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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 M.U.S.T. Pedicle screws system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) and non-pedicle fixation, or anterolateral fixation (78-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The M.U.S.T. Midline Cortical (MC) Screw System is intended to be used as part of the M.U.S.T. Pedicle Screw system (K12115, K132878, K141988, K153664, K162061, K171170, K171758, K193365) for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. pedicle screw system includes cannulated or non-cannulated poly-axial pedicle screws (K121115, K132878, K153664), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K121115, K171758), straight and pre-bent rods (K12115, K141988, K162061), lateral connectors (K162061) and cross connectors (K132878, K193365). The M.U.S.T. pedicle screw system also includes the enhanced screws and rods designed for percutaneous surgery (K141988).

The M.U.S.T. Midline Cortical (MC) Screw System introduce new polyaxial screws and reduction screws (solid and cannulated), developed with a focus on Midline Cortical Trajectory approach. The devices subject of this submission are:

• M.U.S.T. MC polyaxial screws Solid
• M.U.S.T. MC polyaxial screws Cannulated
• M.U.S.T. MC polyaxial reduction screws Solid
• M.U.S.T. MC polyaxial reduction screws Cannulated

Intended purpose and the performance specification of the devices are equivalent to the ones of the current US cleared portfolio: polyaxial screws are already used in the MUST implant construct.

The M.U.S.T. Midline Cortical (MC) Screws and the Inlay are manufactured from Ti-6Al-4V ELI (ISO 5832-3 Implants for surgery -Metallic materials - Part 3: Wrought titanium 6-vanadium alloy + ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); the Tulip and the Setscrew are made of Co-Cr-Mo alloy according to ISO 5832-12:2019, Implants for Surgery - Metallic materials -Part 3: Wrought cobalt-chromium-molybdenum alloy, the same material of the previous cleared M.U.S.T. Pedicle Screw (K153664, K121115, K171170).

Here's an analysis of the provided text regarding the acceptance criteria and study for the M.U.S.T. Midline Cortical (MC) Screw System:

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

The provided document does not explicitly state specific quantitative acceptance criteria for many of its tests. Instead, it describes various tests performed and implies that the results of these tests met the necessary standards for substantial equivalence. For instance, mechanical evaluations were conducted "according to ASTM F1717-18" without specifying the pass/fail thresholds. The "geometrical analysis" was performed "to ensure that the implant has sufficient fixation" and "in comparison to approved and marketed implants," implying an acceptance of similarity or non-inferiority.

To create a table, I will infer the performance reported based on the conclusion of substantial equivalence.

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:
  • Wetlab (Surgical Technique): The "cadaver labs were performed by 3 experienced surgeons." This refers to the number of users of the devices, not a number of distinct device units or anatomical samples tested. The number of cadavers used is not specified.
  • Geometrical Analysis: Not specified, but it would involve measurements of the (new) M.U.S.T. MC implants and approved/marketed implants.
  • Mechanical Performance Testing (ASTM F1717): Not specified. ASTM F1717 standards generally define specific sample sizes (e.g., minimum of 5 samples per test condition for static tests, 3-6 for dynamic fatigue). The document states "Worst Case definition... for mechanical testing," implying specific samples were chosen.
  • Pyrogenicity Assessment: Not specified, but would align with standard biological testing protocols.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not explicitly stated. These were non-clinical studies conducted for regulatory submission. Given the manufacturer is Medacta International SA (Switzerland) and its US counterpart Medacta USA, the testing could have been conducted in any accredited lab globally. They are prospective tests conducted on the device components and system.

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):

• Number of Experts: 3 experienced surgeons were used for the wetlab (surgical technique validation).
• Qualifications of Experts: They are described as "experienced surgeons." No further detailed qualifications (e.g., years of experience, specific sub-specialty) are provided in this document.

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

The document mentions "3 experienced surgeons" performed the wetlab. However, it does not describe an adjudication method for their observations or findings. It simply states the lab was performed "according to MUST MC surgical technique," implying their use was for validation of the technique and device performance, not necessarily for a consensus-driven "ground truth" establishment in the typical sense of diagnostic accuracy.

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

• No, an MRMC comparative effectiveness study was NOT done.
• This device is a medical implant (spinal screw system), not an AI/software device that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this submission.

