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FairFix Adjustable Buttons are intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized.

FarFix Extenders are intended to be used in association with any FairFix Adjustable Button configuration during a knee ligament (i.e. anterior cruciate ligament) reconstruction surgery with a Ø 6 - 11 mm tunnel.

The FairFix Adjustable Button Extender Round implants are a Medacta SportsMed devices line extension providing alternative implantable fixation devices to be used during knee ligament reconstruction surgery for the fixation of the graft in association with the FairFix Adjustable Buttons (cleared within K203259 and K221389) in case of large tunnel conditions (e.g. cortical blowout, revision cases, full tunnel).

The subject FairFix Adjustable Button System implants are available in three different sizes and they consist of a circular metal plate provided with a recess specifically designed to house the FairFix Adjustable Button.

The provided document is a 510(k) summary for a medical device (FairFix Adjustable Button System) and does not describe a study involving an AI/Machine Learning device or a diagnostic accuracy study. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study design, expert involvement, ground truth establishment, or sample sizes related to AI device performance.

The document states:

• "No clinical studies were conducted."
• The performance data provided is based on non-clinical studies (mechanical testing, pyrogenicity, biocompatibility, shelf-life evaluation).
• The substantial equivalence claim is based on technological characteristics and performance data, not on human reader performance or AI system accuracy.

Without information about an AI/ML device or a study involving human readers and AI assistance, it is impossible to fulfill your request for details on:

1. Acceptance criteria and device performance table.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study and effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth (expert consensus, pathology, outcomes data).
8. Training set sample size.
9. How ground truth for the training set was established.

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Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of auto- and allografts.

The MectaScrew Extension includes implantable devices used for the tibial and the femoral fixation of the graft in reconstructive treatment of knee ligament ruptures. They have been developed to provide interference between a ligament graft and a bone tunnel in the ligament reconstruction surgery.

The MectaScrew Extension implants includes MectaScrew C, a composite interference screw made of RESOMER® Composite LR 706S B-TCP, a mixture of 70 % RESOMER® LR 706 S and 30 % B-TCP.

MectaScrew C is available in 19 different configurations ranging from 6 to 12 mm in diameter and 15 to 35 mm in length.

The provided text is a 510(k) summary for a medical device called "MectaScrew Extension." This document outlines the device's characteristics, its intended use, and its comparison to predicate devices to establish substantial equivalence.

Crucially, the document states: "No clinical studies were conducted." This means there is no study evaluating the device's performance against pre-defined acceptance criteria with human subjects or actual clinical outcomes in the format you've requested.

Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance (as no clinical performance criteria or results are given).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications used to establish ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or its effect size.
• Standalone performance.
• Type of ground truth used (as no clinical ground truth was established from a study).
• Sample size for the training set (no AI/ML component described).
• How ground truth for the training set was established (no AI/ML component described).

The document focuses on non-clinical studies (design validation, performance testing like torque resistance and pull-out strength, MR safety, pyrogenicity, and biocompatibility) to demonstrate substantial equivalence to predicate devices. These non-clinical tests would have their own internal acceptance criteria, but these are not for the "device performance" in the clinical sense you are asking for.

In summary, based on the provided text, the MectaScrew Extension did not undergo a clinical study to prove its performance against acceptance criteria in human use. Its clearance was based on demonstrating substantial equivalence through non-clinical data and comparison to existing legally marketed devices.

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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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The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. It is indical for any medical condition in which the use of stereotaxtic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as:

• · Pedicle Screw Placement (Thoracic and Lumbosacral spine)
• Iliosacral Screw Placement
  The NextAR Spine platform is intended to be used in combination with NextAR™M Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning software is used preoperatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

The NextARTM Spine Platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:

• Navigation software which displays information to the surgeon; ●
• Augmented Reality glasses; ●
• Optical tracking system; ●
• PC based hardware platform; ●
• Fiducial Block: ●
• Adaptor for sensor:
• Spine attachment instruments ●
• Reusable surgical instruments for spine surgery procedures. ●
  The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block, and a group of pins and drills are provided sterile.
  The NextAR™ Spine Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time on a screen monitor.
  The NextAR Spine system is a surgical navigation platform which uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D-CArm scan in order to register the spine to navigation elements.
  The registration can be performed with one of the following approaches:
• Direct 3D: based on the use of an intra-operative 3D-CArm scan ●
• . 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D-CArm scan
  The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating numerical acceptance criteria for clinical performance. However, based on the performance data section, the device's accuracy was a key performance metric evaluated. The acceptance criteria for accuracy are not explicitly stated in numerical terms in this document, but the study described aimed to confirm its performance comparable to the predicate.

