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The MyShoulder Planner software is a medical device intended for use by surgeons as a preoperative planning tool for total shoulder replacement surgery in skeletally mature individuals. The MyShoulder Planner software is specifically designed to support the planning of the humeral and glenoid components in a total shoulder replacement using Medacta Shoulder System prosthesis. The MyShoulder Planner software should not be used for diagnostic purposes. The MyShoulder Planner software processes CT scan images in DICOM format to allow surgeons to visualize, measure, and reconstruct anatomic data. These features enable surgeons to make decisions on implant size and positioning, including the ability to annotate anatomical structures. The MyShoulder Planner software leads to the generation of patient-specific planning reports, which summarize the preliminary decisions regarding implant size and positioning. The MyShoulder Planner software allows the surgeons to request the MyShoulder patient matched guides according to the pre-surgical plan.

The MyShoulder Planner is a software designed to create patient-specific preoperative plans based on CT scans. It is used to visualize the effect of different devices and positioning options on the patient's shoulder joint biomechanics. It allows the surgeon to preoperatively plan the humeral and glenoid components in total shoulder replacement after the segmentation of a 3D model of the patient's anatomy that can be performed automatically by the software, which uses machine learning algorithms, or manually by a designated Medacta engineer.

The MyShoulder Planner (5.3SSWPL) is a pre-operative planning tool for total shoulder replacement surgery. Its acceptance criteria and performance are based on non-clinical studies, specifically software verification and validation, including segmentation validation. No clinical studies were conducted for this device.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with numerical targets and reported performance. Instead, it generally states that "Automatic segmentation and landmark acquisition performance was adequately verified in comparison to manual segmentation." This implies the acceptance criterion was "adequate verification" or "demonstration of equivalence" between automatic and manual methods, though exact metrics (e.g., Dice similarity coefficient, mean absolute distance) are not provided in this summary document.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for the test set. It mentions "segmentation validation" and "automatic segmentation and landmark acquisition performance was adequately verified in comparison to manual segmentation."

• Data Provenance: The document does not explicitly state the country of origin of the data. It also does not specify whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number of experts used or their specific qualifications (e.g., number of years of experience, specific certifications) for establishing the ground truth. It only refers to "manual segmentation" as the comparison point, implying that expert-driven manual segmentation was used as the ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) used for the test set. The comparison is stated as "automatic segmentation and landmark acquisition performance... in comparison to manual segmentation," suggesting a direct comparison to a manually derived ground truth without mentioning an adjudication process for that manual ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were conducted." The device is cleared as a pre-operative planning tool with its functionality focused on automated segmentation and landmark acquisition, not on human reader performance improvement.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation was done. The document states: "Automatic segmentation and landmark acquisition performance was adequately verified in comparison to manual segmentation." This indicates that the algorithm's performance (standalone segmentation and landmark acquisition) was evaluated against a manually established ground truth.

7. The Type of Ground Truth Used

The type of ground truth used was expert consensus/manual segmentation. The performance was verified "in comparison to manual segmentation," implying that human experts performed manual segmentations, which served as the reference standard.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set for the machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly detail how the ground truth for the training set was established. However, given that "manual segmentation" was used as the comparison for verification, it is highly probable that the training data's ground truth was also established through manual segmentation by experts, consistent with standard practices for training machine learning models for medical image analysis.

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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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The Arthrex Univers Apex OptiFit Humeral Stem is indicated in replacement when conditions include severe pain or significant disability resulting from degenerative, theumatic disease, or injury of the glenohumeral joint; nonunion humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; of the humeral head; or other difficult clinical management problems where arthrodesis or re-sectional arthroplasty is not acceptable.

The glenoid components are designed fixation in the joint and must only be used with an appropriate bone cement.

The proposed Univers Apex OptiFit Humeral Stem is the humeral stem component of a shoulder prosthesis system. It consists of a stem, a trunion, an inclination block, pins, and screws. All the components are comprised of titanium with a titanium plasma spray (TPS) coating.

The provided text describes the regulatory clearance for a medical device called "Arthrex Univers Apex OptiFit Humeral Stem." It focuses on demonstrating substantial equivalence to a predicate device rather than outlining detailed acceptance criteria and performance data for a novel artificial intelligence (AI) or machine learning (ML) device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of AI/ML. The performance data mentioned refers to:

• Yield strength testing on samples with and without titanium plasma spray coating, with the acceptance criteria being "met for all samples." This is a material property test, not a performance study for an AI/ML diagnostic or assistive device.
• Computational electromagnetic simulation testing to assess RF heating in bone tissue, demonstrating the device is "MR Conditional." This relates to MRI compatibility, not a diagnostic or therapeutic performance study.