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

• No, a standalone (algorithm only) performance study was NOT done.
• As explained above, this is a physical medical implant, not a software algorithm.

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

For the non-clinical studies:

• Wetlab: "Performance by 3 experienced surgeons according to MUST MC surgical technique" implies the ground truth for surgical technique validation was established through expert application/observation and adherence to predefined protocols.
• Geometrical Analysis: Ground truth was the geometric properties of approved and marketed implants used for comparison, and engineering specifications.
• Mechanical Testing (ASTM F1717): Ground truth was defined by the requirements and methodologies of the ASTM F1717-18 standard and comparisons to the mechanical characteristics of the predicate device.
• Pyrogenicity: Ground truth was established by standard biological assessment methods for endotoxins, validated against established limits.

8. The sample size for the training set:

• Not applicable. This device is a physical medical implant, not an AI/machine learning model that requires a training set.

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

• Not applicable. (See point 8).

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The M.U.S.T. Pedicle screws system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) and non-pedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The M.U.S.T. Extension and M.U.S.T. Long Tab is intended to be used as part of the M.U.S.T. Pedicle Screw system (K121115, K132878, K141988, K153664, K162061, K171170, K171758, K193365) for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. pedicle screw system includes cannulated or non-cannulated poly-axial pedicle screws (K121115, K132878, K153664), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K121115, K171758), straight and pre-bent rods (K121115, K141988, K162061), lateral connectors (K162061) and cross connectors (K132878, K193365). The M.U.S.T. pedicle screw system also includes the enhanced screws and rods designed for percutaneous surgery (K141988).

The M.U.S.T. Extension and M.U.S.T. Long Tab introduce new sizes of sterile implantable devices intended to be used for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The devices subject of this submission are:

• New size of Straight Rods (both Titanium and CoCr version): length 600mm Hex interface at the end
• New size of Straight Rods (Anodized Titanium version): length 600mm
• Pre-contoured Rods (both Titanium and CoCr version)
• New sizes of Lateral Connectors: length 80; 100; 125 & 150mm
• New sizes of Enhanced Cannulated Pedicle Screws: Ø8; Ø9; Ø10 length from 30 to 100mm
• New cannulated pedicle screws with thread 4 leads (15 and 25 mm)
• Setscrews in Titanium

This document is a 510(k) Premarket Notification from Medacta International SA for their M.U.S.T. Pedicle Screw Extension and Long Tab Implants. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed clinical study data on device performance against specific acceptance criteria for AI/ML-enabled devices.

Therefore, the requested information regarding acceptance criteria, study details, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment cannot be found in the provided text. The document describes a traditional medical device submission (pedicle screws) which relies on bench testing and comparison to predicates, not AI/ML performance studies.

However, based on the structure of the provided document, I can infer the "acceptance criteria" and "study" are related to the engineering and design validation of the medical device, rather than the performance of an AI/ML algorithm.

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

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

The document describes several non-clinical studies and tests with implied acceptance criteria, but it does not present them in a clear table format with specific quantitative performance results against those criteria. Instead, it lists the types of tests performed.

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

• Test Set Sample Size: Not explicitly stated for each test, but standard ASTM methods often define minimum sample sizes for mechanical testing. For the cadaver surgery, it states "experienced surgeons," implying at least one or more instances.
• Data Provenance: Not specified, but given the company is Medacta International SA (Switzerland) and the testing labs are mentioned (Endolab), the data is presumed to be from their internal testing facilities or contracted labs, likely within Europe. No mention of patient data or clinical data is made, so "retrospective or prospective" is not applicable in the context of this submission. This is a bench test and design validation submission.

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 is not an AI/ML study involving human expert ground truth. The "ground truth" for these tests is defined by engineering standards (e.g., ASTM) and physical measurements. For the cadaver surgery, it states "experienced surgeons" performed the procedure, but their role was to evaluate the instrument's use in a simulated environment, not to establish a "ground truth" for an AI model.

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

Not applicable. This concept is for resolving disagreements in expert labeling for AI/ML ground truth, which is not relevant 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. The device is a physical pedicle screw system, not an AI/ML software.

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

No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm.