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

The document mentions a "Cadaver study" as part of the performance testing.

• Sample Size: The exact number of cadavers used is not specified in the provided text.
• Data Provenance: The study was a "Cadaver study," indicating it was conducted on human cadavers. This is a form of retrospective data in terms of patient-specific outcomes, as the cadavers represent once-living individuals, but the experimental setup is controlled like a prospective study. The country of origin is not specified.

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

The document does not provide details on the number of experts or their specific qualifications (e.g., radiologists with X years of experience) used to establish ground truth within the cadaver study. It states the system is intended to aid surgical placement, implying the ground truth would typically be related to the accuracy of instrument placement or trajectory relative to anatomical landmarks, ideally verified by expert assessment or post-procedure imaging analysis.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1) for the test set (cadaver study).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size regarding human readers improving with AI vs. without AI assistance. The device is a navigation platform for surgeons, implying human-in-the-loop assistance, but a formal MRMC study as typically performed for diagnostic AI is not described.

6. Standalone (Algorithm Only) Performance:

The document does not explicitly describe a standalone (algorithm only without human-in-the-loop performance) study. The device is designed as a "surgical navigation platform" to "aid the surgeon" and display information "in real-time on a screen monitor," indicating an inherent human-in-the-loop design.

7. Type of Ground Truth Used:

For the "Accuracy test" and "Cadaver study" related to placement, the ground truth would likely involve:

• Precise measurements of instrument tip position or trajectory relative to anatomical landmarks.
• Verification using high-resolution imaging (e.g., CT scan) of the cadaver after "screw placement" to assess deviation from planned trajectories or ideal anatomical placement.
  The document does not explicitly state the method for establishing ground truth, but for a navigation system, it would generally be based on anatomic truth verified by imaging or detailed measurements.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. As a substantial equivalence determination, the focus is on performance testing and comparison to predicates, not on the details of algorithmic training. The "Dedicated algorithm" is mentioned as a technological characteristic, implying machine learning components, but its training details are not disclosed here.

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

Since there is no information on a training set, the document does not provide details on how its ground truth was established.

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The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.

Total Hip Arthroplasty with the Mpres stem is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia.
· Avascular necrosis of the femoral head.

• · Acute traumatic fracture of the femoral head.
• Failure of previous hip surgery:
  o Conservative hip surgery,
  o Internal fixation,
  o Arthrodesis,
  o Hip resurfacing replacement.

Partial hip arthroplasty with the Mpres stem is indicated in the following cases:

• · Acute traumatic fracture of the femoral head.
• · Avascular necrosis of the femoral head.
  · Primary pathology involving the femoral head but with a non-deformed acetabulum.

The Mpres Neck Preserving Stem is a cementless short femoral stem intended to be used in total or partial hip arthroplasty for primary or revision surgery with minimally invasive hip replacement techniques. The Mpres Neck Preserving Stem is made of titanium alloy (Ti6Al7Nb) according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite in compliance with ASTM F1185. It is available in 12 sizes (sizes 3-14) for each neck variation configuration: a standard 130° CCD angle or an high offset 123° CCD angle.

This document is a 510(k) Premarket Notification from the FDA regarding the "Mpres Neck Preserving Stem" hip prosthesis. This type of document is generally about establishing substantial equivalence to an existing predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel AI diagnostic would.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or reader improvement with AI assistance, does not directly apply to this document's content.

The document focuses on demonstrating that the Mpres Neck Preserving Stem is substantially equivalent to legally marketed predicate devices based on technological characteristics and non-clinical performance data. It explicitly states that "No clinical studies were conducted."

However, I can extract information related to the performance data and the types of studies that were conducted to support the substantial equivalence claim.

