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The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional polyethylene glenoid. 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 Ascend 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 Ascend Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis with pain .
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) .
• Correction of functional deformity ●
• Fractures of the humeral head ●
• Traumatic arthritis ●
• Revision of other devices if sufficient bone stock remains .

All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.

The Ascend Shoulder System consists of a humeral stem Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a mating humeral head and an optional all polyethylene glenoid. The stem and head may be used alone, as a hemiarthroplasty if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total shoulder replacement system.

The present device submission corresponds to changes made to the version of the device cleared in 510(k) K120794.

This is a 510(k) premarket notification for the Tornier Inc. Ascend Shoulder System, specifically highlighting changes made to a previously cleared version of the device. This document describes a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) are not applicable.

Below is a summary based on the provided text, focusing on the available information regarding the device itself.

Acceptance Criteria and Device Performance for the Tornier Inc. Ascend Shoulder System (K121493)

The document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device (Tornier Ascend Shoulder System: K120794) for regulatory approval. This typically means demonstrating that the modified device is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a premarket notification for a physical medical device (shoulder prosthesis), and the "test set" refers to non-clinical testing of the device itself (e.g., mechanical testing, coating validation), not a dataset for an AI/ML algorithm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This is not an AI/ML device where experts establish ground truth for a diagnostic output. The "ground truth" for a physical device is its material properties, mechanical performance, and biological compatibility, typically assessed through engineering standards and biological evaluations, not expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for ambiguous cases in diagnostic studies, particularly with AI/ML. For a physical device, testing involves defined protocols and measurements.

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

No. This is not an AI/ML device that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

For a physical orthopedic implant, the "ground truth" implicitly refers to:

• Engineering Standards and Specifications: Adherence to established mechanical, material, and performance standards for orthopedic implants.
• Biocompatibility Data: Evidence that the materials used are safe for implantation in the human body.
• Coating Validation Specifications: Specific criteria for the Titanium Plasma Spray (Ti PS) coating, such as adhesion strength, thickness, and morphology.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device, not an AI/ML algorithm.

Summary of Non-Clinical Testing:

The document explicitly states: "The modified Ascend Shoulder System was subjected to non-clinical testing (coating validation)." This indicates characterization and performance testing on the physical device, specifically focusing on the titanium plasma spray (Ti PS) coating. The results of these tests were deemed sufficient to conclude that the modified device is substantially equivalent to the predicate.

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The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional polyethylene glenoid. 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 Ascend 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 Ascend Shoulder System is indicated for use as a replacement of shoulder joints disabled bv:

• Rheumatoid arthritis with pain .
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) .
• Correction of functional deformity ●
• Fractures of the humeral head .
• Traumatic arthritis .
• Revision of other devices if sufficient bone stock remains .

All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.

The Ascend Shoulder System consists of a humeral stem Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a mating humeral head and an optional all polyethylene glenoid. The stem and head may be used alone, as a hemiarthroplasty if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total shoulder replacement system.

The present device submission corresponds to changes made to the version of the device cleared in 510(k) K113413.

This document is a 510(k) premarket notification for the Tornier Inc. Ascend Shoulder System. It describes modifications to an already cleared device. As such, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information about acceptance criteria or a study proving the device meets those criteria in the context of AI/software performance metrics (e.g., sensitivity, specificity, accuracy).

Therefore, I cannot provide the requested information from the given text. The provided document is for a physical medical device (shoulder prosthesis) and evaluates its safety and effectiveness through mechanical and material testing, not through AI/software performance studies.

Ask a specific question about this device

The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional polyethylene glenoid. 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 Ascend 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 Ascend Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.

The Ascend Shoulder System consists of a humeral stem, a mating humeral head and an optional all polyethylene glenoid. The stem and head may be used alone, as a hemiarthroplasty if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total shoulder replacement system.

The present device submission corresponds to changes made to the version of the device cleared in 510(k) K071147.

The provided text describes a Special 510(k) Premarket Notification for the Tornier Inc. Ascend Shoulder System, which is a medical device. This type of submission is for modifications to a previously cleared device and focuses on establishing substantial equivalence to a predicate device, rather than proving device performance against specific acceptance criteria through clinical studies.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided document. The document focuses on regulatory classification, device description, indications for use, and a summary of non-clinical testing to demonstrate substantial equivalence to a predicate device (Tornier Nexa Orthopedics Total Shoulder System, K071147).

The non-clinical testing performed includes:

• Taper disassembly strength
• Mismatch evaluation
• Extraction testing
• Cadaveric evaluation

The document explicitly states: "The results of these non-clinical tests allow us to conclude that the Ascend Shoulder System described in this submission is substantially equivalent and as safe and effective as the original device." This indicates that no separate study proving the device meets specific acceptance criteria as defined by performance metrics (like sensitivity, specificity, accuracy, etc.) was conducted or reported in this submission format, as it's not typically required for a Special 510(k) for a modified Class II orthopedic implant.

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