Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Tornier Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

The Tornier Humeral Nail and Tornier Long Humeral Nail include intramedullary nails and screws. The Tornier Humeral Nail is a straight, cannulated intramedullary nail available in 9mm proximal diameter with a tapered 7mm distal diameter with nail lengths of 210mm, 230mm, 250mm, and 270mm long and a tapered 8mm distal diameter with nail lengths of 130mm, 210mm. 230mm. 250mm, and 270mm long. Both distal diameter sizes are available in right and left configurations. The proximal end of the nail contains screw holes in four axes for proximal locking using 5mm cannulated screws. The proximal end of the nail also contains a cannulated polyethylene insert with screw holes aligned with those of the nail. This insert is intended to help prevent the proximal screws from backing out. The distal end of the 130mm nails incorporate two or three screw holes for distal stabilization using 4.3mm screws. The nails and screws are manufactured from anodized titanium alloy. The polyethylene insert is manufactured from ultrahigh molecular weight polyethylene (UHMWPE).

This document is a 510(k) premarket notification for the Tornier Humeral Nail and Tornier Long Humeral Nail. It seeks to establish substantial equivalence to a predicate device.

1. A table of acceptance criteria and the reported device performance:

The document does not provide specific acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, or other quantitative measures typically associated with AI/ML device evaluations. The submission focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical testing for MR compatibility.

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

No test set for an AI/ML component is mentioned.

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

Not applicable, as no AI/ML component requiring ground truth establishment is described.

4. Adjudication method for the test set:

Not applicable, as no AI/ML component requiring a test set or adjudication 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, as this submission does not involve an AI assist feature for human readers.

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

Not applicable, as this submission does not involve a standalone algorithm for performance evaluation.

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

Not applicable, as no ground truth is required for the evaluation presented in this document.

8. The sample size for the training set:

Not applicable, as this submission does not involve an AI/ML component with a training set.

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

Not applicable, as this submission does not involve an AI/ML component requiring ground truth for a training set.

Summary of Device Evaluation:

The Tornier Humeral Nail and Tornier Long Humeral Nail were evaluated for Magnetic Resonance (MR) compatibility through non-clinical testing. The submission explicitly states:

• "The Tornier Humeral Nail and Tornier Long Humeral Nail has been evaluated in a Magnetic Resonance Environment through non-clinical testing as outlined in the FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment – Guidance for Industry and FDA Staff', dated October 10, 2023."
• "This testing was conducted to characterize the compatibility of the Tornier Humeral Nail System in the MR environment."
• "No clinical studies were performed."

The conclusion is that "The Tornier Humeral Nail System does not raise different questions of safety or effectiveness. Based upon a comparison of the intended use, materials, summary of technological characteristics, and non-clinical evaluation, the subject Tornier Humeral Nail and Tornier Long Humeral Nail is considered substantially equivalent to the current Tornier Humeral Nail and Tornier Humeral Long Nail (cleared as Aequalis Humeral Nail System on K133376)."

This document focuses on regulatory clearance for a medical device (intramedullary fixation rod) by demonstrating substantial equivalence to a predicate device, specifically addressing MR compatibility. It does not involve the evaluation of an AI/ML component or associated criteria like performance metrics for an AI system.

Ask a specific question about this device

In Anatomic:
The Tornier Perform Humeral System - Fracture combined with a 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 Tornier Perform Humeral System - Fracture is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain.
The Tornier Perform Humeral System - Fracture is indicated for use as a replacement of shoulder joints disabled by: • Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral head fracture and displaced 3-or 4-part proximal humeral fractures
· Fracture sequelae

• Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction
  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 without a suspected material sensitivity to cobalt alloy.
  All components are single use. The fracture stems are intended for cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. In a total shoulder arthroplasty, the Tornier Perform Humeral System - Fracture is intended to be used with cemented polyethylene glenoid components.

In Reverse:
The Tornier Perform Humeral System - Fracture combined with a reverse insert is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by: • 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
• Proximal humerus bone defect
· Fracture sequelae
• Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed fracture stem for patients with a functional deltoid muscle.
All components are single use. The fracture stems are intended for cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. The Tornier Perform Humeral System – Fracture is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

The Tornier Perform Humeral System – Fracture is a convertible humeral fracture system for anatomic, reverse, and hemiarthroplasty of the shoulder. The system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The Tornier Perform Humeral System - Fracture is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty.
The Tornier Perform Humeral System – Fracture includes titanium fracture stems, titanium couplers, titanium spacers and titanium screws. The system is compatible with commercially available Perform humeral heads and reversed inserts. The system also includes reusable instruments used to implant the shoulder prosthesis.

This document is a 510(k) premarket notification for a medical device (Tornier Perform Humeral System - Fracture), not a study evaluating an AI device's performance. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for AI model training and testing is not applicable.