Here's an adaptation of the requested information based on the provided text, highlighting what is available and what is not:

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

Since this is a substantial equivalence submission for a mechanical implant, performance is demonstrated through biomechanical testing and material characterization against established standards, rather than clinical performance metrics typically associated with diagnostic devices. The acceptance criteria are implicit in meeting the requirements of the cited ISO/ASTM 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 explicitly stated in terms of specific numbers of devices tested for each non-clinical study. The reports cited (e.g., "Endolab Test Report," "CeramTec AG Test Reports," "Accentus Test Report") would contain this detail, but it's not present in this summary. For "cadaveric evaluation," the number of cadavers is not given.
• Data Provenance: The testing appears to have been conducted by various external and internal labs (e.g., EndoLab, CeramTec AG, Accentus). The company, Medacta International SA, is based in Switzerland, and Medacta USA is in Tennessee, USA. The standards cited are international (ISO, ASTM, EN) and US (USP, European Pharmacopoeia). This indicates a varied provenance tied to international standards for medical device testing.
• Retrospective or Prospective: These non-clinical performance tests are "prospective" in the sense that they are specifically performed for the purpose of this submission and validate the current design. They are not observational studies on existing 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 concept does not apply to this type of device submission. There is no "ground truth" established by experts in the context of diagnosing or interpreting images, as this is a hip implant, not an AI diagnostic device. The "ground truth" for these tests is the adherence to established engineering and material science standards.

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

This concept does not apply. Adjudication methods are relevant for clinical studies or studies involving expert interpretation, which were not performed 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is designed for AI diagnostic aids, not for a hip implant. The document explicitly states: "No clinical studies were conducted."

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

This concept does not apply. A hip implant is a physical device, not an algorithm.

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

The "ground truth" here is the performance against established engineering and material science standards (e.g., ISO, ASTM, EN, USP). For example, a fatigue test must demonstrate that the device can withstand a certain number of cycles at a specific load without failure, as defined by the standard.

8. The sample size for the training set

This concept does not apply. There is no "training set" as this is not an AI/ML device.

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

This concept does not apply.

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The PAO cortical screws are intended to refixate the acetabular fragment to the ilium, after Periacetabular osteotomy.

The PAO cortical screws are implantable devices for acetabular refixation after a Periacetabular osteotomy. They are provided sterile and single-packaged, for single use only. The PAO cortical screws are designed in two different sizes (Ø3.5mm and Ø4.5mm), both available in different working lengths (from 20mm to 140mm and from 50mm to 140mm respectively) to be suitable to treat all the desired population. The PAO Cortical Screws are made of Stainless Steel AISI 316 LVM according to ISO 5832-1.

This document pertains to the Medacta International SA PAO Cortical Screw, a medical device intended for refixating the acetabular fragment to the ilium after a Periacetabular osteotomy. As such, the information provided does not describe an AI/ML powered device, but rather a physical implantable device. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical medical device (cortical screw) and not an AI/ML powered device, the "acceptance criteria" and "device performance" are related to mechanical and material properties, not diagnostic or predictive performance metrics. The document references performance testing according to ASTM standards.

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

• Sample Size for Test Set: Not explicitly stated in the document. The performance tests (e.g., ASTM F543-17) would have involved a certain number of screws, but the specific quantity is not reported.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no patient data involved in these non-clinical studies.

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

• Not applicable as this is a physical device and not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for mechanical properties is established by the specifications of the ASTM standard.

4. Adjudication Method for the Test Set:

• Not applicable for a physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is not an AI/ML system being compared to human readers.

6. Standalone Performance Study (Algorithm only without Human-in-the-Loop):

• Not applicable. This is a physical medical device.

7. Type of Ground Truth Used:

• For the non-clinical performance and material tests, the "ground truth" is defined by the specifications and methodologies outlined in the referenced international standards (e.g., ASTM F543-17, ISO 5832-1, European Pharmacopoeia §2.6.14, USP chapter , USP chapter ).