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

The "ground truth" in this context is based on:

• Engineering Standards: Adherence to established ASTM (American Society for Testing and Materials) standards for spinal implants and medical bone screws to define acceptable mechanical properties.
• Physical Measurements/Analysis: Geometrical analysis of threads and characterization of mechanical properties (tensile strength, torsion, etc.).
• Risk Analysis: Identification of new risks and verification against predefined acceptance criteria based on this analysis, likely conforming to ISO standards for medical device risk management.
• Biocompatibility Testing: Demonstrated through pyrogenicity assessment reports.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As above, no AI/ML device with a training set.

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The M.U.S.T. Mini posterior cervical screw system is intended to provide immobilization of spinal segments as an adjunct to fusion, in skeletally mature patient, for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g., pseudarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The M.U.S.T. Mini posterior cervical screw system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the M.U.S.T. Mini posterior cervical screw system may be connected to the M.U.S.T. system rods with the M.U.S.T. Mini rod connectors. Transition rods with differing diameters may also be used to connect the M.U.S.T. Mini posterior cervical screw system to the M.U.S.T. system. Refer to the M.U.S.T. system package insert for a list of the M.U.S.T. indications of use.

When used with the Occipital Plate the M.U.S.T Mini posterior cervical screw system is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic junction(occiput - T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.

The M.U.S.T. MINI Anodized Rods and the Rod to Rod Connectors (parallel and in-line) are a line extension to the previously cleared Medacta M.U.S.T. MINI Posterior Cervical Screws System (K171369), M.U.S.T. MINI Posterior Cervical Screws System extension (K182837) and M.U.S.T. MINI Posterior Cervical Screws System extension (K200130).

Rod to rod connectors are extended to additional design: the parallel and the In-line design, available in both open/closed design. Connectors are designed to accommodate both the rods in 03.5mm and Ø5.5mm. This solution allows to connect the cervical and upper thoracic spine with axial or parallel rods from equal diameter or different: 3.5mm versus 3.5mm versus 5.5mm.

Anodized rods (straight and pre-curved) are provided in straight and pre-curved designs and the diameters and lengths are within the range of existing M.U.S.T. MINI Posterior Cervical Screws System rods product range, with equivalent overall characteristics: same intended use, diameter 3.5mm, in the range 30-420mm, material, machining, washing, packaging and final storing condition.

The subject devices are manufactured from Ti-6A1-4V ELI (ISO 5832-3 Implants for surgery --Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium allov + ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), the same material of the previous cleared M.U.S.T. MINI Posterior Cervical Screws System (K171369) and M.U.S.T. MINI Posterior Cervical Screws System Extension (K182837 and K200130).

Surface finishing of both subjects devices is further characterized by color anodization like for existing Polyaxial screws, hooks, lateral connector, rod to rod connector, cross connector clamp and spinous reconstruction cross connectors (all cleared under K171369), Occipital Plates (K182837) and are Type III color anodized.

This document describes the M.U.S.T. MINI Posterior Cervical Screws System, a medical device for spinal immobilization. The information provided is a 510(k) summary submitted to the FDA, which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific, quantitative acceptance criteria through a rigorous clinical study involving human readers and ground truth for an AI-powered diagnostic device.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study design are not applicable or extractable from this document. This document details a mechanical device, not a diagnostic AI.

Here's an analysis based on the provided text, highlighting what's present and what's missing due to the nature of the device:

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

• Not Applicable / Not Provided in this format. For a mechanical spinal implant, acceptance criteria are typically related to biocompatibility, mechanical strength (fatigue, static compression), material properties, and manufacturing consistency, demonstrated through engineering tests rather than performance metrics like sensitivity/specificity for a diagnostic AI. The document states a "comparative analysis" and that "the line-extension can be considered within the scope of the design verification and validation testing previously completed for the initial MUST MINI implants product range." This implies that the new components meet the same (unspecified in detail here) acceptance criteria as the original system.

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

• Not Applicable / Not Provided. This document does not describe a "test set" in the context of data for an AI/ML model. The "testing" mentioned refers to engineering and mechanical tests of the physical device components.

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

• Not Applicable. Ground truth, in the context of diagnostic AI, involves expert annotation of medical images or other data. This is not relevant for a mechanical spinal implant.

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

• Not Applicable. See point 3.

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

• Not Applicable. This is a mechanical device, not an AI-assisted diagnostic tool. No human reader study would be performed.

