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Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:

• Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary or secondary necrosis of the humeral head
• -Displaced 4-part upper humeral fracture
• Humeral head fracture -
  Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable.
  Revision surgery when other treatments or devices have failed.
  The Aequalis monobloc stem is cemented use. The Aequalis Press-Fit is for uncemented use. Glenoid component is for cemented use.

The Aequalis Shoulder System is intended to restore the shoulder joint to its best working condition and to reduce or eliminate pain. It consists in a humeral stem and a humeral head. With these systems the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Acqualis Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement. The present device modification submission consists in the addition of a new glenoid system, named Tornier Glenoid, to the current cleared model. The Tornier Glenoid system is a comprehensive offering that includes a variety of anchorage options such as a keel, standard peg and Cortil oct 14 peg available in a variety of sizes. The Tornier Glenoid has been designed to be compatible with the Aequalis, Affiniti and Ascend humeral head systems in certain combinations. The new Tomier Glenoid completes the Tornier range of glenoid implants. Tornier Glenoid component is intended for cemented use only.

This document is a 510(k) premarket notification for a medical device modification, specifically the addition of a new glenoid system ("Tornier Glenoid") to the existing Aequalis Shoulder System. The primary purpose of this submission is to demonstrate "substantial equivalence" of the modified device to legally marketed predicate devices, not to establish new performance criteria through a study with the modified device.

Therefore, the document does not contain acceptance criteria and a study demonstrating the device meets these criteria in the typical sense of a novel device demonstrating efficacy or performance through clinical trials. Instead, it argues for equivalence based on similar design, materials, indications for use, and a limited set of non-clinical bench tests confirming that the modifications do not introduce new risks.

Here's a breakdown of the requested information based on the provided text, with explanations where direct answers are not available due to the nature of a 510(k) submission:

1. Table of acceptance criteria and the reported device performance

This document does not present a table of specific numerical acceptance criteria (e.g., minimum tensile strength, maximum wear rate) and corresponding reported performance values for the new Tornier Glenoid. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, focusing on similarity rather than novel quantitative metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for the test set: Not explicitly stated as a "test set" in the context of a clinical study. The "test set" refers to the new Tornier Glenoid components that underwent non-clinical bench testing. The specific number of components tested for each bench test is not provided in this summary.
• Data provenance: The non-clinical testing was performed by Tornier S.A.S. in France. This is implied by the company's address and the nature of manufacturing and R&D activities. The data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As this is a 510(k) submission for a device modification, "ground truth" in the sense of clinical disease diagnosis or outcome for a test set of patients (as would be established by medical experts) is not part of the submission criteria. The "ground truth" here is adherence to design specifications, material standards, and performance in bench tests against established engineering principles, which would be managed by product development engineers and quality assurance personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or clinical outcomes that would require an adjudication method among experts.

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 is a submission for a physical medical device (shoulder prosthesis) modification, not an AI or imaging diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical testing is based on:

• Established engineering standards and design specifications for prosthetic implants (implied by the bench testing, e.g., acceptable range of motion, pull-out strength).
• Material standards (e.g., ISO 5834-2 for UHMWPE, ISO 5832-7 for CoCr alloy).
• Performance of predicate devices, used as a basis for comparison to ensure the modified device performs similarly and safely in simulated conditions.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of machine learning. If "training set" is being reinterpreted as the data or knowledge base used to design and develop the device, it would encompass all prior design data, material science knowledge, and manufacturing experience for the Aequalis system and similar prostheses. However, this is not quantified in the document.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" in the machine learning sense. The design and validation of the device rely on established engineering principles, material science, and regulatory standards for medical device safety and performance. Manufacturing quality controls ensure that each produced device conforms to these established specifications.

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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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Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System): Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary and secondary necrosis of the humeral head Displaced 4-part upper humeral fracture Humeral head fracture Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable Revision surgery when other treatments or devices have failed. Aequalis Shoulder Fracture System Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures. Revision surgery when other treatments or devices have failed.

The labeling for the Aequalis Shoulder Fracture System and Aequalis Shoulder System is being modified to indicate that, when used as total shoulder prostheses, the Aequalis Shoulder Fracture System humeral stems, Aequalis Shoulder System humeral stems and Aequalis humeral heads are compatible with the Affiniti pegged glenoid components in addition to the Aequalis glenoid components that have been previously cleared for use with these systems. The Affiniti pegged glenoid components are available in sizes 40 - 56.

The provided text is a 510(k) summary for a medical device (Aequalis Shoulder System and Fracture System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study or even a standalone technical performance study.

Therefore, the document does not contain the information requested about acceptance criteria, device performance, test set details (sample size, provenance, ground truth experts, adjudication), MRMC studies, or standalone algorithm performance.

The reason for this is that the submission states:

"The indications, intended uses, designs, materials and manufacturing methods for the Aequalis Shoulder Fracture System and Aequalis Shoulder System have not changed from those cleared previously in K060209. These systems, with labeling modified to include compatibility with the Affiniti pegged glenoid components, are therefore substantially equivalent to the systems that have been cleared previously."

This indicates that the submission is for a minor modification (compatibility with new glenoid components) to an already cleared device, relying on the substantial equivalence principle rather than new performance testing.

However, I can extract the following information based on the provided text:

• Device Name: Aequalis Shoulder Fracture System and Aequalis Shoulder System
• Device Type: Total shoulder prosthesis (Shoulder joint metal/polymer semi-constrained cemented prosthesis)
• Classification: Class II
• Product Codes: 87 KWS
• Predicate Devices: K994392, K003728, K012212, K032679, K060209 (for Fracture System) and K952928, K980244, K012212, K041339, K043077, K060209, K060988 (for Shoulder System).

In summary, there is no information in the provided document to answer the questions about acceptance criteria and device performance studies because the submission is based on substantial equivalence to predicate devices, not new performance data.

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