standards) and material science principles, not expert consensus from medical professionals. The "experts" would be engineers, material scientists, and quality assurance personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this refers to human expert review of clinical data, which was not the basis of this submission. The "adjudication" is met by demonstrating compliance with established engineering and material standards through testing.
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. This device is a physical orthopedic implant, not an AI/software as a medical device (SaMD) that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's acceptance is established through compliance with existing engineering standards and successful completion of specified mechanical and material property tests. These tests are designed to simulate physiological loads and conditions to ensure the device's durability and performance.
8. The sample size for the training set:
Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided document is a 510(k) clearance for a physical medical device (shoulder system). The "acceptance criteria" and "study" details you requested are tailored to AI/software products. For this device, acceptance is based on non-clinical (engineering) performance data demonstrating substantial equivalence to older, already cleared devices, rather than clinical trials or AI performance metrics.
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(286 days)
AETOS Shoulder System
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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