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Hardware: The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed 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.

Software: Blueprint® is a medical device for surgeons. Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific instruments and Tornier Perform patient-matched primary reversed glenoid*) based on the pre-surgical plan. Blueprint® leads to the generation of a planning report. Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and Blueprint® (software).

Hardware: The BLUEPRINT ™ Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software Blueprint®.

Software: Blueprint® 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 components when appropriate.

The provided text is a 510(k) premarket notification for the BLUEPRINT™ Patient Specific Instrumentation, which includes both hardware (Glenoid Guides) and software (Blueprint®). While it describes the device, its intended use, and comparison to predicate devices, it does not contain the detailed performance data or acceptance criteria typically found in a study report.

Therefore, I cannot provide the requested information regarding specific acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study details. The document states that "Technological differences between the subject and predicate software devices are supported by software verification and validation activities. These activities include functional tests, validation and compatibility for new implant integration, as well as the validation and reproducibility of anatomical measures, planning measures, planning features, and segmentation." However, it does not present the results or specific criteria of these activities.

In the absence of a detailed study report within the provided text, I can only state that the document asserts that:

• Differences in design specifications do not raise different questions of safety and effectiveness over the predicate device as demonstrated in validation testing.
• The subject device, the BLUEPRINT™ Patient Specific Instrumentation, does not raise new questions of safety or effectiveness.
• Differences in technological characteristics have been addressed by software verification and validation activities.

To answer your request, a more detailed study report or validation protocol would be necessary.

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The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: · severe arthropathy and/or; · a previously failed joint replacement and/or: · fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed Delta Xtend Reverse Shoulder. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.

The Delta Xtend Reverse Shoulder System consists of humeral stem, modular epiphysis, humeral spacer, humeral cup, glenosphere, metaglene and metaglene screws. The glenosphere and metaglene are used for total reverse shoulder arthroplasty. The humeral spacer can be added between the epiphysis and the humeral cup if necessary. Humeral head can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.

The provided document pertains to the 510(k) premarket notification for the DePuy Delta Xtend™ Reverse Shoulder System, specifically for the addition of lateralized glenosphere components. This document is a regulatory submission for a medical device (a shoulder prosthesis), NOT an AI/ML medical device. Therefore, the information requested regarding acceptance criteria and study proving device performance for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth sources) is not applicable here.

The document discusses the substantial equivalence of the new components to predicate devices based on:

1. Biocompatibility: Confirmed per ISO10993-1.
2. Range of Motion: Theoretical simulated range of motion analyses showed an increase compared to the predicate non-lateralized glenosphere.
3. Glenoid Loosening/Disassociation: A study demonstrated substantial equivalency of glenoid fixation performance to the predicate.

The document explicitly states:

• "Summary of animal study: Animal study was not necessary."
• "Summary of clinical study: Clinical study was not necessary."

This indicates that clinical trials or studies that would involve human patient data, ground truth establishment by experts, or detailed statistical analysis of performance (as would be typical for AI/ML device validation) were not required for this specific 510(k) submission, as it focused on demonstrating substantial equivalence through non-clinical performance and design comparisons.

Therefore, I cannot extract the information required for an AI/ML device's acceptance criteria and study results from this document.

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IN ANATOMIC:

The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral 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 Aequalis Fx2 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 Aequalis Ex2 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 proximal humerus except for size 50mm(1)
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains except for size 50mm(1)

IN REVERSE:

The Aequalis Fx2 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 (i.e. osteoarthritis and avascular necrosis)

• Correction of functional deformity

• Fractures of the proximal humerus except for size 50mm(1

• Traumatic arthritis

• Revision of the devices if sufficient bone stock remains except for size 50mm( ).. The reversed insert is permitted to be used in the transformation from anatomic to reverse Aequalis Fx2 without the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle.

The Aequalis Fx2 is a non-constrained prosthesis intended for the total or partial replacement of the gleno-humeral articulation.

The Aequalis Fx2 consists of:

• in an anatomic configuration, a humeral stem compatible with Flex Shoulder System humeral heads (K122698 ; K140082);

or

• in a reversed configuration, a humeral stem and a reversed insert, compatible with Aequalis Reversed/Aequalis Reversed II glenoid implants (K081059; K140478).

The Aequalis Fx2 is intended for use as:

• 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,

• in case of bone defect in the proximal part of the humerus,

• a replacement of shoulder joints in primary anatomic or in primary reverse,

• a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.

