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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 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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The Aequalis Ascend Modular Anatomic 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

Notes:

• All components are single use
• The humeral stem is intended for cemented or cementless use
• The glenoid component is intended for cemented use

The Aequalis Ascend Modular Anatomic Shoulder system is supplied in separate sterile packages which will be assembled in the operating room. The system is comprised of the following components:

• The Modular Distal Stem
• The Modular Anatomic Metaphysis
• The Modular Anatomic Assembly Screw.
  This assembly will mate with existing; FDA cleared Tornier Ascend Monolithic Humeral Heads (K071147) which were designed to articulate with FDA cleared Tornier Aequalis and Affiniti Glenoid replacements (K063081 and K060988 respectively).

This submission corresponds to a change made to the Aequalis Ascend Modular Anatomic Shoulder System (previously cleared in 510(k) K102924).

The provided text is for a 510(k) summary for a medical device called the "Aequalis Ascend Modular Anatomic Shoulder System." It focuses on demonstrating substantial equivalence to a predicate device through bench testing. Biomedical devices, unlike AI/ML devices, do not have the same set of acceptance criteria, study types, and ground truth definitions. The document does not contain information about the topics requested in the input.

Therefore, I cannot provide the requested information based on the provided text.

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The Aequalis Ascend Modular Anatomic 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

Notes:

• All components are single use
• The humeral stem is intended for cemented or cementless use
• The glenoid component is intended for cemented use

The Aequalis Ascend Modular Anatomic Shoulder system is a modular version of the Ascend Monolithic Shoulder System (K071147) with anatomic adapters.

The Aequalis Ascend Modular Anatomic Shoulder system is supplied in separate sterile packages which will be assembled in the operating room. The components provided will be:

• The Modular Distal Stem.
• The Modular Anatomic Metaphysis.
• The Modular Anatomic Assembly Screw.

This assembly will mate with existing; FDA cleared Tornier Ascend Monolithic Humeral Heads (K07) 147) which were designed to articulate with FDA cleared Tornier Aequalis and Affiniti Glenoid replacements (K063081 and K060988 respectively ).

The provided text is a 510(k) summary for a medical device (Aequalis Ascend Modular Anatomic Shoulder System). It does not describe any acceptance criteria or study that proves the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to previously marketed devices.

Therefore, the requested information cannot be extracted from this document.

Here's why and what's missing:

• Acceptance Criteria & Device Performance: The document lists "Indications for Use" but does not define any quantitative performance metrics (e.g., strength, durability, wear resistance, clinical outcome scores) that would serve as acceptance criteria. It also doesn't report any device performance against such criteria.
• Study Description: There is no mention of a study (clinical or non-clinical) conducted to assess the performance of the Aequalis Ascend Modular Anatomic Shoulder System. The submission relies on demonstrating similarity to predicate devices.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: All these points relate to specific study methodologies, which are entirely absent from this 510(k) summary.

In summary, the provided text does not contain the information required to answer your questions about acceptance criteria and a study proving the device meets them. 510(k) summaries primarily aim to establish "substantial equivalence" to existing cleared devices, often through comparison of design, materials, and intended use, rather than presenting new performance study data against defined acceptance criteria.

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