Search Results

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.

Ask a specific question about this device

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

• Degenerative pathologies: arthrosis, rheumatoid arthritis, posttraumatic 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.

The usual goal of total shoulder and hemi-arthroplasty replacement of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder System is intended to accomplish these goals.
It consists of 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 Aequalis Shoulder 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-arthrosplasty to a total shoulder replacement.
The present device submission corresponds to the addition of a new glenoid model to the current cleared model. The new glenoid model is a modification of the shape of the current model. The technological characteristics (materials, manufacturing, sterilization, sizing and indications) of the new glenoid of the Aequalis Shoulder System are similar or identical to the predicate devices.
The glenoid component is made of ultra high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2.

The provided text describes a medical device submission (Aequalis Shoulder System, K063081) but does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

This document is a 510(k) premarket notification for a medical device (Aequalis Shoulder System). Such notifications primarily aim to demonstrate substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study results against predefined acceptance criteria.

The information provided describes:

• Device Name: Aequalis Shoulder System
• Submitter: Tornier
• Device Classification: Class II, Orthopedic product, Product code HSD
• Equivalent/Predicate Devices: Aequalis Shoulder System (K952928, K043077, K060209); DePuy Global Shoulder System (K060874)
• Device Description: A humeral stem and humeral head for total shoulder replacement or hemi-shoulder. The specific submission is for a new glenoid model, a modification of an existing cleared model, with similar/identical technological characteristics (materials, manufacturing, sterilization, sizing, indications) to predicate devices.
• Materials: Glenoid component made of UHMWPE (ISO standard 5834-2).
• Indications for Use: 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 are unacceptable, and revision surgery.
• FDA Conclusion: The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details because it is not present in the provided document. The document focuses on regulatory approval through substantial equivalence, not detailed performance testing against acceptance criteria.

Ask a specific question about this device

Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; non-union humeral head fracture; displaced 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable. The AEQUALIS Shoulder System is intended for cemented use only.

The AEQUALIS Shoulder System is intended to treat conditions such as extensive soft tissue damage to the gleno-humeral joint, osteoarthritis, rheumatoid otheritis, traumatic arthritis, and osteonecrosis following severe trauma to the joint. The usual goal of such surgery is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The SEQUALIS Shoulder System is intended to accomplish these goals. With the AEQUALIS Shoulder System the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease of injury. Through the AEQUALIS Shoulder System is primarily intended for use as a cemented total shoulder replacement system, it is equally useful as a hemi-shoulder. The modular nature of this system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement. The present Device Modification submission corresponds to the addition of 3 long humeral stems to 3 Inc pressite 2010 stem/neck angle, with the same indications for use already covered by the previous 510(k) clearance.

This is an orthopedic device submission, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study design for AI/ML performance is not applicable and cannot be extracted from the provided text.

The document describes the AEQUALIS Shoulder System, a total-shoulder and hemi-shoulder system, and a modification adding three long humeral stems. The submission is a Special 510(k) for device modification, indicating a comparison to a legally marketed predicate device (AEQUALIS Shoulder system, K952928, and Select Shoulder CoCr Humeral stem, K962315) to establish substantial equivalence.

The "study that proves the device meets the acceptance criteria" in this context refers to demonstrating substantial equivalence to a predicate device, typically through documentation of design specifications, materials, manufacturing processes, and sometimes bench testing or biocompatibility testing, rather than performance metrics of an AI algorithm.

Therefore, the table for acceptance criteria and device performance, and all subsequent points related to AI/ML study design, cannot be created or answered from this document.

Ask a specific question about this device