The Aequalis Fx2 also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

This submission corresponds to the design modification related to the Aequalis Fx2 assembly zone (humeral stems and reversed inserts) compatible only with each other. This design modification does not affect the intended use of the device or alter the fundamental scientific technology of the device. The pending humeral stems are compatible with the cleared Flex Shoulder humeral heads and the pending reversed inserts are compatible with the cleared Aequalis Reversed II glenoid implants. There is no change regarding the material of the pending Aequalis Fx2 humeral stems. The design change related to the pending Aequalis Fx2 reversed inserts does not include a titanium locking ring in contrast to the previously cleared Aequalis Fx2 reversed inserts.

Here's a breakdown of the acceptance criteria and the study information for the Aequalis Fx2 device based on the provided document:

This document is a 510(k) premarket notification for a medical device (Aequalis Fx2), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study on human-in-the-loop performance or diagnostic accuracy. Therefore, many of your requested points related to AI/algorithm performance (standalone performance, MRMC studies, ground truth establishment for training/test sets, expert qualifications) are not applicable to this type of submission.

The "study" described here consists of various engineering and physical tests to demonstrate that the modified device's performance is acceptable and comparable to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a numerical sample size in terms of units tested for each validation method. It refers to "the design modification" and "the pending Aequalis Fx2 humeral stem and reversed insert," implying that these tests were conducted on representative samples of the device components.
• Data Provenance: The tests are described as physical/bench tests conducted by the manufacturer, Tornier S.A.S., which is based in Montbonnot Saint-Martin, France. This is not patient-derived data; it's engineering test data.

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

This information is not applicable. The "ground truth" for these engineering tests is established by industry standards, engineering specifications, and predicate device performance, not by medical experts interpreting data like in a diagnostic study.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations, which is not relevant to the physical testing described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This information is not applicable. This document is for a shoulder prosthesis and does not involve AI or human reader performance.

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

This information is not applicable. This document is for a physical medical device (shoulder prosthesis) and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these performance tests is based on:

• Engineering Specifications and Design Requirements: For dimensional comparisons, assembly methods, and convertibility.
• Predicate Device Performance: For tests like Pull-out and Torque testing, where the modified device's performance is compared for equivalence to previously cleared devices (K030941 and K141345).
• Failure Criteria: For fatigue testing ("No failure after the test").

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an engineering evaluation for a mechanical implant.

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

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

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The Aequalis Adjustable Reversed Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non repairable rotator cuff tear 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 the devices if sufficient bone stock remains

The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis AscendTM Modular Reverse Shoulder System K110599.

The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty.

The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options:

• Uncoated,
• Hydroxylapatite (HAP) coated,
• HAP over titanium plasma spray (HAP/Ti PS) coated.

The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120):

The purpose of this 510(k) is to add an additional stem configuration that does not have HAP Coating and that has plasma titanium spray coating on a portion of the stem (20mm proximal portion of stem), and has a fluted surface on a portion of the stem instead of the full length of the stem (i.e., the HAP coating and fluted surface on 20mm proximal portion of stem. In addition, an alternate plasma titanium spray coating supplier has been validated to perform this manufacturing operation.

The provided text from the FDA 510(k) summary (K141029) describes a medical device, the Aequalis Adjustable Reversed Shoulder System, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document discusses:

• Device: Aequalis Adjustable Reversed Shoulder System (a shoulder joint prosthesis).
• Predicate Device: Tornier Aequalis Adjustable Reverse Shoulder System, K120739.
• Purpose of this 510(k): To add an additional stem configuration (without HAP Coating, with plasma titanium spray coating on a portion, and a fluted surface on a portion) and validate an alternate plasma titanium spray coating supplier.
• Non-clinical Tests: Performed to evaluate device performance per design requirements and risk analysis. These included:
  • Demonstration of design equivalence
  • Fatigue testing
  • Shear fatigue strength
  • Static shear strength per ASTM F1044
  • Static tensile strength per ASTM F1147
  • Abrasion resistance per ASTM F1978
  • Thickness per ASTM F1854
  • Mean void intercept length per ASTM F1854
  • Mean volume percent of void per ASTM F1854
• Conclusion: "All testing results met pre-established acceptance criteria." and "the Tornier Aequalis Adjustable Reverse Shoulder System was found to be substantially equivalent to the predicate device."

Based on the provided text, I cannot answer your questions because the document describes a mechanical orthopedic implant, not an AI or algorithm-based medical device. Your questions are tailored for evaluating the performance of an AI/algorithm.

Therefore, for each of your specific questions, the answer is that the information is not available in the provided document.