In summary, this document is a 510(k) premarket notification for a traditional medical device (humeral stem), not an AI/ML device. As such, it does not provide the information requested about AI/ML device acceptance criteria, performance studies, sample sizes, expert involvement, or ground truth establishment.

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The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis

• · Rheumatoid and other inflammatory arthritis
• · Correction of functional deformity, including fracture malunion
• · Humeral head fracture
• · Revision of other devices if sufficient bone stock remains

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.

Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. Glenoid components are indicated for cemented use only.

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers (Full-Wedge), as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.

This FDA 510(k) summary is for the AltiVate® Anatomic Shoulder AG e+™ with Markers. It is a premarket notification, not a study report. Therefore, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving device performance in the way a clinical trial report would.

However, based on the provided text, I can infer some aspects and directly state where information is not available.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria or reported device performance in the sense of clinical metrics (e.g., pain reduction, range of motion improvement). Instead, it discusses the substantial equivalence to a predicate device based on material, design, and manufacturing standards.

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 Test Set: Not applicable in the context of the testing performed for this 510(k). The mechanical testing mentioned (ASTM F2028-17) would have a sample size of components, but it is not specified here. There was no clinical study.
• Data Provenance: Not applicable as a clinical test set. The mechanical testing would have been conducted in a lab.

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 with human interpretation requiring ground truth by experts was conducted or needed for this 510(k) submission.

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

Not applicable. No clinical test set requiring adjudication was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a shoulder implant, not an AI-assisted diagnostic tool.

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

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

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

Not applicable. The "ground truth" for this device's regulatory clearance is established through demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering principles, material science, and adherence to relevant ASTM standards for mechanical performance.

8. The sample size for the training set

Not applicable. The device is a mechanical implant; there is no "training set" in the context of machine learning or algorithms.

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

Not applicable. See point 8.

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

The AETOS 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 AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The coated humeral component is intended for uncement is intended for cement is intended for cemented use only.

In Reverse:
The AETOS Shoulder System is 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
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of devices if sufficient bone stock remains

The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.

The coated humeral stem is indicated for uncemented use. The coated glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Note: All implant components are single use.

The AETOS Shoulder System consists of:

In an anatomic configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible humeral head (CoCr) with a compatible glenoid (UHMWPE). The AETOS Shoulder System stem and head may be used by themselves for hemiarthroplasty.

In a reverse configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible liner (UHMWPE), glenoid baseplate (Titanium with Titanium plasma spray), glenosphere (CoCr with Titanium retaining component), peripheral screws (Titanium), center screw (Titanium), optional humeral spacer (Titanium), and optional post extension (Titanium with Titanium plasma spray).

This document is a 510(k) Premarket Notification from the FDA regarding the AETOS Shoulder System. It is primarily concerned with establishing substantial equivalence to previously cleared devices based on non-clinical performance data and technological similarities/differences.

Therefore, a study proving the device meets acceptance criteria related to AI/algorithm performance (as described in your prompt, e.g., sensitivity, specificity, human reader improvement) was not performed nor is it relevant to this specific FDA submission.

The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device."

Instead, the acceptance criteria for this device are established through engineering and mechanical testing, ensuring the physical device components meet design specifications and performance standards comparable to legally marketed predicate devices.

Here's how to interpret the available information in the context of your request:

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

The acceptance criteria are implied by the non-clinical performance data testing listed, which assess the mechanical integrity and function of the shoulder system components. The "reported device performance" is that the device met these standards, demonstrating substantial equivalence to the predicate devices. This type of submission relies on the device performing as well as the predicate in relevant mechanical and material property tests to prove safety and effectiveness.

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

• Sample Size: Not explicitly stated in terms of patient data. The "test set" here refers to the physical components of the shoulder system subjected to mechanical testing. The sample size for these engineering tests would typically be a specific number of manufactured components.
• Data Provenance: This is not patient- or human-read data. It's likely from internal laboratory testing conducted by the manufacturer (Smith & Nephew, Inc. at Cordova, Tennessee). It's not retrospective or prospective clinical data.

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

This is not applicable. The "ground truth" for mechanical performance of an orthopedic implant is established through standardized engineering tests (e.g., ASTM standards) and material science principles, not expert consensus from medical professionals. The "experts" would be engineers, material scientists, and quality assurance personnel.

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

Not applicable, as this refers to human expert review of clinical data, which was not the basis of this submission. The "adjudication" is met by demonstrating compliance with established engineering and material standards through testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical orthopedic implant, not an AI/software as a medical device (SaMD) that assists human readers.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this device's acceptance is established through compliance with existing engineering standards and successful completion of specified mechanical and material property tests. These tests are designed to simulate physiological loads and conditions to ensure the device's durability and performance.

