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Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries.

Mpact 3D Metal Augments are indicated in cases of:

• Acetabular dysplasia;
• Acetabular fractures;
• Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.

The Mpact 3D Metal Augment II is an acetabular implant intended to be used in Total Hip Arthroplasty cemented to its Medacta compatible Acetabular Shell. It is provided sterile and individually packaged to the end user.

The devices subject of this submission are:

• Mpact 3D Metal Augments II from size Ø46 to Ø80, made of Ti6Al4V according to ASTM F2924;
• Double Augment Technique Screw, made of Ti6Al4V according to ISO 5832-3.

The Mpact 3D Metal Augments II represent the second generation of the Mpact 3D Metal Augments cleared within K171966.

This FDA 510(k) clearance letter pertains to a medical device, specifically the Mpact 3D Metal Augments II, which are implants for hip replacement surgeries. The document focuses on establishing substantial equivalence to existing predicate devices based on design and performance testing. However, it does not describe a clinical study in the traditional sense, especially not one that involves human subjects or assesses AI performance.

The provided text details non-clinical performance data and validations to support the device's substantial equivalence to its predicate. It does not contain information about acceptance criteria for AI performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, many of the requested sections (including specific tables for acceptance criteria and device performance based on AI metrics, details about test sets, ground truth establishment for AI, MRMC studies, and standalone performance) cannot be filled from the provided document.

Here's a breakdown of the information that is available:

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

The document describes performance testing as "Fatigue testing in single and double augment configurations" and "Rationale of comparison – EBM Additive Manufacturing Technology." It also mentions "Design Validation on Mpact 3D metal Augments II." However, it does not disclose specific acceptance criteria or quantitative performance results for these tests. It only states that "testing activities were conducted to written protocols" and these validations are "provided in support of the substantial equivalence determination." This is typical for a 510(k) summary, which generally summarizes the data rather than providing all raw or detailed results.

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 "tests" here refer to non-clinical laboratory and material tests, not clinical studies involving patient data.

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 is not applicable to the type of device and study described. There's no "ground truth" to be established by experts in the context of material fatigue or design validation for an orthopedic implant as presented here.

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

This is not applicable to the type of device and study described. Adjudication methods are typically used in clinical trials or studies involving expert review of medical images or outcomes.

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

There is no MRMC or comparative effectiveness study mentioned, as this is a physical medical device (hip augments), not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is an orthopedic implant, not an algorithm.

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

This is not applicable in the sense of medical diagnosis or AI performance. The "truth" for these non-clinical tests would be the physical properties and performance characteristics determined by established engineering and materials testing standards.

8. The sample size for the training set

This is not applicable, as there is no "training set" for an AI algorithm mentioned in this document.

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

This is not applicable, as there is no "training set" or "ground truth" for it in the context of AI.

Summary of what the document does provide regarding the study/testing:

The document describes non-clinical testing and validations performed to demonstrate the substantial equivalence of the Mpact 3D Metal Augments II to its predicate devices. These tests include:

• Design Validation: Performed on Mpact 3D Metal Augments II (details not provided).
• Performance Testing:
  • Fatigue testing in single and double augment configurations.
  • Rationale of comparison – EBM Additive Manufacturing Technology.
• Pyrogenicity: Control validated using bacterial endotoxin test (LAL test) per ISO11737-3 and European Pharmacopoeia §2.6.14, and in-vivo evaluation in rabbits per USP .
• Biocompatibility assessment.
• Shelf-life evaluation.

The document states that Medacta International S.A., based in Switzerland, submitted this 510(k). The tests are non-clinical, so data provenance regarding country of origin or retrospective/prospective does not apply in the same way as for clinical data. The studies are laboratory-based and conducted according to written protocols to ensure materials and design meet safety and performance standards for orthopedic implants.

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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

The Reverse Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

Glenoid Reconstruction System (GRS) Full Wedge baseplate is a Medacta Shoulder System line extension to provide a larger product offering.

It includes GRS Full Wedge baseplate and central screws, sterile implantable devices used to replace only the glenoid side of the gleno-humeral joint in a shoulder reverse configuration.