8. Sample Size for the Training Set:

• Not applicable. There is no AI/ML algorithm involved, therefore no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. There is no AI/ML algorithm involved, therefore no "training set" or corresponding ground truth establishment.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's substantial equivalence to predicate devices and its safety and effectiveness are supported by non-clinical studies focused on its mechanical performance and material properties. These studies include:

• Design Validation: A specific design validation for the PAO Cortical Screws was conducted.
• Performance Testing: This involved static tests on the PAO Cortical Screws according to ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws. The evaluation specifically included torsional properties, driving torque, axial pull-out strength, and self-tapping performance.
• Pyrogenicity Testing: Bacterial endotoxin tests were conducted according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter ), and pyrogen tests were performed according to USP chapter .

The document also states that the material used (Stainless Steel AISI 316 LVM according to ISO 5832-1) is shared with reference devices, addressing potential new safety and effectiveness questions related to material differences.

No clinical studies were conducted as part of this submission for substantial equivalence. The conclusion is that "the PAO cortical screws implants are substantially equivalent to the predicate devices" based on the provided non-clinical data, comparison of technological characteristics, and risk analysis.

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The MySpine WebPlanner is a surgical pre-operative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of the spinal fixation devices. The MyBalance, a module of the MySpine WebPlanner, allows to perform generic as well as specific measurements of patient's sagittal alignment and to plan spinal surgical procedures ( osteotomies or Lordosis/ Kyphosis correction in spinal fusion surgeries). To properly use the MySpine WebPlanner, and the MyBalance module, clinical judgment and experience are required.

The subject device MySpine WebPlanner & MyBalance is an interactive web application using the patient's radiological images and the related bone segmentations to allow the end-users performing a pre-operative surgical planning. The data and the information displayed in the web interface named WebPlanner are computed and loaded by an internal software named MyPlanner. The MyBalance is an optional module of the MyPlanner, thus available on the WebPlanner interface, and it allows the surgeon to verify the actual patient sagittal alignment and to simulate a sagittal correction in order to determine balance condition after the planned correction. The image format supported is DICOM. The end-user with its credentials can access the MySpine WebPlanner at https://myspine.medacta.com/.

The provided text does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.

The document is a 510(k) summary, which is a regulatory submission to the FDA. It declares the device to be "substantially equivalent" to predicate devices and describes the general purpose and interaction of the system. While it mentions "software verification" and "software validation, including accuracy and repeatability test for MyBalance measurements" as non-clinical studies, it does not provide the specific metrics or results of these tests. It explicitly states: "No clinical studies were conducted."

Therefore, I cannot provide the requested information. The text does not elaborate on:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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: Explicitly stated "No clinical studies were conducted," so an MRMC study was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: While "accuracy and repeatability test for MyBalance measurements" are mentioned, the specific results or methodology (standalone vs. human-in-the-loop) are not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document focuses on the regulatory aspects of substantial equivalence rather than detailed performance study results.

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The Evolis/GMK knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases:

• · Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis or polyarthritis.
• Avascular necrosis of femoral condyle.
• · Post traumatic loss of joint configuration.
• · Primary implantation failure.

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate.

In case a semi-constrained liner is used, an extension stem must be implanted both on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted.

GMK Sphere/Spherika can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, this knee replacement system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis, rheumatoid arthritis.

• · Collagen disorders, and/or avascular necrosis of the femoral condyle.
• · Moderate valgus, varus, or flexion deformities.

The purpose of this submission is to notify the FDA of the GMK SPHERE range Extension, that includes GMK Spherika Femurs and GMK Fixed Tibial Trays Plus.

Subject devices are sterile implantable devices designed for tricompartment of the natural knee joint.

The subject devices are marketed as individually packaged femoral and tibial components, designed for cemented use in total knee arthroplasty procedures.

GMK Spherika femoral component is an implantable device intended to be used in case of total knee arthroplasty to replace the femoral articular surfaces of the knee joint. GMK Spherika femoral component can be used in Kinematic Alignment surgical technique. The Kinematic Alignment surgical technique was already cleared in K173890.

GMK Tibial Trays Plus are a range extension of the GMK Tibial trays already cleared, in details they are fixed intermediate sizes of the tibia trays.