8. The sample size for the training set:

Not applicable. This device does not involve a training set for an algorithm.

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

Not applicable.

In summary: The provided document is a 510(k) clearance for a physical medical device (shoulder system). The "acceptance criteria" and "study" details you requested are tailored to AI/software products. For this device, acceptance is based on non-clinical (engineering) performance data demonstrating substantial equivalence to older, already cleared devices, rather than clinical trials or AI performance metrics.

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The AETOS Shoulder System is intended for:
• Replacement of shoulder joints in primary anatomic or primary reverse arthroplasty.
• Replacement of shoulder joint devices in revision cases if sufficient bone stock is present.
• The AETOS Shoulder System also allows for conversions from anatomic to reverse in case of revision.

Indications for Use

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

The AETOS 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 stability and to relieve pain. The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:
• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The coated humeral component is intended for uncemented use. The glenoid component is intended for cemented use only.

In Reverse:
The AETOS Shoulder System is 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
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of devices if sufficient bone stock remains

The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.

The coated humeral stem is indicated for uncemented use. The coated glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Note: All implant components are single use.

The AETOS Shoulder System consists of:

In an anatomic configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible humeral head (CoCr) with a compatible glenoid (UHMWPE). The AETOS Shoulder System stem and head may be used by themselves for hemiarthroplasty.

In a reverse configuration: A humeral stem (Titanium) with a plasma spray coating (Titanium), a compatible liner (UHMWPE), glenoid baseplate (Titanium with Titanium plasma spray), glenosphere (CoCr with Titanium retaining component), peripheral screws (Titanium), center screw (Titanium), and optional post extension (Titanium with Titanium plasma spray).

The provided text is a 510(k) Summary for the AETOS Shoulder System. It details the device's description, indications for use, and a summary of nonclinical performance data. However, it explicitly states that "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device."

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets these criteria in the context of clinical performance, as no such clinical study was deemed necessary or performed for this 510(k) submission.

The document focuses on nonclinical performance data to establish substantial equivalence to predicate devices. Here's what can be extracted regarding the nonclinical evaluation:

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

The document does not provide a table with explicit acceptance criteria (e.g., "Must withstand X N of force") and specific reported device performance values (e.g., "Device withstood Y N of force"). Instead, it lists the types of nonclinical testing performed to demonstrate substantial equivalence. The implication is that the performance in these tests was considered acceptable compared to the predicate devices and relevant standards.

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

• Sample Size: Not specified in the provided text for any of the nonclinical tests.
• Data Provenance: The tests are nonclinical (bench testing) and were performed by the manufacturer, Smith & Nephew, Inc. No country of origin for the data or whether it was retrospective/prospective is given, as these are typically not relevant for bench testing in the same way they are for clinical studies.

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

This information is not applicable as there was no clinical study, and thus no "ground truth" established by experts in a diagnostic context. The "ground truth" for the nonclinical tests would be the measurement results against engineering specifications or established standards.

4. Adjudication method for the test set:

This information is not applicable as there was no clinical study requiring adjudication of expert interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device."

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

This information is not applicable as the AETOS Shoulder System is a physical orthopedic implant, not an AI algorithm or software device.

7. The type of ground truth used:

For the nonclinical (bench) testing, the "ground truth" would be the engineering specifications, material science properties, and performance standards relevant to orthopedic implants, against which the device's performance in mechanical and material tests was evaluated for substantial equivalence to predicates.

8. The sample size for the training set:

This information is not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.

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

This information is not applicable for the same reason as above.

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The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.

The Catalyst EA Convertible Stemmed Shoulder is an anatomic designed total shoulder prosthesis that mates with the Catalyst R1 humeral stems cleared in K202611. This submission adds conversion adapters, locking screw and humeral heads to mate with the previously cleared Catalyst R1 humeral stems. The humeral head components are compatible with previously cleared CSR 3 Peg glenoid components or for articulation with the glenoid cavity of the scapula. When the humeral stem (cleared K202611), adapter and humeral head are mated together, this creates a hemiarthroplasty (product code HSD). When the humeral stem, adapter and humeral head are used in conjunction with the CSR glenoid components (cleared K191811 and K173812), this creates a total shoulder arthroplasty (product code KWS). The adapters and locking screw are manufactured from Ti-6A1-4V ELI conforming to ASTM F136. The humeral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.

The provided document describes a 510(k) premarket notification for the "Catalyst EA Convertible Stemmed Shoulder" device. This is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices, not a study proving the device meets explicit acceptance criteria in the context of a clinical trial or AI performance.

Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory document. Specifically, there is no mention of acceptance criteria related to AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies.