The GRS Full Wedge baseplate, intended for cementless application, is designed to be fixed into the glenoid bone by means of both a press-fit central post and Glenoid Polyaxial Screws. If desired, a GRS Central Screw can be used to provide additional stability.

The GRS Full Wedge baseplate is designed to provide an interface for glenosphere coupling.

The subject baseplate is available in two taper diameters (024.5 and 027) with two different lengths (20 and 30 mm) of the central post and 4 full wedge options (10°, 15°, and 20°).

It is made of Ti6Al7Nb according to ISO 5832-11 and double coated with Ti coating according to ASTM F1580-18 and HA coating according to ASTM F1185-03.

The provided text describes the 510(k) premarket notification for the "Glenoid Reconstruction System - Full Wedge Baseplate." It outlines the device, its intended use, and a comparison to predicate devices, but it does not contain information regarding acceptance criteria or a study that proves the device meets those criteria in the context of a human-AI performance study. Instead, it focuses on non-clinical performance data (e.g., fatigue testing, micromotion assessment, material characterization) to demonstrate substantial equivalence to existing devices.

Therefore, many of the requested fields cannot be filled from the provided document.

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

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

• Cannot be provided. The document lists non-clinical studies performed (e.g., fatigue testing, micromotion assessment, material characterization), but it does not specify quantitative acceptance criteria or the specific performance results for those criteria. It states that "performance testing was conducted to written protocols," implying that there were pre-defined criteria, but these are not detailed.

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

• Cannot be provided. The studies mentioned are non-clinical (mechanical, material, biocompatibility testing) and do not involve human patients or test sets in the typical sense of AI performance evaluation. Thus, there is no sample size of patients/cases or data provenance to report.

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. This information is relevant for studies involving human interpretation or AI performance assessment against expert ground truth, which is not present in this document.

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

• Not applicable. As above, this pertains to studies involving human interpretation and ground truth establishment.

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. The document explicitly states: "No clinical studies were conducted." Therefore, no MRMC study with AI assistance was performed or reported.

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

• Not applicable. The device is a physical medical implant (glenoid reconstruction system), not a software algorithm or AI device.

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

• Not applicable. For the non-clinical studies mentioned, the "ground truth" would be established engineering specifications, material standards (e.g., ASTM, ISO), and validated testing methods. It is not related to clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, there is no training set mentioned or relevant.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

Summary of available information regarding compliance:

The device's substantial equivalence to predicate devices is supported by the following non-clinical studies:

• Design Validation: Glenoid Reconstruction System Full Wedge Baseplate Design Validation.
• Performance Testing:
  • Fatigue testing on glenoid reconstruction system.
  • Micromotion assessment on Glenoid reconstruction system Full Wedge Baseplate according to ASTM F2028-17.
  • Range of Motion Assessment.
  • Characterization Report "Y367" Titanium + "Osprovit" Hydroxyapatite double coating on GRS Glenoid baseplate component.
  • Scanning electron microscopy pictures of the "Y367" Titanium + "Osprovit" HA implant surfaces of the GRS Glenoid baseplate.
  • Cross sectioned area of "Y367" Titanium + "Osprovit" HA implant surfaces of the GRS Glenoid baseplate.
  • Rationale comparison between features of the Hydroxyapatite Osprovit coating deposited on the Medacta GRS Glenoid baseplate and on planar samples made of Ti6A17Nb, based on XRD analyses.
• Pyrogenicity:
  • Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter ).
  • Pyrogen test according to USP chapter for pyrogenicity determination.
• Biocompatibility evaluation.
• Shelf-life evaluation.

The document states that "performance testing was conducted to written protocols," implying that these tests were designed to confirm the device's performance against predetermined specifications derived from industry standards and predicate device characteristics, thereby demonstrating substantial equivalence. However, the specific quantitative acceptance criteria and results are not detailed in this FDA summary letter.

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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.

The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System can be used to provide additional fixation.

The Reverse Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.

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.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The humeral short stem is intended for cementless use.

The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

The Glenoid Reconstruction System is a Medacta Shoulder System line extension to provide a larger product offering. It includes GRS baseplates and central screws, sterile implantable devices used to replace only the glenoid side of the gleno-humeral joint in a shoulder reverse configuration.