The subject devices are a line extension to Medacta previously cleared implants: GMK Sphere (K121416), GMK Sphere Extension (K140826), GMK Knee Prosthesis- GMK Sphere Tibial Insert Flex (K162035), GMK Sphere - Kinematic Alignment ( K173890), GMK Sphere CR Tibial Inserts (K181635), GMK Sphere E-Cross (K202022), GMK Total Knee System-TiNbN Coating (K202684), Medacta International SA, GMK Total Knee System (K090988), GMK Line Extension (K120790), GMK Narrow K122232, MK Extension (K142069) and

The subject devices are manufactured with the same materials of the previous cleared femurs and tibial trays.

The submission includes the following implants:

• . GMK Spherika Femoral Component Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4)
• . GMK Spherika Femoral Component Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated
• . GMK Spherika Femoral Component Anatomical, Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4)
• GMK Spherika Femoral Component Anatomical, Left and Right, Sizes from 1 to 7 and . from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated
• Tibial tray fixed cemented, Left and Right, Sizes from 1+ to 5+ plus 4 intermediate sizes ● made in Co-Cr-Mo (ISO 5832-4)
• Tibial tray fixed cemented, Left and Right, Sizes from 1+ to 5+ plus 4 intermediate sizes made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated

The subject devices, both Femoral Components and Tibial Trays, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Allov.

In regards to the Femurs and Tibial Trays TiNbN Coating, they are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Niobium Nitride (TiNbN) coating.

Like the predicate tibial trays devices, the tibial trays plus subject of this submission have a Fixed Tibial Tray Plug that is manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) per ISO 5834-2: 2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms.

The subject device also includes the utilization of the GMK Sphere E-cross tibial insert FLEX, already cleared (K202022) in case of retention of an efficient posterior cruciate ligament in the Kinematic Alignment configuration.

The Kinematic Alignment surgical technique was already cleared in K173890.

In this case there are no new implants or instruments, GMK Sphere E-cross tibial insert FLEX, already cleared (K202022).

The provided text describes mechanical performance tests for knee implants, not a study evaluating an AI/ML powered device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth, or human-in-the-loop performance for an AI/ML device.

The document is a 510(k) summary for a submission by Medacta International SA for a knee prosthesis, the "GMK-SPHERE Spherika Femurs and Tibial Trays plus". It focuses on demonstrating substantial equivalence to already cleared predicate devices through design comparisons and non-clinical mechanical testing, which is typical for traditional (non-AI/ML) medical devices.

No information about an AI/ML device, its acceptance criteria, or a study proving those criteria are met is present in this regulatory document.

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The Shoulder NextAR™ RSA Platform supports the surgeon during glenoid implantation in reverse shoulder replacement procedures providing information on bone preparation, instrument guidance, and implant positioning. The Shoulder NextAR™ RSA Platform works in conjunction with NextAR™ stereotaxic instruments and general surgical instruments to implant the Medacta Shoulder System Reverse Shoulder Arthroplasty). As an optional display, the smart glasses can be used auxiliary to the Shoulder NextAR™ Platform to view the same 2D stereotaxic information as presented by the Shoulder NextARTM Platform.

The Shoulder NextAR™ stereotaxic instruments are to support the surgeon during specific orthopedic surgical steps by providing information on bone preparation, instrument guidance, and implant positioning. Once registered, the NextAR™ stereotaxic instruments provide reference to a patient's rigid anatomical structures on the surface of the glenoid that are identified relative to preoperative C.T. based planning.

The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

The Shoulder NextAR™ RSA Platform is a CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid and includes the following components:

• PC based hardware platform; (K193559 and K202152)
• optical tracking system; (K193559 and K202152)
• Augmented Reality glasses; (K193559 and K202152)
• Platform (K193559 and K202152)
• navigation software which displays information to the surgeon in real-time;
• Reusable surgical instruments to perform the surgical steps of a shoulder reverse arthroplasty ● on the glenoid.

The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the markers. Tracking sensors attached to the scapula and surgical instruments enable the surgeon to view the position and orientation of scapula and instrumentation relative to preoperative data in real-time while performing the surgical procedure. The tracking sensors are provided sterile.

Shoulder NextAR™ RSA Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time on a screen monitor.