The document describes the device, its indications for use, and a comparison to predicate devices. It states that no clinical studies were performed to prove the device meets acceptance criteria. Instead, non-clinical performance testing was conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the information provided in the document as it relates to your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria with corresponding performance metrics for a digital health or AI device. The "performance" described refers to the results of non-clinical engineering tests to demonstrate the device's physical properties and compatibility, rather than clinical efficacy or diagnostic accuracy.

Non-clinical Performance Testing Performed:

• Fatigue testing
• Static taper evaluation
• ASTM F543 screw testing
• Evaluations for compatibility with existing components
• Range of motion analysis
• MRI compatibility evaluation
• Biocompatibility, sterilization, cleaning, endotoxin, packaging, shelf life, and distribution assessments (in accordance with recognized consensus standards).

Reported Device Performance:
The document states: "The results of performance testing for the Tornier Perform Humeral System – Fracture support substantial equivalence to the predicate Aequalis Reversed Fracture Shoulder Prosthesis and Aequalis Shoulder Fracture System (K131231)." This implies that the device performed adequately in these non-clinical tests to be considered comparable to the predicate. Specific quantitative results or acceptance thresholds are not detailed 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)

Not applicable. No clinical test set. The "testing" referred to是在工程实验室进行的非临床性能测试，而不是对临床数据进行的测试。

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. No clinical test set or ground truth established by experts.

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

Not applicable. No clinical test set.

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 medical implant device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

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

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

Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" equivalent for this device would be engineering specifications and standards for its physical and material properties.

8. The sample size for the training set

Not applicable. This is a medical implant device, not an AI model requiring a training set.

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

Not applicable. No training set for an AI model.

In summary: The provided document is an FDA 510(k) clearance letter and its associated Indications for Use and Device Description/Comparison. It describes a medical implant device that demonstrated substantial equivalence through non-clinical performance testing, not through clinical trials or the evaluation of an AI-powered diagnostic/therapeutic tool. Therefore, the questions related to AI device performance evaluation are not relevant to this document.

Ask a specific question about this device

The nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement.

The Tornier Perform® Humeral System - Stemless is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide mobility, stability, and to relieve pain. The Tornier Perform Humeral System -Stemless is indicated for use as a replacement of shoulder joints disabled by:

• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
• · Post-traumatic arthritis

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 without a suspected material sensitivity to cobalt alloy.

All components are single use and intended for cementless use.

The Tornier Perform Humeral System - Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.

The Tornier Perform Humeral System - Stemless is metaphyseal humeral system intended for anatomic total shoulder arthroplasty. The Perform Humeral System - Stemless is implanted with existing Tornier anatomic glenoid systems.

The Tornier Perform Humeral System – Stemless includes new titanium nucleus components and previously-cleared modular humeral heads (K201315). The system also includes reusable instruments used to implant the shoulder prosthesis.

The provided document is a 510(k) premarket notification for a medical device, the Tornier Perform Humeral System - Stemless. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies proving acceptance criteria through device performance.

Therefore, the requested information on acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance, is largely not applicable to this document. The document explicitly states: "No clinical studies were performed."

However, I can extract information about the non-clinical testing performed to demonstrate substantial equivalence, which serves a similar purpose in the context of a 510(k) by showing the device performs comparably to an already cleared device.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance:

Since no clinical studies were performed to establish performance against pre-defined acceptance criteria in terms of human-in-the-loop performance or diagnostic accuracy, such a table cannot be created from this document. The document focuses on demonstrating substantial equivalence to an existing predicate device through non-clinical performance testing.

The types of "performance" mentioned are related to mechanical and material properties:

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

Not applicable. No "test set" in the context of clinical or AI performance evaluation was used. The testing was non-clinical (laboratory/mechanical).

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" for a test set based on expert review was established or required for this type of submission focused on mechanical device equivalence.

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

Not applicable. No "test set" requiring adjudication by experts was used.

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 mechanical orthopedic implant, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance in that context.

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

Not applicable. This is a mechanical orthopedic implant, not an algorithm or AI.

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

Not applicable. The "ground truth" for the non-clinical tests would have been established engineering specifications, material standards, and performance of the predicate device.

8. The sample size for the training set:

Not applicable. This is a mechanical orthopedic implant, not an AI or algorithm that requires a training set.

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

Not applicable.

Ask a specific question about this device

Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator 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, Revision of glenohumeral joint if sufficient native glenoid bone remains. All components are single use. The Patient-Matched Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Tornier Perform Patient-Matched Primary Reversed Glenoid implant.