The GRS baseplate, intended for cementless application, is designed to be fixed into the glenoid bone by means of both a press-fit central post and Glenoid Polyaxial Screws. If desired, a GRS Central Screw can be used to provide additional stability. The GRS baseplate is designed to provide an interface for glenosphere coupling.

The subject baseplate is available in two taper diameters (024.5 and 027) with two different lengths (20 and 30 mm) of the central post and 3 lateralization options (0 mm, +3 mm and +6 mm). It is made of Ti6A17Nb according to ISO 5832-11 and double coated with Ti coating according to ASTM F1580-18 and HA coating according to ASTM F1185-03.

The GRS central screw is available in 4 different lengths, from 15 to 30 mm and it is made of Ti6Al4V according to ISO 5832-3.

The provided text describes a 510(k) premarket notification for the Glenoid Reconstruction System, specifically for new GRS baseplates and central screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with acceptance criteria based on patient outcomes.

Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

Here's why and what can be extracted from the document in relation to device performance and testing:

Why the requested information is not present:

• Device Type: The Glenoid Reconstruction System is a medical implant (shoulder prosthesis components), not an AI/ML-powered diagnostic or therapeutic device. The types of evaluations, acceptance criteria, and studies are fundamentally different.
• Regulatory Pathway (510(k)): A 510(k) submission primarily relies on demonstrating that a new device is "substantially equivalent" to an existing legally marketed device (the predicate). This often involves comparing technological characteristics and performing bench testing (non-clinical studies) to ensure it performs as intended and is as safe and effective as the predicate. Clinical studies are often not required for 510(k)s, especially for incremental changes or extensions of existing product lines, which is the case here.
• Focus on Performance Data: The "Performance Data" section lists non-clinical studies (design validation, fatigue testing, micromotion assessment, static tests, material characterization, biocompatibility, shelf-life). These are engineering and material science tests, not AI/ML performance metrics like sensitivity, specificity, or AUC.

What information can be extracted/inferred related to the device's performance, but not in the AI/ML context you've asked for:

• No Acceptance Criteria for AI/ML performance: As it's not an AI/ML device, there are no acceptance criteria related to metrics like sensitivity, specificity, accuracy, etc.
• No Reported Device Performance (as AI/ML metrics): The document doesn't report performance in terms of AI/ML metrics.
• Sample Size (for an AI/ML test set): Not applicable. The "test set" here refers to physical components undergoing engineering tests.
• Data Provenance (for an AI/ML test set): Not applicable.
• Number of experts / Adjudication Method: Not applicable. These relate to establishing ground truth for AI/ML studies. The "experts" involved here would be materials scientists or mechanical engineers for the non-clinical tests.
• Multi-reader Multi-case (MRMC) study: Not applicable. This is specific to diagnostic imaging interpretation, often with human interpretation.
• Standalone (algorithm-only) performance: Not applicable.
• Type of Ground Truth (for AI/ML): Not applicable. The "ground truth" for the a glenoid reconstruction system is established through engineering principles, material standards, and biomechanical testing. For example, for fatigue testing, the ground truth is whether the component withstands a specified number of cycles at a certain load without failure, according to a standard. For material characterization, the ground truth is the chemical composition and microstructure matching specifications.
• Training Set Sample Size & Ground Truth (for AI/ML): Not applicable.

In summary, the provided document describes the regulatory approval of a physical medical implant, not an AI/ML-powered device. Therefore, it does not contain the specific information you've requested regarding AI/ML acceptance criteria and performance studies.

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The Mpact® 3D Metal™ implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, rheumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis

• · Avascular necrosis of the femoral head
  · Acute traumatic fracture of the femoral head or neck

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present

The Mpact® 3D Metal Implants - DMLS Technology are sterile implantable devices intended to be used during Total Hip Arthroplasty. The devices subject of this submission are:

• Mpact® 3D Metal Acetabular Shells Two-Hole Ø 46-66 mm manufactured through DMLS ● Technology;
• . Mpact® 3D Metal Acetabular Shells Multi-Hole - Ø 46-72 mm - manufactured through DMLS Technology:
• . Mpact® 3D Metal Acetabular Shells Multi-Hole Thin - Ø 48-60 mm - manufactured through DMLS Technology; and
• . Compression Polyaxial Locking Screws - 11 sizes depending on screw length: from 20 to 70mm in 5mm steps.