The NextAR™ RSA system is intended to assist the surgeon in executing a preoperative surgical planning. The navigation platform tracks the surgical instruments in real-time and displays intraoperative and planned surgical parameters on a screen, thus allowing the surgeon to match the intraoperative parameters with the planned ones.

Specifically, the navigation system utilizes established technologies of navigation and via an active infrared camera rigidly coupled with the scapula and an active infrared tracker that can be rigidly coupled to the surgical instruments. The registration of the patient's scapula on the preoperative scapula model is performed through the use of dedicated surgical instruments (pointers) and a dedicated registration algorithm.

The provided text describes the 510(k) summary for the Medacta International SA NextAR™ RSA Platform, a CT-based computer-assisted surgical navigation platform for reverse shoulder arthroplasty. The performance data section is brief, stating that testing was conducted according to written protocols with acceptance criteria based on standards, and mentions a "cadaver study" and an "in vitro study." However, it does not provide specific details about the acceptance criteria themselves, the reported device performance against those criteria, the sample sizes, expert qualifications, ground truth methods, or any MRMC study results. The text indicates that some studies were accepted from previous submissions of related devices (NextAR™ TKA Platform K193559 and K202152), but these are general safety and performance tests (biocompatibility, sterilization, shelf-life, electrical safety, EMC, mechanical/optical properties) and not performance data explicitly proving the navigation system's accuracy or effectiveness in its specific use case for shoulder arthroplasty.

Therefore, based solely on the provided text, I cannot populate most of the requested information regarding the acceptance criteria and the study that proves the device meets them. The document states that the studies were performed "in support of a substantial equivalence determination," but it does not present the detailed results of these specific performance studies.

Here's a breakdown of what can be inferred or what is explicitly missing:

Acceptance Criteria and Device Performance (As much as can be extracted from the provided text)

The document broadly states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." However, it does not present a table of specific acceptance criteria or the reported device performance against them.

Study Details:

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

   • Not provided in the document. The document mentions "acceptance criteria that were based on standards" but does not list them or the performance results.

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

   • The document mentions a "cadaver study" and an "in vitro study."
   • Sample Size: Not specified for either study.
   • Data Provenance: Not specified (e.g., country of origin). Both appear to be prospective experimental studies (cadaveric and in vitro).

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

   • Not specified. The document does not describe how ground truth was established for the cadaver or in vitro studies, nor does it mention experts for this purpose.

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

   • Not specified.

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 specified. The document does not mention an MRMC study or any assessment of human reader improvement with AI assistance. The device is a surgical navigation platform, not an AI diagnostic tool that assists human readers.

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

   • The document mentions "performance testing to evaluate mechanical and optical properties" and "software validation," which would likely involve standalone performance evaluations of system components and the algorithm. However, specific details of these tests as they relate to clinical accuracy or a defined "standalone" performance metric for the navigation itself are not elaborated. The cadaver and in vitro studies would assess the system's performance, but how "standalone" vs. "human-in-the-loop" was defined and measured is not clear.

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

   • Not specified. For a navigation system, ground truth would typically refer to highly accurate measurements of actual bone or instrument positions relative to an established plan. The method (e.g., CMM measurements, highly accurate image registration) is not detailed.

8. The sample size for the training set:

   • Not applicable/Not specified. The document describes a navigation system based on "established technologies of navigation" and "dedicated registration algorithm," rather than a machine learning model that requires a "training set" in the conventional sense for AI. If elements of the "software validation" involved training machine learning components, this is not disclosed.

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

   • Not applicable/Not specified, for the same reasons as #8.

Summary of Missing Information:

The provided 510(k) summary is very high-level regarding the specific performance studies. It confirms that a cadaver study and an in vitro study were performed to support substantial equivalence, but it omits the critical details of these studies, such as:

• Specific quantitative acceptance criteria.
• The numerical results obtained from the device (e.g., accuracy, precision values).
• The number of samples (cadavers, in vitro setups).
• The methodologies for establishing ground truth.
• Any details about expert involvement or adjudication.

This type of detailed information is typically found in the full testing reports or sections within the 510(k) submission that are not publicly available in this summary format.

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The Mpact 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, post-traumatic 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 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 Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multi-hole acetabular cup in hip replacement surgeries.