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

• Not Applicable. This is not an algorithm.

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

• Not Applicable. For a mechanical device, "ground truth" would relate to verifiable material properties, mechanical performance under stress, and biocompatibility, typically established through standardized testing protocols (e.g., ISO, ASTM standards) rather than clinical ground truth methods.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device requiring a training set.

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

• Not Applicable.

Summary of Device Performance (Based on the document):

The document states that the M.U.S.T. MINI Posterior Cervical Screws System performs "as safe and effective as the predicate devices." The core argument for acceptance is substantial equivalence to previously cleared devices.

Key points from the document regarding performance/testing, though not in the form of AI acceptance criteria:

• Engineering Rationale: A comparative analysis was performed to determine if the line-extension (new rods and rod-to-rod connectors) created a new worst-case product size.
• Conclusion: It was determined that the subject devices are substantially equivalent to the previously cleared predicate device and that the line-extension can be considered within the scope of the design verification and validation testing previously completed for the initial M.U.S.T. MINI implants product range.
• Technological Characteristics Shared with Predicates: diameter, materials of construction, biocompatibility, device usage, sterility, shelf life, and packaging.
• Material: Manufactured from Ti-6A1-4V ELI (ISO 5832-3 and ASTM F136), the same material as previous cleared M.U.S.T. MINI systems.
• Surface Finishing: Type III color anodized, like existing components cleared under K171369 and K182837.
• Performance Claim: Minor differences (e.g., new designs for rod-to-rod connectors, extended rod lengths) do not raise new questions of safety or effectiveness.

In essence, the "study" proving the device meets its acceptance criteria (which are mechanical and material-based, not diagnostic AI performance) is a comparative analysis and reliance on prior design verification and validation testing of the predicate devices.

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MySpine S2-Alar/Alar-Iliac is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use. MySpine S2-Alar/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the surgical equipment selected. MySpine guides are intended for single use only.

The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. Identical to the other Medacta MySpine products, the MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System (K12115, K132878, K141988, K153664, K162061, and K171170). Specifically, the subject MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides are intended to be used as anatomical perforating guides to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Screw Placement Guides fitting the patient's vertebral anatomy. The MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.

The provided text describes a medical device, the "MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides," and its substantial equivalence determination by the FDA. However, the document does NOT contain information about specific acceptance criteria for a device's performance (like sensitivity, specificity, accuracy, etc.) nor does it usually detail specific studies that prove the device meets such criteria in terms of quantitative metrics suitable for the requested table.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics (manufacturing process, material, biocompatibility, device usage, sterility, shelf life, packaging) and performance data from non-clinical studies (software validation, cadaver testing, guide accuracy, stability assessment). The "guide accuracy" mentioned is a general category and not a specific set of acceptance criteria with reported performance.

Therefore, I cannot fill in the table of acceptance criteria and reported device performance, nor can I answer questions related to sample size, expert qualifications, or ground truth establishment for a standalone algorithm performance study, because this information is not present in the provided text. The document explicitly states: "No clinical studies were conducted." and it does not describe an AI algorithm with human-in-the-loop performance.

Here's an overview of what can be extracted or inferred based on the provided text, and where information is missing:

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

• Acceptance Criteria: Not explicitly stated with quantifiable metrics (e.g., "accuracy must be > 95%"). The document talks about "software validation," "cadaver testing," "guide accuracy," and "stability assessment" as general categories of testing performed, aiming to show safety and effectiveness comparable to the predicate.
• Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy percentages, error margins) are reported in the document.

Therefore, this table cannot be filled based on the provided input.

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

• Test Set Sample Size: Not specified. The document mentions "Cadaver testing" and "Guide accuracy" testing, but no details on the number of cadavers or cases used for these tests are provided.
• Data Provenance: Not specified.

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 as no detailed test set and ground truth establishment methodology is described in the provided text. The document refers to "surgical planning software" that "pre-operatively plans the positions of the components based upon radiological images," but this is part of the device's function, not a ground truth establishment for an AI algorithm's performance evaluation.

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

• Not applicable as no detailed test set and ground truth establishment methodology is described.

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

• MRMC Study: No. The document explicitly states: "No clinical studies were conducted." The device (surgical guides) assists surgeons, but the documentation does not describe a study involving human readers and AI assistance.

