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Tornier Humeral Reconstruction System (Tornier HRS)

IN ANATOMIC:
The Tornier HRS is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Tomier HRS 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

IN REVERSE:
The Tornier HRS is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:

• · Rheumatoid arthritis
• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• · Massive and non-repairable rotator cuff tear
• · Revision of other devices if sufficient bone stock remains

The reversed tray and polyethyiene inset are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.

Notes:

• · All components are single use.
• · The coated humeral stem is intended for cemented or cementless use.
• · The all-poly glenoid components are intended for cemented use only
• · The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
• · Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity.
• The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.

The PERFORM™ Humeral System – Stem 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 PERFORM Humeral System - Stem is indicated for use as a replacement of shoulder joints disabled by:
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis

• · Proximal humeral malunions
• · Post-traumatic arthritis
• · Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is recommended for patients with a suspected material sensitivity to cobalt alloy.

All components are single use. The humeral stems are intended for cementless use.

The PERFORM Humeral System – Stem is intended to be used with cemented components, in a total shoulder arthroplasty.

In Reverse:
The PERFORM™ Humeral System – Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis

• · Pseudoparalysis or anterior superior escape
• · Rotator cuff tear arthropathy
• · Proximal humeral malunions
• · Post-traumatic arthritis
  · Revisions or fractures of the humere adequate fixation can be achieved and adequate bone stock remains

The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.

All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

Tornier HRS (formerly branded Aequalis Flex Revive Shoulder System) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation.

The Tornier Humeral Reconstruction System (Tornier HRS) is a line existing Aequalis™ Flex Revive™ Shoulder System (AFR) (K191318, cleared June 14, 2019) that builds upon the AFR system with additional sized distal stems, proximal bodies, and reversed insert trays, new monoblock stems, humeral head couplers and MR Conditional labeling for Tornier HRS line extension components.

The Tornier Perform Humeral System (Tornier PHS-Stem) (K2013 15) is also being expanded to include additional sized Vitamin E UHMWPE reversed inserts and a renaming of these inserts for clarity.

This is a 510(k) Premarket Notification from the FDA for a medical device called the Tornier Humeral Reconstruction System (Tornier HRS) and the Tornier Perform Humeral System - Stem (Tornier PHS-Stem). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new acceptance criteria and proving performance against them through a clinical study.

Therefore, the sections of your request regarding acceptance criteria, study details, expert consensus, and effects size are not applicable (N/A) in this context. The primary evidence presented here is non-clinical testing to show that the modified device and its extensions are as safe and effective as the predicate devices.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. The document refers to "non-clinical testing," which typically involves bench testing of components and assemblies, not human subjects.
• Data Provenance: Not applicable. The testing is described as non-clinical performance testing, likely conducted in a laboratory setting by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. This type of non-clinical testing does not involve establishing ground truth from expert consensus in the way a diagnostic AI would. The "ground truth" is determined by established engineering and material science standards and test methods.
• Qualifications of Experts: N/A.

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

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in clinical studies or for establishing ground truth in diagnostic performance evaluations, which is not what occurred here.

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:

• MRMC Study: No. The document explicitly states: "No clinical studies were performed."
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical orthopedic implant system, not a software algorithm or AI device.

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

• Type of Ground Truth: Not applicable. For non-clinical performance testing of medical devices, "ground truth" in the diagnostic sense is not typically generated. Instead, performance is measured against established engineering specifications, material properties, and mechanical limits as defined by relevant standards (e.g., ISO, ASTM).

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Ground Truth for Training Set: Not applicable. This is not a machine learning or AI device.

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IN ANATOMIC:

The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The Tornier HRS 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 Tornier HRS 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

IN REVERSE:

The Tornier HRS Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Massive and non-repairable rotator cuff tear
• Revision of the devices if sufficient bone stock remains

The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.

Notes:

• All components are single use.
• The coated humeral stem is intended for cemented or cementless use.
• The all-poly glenoid components are intended for cemented use only.
• The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
• Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

Tornier HRS (formerly branded Aequalis™ Flex Revive™ Shoulder System) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant system intended for total or partial replacement of the glenohumeral articulation. Tornier HRS includes a proximal body (metaphysis), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Tornier Flex (formerly branded Ascend Flex) Humeral Heads and Tornier Flex (formerly branded Ascend Flex) reversed trays and poly inserts.

Tornier HRS is implanted by a surgeon and is designed to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Tornier Flex (formerly branded Ascend Flex) Humeral Heads and Tornier Flex (formerly branded Ascend Flex) reversed trays and inserts. In addition, Tornier HRS can be transformed from anatomic to reverse shoulder prosthesis without the humeral implant assembly during revision surgery.

The humeral length is measured to determine the overall humeral implant construct length is assembled from 120 mm (using the short proximal body and stem) to 300 mm (using the standard proximal body, spacers, and stem) in 10 mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity.

The proximal body, stem, and spacers are made from Ti6A4V per ASTM F-136. The proximal body and stem have a Titanium plasma spray coating. The assembly screw and locking cap are made of CoCr per ISO 5832-12. All implant parts are single use and packaged sterile, using gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10-6.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Tornier Humeral Reconstruction System (Tornier HRS)." This document primarily focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI or diagnostic system.

The "study" described is a non-clinical testing in a Magnetic Resonance (MR) Environment to characterize the compatibility of the Tornier HRS. This is a safety assessment for an implantable device, not a performance study for, for example, a diagnostic AI.

Therefore, many of the requested elements (acceptance criteria for device performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone AI performance, etc.) are not applicable in the context of this specific regulatory document.

However, I can extract the relevant information regarding the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states "The Tornier HRS system does not raise different questions of safety or effectiveness," which implies the device met the safety requirements for MR compatibility.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified (refers to the devices evaluated in MR environment, not typically "sample size" in the context of clinical or AI studies).
• Data Provenance: Not applicable in the traditional sense; this is non-clinical lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" here is the physical interaction of the device with an MR field, evaluated against established safety standards.

4. Adjudication method for the test set:

• Not applicable. This was based on non-clinical testing against FDA guidance.

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:

• No, an MRMC comparative effectiveness study was not done. This device is not an AI diagnostic tool that human readers would use.

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

• Not applicable. This is not a software algorithm or AI device.

7. The type of ground truth used:

• The ground truth for this non-clinical testing is compliance with established safety standards and guidance for medical devices in an MR environment (as outlined in "FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment – Guidance for Industry and FDA Staff'").

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

In summary: The provided document is for a traditional medical implantable device, not an AI or diagnostic system. The "study" mentioned is non-clinical testing for MR compatibility to ensure safety, not a performance study in the context of AI or diagnostic accuracy.

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