However, I can extract the information that is relevant to the non-clinical testing performed for this device.

Acceptance Criteria and Device Performance (Non-Clinical)

Study Details (Non-Clinical)

Your prompt asks for specific details related to AI/clinical studies that are not present in this 510(k) summary. Here's a breakdown of why and what information is available:

1. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical bench testing of a medical implant, not AI or clinical data. The "test set" would refer to the physical prototypes or samples used for mechanical testing. The specific number of samples for each test (e.g., how many constructs for fatigue testing) is not detailed in this summary.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI or diagnostic studies is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and specifications.
3. Adjudication method for the test set: Not applicable. There is no expert review or adjudication process described for the lab-based mechanical tests.
4. 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. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices." This is a mechanical implant, not a diagnostic AI device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is not an algorithm or AI device.
6. The type of ground truth used: For the non-clinical testing, the "ground truth" would be established by engineering specifications, material standards (e.g., ASTM F136, ASTM F1537), and predetermined acceptance criteria for mechanical performance (e.g., fatigue life, disassembly forces).
7. The sample size for the training set: Not applicable. No AI training was performed.
8. How the ground truth for the training set was established: Not applicable. No AI training was performed.

Context from the Document:

The document clearly states:

"Non-Clinical Testing: Range of motions analyses, biocompatibility assessment and construct fatigue testing were all conducted. Axial disassembly tests were performed pre-fatigue and post-fatigue testing. The construct fatigue testing demonstrated that the construct of the Catalyst EA Convertible Stemmed Shoulder humeral heads with conversion adapter, met the pre-determined acceptance criterion. All testing has determined that the device is substantially equivalent to the predicate device."

And:

"Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices."

This indicates that the FDA cleared this device based solely on non-clinical (i.e., lab/mechanical) testing and comparison to predicate devices, and not on AI performance, clinical trials, or human diagnostic studies.

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The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
• Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis
· Rheumatoid and other inflammatory arthritis

• · Correction of functional deformity, including fracture malunion
• · Humeral head fracture
• · Revision of other devices if sufficient bone stock remains

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.

Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers, as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.

This document is a 510(k) summary for a medical device (AltiVate® Anatomic Shoulder AG e+™ with Markers), not a study report demonstrating device performance against specific acceptance criteria for AI/ML. Therefore, the information required to answer your specific questions about AI/ML device performance, ground truth, expert adjudication, or MRMC studies is not present in the provided text.

The closest relevant sections are:

• Mechanical and acoustic testing: "Dynamic evaluation of glenoid loosening or disassociation was performed per ASTM F2028-17." This refers to physical testing of the implant, not AI/ML performance.
• Clinical Studies: "Clinical data was not required." This explicitly states that clinical studies (which would involve human or AI/ML performance data) were not performed for this 510(k) submission.

Since the provided text does not describe an AI/ML device or its performance evaluation, I cannot generate the table or provide details about sample sizes, ground truth establishment, or expert involvement in such a study.

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant; in case of SMR Short Stems only if sufficient bone stock remains);
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs are intended for cemented and uncemented use as specified in the following table.

The SMR Shoulder System is a shoulder system. The SMR TT Hybrid Glenoid and the SMR 3-Pegs Cemented Glenoid are glenoid components intended to be used in combination with the previously cleared components of the SMR Shoulder System (humeral stems, humeral bodies, adaptor tapers, humeral heads) to achieve an anatomic configuration.

The purpose of the Special 510(k) is to add an alternative sterilization method for SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid.

The SMR TT Hybrid Glenoid is composed by a poly baseplate and a peg. The poly baseplate is manufactured from conventional (non-crosslinked) UHMWPE (ISO 5834-2 ASTM F648) and Tantalum (ISO 13782 ASTM F560). The peg is manufactured from Ti6Al4V (ISO 5832-3 ASTM F1472).

The SMR 3-Pegs Cemented Glenoid is manufactured from conventional (non-crosslinked) UHMWPE (ISO 5834-2 ASTM F648).

The SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid can be sterilized using a minimum gamma radiation dose of 25 kGy.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a shoulder implant system, the SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid.

It discusses the substantial equivalence of these devices to previously marketed predicate devices and mentions preclinical testing (sterilization validation, packaging validation, UHMWPE characterization).

Crucially, it explicitly states under "Clinical Testing: Clinical testing was not necessary to support substantial equivalence." This means no clinical study was performed or needed to demonstrate the device's performance against specific acceptance criteria in a human-in-the-loop or standalone AI context.

Therefore, I cannot extract the information you requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study and effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to the clearance of a medical implant, not an AI/software device that would typically undergo the kind of performance evaluation you've described.

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