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

• The device is a physical surgical guide produced using software, not a standalone AI algorithm that provides diagnostic or prognostic outputs. The "MySpine software platform" is integral to creating the guides. "Software validation" was performed, but no standalone algorithm performance as typically understood in AI/ML context (e.g., measuring diagnostic accuracy against ground truth without human intervention) is described.

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

• Not explicitly stated for any performance evaluation in terms of AI. For the device itself and its intended use, the anatomical landmarks from patient CT scans and selected surgical equipment (per planning software) would form the basis for the design of the patient-specific guides. The "guide accuracy" testing would presumably involve comparing the guide's output (screw trajectory) against the planned trajectory or anatomical reality, but the specific ground truth methodology for this testing is not detailed.

8. The sample size for the training set

• Not applicable. The document describes a medical device (surgical guides) and the software that creates them for individual patients. It does not refer to a machine learning model that requires a "training set" in the conventional sense for AI performance. The software uses patient-specific CT data for planning.

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

• Not applicable, as there is no mention of a "training set" for an AI model.

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MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.

The device is provided with two options:

• Drill based
• K-wire based

MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.

Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

MySpine MC and Drill Pilot guides are intended for single use only.

The MySpine Pedicle Screw Placement Guides – MC (Midline Cortical) and Drill Pilot Instruments are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. The MySpine Pedicle Screw Placement Guides – MC and S1 Guide Instruments are for use in spinal levels L5 to S1. The MySpine Pedicle Screw Placement Guides - Drill Pilot Guide Instruments are for use in spinal levels T1 to S1.

The MySpine product line is a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System based on the patient's anatomy. The MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments are intended to be used with Medacta's M.U.S.T. Pedicle Screw System (K121115, K132878, K141988, K153664, K162061, and K171170) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudo-arthrosis, and failed previous fusion.

The MySpine platform allows the surgeon to complete pre-operative planning in 3D, based on the patient's spinal CT scans. Medacta International SA uses these images in combination with SW Mimics® (Materialize®) and W Solidworks® (Dassault Systèmes®) to import DICOM images from a patient's CT scans and then process the scans into accurate 3D models. CT imaging is used to create a 3D model of the vertebrae according to the patient's anatomy. The subsequent vertebral model represents the template used to generate the corresponding MySpine Screw Placement Guides to fit the patient's vertebral anatomy.

The provided document is a 510(k) premarket notification for the MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices.

However, the document does not contain specific acceptance criteria or performance data for an AI-powered device. The MySpine system described is a patient-matched surgical guide system that uses pre-operative CT scans to create 3D models and fabricate patient-specific guides. It utilizes software for planning, but it is not an AI/ML-driven device as understood in the context of diagnostic or prognostic AI.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance for an AI/ML device from this document. The document primarily focuses on the physical design, manufacturing process, materials, and intended use of the surgical guides, along with non-clinical performance tests relevant to mechanical and design validation, and a statement that no clinical studies were conducted for this particular submission.

To answer your request, if this were an AI or ML-enabled device, the information would typically include:

1. A table of acceptance criteria and the reported device performance: This would detail metrics like sensitivity, specificity, accuracy, precision, recall, F1-score, AUC, etc., along with the target thresholds (acceptance criteria) and the actual performance achieved.
2. Sample size used for the test set and the data provenance: Number of cases/patients in the test set, and details like country of origin, whether it was retrospective or prospective data, etc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For example, 3 radiologists with 5+ years of experience each.
4. Adjudication method for the test set: How disagreements among experts establishing ground truth were resolved (e.g., 2+1 means 2 experts agree, if not, a 3rd expert adjudicates; 3+1 means 3 experts agree, if not, a 4th adjudicates).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Details on the study design and the effect size (e.g., human readers improved AUC by X with AI assistance).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The results of the algorithm's performance without human intervention.
7. The type of ground truth used: For instance, expert consensus, pathology reports, clinical outcomes data, follow-up imaging, etc.
8. The sample size for the training set: Number of cases/patients used to train the AI model.
9. How the ground truth for the training set was established: Similar to the test set, but often less stringent or by different methods depending on the training methodology.