The Mpact® 3D Metal Acetabular Shells manufactured through DMLS Technology are a line extension to the Mpact® 3D Metal Acetabular Shells and 3D Metal Augments (K171966) and to the Mpact® Acetabular Systems Shells (K103721, K122641 and K132879) and are designed to be used with the Medacta Total Hip Prosthesis System.

The subject Mpact® 3D Metal Acetabular Shells are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder. DMLS is a metal additive layer manufacturing process that uses a precise and high-wattage laser to "sinter" powdered metals and alloys to form accurate, complex and fully-functional metal parts directly from CAD data.

Compression Polyaxial Locking Screws have been designed to provide fixation of implants to the cancellous bone and they can be considered a line extension to the predicate devices, Cancellous Bone Screws flat head, previously cleared within K103721 and K132879. The subject screws have a thread diameter of 6.5 mm and they can be coupled with implants that have dedicated fixation holes with a spherical seat shape of Ø8mm.

The outer screw of the Compression Polyaxial Locking Screws is made of titanium alloy (Ti6-Al4-V) according to ISO 5832-3:2016, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6aluminum 4-vanadium alloy, while, the inner part, not in contact with bone, is made of Co-Cr-Mo alloy according to ISO 5832-12:2019, Implants for Surgery - Metallic materials - Part 3: Wrought cobaltchromium-molybdenum alloy.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device (hip implants), which focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and design validation.

The information you are asking for, such as:

• Acceptance criteria and reported device performance (in a table)
• Sample size and data provenance for a "test set"
• Number of experts and their qualifications for ground truth establishment
• Adjudication method for a test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

These elements are typically requested for AI/Machine Learning-based medical devices that perform diagnostic or interpretative functions, where the device's "performance" is measured in terms of metrics like sensitivity, specificity, accuracy, or reader improvement, and involves substantial data sets with established ground truth.

The provided document explicitly states: "No clinical studies were conducted." This further confirms that the type of performance evaluation (and associated data provenance, ground truth establishment, expert involvement, etc.) relevant to AI/ML devices was not part of this specific 510(k) submission.

Therefore, I cannot extract the information you requested from the provided text for the following reasons:

1. Device Type: This is a physical implant, not an AI/ML diagnostic or interpretative device.
2. Regulatory Pathway: The 510(k) for this device focuses on demonstrating substantial equivalence through engineering and biomechanical testing, not through AI model performance metrics.
3. Absence of Clinical Studies: The document explicitly states no clinical studies were performed, which is where performance data related to human-in-the-loop or standalone AI would typically come from.
4. No AI Mentioned: There is no mention of AI, machine learning, algorithms for interpretation, or any kind of software performance criteria beyond mechanical and material properties.

The "Performance Data" section in the document (Section VII) lists non-clinical studies such as:

• Design Validation (cadaver workshops, evaluation forms, rationales)
• Performance Testing (stereological evaluation, static and fatigue shear tests, tension tests, ROM evaluation, fatigue and deformation tests, liner stability tests, mechanical tests for screws)
• Pyrogenicity testing
• Biocompatibility assessment

These are typical tests for a physical orthopedic implant seeking 510(k) clearance, not for an AI/ML software as a medical device (SaMD).

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Medacta Shoulder System - Reverse

Reverse Shoulder Prosthesis

The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint, severe arthropathy failed joint replacement and a grossly rotator cuff deficient shoulder joint.

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.

The glenoid baseplate is intended for cementless application of screws for primary stability.

Short Humeral Diaphysis

The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.

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.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Medacta Shoulder System - Anatomic

Anatomic Shoulder Prosthesis

The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

Short Humeral Diaphysis

The Medacta Anatomic Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

The Medacta Shoulder Systems are modular systems intended to be used for shoulder arthroplasty (anatomical or reverse). System components were previously cleared by the FDA under K170910 (anatomic shoulder prosthesis) and K170452 (reverse shoulder prosthesis).

