Search Results
Found 5 results
510(k) Data Aggregation
(121 days)
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.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Intended Use: Identical to predicate Aequalis and similar to Affiniti™ Shoulder Systems. | Met: "The intended use of the new Tornier Glenoid are identical to the intended use of predicates..." |
| Indications for Use: Identical to predicate Aequalis and similar to Affiniti™ Shoulder Systems. | Met: "The indications for use of the new Tornier Glenoid are identical to the indications for use of the predicate Aequalis System... and are very similar with the other predicate the Affiniti™ Shoulder System..." |
| Material Composition: Identical raw materials to predicate devices. | Met: "The raw materials of the new components of the Tornier Glenoid are identical to the raw materials of predicates Aequalis Shoulder System... and the Affiniti™ Shoulder System." |
| Fixation Method: Identical to predicate devices. | Met: "The fixation method of the new Tornier Glenoid is identical to the fixation method of the predicate components of the Aequalis Shoulder System... and the Affiniti Shoulder System." |
| Technological Characteristics: Equivalent general features, polyethylene thickness, materials, means of fixation, and prosthetic dimensions to predicate devices. | Met: "Major technological characteristics are equivalent between the Tornier Glenoid and the predicate devices: Equivalence of general features, Equivalent polyethylene thickness, Equivalent materials, Equivalent means of fixation, Equivalent prosthetic dimensions." |
| Safety: Does not introduce new or higher risks compared to predicate devices. | Met: "The results of those evaluations allow us to conclude that the proposed new Tornier Glenoid described in this submission does not induce any new or higher risk compared to the predicate devices..." |
| Non-clinical performance: Satisfactory results from bench tests (Range of motion, preliminary testings of pegs, pull out & shear testings, subluxation and loosening tests). | Met: Bench tests were performed and results supported the conclusion of no new or higher risk. Specific numerical results are not provided in this summary. |
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
(88 days)
The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint :
- in case of 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, or
- in case of bone defect in proximal humerus. .
The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.
When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed Fracture Shoulder humeral stem, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.
The Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.
The Aequalis Reversed Fracture Shoulder Prosthesis is intended to relieve pain or significant disability following massive cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.
Therefore, the usual goal of surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Fracture Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm and its Aequalis Fracture Shoulder humeral stem-like design allows to facilitate the bone reconstruction and improve the tuberosity healing and fixation.
The Aequalis Reversed Fracture Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
This document is a 510(k) premarket notification for the "Aequalis Reversed Fracture Shoulder Prosthesis." It outlines the device's indications for use, materials, and provides a comparative analysis to predicate devices to establish substantial equivalence.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
This document describes a medical device (Aequalis Reversed Fracture Shoulder Prosthesis) and its substantial equivalence to predicate devices, rather than an AI/software device. Therefore, the concept of "acceptance criteria" as typically applied to performance metrics like sensitivity, specificity, or accuracy for an AI system is not directly applicable here.
Instead, the "acceptance criteria" implicitly referred to are the regulatory requirements for showing substantial equivalence to legally marketed predicate devices, as defined by the FDA's 510(k) process. This involves demonstrating that the new device is as safe and effective as the predicate device(s). The document indicates that the device meets these criteria as the FDA issued a "substantially equivalent letter."
The "reported device performance" is not quantified in terms of clinical outcomes or performance metrics in this document, but rather in terms of its design, materials, and intended use being comparable to existing devices already deemed safe and effective.
| Acceptance Criteria (Implied for 510(k) Clearance) | Reported Device Performance (as per document) |
|---|---|
| Substantial Equivalence to Legally Marketed Predicate Devices | The FDA has determined the device is substantially equivalent for the stated indications for use to legally marketed predicate devices. This implies that the Tornier Aequalis Reversed Fracture Shoulder Prosthesis is considered as safe and effective as the predicate devices. This assessment is based on comparisons in design, materials, and intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document is a regulatory submission for a medical implant (a shoulder prosthesis), not a study evaluating an AI device's performance. Therefore, there is no test set, sample size, or data provenance information related to an AI algorithm's evaluation. The evaluation is based on a comparison to predicate devices, materials testing, and design specifications.
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 medical device submission, not an AI study requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a medical device submission.
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, as this is a medical device submission, not an AI or software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a medical device submission, not an AI or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this medical device, the "ground truth" for regulatory clearance is the established safety and effectiveness of the legally marketed predicate devices. The new device demonstrates substantial equivalence by showing similar technological characteristics, materials, and intended use, supported by engineering testing and clinical experience with similar devices, rather than a specific "ground truth" derived from patient data in the context of an AI algorithm validation.
8. The sample size for the training set
Not applicable, as this is a physical medical device submission, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a physical medical device submission.
Ask a specific question about this device
(30 days)
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.
Ask a specific question about this device
(39 days)
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.
Ask a specific question about this device
(108 days)
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.
The usual goal of total shoulder replacement is to relieve or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid is 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 hemiarthroplasty to a total shoulder replacement. The present Device Modification submission consists in the addition of a long stem to each diameter of the previous range.
This document is a 510(k) premarket notification for a medical device (AEQUALIS Shoulder Fracture System), not a study report. Therefore, it does not contain the information required to describe acceptance criteria and a study proving the device meets those criteria.
The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device meets the regulatory requirements for marketing, but it does not involve a specific clinical study with acceptance criteria and a detailed performance evaluation as would be found in a clinical trial report.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance criteria and reported device performance: This document does not detail specific acceptance criteria for performance metrics (e.g., success rates, complication rates, range of motion improvements) or report any performance data from a study.
- Sample size, data provenance: No study is described, so no sample size or data origin is mentioned.
- Number of experts, qualifications, adjudication method: These pertain to establishing ground truth in a clinical or imaging study, which is not present here.
- MRMC comparative effectiveness study: No such study is mentioned or implied.
- Standalone (algorithm only) performance: This is a physical implant, not an algorithm.
- Type of ground truth: Ground truth is not relevant in this context, as no performance data based on ground truth is being presented.
- Training set sample size/ground truth: This pertains to machine learning models, which is not what this document is about.
In summary, the provided text is a regulatory filing for marketing clearance, not a scientific or clinical study report.
Ask a specific question about this device
Page 1 of 1