Since the provided document does not pertain to an AI/ML device, I am unable to provide the specific details requested. The "Performance Data" section (page 7) lists only non-clinical studies related to design validation, stability, post-operative evaluation (accuracy of the physical guide), and wear tests for the physical instruments. It explicitly states "no clinical studies were conducted."

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M-ARS ACL: Anatomic Ribbon Surgery System - M-ARS ACL Tibial Pull Suture Plate (PSP): Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.

M-ARS ACL: Anatomic Ribbon Surgery System: M-ARS ACL Extracortical Femoral Button: Reconstructive therapy of ruptures to the anterior cruciate ligament by means of autologous grafts.

The M-ARS ACL: Anatomic Ribbon Surgery System components are implantable devices used for the reconstructive treatment of ligament ruptures as well as the fixation of an implanted Anterior Cruciate Ligament graft by means of suspensory extracortical fixation.

The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button component is an implantable extracortical suspension device used to secure the graft fixation on the femoral side during ACL reconstruction surgery. The M-ARS ACL: Anatomic Ribbon Surgery System Tibial Pull Suture Plate (PSP) component is an implantable extracortical suspension device used to secure the graft fixation on the tibial side during ACL reconstruction surgery.

The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button and Tibial Pull Suture Plate are manufactured with Titanium-6 Vanadium Extra Low Interstitial (Ti-6Al-4V ELI).

The provided text describes a 510(k) premarket notification for the "M-ARS ACL: Anatomic Ribbon Surgery System," which is a medical device for reconstructive treatment of ruptured anterior and posterior cruciate ligaments. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with acceptance criteria.

Therefore, many of the requested categories (e.g., acceptance criteria table, sample sizes, expert ground truth, MRMC study, standalone performance, training set data) are not applicable as this submission is for a medical device that relies on the established safety and effectiveness of predicate devices, and the studies conducted are primarily non-clinical and comparative in nature, not performance studies with specific statistical acceptance criteria for a new AI or diagnostic device.

Here's an analysis based on the available information:

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

This information is not provided in the document as it is a 510(k) submission for a surgical implant device, not a diagnostic or AI device that typically presents performance metrics against acceptance criteria. The focus is on demonstrating substantial equivalence to predicate devices through material, design, and functional comparisons, along with non-clinical testing for safety.

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

• Sample Size (Test Set): Not applicable for the type of studies performed. The document mentions "design comparison" and "cadaver workshop." These are not statistical studies with defined test set sample sizes in the context of device performance metrics.
• Data Provenance: Not applicable. The studies are non-clinical (design comparison, cadaver workshop).

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):

• Experts and Qualifications: For the "cadaver workshop," the text mentions "surgeon evaluations to verify the design features and surgical technique." The specific number or qualifications of these surgeons are not detailed. This workshop serves to evaluate usability and design, not to establish a "ground truth" in the way it would be for a diagnostic AI system.

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

• Adjudication Method: Not applicable. There is no mention of a formal adjudication process for the non-clinical studies described.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI tools, which is not the nature of the M-ARS ACL system.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No, a standalone performance study was not done. This device is a surgical implant, not an algorithm.

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

• Type of Ground Truth: Not applicable in the traditional sense of a diagnostic or AI device. For the non-clinical studies, "ground truth" would be related to engineering specifications, material properties, and surgical technique verification by surgeons. There's no pathological or outcomes data used to establish "ground truth" for the device's technical performance in this context.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This device is not an AI or machine learning algorithm requiring a training set.

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

• Training Set Ground Truth Establishment: Not applicable.

Summary of Device Performance and Acceptance Criteria (as described in the context of a 510(k) submission for this device):

The document does not explicitly state "acceptance criteria" for performance metrics in the way one would for a diagnostic test (e.g., sensitivity, specificity thresholds). Instead, the "performance" is demonstrated through:

• Design Comparison: Geometrical and comparative analysis between the M-ARS ACL System and predicate devices to show mechanical equivalence. The acceptance criterion here is implied as being "substantially equivalent" in design and mechanical properties to legally marketed predicate devices.
• Cadaver Workshop: Surgeon evaluations to verify design features and surgical technique. The implied acceptance criterion would be that surgeons can successfully use the device and technique, and that the design is appropriate for its intended use.
• Substantial Equivalence Evaluation: A comparative analysis, especially for the Tibial Pull Suture Plate, against the predicate device. This ensures that any differences in design do not raise new questions of safety or effectiveness.
• Biocompatibility and Sterilization: The device materials (Titanium Alloy ELI) have an extensive history of use in medical devices and have been previously reviewed by the FDA, implying they meet established biocompatibility standards. The device is sterile and single-use, meeting standard regulatory requirements for such implants.
• Pyrogenicity: Medacta uses Bacterial Endotoxin Test (LAL test) and Pyrogen Test (USP chapter ), indicating compliance with standards for sterility and pyrogenicity, though they do not label the devices as non-pyrogenic or pyrogen-free.