Here's why:

1. AI/Algorithm Focus: The core of your questions (e.g., test set, ground truth, experts, MRMC studies, standalone performance, training set) directly pertains to the evaluation of AI/machine learning algorithms. The Aequalis Adjustable Reversed Shoulder System is a physical implant, and its evaluation focuses on mechanical and material properties.

I can only extract information that is present in the document.

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The Aequalis Adjustable Reverse Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non-repairable rotator cuff tear 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 the devices if sufficient bone stock remains

The Aequalis Adjustable Reverse Shoulder system is a modular Reverse version of the Aequalis Shoulder System (K100142, K081059). The Aequalis Adjustable Reverse Shoulder system is supplied in separate, sterile packages which will be assembled in the operating room. The components provided will be: Metaphysis, Stem Spacers, Stems, Assembly Screw, Securitization System: Securitization Bracket and Screw. The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis® Ascend™ Modular Reverse Shoulder System K110599. The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty. The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options: Uncoated, Hydroxylapatite (HAP) coated, HAP over titanium plasma spray (HAP/Ti PS) coated. The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120).

The provided document is a 510(k) premarket notification for a medical device (Aequalis Adjustable Reverse Shoulder System). It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or diagnostic accuracy.

The document discusses the substantial equivalence of this new device to previously marketed predicate devices based on material, design, sizing, indications for use, and non-clinical mechanical testing (e.g., fatigue, fretting corrosion). It's a regulatory submission for a physical orthopedic implant, not a software-driven diagnostic or prognostic tool.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance using the details from this document, as those types of studies and criteria are not applicable to the content provided.

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The Aequalis Ascend Modular Reverse Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and nonrepairable 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
  The Reverse Metaphysis and Assembly Screw or the Reverse Metaphysis, Reverse Spacer, and Reverse Spacer Assembly Screw are indicated for use as components of the Aequalis Ascend Modular Reverse total shoulder replacement and for transformation of the Aequalis Ascend Anatomic shoulder into a reverse shoulder prosthesis without the removal of the Diaphyseal stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if:
• The Diaphyseal stem is well fixed
• The patient has a functional deltoid muscle
• The arthropathy is associated with a massive and non-repairable rotator cuff-tear.
  Notes:
• All components are single use
• The humeral stem is intended for cemented or cementless use
• The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

The Aequalis Ascend Modular Reverse shoulder prosthesis is a component of semi-constrained reverse shoulder prosthesis.
The Aequalis Ascend Modular Reverse Shoulder system is supplied in separate sterile packages which will be assembled in the operating room. The components provided are:

• The Modular Reverse Metaphysis and Modular Reverse Assembly Screw
• The Modular Reverse Inserts
• An optional Modular Reverse Spacer and Modular Reverse Spacer Assembly Screw can be used when maximum insert thickness does not achieve sufficient tension.
• When the Modular Reverse Spacer is implanted, the Modular Reverse Spacer Assembly Screw will be used in place of the Modular Reverse Assembly Screw.
  The present device submission corresponds to changes made to the version of the device cleared in 510(k) K110599.

The provided text describes a medical device called the "Aequalis Ascend Modular Reverse Shoulder System" and its indications for use, but it does not contain information about acceptance criteria for a study, performance metrics, or study details such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment.

The document is a 510(k) premarket notification letter from the FDA to Tornier, Incorporated, confirming substantial equivalence to a predicate device. It outlines the device's classification, indications for use, and a summary of safety and effectiveness information, which primarily focuses on non-clinical testing (fatigue and insert disassembly testing) to demonstrate substantial equivalence to a legally marketed predicate device (Tornier Aequalis Ascend Modular Reverse Shoulder System, K110599).

Therefore, I cannot fulfill your request for the detailed table and study information as the provided text does not contain that level of detail regarding device performance or clinical study methodologies.