BLUEPRINT™ Patient Specific Instrumentation:
BLUEPRINT ™ Glenoid Guides: The BLUEPRINT™ Glenoid Guides are intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
BLUEPRINT™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder replacement surgerv. BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format. BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific components (Patient-Specific instruments and Tornier Perform™ Patient-Matched Primary Reversed Glenoid*) based on the pre-surgical plan. BLUEPRINT™ 3D Planning Software leads to the generation of a planning report. BLUEPRINT™ 3D Planning Software is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose. Note: Measures and patient specific guide design are provided depending on the case profiles. *Only if Patient-Specific instruments or Tornier Perform™ Patient-Matched Primary Reversed Glenoid are available in your geography.

Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant (Patient-Matched Glenoid) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis. The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

BLUEPRINT™ Patient Specific Instrumentation: BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the BLUEPRINT™ Glenoid Guides and BLUEPRINT™ 3D Planning Software is the responsibility of Tornier is the legal manufacturer for the hardware and the software.
BLUEPRINT ™ Glenoid Guides: The BLUEPRINT ™ Glenoid Guides are patient-specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D Planning Software.
BLUEPRINT™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed). It is intended to help to plan an operation by allowing surgeons to: Plan for shoulder arthroplasty cases, Position and select glenoid and humeral implants, Simulate the prosthetic range of motion, Interact with implants and different computed measurements, Generate information required to design a patient-specific glenoid component when appropriate.

This document, K211359, is a 510(k) premarket notification for the Tornier Perform™ Patient-Matched Primary Reversed Glenoid (implant) and BLUEPRINT™ Patient Specific Instrumentation (hardware and software). The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through clinical trials. As such, the information provided focuses on non-clinical performance and verification/validation, largely relying on the predicate device's established safety and effectiveness.

Therefore, the following information, which typically applies to AI/software as a medical device (SaMD) clearances involving complex algorithms and clinical performance studies, is largely not present in this 510(k) summary. The provided text explicitly states that "No clinical studies were performed." This indicates that the device's performance was not evaluated through a study comparing it to an established ground truth in the way a traditional AI/SaMD clinical study would.

Here is a breakdown based on the provided document and the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing for both the implant and the instrumentation. These are engineering/material specifications rather than clinical performance metrics for an AI algorithm.

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

• Test Set Sample Size: Not applicable in the context of a clinical performance test for an AI algorithm. The tests described are non-clinical engineering/materials tests (e.g., pullout, fatigue). For the software, "verification and validation evaluations" were performed, but no specific number of cases or data provenance is detailed, as it's a conformity assessment to the predicate's operating principle.
• Data Provenance: Not applicable for an AI algorithm evaluation in this context. The document mentions "cadaveric test performed on the subject device" for the hardware, which would be test data, but not a "test set" in the sense of clinical images for an AI.

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

• Not applicable as no clinical study or AI algorithm evaluation with human expert ground truth was performed.

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

• Not applicable as no clinical study or AI algorithm evaluation with adjudicated ground truth was performed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." Therefore, there is no effect size on human reader improvement with AI assistance.

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

• For the BLUEPRINT™ 3D Planning Software, "verification and validation evaluations" were performed. While these evaluations assess the algorithm's functionality, they are not presented as a standalone performance study in a clinical context (e.g., measuring diagnostic accuracy against a ground truth dataset). The software is a planning tool, not a diagnostic AI.

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

• For the non-clinical tests (implant): Engineering specifications, material properties, and established consensus standards serve as the "ground truth" for the physical device's performance.
• For the software: The ground truth would be the accuracy and correctness of the planning outputs and measurements generated by the software, compared to expected or designed values. This is typically assessed through software verification and validation against a golden standard or internal reference data, not clinical ground truth like pathology or outcomes.

8. The sample size for the training set:

• Not applicable, as this is a 510(k) for an orthopedic implant and a planning software, not a deep learning AI model that requires a "training set" in the same sense. The software's design and programming are based on established anatomical and biomechanical principles.

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

• Not applicable, as no external "training set" with established ground truth, typical for AI model development, is mentioned.

Ask a specific question about this device

The Tornier Perform Reversed Glenospheres are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear 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
• · Revision of the devices if sufficient bone stock remains

Notes:

• · All components are single use.
• The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.

The Tornier Perform™ Reversed Glenoid Cannulated Glenospheres are part of a reverse shoulder prosthesis consisting of cannulated cobalt chromium and titanium alloy glenospheres. The Tornier Perform Reversed Glenoid Cannulated Glenospheres are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.

The Tornier Perform Reversed Glenoid Cannulated Glenospheres must be used in association with a compatible Tornier reversed glenoid and humeral component. The cannulated glenosphere can be used as part of the glenoid implant. The glenoid implant is composed of a baseplate with central and peripheral anchoring screws and a glenosphere. An optional press-fit post is available that can be used in lieu of the central anchoring screw.

Ancillary instruments are also provided for the implantation of the prosthesis.

The provided text describes a 510(k) premarket notification for a medical device, the Tornier Perform™ Reversed Glenoid Cannulated Glenospheres. This document does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML powered device.