The Long Humeral Diaphysis implants, subject of this 510(k), are implantable devices used to replace the humeral side of the gleno-humeral joint. The product is intended to be used with the Medacta Shoulder System components as an alternative to the Standard Humeral Diaphysis components provided with those systems.

The Medacta Shoulder System Long Humeral Diaphysis couples with the Humeral Reverse Metaphysis (K170452) in the reverse configuration and the cemented and cementless Humeral Anatomic Metaphysis (K170910) in the anatomic configuration. The long humeral diaphysis, provided in 160 mm and 200 mm length options, may be used when additional distal stability in the humeral canal is needed.

The subject devices are manufactured from titanium alloy (Ti6A17Nb) and are provided sterile in 11 sizes per length option.

This device is a medical implant, not an AI/ML device, therefore, the requested information regarding acceptance criteria and study details related to AI/ML performance is not applicable. The provided text is an FDA 510(k) clearance letter and summary for a physical medical device: the Medacta Shoulder System. This document focuses on demonstrating substantial equivalence to a predicate device through material, design, and performance testing, which are different from the criteria typically found in AI/ML device evaluations.

However, I can provide a summary of the performance data that was provided in support of the substantial equivalence determination for this medical device, as described in the document.

Performance Data Provided:

The 510(k) summary lists the following performance data:

• Sterilization Validation: Per UNI EN ISO 11137-1:2015 and AAMI/ANSI/ISO 11137-2:2013. This ensures the device can be properly sterilized for safe use.
• Fatigue Testing: Per ASTM F1378-17. This evaluates the device's mechanical durability and its ability to withstand repeated stress over time, simulating conditions within the human body.
• Cadaver Studies: These studies typically assess surgical technique, implant fit, and preliminary biomechanical performance within an anatomical context.

Please note that none of the specific AI/ML related questions (sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) are relevant to the information presented in this 510(k) summary for the Medacta Shoulder System.

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The MyShoulder guides are intended to be used as guides specifically designed for the anatomy of a single patient. The humeral guide is used to define the level and orientation of the humeral head resection cut. The glenoidal guide is used to position and orient the K-wire that will subsequently guide the glenoidal reaming.

Both anatomical and reverse total joint configurations are acceptable.

Both humeral and glenoid guides are suitable for a delto-pectoral approach only.

MyShoulder Patient-Matched Guides are intended for use with Medacta Shoulder System and its cleared indications for use.

MyShoulder Patient-Matched Guides are intended for single use only.

The MyShoulder" Placement Guides are patient specific surgical instruments that allow for guided shoulder implants placement of both Medacta Shoulder Reverse System (K170452) and Medacta Anatomic Shoulder Prosthesis (K170910) and the additional products cleared under K181826 (Glenoid Polyaxial Non-locking screws), K180089 (Short Humeral Stem) and K171058 (Threaded Glenoid Baseplate).

The MyShoulder™ Placement guides uses the patient's CT Scan to perform a 3D planning of the glenohumeral joint replacement surgery. Then, following this planning the humeral and glenoidal guides are created. The MyShoulder™ Placement guides are anatomical guides for a single patient anatomy.

The MyShoulder™ Placement guides subject of this submission are comprised of the following products:

• 1. MyShoulder™ humeral guide: it will allow to perform an accurate humeral resection
• 2. MyShoulder™ glenoidal guide: it will provide a precise alignment reference that will guide the glenoidal reaming and final implant positioning.

The MyShoulder™ Placement guides are manufactured from medical grade nylon for sintering (Polyamide PA 12) which is identical to Medacta reference device MySpine Pedicle Screw Placement Guides (132788). The MyShoulder™ Placement guides are single use, external communicating devices with limited (

The provided text does not contain detailed acceptance criteria or the full study that explicitly demonstrates the device meets specific numerical acceptance criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone performance study with detailed acceptance criteria and results.

However, I can extract information related to the performance data provided to support substantial equivalence.

Here's a breakdown of the available information, addressing each point as much as possible:

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

The document does not explicitly state numerical acceptance criteria for various performance metrics, nor does it provide a table of reported device performance against such criteria. It mentions "testing was conducted according to written protocols with acceptance criteria," but these specific criteria and their corresponding results are not detailed in this summary.