The Augments 3D Metal are indicated in cases of:

• Congenital dysplasia.
• · Acetabular fractures.

· Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures.

The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole 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, post-traumatic 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 arthroplastv, or total hip replacement where sufficient bone stock is present.

The MPACT Extension implants subject of this submission are twelve (12) sizes of Cancellous Bone Screws.

The subject devices are sterile implantable devices intended to be used during Total Hip Arthroplasty.

Analogously to the predicate Cancellous Bone Screws flat head (K103721 and K132879), the subject Cancellous Bone Screws, are made of titanium alloy (Ti6-A14-V) according to ISO 5832-3:2016 Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4vanadium allov. As the predicate devices, they have been designed with a thread diameter of 6.5 mm to provide fixation of implants to the cancellous bone. They can be coupled with implants that have dedicated fixation holes with a spherical seat shape of Ø8mm.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called "MPACT Extension," which consists of Cancellous Bone Screws for total hip arthroplasty.

Based on the provided text, a conventional "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD) study (as implied by the detailed breakdown requested in the prompt) were not performed. The document describes the acceptance criteria and study for a physical implantable medical device, specifically cancellous bone screws, not a software or AI product.

Therefore, many of the requested points, such as AI-specific acceptance criteria, multi-reader multi-case studies, ground truth establishment for training sets, etc., are not applicable to this document.

However, I can extract the relevant information provided for the device described:

1. A table of acceptance criteria and the reported device performance (for the hardware device):

The document does not explicitly present a table of numerical "acceptance criteria" for the performance of the cancellous bone screws in the way one might for a software or AI algorithm (e.g., target accuracy, sensitivity). Instead, acceptance is based on demonstrating substantial equivalence to predicate devices through various tests and material properties. The performance is assessed through meeting standards and showing compatibility.

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

• Sample Size for Test Set: Not specified in the document in terms of traditional "test sets" for a software algorithm. The "test set" for this physical device would refer to the number of screws tested during design validation, biocompatibility, and sterility testing. This number is not provided.
• Data Provenance: Not applicable in the context of a software data set (e.g., country of origin, retrospective/prospective). The document describes non-clinical studies performed on the device itself.

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

• Not applicable. This pertains to a physical medical device, not a software/AI product requiring expert ground truth for image interpretation or similar. The "ground truth" for this device would be its physical and chemical properties and mechanical performance as evaluated through standard laboratory testing.

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

• Not applicable. This is a method for reconciling differences in expert annotations for AI/software ground truth.

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. The device is a physical implant, not an AI or diagnostic software tool.
• Effect size: Not applicable.

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

• Not applicable. This refers to AI algorithm performance.

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

• For this physical device, the "ground truth" is established through objective laboratory testing against recognized standards (e.g., ISO for materials, biocompatibility tests, pyrogenicity tests). It's about demonstrating the device's physical properties and safety characteristics meet established benchmarks, rather than interpretation of data by experts.

8. The sample size for the training set:

• Not applicable. This refers to an AI training set.

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

• Not applicable. This refers to an AI training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The acceptance of the MPACT Extension device (Cancellous Bone Screws) is based on demonstrating its substantial equivalence to established predicate devices (Medacta International SA, MPACT, K103721 and MPACT Extension, K132879). This substantial equivalence is supported by a series of non-clinical studies:

• Design Validation: Specific rationales were provided for the design validation of the Ø6.5 Cancellous Bone Screw and its compatibility with acetabular shells. This ensures the device's design is adequate for its intended use.
• Biocompatibility Evaluation: Performed according to ISO 10993, demonstrating the device is suitable for implantation without adverse biological reactions.
• Shelf-Life Testing: Conducted according to ISO 11607-1 and ISO 11607-2, ensuring the device maintains its properties and sterility over its intended shelf life.
• Pyrogenicity Testing: Bacterial Endotoxin Test (LAL test) per European Pharmacopoeia §2.6.14 (equivalent to USP chapter ) and Pyrogen test per USP chapter were performed to ensure the device is not pyrogenic.

No clinical studies were conducted for this 510(k) submission, as stated under "Clinical Studies" in Section VII. The substantial equivalence was determined based on the comparison of intended use, design, technological characteristics, and the non-clinical design validations.

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