Conclusion stated in the document: "Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics as well as performance evaluations. The M-ARS ACL: Anatomic Ribbon Surgery System is as safe and effective as the predicate devices, Karl Storz's Flipptack (K982571) and Karl Storz's Endotack (K022853)."

In essence, the "acceptance criteria" are the demonstration of substantial equivalence to predicate devices, supported by non-clinical studies verifying design, materials, and surgical technique.

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The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) and non-pedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis and failed previous fusion in skeletally mature patients.

The M.U.S.T. Combined Set Screws are intended to be used as part of the M.U.S.T. Pedicle Screw System (cleared under K12115, K132878, K141044, K141988, K153664, K162061, and K171170) for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Pedicle Screw System includes: cannulated or non-cannulated poly-axial pedicle screws (K12115 and K132878), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K12115), straight and pre-bent rods (K121115 and K162061), cross connectors (K132878), hooks (K141044), enhanced screws and rods designed for percutaneous surgery (K141988 and K162061), cannulated or non-cannulated reduction screws (K153664), connectors (K162061 and K171170), and standard, enhanced, and reduction pedicle screws (K171170). The M.U.S.T. Combined Set Screws are manufactured from CoCrMo alloy (ISO 5832-12 and ASTM F1537-11) and are provided sterile and non-sterile screw is packaged individually as well as in packages of 2, 4, 6, and 8 screws. The non-sterile screw is packaged individually.

The provided text describes a 510(k) premarket notification for a medical device, the M.U.S.T. Combined Set Screws. It focuses on demonstrating substantial equivalence to a predicate device, not on validating an AI algorithm. Therefore, many of the requested items related to AI device performance, such as human reader improvement with AI, ground truth establishment for training and test sets, and multi-reader multi-case studies, are not applicable or cannot be extracted from this document.

However, I can extract information regarding the device's acceptance criteria, the study conducted, and other relevant details provided in the submission for the M.U.S.T. Combined Set Screws.

Here's a breakdown of the requested information based on the provided document:

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

The document does not explicitly state numerical "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, it refers to performance studies conducted in accordance with specific ASTM standards. The acceptance criteria are implicitly that the device performs equivalently to the predicate device and meets the requirements of these standards. The reported device performance is that it met these standards and thus is "as safe and effective as the predicate devices."

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 does not specify a "test set" in the context of an AI algorithm, nor does it provide details on sample sizes for the mechanical and pyrogenicity tests beyond indicating that the tests were performed. The "data provenance" information (country of origin, retrospective/prospective) is not applicable to the device testing described. The materials for the device itself are CoCrMo. The manufacturing company, Medacta International SA, is located in Switzerland.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a physical medical implant (surgical screws), not an AI diagnostic or prognostic tool requiring expert-established ground truth from images or clinical data. The "ground truth" for this device would be its physical and mechanical properties, assessed through standardized laboratory tests.

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

This information is not applicable, as there is no "test set" in the context of expert review for an AI algorithm. The device's performance was evaluated through laboratory testing against established engineering and material standards.

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

This information is not applicable. The M.U.S.T. Combined Set Screws are a physical orthopedic implant, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable. The "device" in question is a physical hardware component, not an algorithm.

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

The "ground truth" for this device is based on established engineering standards and material properties, specifically through performance testing in accordance with:

• ASTM F1717-15 (for dynamic compression bending of spinal implant constructs)
• ASTM F1798-13 (for static and fatigue properties of interconnection mechanisms)
• Sawbones Testing (a simulated biomechanical environment)
• LAL Endotoxin Test (for pyrogenicity/safety of materials)

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI algorithm.

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

This information is not applicable. There is no "training set."

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