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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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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.

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AEQUALIS Shoulder Range (except AEQUALIS for Fracture): 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 for Fracture: 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 usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, 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 hemiarthrosplasty to a total shoulder replacement. The present submission corresponds to the following modifications: - addition of two large glenoid components to the four existing sizes of glenoid both for the Aegualis shoulder Fracture System and the Aequalis shoulder System, - addition of a model of Fracture Stem covered with hydroxylapatite to the Aequalis shoulder Fracture -System, the new stem is strictly identical to the previously cleared device except for the coating.

The provided text is a summary of a 510(k) premarket notification for the Aequalis Shoulder Fracture System and Aequalis Shoulder System. It focuses on the device description, materials, indications for use, and regulatory classification.

There is no information in the provided document about:

• Acceptance criteria: The document does not specify any performance-based acceptance criteria for the device beyond the general goal of restoring the shoulder joint and reducing pain.
• Studies or performance data: The document states that the FDA determined the device is "substantially equivalent" to legally marketed predicate devices, but it does not provide any specific studies, test results, or performance metrics (like sensitivity, specificity, accuracy, or effect size) for the Aequalis Shoulder systems themselves. The substantial equivalence determination is often based on design similarities, material biocompatibility, and similar indications for use to already approved devices, rather than new extensive clinical performance studies for 510(k) applications.

Therefore, I cannot populate the table or answer most of your detailed questions based on the input text.

Here's what I can extract and state explicitly about the lack of information:

1. Table of Acceptance Criteria and Reported Device Performance

Additional Information (based on the lack of data in the provided document):

2. Sample size used for the test set and the data provenance: Not provided. The submission is a 510(k), which typically relies on substantial equivalence to predicate devices rather than new clinical outcome studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no specific test set or ground truth establishment is described for the Aequalis devices' performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no specific test set or ground truth establishment is described.
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 surgical implant, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance studies are described. The regulatory approval is based on substantial equivalence to predicate devices for mechanical and material properties and intended use.
8. The sample size for the training set: Not applicable, as no development of an AI algorithm or similar data-driven model is described.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

• Device Name: Aequalis Shoulder Fracture System & Aequalis Shoulder System
• Predicate Devices: K952928, K041339, K043077 (Aequalis Shoulder system); K994392, K003728, K032679, K043077 (Aequalis Shoulder Fracture system)
• Regulatory Mechanism: 510(k) Premarket Notification based on substantial equivalence.
• Modifications in current submission: Addition of two large glenoid components and a fracture stem covered with hydroxylapatite (which is strictly identical to a previously cleared device except for the coating).
• Materials: Humeral implant: titanium alloy (Ti6Al4V) or chromium-cobalt alloy (CrCo). Glenoid component: ultra-high molecular weight polyethylene (UHMWPE). Hydroxylapatite coating.
• Indications for Use: Detailed for both the Aequalis Shoulder Range (except for Fracture) and Aequalis for Fracture, covering degenerative pathologies, necrosis, various humeral fractures, and revision surgeries.

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AEQUALIS Shoulder Range (except AEQUALIS for Fracture): 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. i Primary and secondary necrosis of the humeral head - Displaced 4-part upper humera! 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 for Fracture: Traumatic or pathologic conditions of the shoulder resulting in fracture of the Fraumatio of painting of joing humeral head fracture and displaced 3-or 4-part proximal humeral fractures. Revision surgery when other treatments or devices have failed.

Total-Shoulder System and Hemi-Shoulder System. Shoulder joint metal/polymer semi-constrained cemented prosthesis.

This document is a 510(k) premarket notification for a medical device (AEQUALIS Shoulder Fracture System, AEQUALIS Shoulder System). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/software as a medical device.

The provided text is a regulatory filing for a physical medical device (shoulder prosthesis), focusing on establishing substantial equivalence to previously marketed predicate devices. It lists indications for use, device classification, and administrative details for FDA approval.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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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.

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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 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 present Device Modification submission corresponds to the addition of humeral heads made from Cobalt-Chromium-Molybdenum Alloy according to the standard ISO 5832-12 to the previous range with the same indications for use already covered by the previous 510(k) clearance. The hunteral stem and the glenoid component are unchanged.

The manufacturing methods, intended use, packaging and sterilization of the subjected device are identical to the predicate device.

The provided text describes a Special 510(k) submission for a device modification to the AEQUALIS Shoulder System. This document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of the device against specific acceptance criteria.

The submission is specifically for the addition of humeral heads made from Cobalt-Chromium-Molybdenum Alloy (ISO 5832-12) to the existing AEQUALIS Shoulder System. The manufacturing methods, intended use, packaging, and sterilization of the modified device are stated to be identical to the predicate device.

Therefore, the acceptance criteria and study information typically associated with evaluating a device's performance (e.g., sensitivity, specificity, accuracy, reader studies) are not present in this document. This is because the regulatory pathway chosen (Special 510(k) for device modification) relies on demonstrating that the changes do not alter the fundamental safety and effectiveness of the device compared to its already cleared version.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document does not describe performance metrics or acceptance criteria for the modified device in terms of clinical outcomes or diagnostic accuracy. It focuses on material equivalence and manufacturing processes.

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of clinical performance evaluation is mentioned. The submission is based on engineering and material equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating diagnostic performance, which is not the focus of this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical implant, not an AI algorithm.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. This is not a machine learning model.

9. How the ground truth for the training set was established: Not applicable.

Summary of what is available in the document regarding the "study" (which is essentially the justification for substantial equivalence):

• Device Type: Aequalis Shoulder System (humeral heads made from Cobalt-Chromium-Molybdenum Alloy).
• Regulatory Pathway: Special 510(k): Device modification - Premarket Notification.
• Basis for Acceptance: Substantial equivalence to a legally marketed predicate device (the previous Aequalis Shoulder System).
• Key Argument for Equivalence:
  • The modification is the addition of humeral heads made from a different but suitable alloy (Cobalt-Chromium-Molybdenum Alloy according to ISO 5832-12).
  • The intended use remains the same.
  • The humeral stem and glenoid component are unchanged.
  • Manufacturing methods, packaging, and sterilization are identical to the predicate device.
  • Materials for other components (stem, glenoid) are specified (Cobalt Chromium alloy according to ISO 5832-4, UHMWPE according to ISO 5834-2).

In essence, the "study" demonstrating the device "meets the acceptance criteria" in this context is the technical and material comparison to the predicate device, arguing that the new material for the humeral head is equally safe and effective for the stated indications. The acceptance criteria are implicit in the FDA's "substantial equivalence" determination, meaning the modified device performs as safely and effectively as, and is as technologically advanced as, existing legally marketed devices.

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