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The Aequalis Ascend Modular Reverse 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 (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
  The Reverse Metaphysis and Assembly Screw or the Reverse Metaphysis, Reverse Spacer, and Reverse Spacer Assembly Screw are indicated for use as components of the Aequalis Ascend Modular Reverse total shoulder replacement and for transformation of the Aequalis Ascend Anatomic shoulder into a reverse shoulder prosthesis without the removal of the Diaphyseal stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if:
• The Diaphyseal stem is well fixed
• The patient has a functional deltoid muscle
• The arthronathy is associated with a massive and non-repairable rotator cuff-tear.
  Notes:
• All components are single use
• The humeral stem is intended for cemented or cementless use
• The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

The Aequalis Ascend Modular Reverse Shoulder system is a modular Reverse version of the Aequalis Ascend Modular Anatomic Shoulder System (K102924) with Reverse adapters. The Aequalis Ascend Modular Reverse Shoulder system is supplied in separate sterile packages which will be assembled in the operating room. The components provided will be:

• The Modular Reverse Metaphysis and Modular Reverse Assembly Screw.
• The Modular Reverse Inserts
• The Modular Reverse Angled Inserts
• An optional Modular Reverse Spacer and Modular Reverse Spacer Assembly Screw can be used when maximum insert thickness does not achieve sufficient tension.
• When the Modular Reverse Spacer is implanted, the Modular Reverse Spacer Assembly Screw will be used in place of the Modular Reverse Assembly Screw.

Primary Reverse Shoulder:
The Aequalis Ascend Modular Reverse Metaphysis and Aequalis Ascend Modular Reverse Assembly Screw will mate with the existing; FDA cleared Tornier Aequalis Ascend Modular Anatomic Distal Stem (K102924) which when assembled together with the Aequalis Ascend Modular Reverse Insert form complete reverse prostheses. The reverse assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants (K081059).

Conversion Reverse Shoulder:
The Aequalis Ascend Reverse Metaphysis and Aequalis Ascend Modular Reverse Assembly Screw are designed to allow the transformation of the Aequalis Ascend Anatomic shoulder (K102924) into an Aequalis Ascend Modular Reverse Shoulder without removal of the Diaphyseal Stem if the stem is well fixed during revision surgery. The Aequalis Ascend Reverse Metaphysis is a metal component aimed to articulate as a reverse prosthesis with a specific polyethylene insert. The metal metaphysis is impacted onto the taper of the Diaphyseal Stem and then secured with the Ascend Modular Reverse Assembly Screw. The screw is tightened until it is firmly seated on the Reverse Metaphysis. A Reverse Spacer can be used when the maximum insert thickness does not achieve sufficient tension. During these situations, after impaction of the Reverse Metaphysis on the Diaphyseal stem, the metal spacer is impacted on the taper of the Reverse Metaphysis and then secured with the Ascend Modular Reverse Spacer Assembly Screw. The screw is tightened until it is firmly seated on the Reverse Spacer.

This document is a 510(k) summary for the Aequalis® Ascend™ Modular Reverse Shoulder System. It does not describe an AI/ML powered device, but rather a medical implant. Therefore, the requested information about acceptance criteria and study details for an AI/ML device is not applicable or available in this document.

However, I can extract information related to the device's testing and safety from the provided text, which serves a similar purpose to demonstrating that the device meets certain criteria for market approval.

Here's an interpretation of the document in the context of device approval, where "acceptance criteria" can be broadly understood as the standards it needed to meet for FDA clearance:

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

The document does not specify quantitative acceptance criteria with numerical targets. Instead, the device's "performance" is assessed through non-clinical tests to demonstrate substantial equivalence to predicate devices, implying it meets the same safety and effectiveness standards.

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

This information is not provided in the document. The document refers to "non-clinical testing" (Fatigue Testing, Fretting Corrosion, Static Disassembly Testing) but does not specify sample sizes for these tests or their provenance.

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)

This information is not applicable to this type of device (a physical implant) and is not provided. "Ground truth" in this context would generally refer to expert-labeled data for AI models, which is not relevant here. The "experts" involved would be engineers and materials scientists performing and evaluating the non-clinical tests.

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

This information is not applicable to this type of device and is not provided. Adjudication methods are typically used for expert consensus on clinical or imaging data in AI/ML studies.

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

This information is not applicable as this is a physical medical implant, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable as this is a physical medical implant, not an algorithm.

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

This information is not applicable in the AI/ML sense. For this device, the "ground truth" for the non-clinical testing is based on established engineering principles, material science standards (ASTM, ISO), and comparisons to previously cleared predicate devices. The safety and effectiveness are inferred from these tests and the device's substantial equivalence to predicates.

8. The sample size for the training set

This information is not applicable as this is a physical medical implant, not an AI model requiring a training set.

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

This information is not applicable as this is a physical medical implant, not an AI model.

In summary, the provided document describes the FDA 510(k) clearance for a physical medical device (shoulder prosthesis). The core of its approval lies in demonstrating "substantial equivalence" to predicate devices through non-clinical (mechanical and material) testing, rather than through AI/ML performance metrics and studies.

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