The "Performance Data" section lists several non-clinical studies:

• Characterization Tests:
  • Cadaver Lab Test Report 1
  • Surgical Evaluation Test Report 2
  • MyShoulder accuracy and positioning variability cadaver test Test Report 4
  • MyShoulder accuracy test Test Report 5
• Performance Tests:
  • Effects of the Sterilization on the geometry of the MyShoulder Glenoidal Guide -Test Report 3
  • Wear Test, according to RPO-01.028.009

Without access to these specific test reports (numbers 1-5 and RPO-01.028.009), the detailed acceptance criteria and reported performance cannot be provided. The general statement is that "Risks were identified based on the proposed design and testing was conducted to mitigate those risks."

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

The document mentions "Cadaver Lab Test Report" and "MyShoulder accuracy and positioning variability cadaver test." This indicates the use of cadaveric samples for testing. The number of cadavers or individual samples used in these tests is not specified.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective in a clinical sense, as no clinical studies were performed. The "cadaver" tests would be considered prospective for the device evaluation.

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 provided in the document. The studies listed are non-clinical (cadaver and performance tests). While surgeons might have been involved in the "Surgical Evaluation Test Report" or "Cadaver Lab Test Report," their number and qualifications are not mentioned.

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

This information is not applicable/provided as the studies are non-clinical performance and characterization tests on cadavers and materials, not diagnostic interpretation or clinical outcome studies requiring adjudication.

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 MRMC study was done. The device is "MyShoulder™ Placement Guides," which are patient-specific surgical instruments for guiding shoulder implant placement. This is not an AI-based diagnostic tool for interpretation by human readers, so an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

The device itself is a physical surgical guide. The "planning" step involves using a patient's CT scan to perform a 3D planning of the joint replacement surgery, and then the guides are created based on this planning. This implies a human-in-the-loop process for surgical planning, followed by the physical device. The listed non-clinical studies evaluate the accuracy and performance of these physical guides. Therefore, a "standalone algorithm only" performance is not directly applicable to this type of device in the typical sense of AI algorithms. The accuracy tests (e.g., "MyShoulder accuracy test") would be evaluating the performance of the guide itself in achieving its intended surgical goal based on the planning.

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

For the "MyShoulder accuracy and positioning variability cadaver test" and "MyShoulder accuracy test," the ground truth would likely be established by precise measurements of the actual resection planes, K-wire positioning, or implant placement relative to the pre-operative 3D plan on the cadaveric specimens. This would typically involve physical measurements using highly accurate instruments, compared against the pre-operative 3D plan. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

The document states that the "MyShoulder™ Placement guides uses the patient's CT Scan to perform a 3D planning of the glenohumeral joint replacement surgery." This suggests that each guide is patient-specific and generated individually. There is no mention of a "training set" in the context of an algorithm learning from a large dataset. The customization is based on an individual patient's CT scan. If there are underlying algorithms or software used for the 3D planning itself, the training data for that specific software is not detailed in this submission.

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

As there is no "training set" described in the context of a machine learning algorithm for the device itself, this question is not applicable as presented. The process involves creating a custom guide for each patient based on their individual CT scan and a 3D planning process.

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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy failed joint replacement and a grossly rotator cuff deficient shoulder joint.

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.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The purpose of this submission is to gain clearance for the new Medacta Shoulder System: Threaded Glenoid Baseplate (also referred to as Threaded Glenoid Baseplate) which is part of the Medacta Shoulder System: Reverse; a modular system intended to be used for Reverse Shoulder Arthroplasties (RSA). The Medacta Shoulder System: Threaded Glenoid Baseplate is an alternative option to the pegged glenoid baseplate that is part of reference device Medacta Shoulder System (K170452). The Medacta Shoulder System: Threaded Glenoid Baseplate is made of titanium alloy.

The Threaded Glenoid Baseplate is intended to replace only the glenoid side of the glenohumeral joint. The Threaded Glenoid Baseplate is intended to be used in the reverse configuration only. The Threaded Glenoid Baseplate is designed to be fixed on the glenoid bone by means of a central threaded post and the help of Glenoid Polyaxial Locking Screws. The Glenoidsphere is intended to be assembled with a Glenoid Baseplate by means of a taper Morse connection and secured by a central securing screw. The Threaded Glenoid Baseplate directly couples with the Glenoid Polyaxial Locking Screws and Glenoidsphere as part of the Medacta Shoulder System (K170452).