The document states:

• "Non-clinical bench testing and process validations were performed to demonstrate substantial equivalence to the predicate device."
• "No clinical studies were performed."

Therefore, there is no information available in the provided text to answer the specific questions about acceptance criteria for an AI/ML device, performance studies, sample sizes, expert involvement, or ground truth establishment. The document describes mechanical bench testing (Glenosphere Loosening, Taper Disassembly, Glenosphere Fatigue) and simulated use to demonstrate substantial equivalence to a legally marketed predicate device, K161742.

Ask a specific question about this device

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, stability, 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 .
• Correction of functional deformity
• Post-traumatic arthritis 0
• o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains

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 without 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 polyethylene glenoid 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:

• o Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
• Pseudoparalysis or anterior superior escape ●
• Rotator cuff tear arthropathy
• Correction of functional deformity
• Post-traumatic arthritis
• o Revisions or fractures of the humeral head where 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 cemented or 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.

The PERFORM Humeral System - Stem is an inlay convertible humeral system intended for anatomic, reverse, and hemiarthroplasty of the shoulder system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The PERFORM Humeral System - Stem is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty.

The PERFORM Humeral System – Stem includes titanium humeral stems, cobalt chrome and titanium humeral heads, titanium humeral head couplers, conventional and Vitamin E UHMWPE reversed inserts, and titanium humeral spacers. The system also includes reusable instruments used to implant the shoulder prosthesis.

This FDA 510(k) summary describes the Tornier PERFORM™ Humeral System - Stem, a shoulder prosthesis. The document does not describe an AI/ML powered device, therefore, the requested information cannot be fully provided.

However, based on the provided text, here is what can be extracted regarding the device (a physical medical implant) and its non-clinical performance testing:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific quantitative acceptance criteria or reported device performance values in a comparative format. Instead, it lists the types of non-clinical performance testing conducted to support substantial equivalence to a predicate device.

Ask a specific question about this device

The LATITUDE EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The LATITUDE EV™ Total Elbow Arthroplasty system is intended for cemented use only.

The LATITUDE EVI™ Total Elbow Arthroplasty system is a total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The LATITUDE EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the prosthesis is a semiconstrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.

The provided text is a summary of an FDA 510(k) premarket notification for a medical device called the LATITUDE EV™ Total Elbow Arthroplasty system. This document focuses on the regulatory approval and comparison to predicate devices, and therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning AI/algorithm performance.

The document explicitly states: "No clinical studies were performed." This indicates there was no study conducted to assess the performance of the device in a clinical setting in the context of this 510(k) submission. Furthermore, there is no mention of any AI or algorithmic component to the device.

Therefore, I cannot provide the requested information.

Ask a specific question about this device

The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The ORTHOLOC™ SPS Shoulder Plating System is designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws. The plates are available in three designs: Standard, Posterior, and Greater Tuberosity (GT) and are manufactured from stainless steel per ASTM F138. The system also includes locking screws manufactured from stainless steel per ASTM F2229 and non-locking screws manufactured from stainless steel per ASTM F138 or ASTM F2229. The system is provided non-sterile and requires steam sterilization prior to use.

The provided text is a 510(k) premarket notification for a medical device called the ORTHOLOC™ SPS Shoulder Plating System. This type of document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than presenting a study proving a device meets specific clinical performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance studies are not available within this document because clinical studies were not performed.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Note: The specific numerical acceptance criteria from ASTM F543-17 are not detailed in this document, only that the device met them and they were the same as the predicate device.

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

• Sample Size for Test Set: Not specified for the bench testing. The document states "No clinical studies were performed."
• Data Provenance: The document refers to "non-clinical bench testing" performed to ASTM F543-17 standards. This implies laboratory-based testing, not human or animal data. No country of origin for the data is specified, but the applicant company is located in Bloomington, MN, USA. The testing is prospective for the purpose of this 510(k) submission.

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

• Not applicable. This information pertains to studies involving human interpretation or clinical outcomes. Since only non-clinical bench testing was performed, no experts were used to establish ground truth in this context. The "ground truth" for bench testing would be the physical measurements against engineering specifications.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert opinions or diagnoses. For bench testing, results are typically determined by instrumental measurements and adherence to test standards.

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 performed. This document is for a mechanical orthopedic implant, not an AI-assisted diagnostic device, and no clinical studies were performed.

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

• No. A standalone performance study was not performed. This device is a mechanical implant, not an algorithm or AI system.

7. The type of ground truth used:

• For the non-clinical bench testing, the "ground truth" would be engineering specifications and the established performance criteria within ASTM F543-17. There is no pathology or outcomes data mentioned.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned as no clinical studies or AI/machine learning development were discussed. The device itself (the implant) does not have a "training set."

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

• Not applicable. As there is no training set, there is no ground truth for one.

Ask a specific question about this device