The provided text describes a 510(k) premarket notification for a medical device (Medacta Shoulder System: Threaded Glenoid Baseplate), not an AI/ML powered device. Therefore, the information requested in the prompt, such as acceptance criteria for AI performance metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical performance testing for a physical implant. The relevant "acceptance criteria" in this context refer to the successful completion and passing of these mechanical and material tests based on established standards.

Here's the information that can be extracted or inferred from the provided text, framed within the spirit of the request as much as possible for a non-AI device:

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

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: Not specified as individual units. For mechanical testing, samples are typically tested until the standard's criteria are met or failure modes are understood. The text states "testing was conducted."
• Data provenance: The tests were non-clinical (laboratory/mechanical testing). The device manufacturer is Medacta International SA, located in Switzerland. The testing was conducted in support of an FDA 510(k) submission in the USA.

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. This device is a physical implant, not an AI model that requires expert-established ground truth from medical images or data. The "ground truth" here is the physical and mechanical performance of the device against engineering standards.

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

• Not applicable. This is not an AI/ML clinical study. Adjudication methods are relevant for resolving discrepancies in human expert evaluations, which is not pertinent to mechanical 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

• No. The document explicitly states: "No clinical studies were conducted." This relates to a physical implant, not an AI device, so MRMC studies examining reader performance with or without AI assistance are not relevant.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

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

• The "ground truth" for this device's performance is defined by established engineering and material science standards (e.g., ASTM F1378-12, ASTM F2028-14, European Pharmacopoeia, USP chapters). Compliance with these standards demonstrates the physical and mechanical integrity and biocompatibility of the implant.

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. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

The Medacta Anatomic Shoulder Prosthesis is a modular system intended to be used for anatomical shoulder arthroplasty.

The Medacta Anatomic Shoulder Prosthesis is composed of the following components:

• Standard Humeral Diaphysis - Cementless (sizes 6 to 16)
• Standard Humeral Diaphysis Cemented (sizes 6 to 16)
• Humeral Anatomical Metaphysis Cementless (128°, 135° and 142° inclinations, sizes 6 to 16)
• Humeral Anatomical Metaphysis Cemented (128°, 135° and 142° inclinations, sizes 6 to 16)
• Double Eccenter
• Cobalt-Chromium Humeral Head (10 sizes, Ø 40 mm to Ø 58 mm)
• Highcross PE Pegged Glenoid (10 sizes, Ø 40 mm to Ø 58 mm)
• Humeral Stem Screw

The Standard Humeral Diaphysis and the Humeral Anatomical Metaphysis are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Humeral Stem Screw. The Double Eccenter is also connected to the Humeral Anatomical Metaphysis by means of a press-fit cylinder and a securing screw. The Cobalt-Chromium Humeral Head is coupled to a Double Eccenter by means of a taper Morse connection.

The Glenoid Anatomical Implant is composed of the Highcross PE Pegged Glenoid only, which is cemented into the glenoid bone.

The Medacta Anatomic Shoulder Prosthesis components are single-use only, are provided sterile via gamma irradiation or ethylene oxide, and are packaged individually.

The standard humeral diaphysis, humeral anatomical metaphysis, double eccenter, and humeral stem screw are manufactured from titanium alloy. The humeral head is manufactured from CoCr, and the highcross glenoid is manufactured from polyethylene.

The provided text describes the "Medacta Anatomic Shoulder Prosthesis" and its regulatory clearance. However, it does not contain information about acceptance criteria for device performance related to a diagnostic or AI-driven system, nor does it detail a study proving such criteria are met.

This document is a 510(k) summary for a medical device (a shoulder prosthesis), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. The performance data presented focuses on the mechanical, material, and sterilization aspects of the physical implant, NOT on the performance of an AI or diagnostic system.

Therefore, I cannot provide the requested information in the format specified because the input document does not contain the relevant data for an AI/diagnostic device.

To answer your request, the input document would need to describe a study evaluating the performance of an AI or diagnostic device, including its acceptance criteria and the results of that evaluation.

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