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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 fraumatic 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 subject M.U.S.T. MINI Posterior Cervical Screws System Extension is a Medacta M.U.S.T. MINI Posterior Cervical Screws System line extension. Specifically, the current submission includes the following implants:

• M.U.S.T. MINI Polyaxial screw dual lead solid and cannulated with diameters ranging from 4 to . 6mm and lengths from 20 to 50mm;
• M.U.S.T. MINI cross connector top load, four sizes. ●

The subject devices are made of Ti6A14V ELI according to ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy and ASTM F136-13 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text is a 510(k) Summary for the Medacta M.U.S.T. MINI Posterior Cervical Screws System Extension. This document describes a medical device (surgical implants) and its substantial equivalence to previously cleared devices. It does not contain information about an AI/ML powered medical device, therefore, the requested information cannot be extracted.

The request asks for specific details related to an AI/ML powered medical device, such as acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, and results of comparative effectiveness studies (MRMC) or standalone performance studies. These are all concepts relevant to the evaluation of AI/ML software.

Since the provided text concerns mechanical surgical implants, these categories do not apply. The "Performance Data" section in the document refers to non-clinical studies (design validation, geometric comparison, dynamic biomechanical testing, pyrogenicity, biocompatibility, shelf-life) and explicitly states "No clinical studies were conducted." The non-clinical studies support the substantial equivalence of the new implants to previously cleared mechanical implants, not the performance of an AI/ML algorithm.

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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 (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. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/ilum) and 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 purpose of this submission is to add the M.U.S.T. MC Cross Connectors to the M.U.S.T. Pedicle Screw System (K132878, K171170, K121115, K153664, K141988) for the stabilization and fusion of the non-cervical spine. The M.U.S.T. Pedicle System includes a wide range of implants: Rods, Polyaxial and Mono-axial Pedicle Screws, Hooks, Connectors of various design and size, that are used in combination to compose a spinal construct.

The provided text describes a 510(k) premarket notification for the M.U.S.T. Pedicle Screw System, which is a medical device for spinal fixation. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing novel clinical studies to prove performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert validation, ground truth, MRMC studies, standalone performance, training set) typically associated with a de novo or PMA submission for a new device's efficacy and safety is not applicable to this 510(k) summary.

Here's how the provided information aligns with the request, highlighting what is and isn't available from this document:

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

• Not Applicable in this Context. For a 510(k), the "acceptance criteria" for the device's performance are primarily established by the performance of the predicate devices. The study performed is to demonstrate that the new device (M.U.S.T. MC Cross Connectors) performs equivalently to the predicate devices and meets relevant industry standards rather than achieving specific performance metrics against a disease outcome.

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

• Not Applicable for clinical data.
• Mechanical Testing:
  • Sample Size: The document states that "worst-case implants" were tested, but it does not specify the exact number of samples used for each test (Static compression/bending, Dynamic compression bending).
  • Data Provenance: The provenance of the data is from internal testing conducted by Medacta International SA. The country of origin for the testing facility is not explicitly stated, but Medacta International SA is based in Switzerland. The studies are prospective in the sense of being planned tests on newly manufactured components.

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 a mechanical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth establishment. The "ground truth" for mechanical testing is derived from engineering principles and validated test standards.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert review of images or clinical outcomes. For mechanical performance testing, the results are typically quantitative and objective, based on physical measurements and material properties.

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. An MRMC study is relevant for diagnostic devices, particularly those involving image interpretation by human readers, often comparing human performance with and without AI assistance. This device is a surgical implant, not a diagnostic tool, and involves no human "readers" in the context of interpretation.

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

• Not Applicable. This question is also relevant for AI/software as a medical device (SaMD). The M.U.S.T. Pedicle Screw System is a physical implant, not an algorithm.

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

• Mechanical Testing Standards. For the non-clinical performance tests, the "ground truth" is implied by the adherence to and successful completion of established industry standards for spinal implant testing, specifically ASTM F1717 (Static compression/bending and Dynamic compression bending) and European Pharmacopoeia §2.6.14 / USP chapter and for pyrogenicity. The acceptance criteria are embedded within these standards.

8. The sample size for the training set

• Not Applicable. The concept of a "training set" doesn't apply to the mechanical testing of a physical medical device like this, which doesn't involve machine learning algorithms.

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

• Not Applicable. As there is no training set for an algorithm, this question is not relevant.

Summary of Relevant Information from the Document for a 510(k):

The document explicitly states:

• "No clinical studies were conducted." This reinforces that the focus is on non-clinical, mechanical performance and comparison to predicate devices.
• Performance Tests: The device underwent "Non-Clinical Studies" including:
  • Static compression / bending per ASTM F1717
  • Dynamic compression bending per ASTM F1717
  • Cadaver studies (though no specifics are given beyond "Cadaver studies O")
  • Pyrogenicity testing (Bacterial Endotoxin Test per European Pharmacopoeia §2.6.14/USP chapter and pyrogen test per USP chapter ).
• Acceptance Criteria for Non-Clinical Tests: "Testing was conducted according to written protocols with acceptance criteria that were based on standards." The implicit acceptance criteria are that the device meets or exceeds the performance of legally marketed predicate devices, as defined by the standards (e.g., ASTM F1717) and the specific testing protocols.

In essence, for a 510(k) for a physical implant, the "study that proves the device meets the acceptance criteria" is primarily the non-clinical performance testing demonstrating that the device is substantially equivalent to existing, legally marketed predicate devices, by meeting relevant recognized standards. This is a comparison of technological characteristics and performance, not a clinical efficacy study with human subjects.

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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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The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) 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 consists of the following implants that are to be used as part of the M.U.S.T. pedicle screw system (K121115):

• New sizes (diameter and length) of the solid polyaxial pedicle screws that were cleared under K121115
• Solid and cannulated monoaxial pedicle screws
• Cross connectors
  The M.U.S.T. Extension is intended to be used as part of the M.U.S.T. pedicle screw system for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Extension includes different sizes of screws and cross connectors. The screws are fixed in the pedicle and the vertebrae. The straight and pre-bent rods (K121115) act as a connector between the different screws to create a stable construct. The cross connectors act as a stabilizing construct between the rods on each side of the vertebrae. The cross connectors have an adjustable medial/lateral length in order to address various distances between the rods depending on the patient's anatomy. Rod distances from 35mm to 98 mm can be addressed with the various connector sizes. The connector offers an angular adjustable central joint in order to align the connection to the rod. The anqular adjustable feature as well as the size range of the connectors is within the range of the predicate devices. The M.U.S.T. Extension can be applied with the common surgical technique for posterior instrumentation.
  The M.U.S.T. Extension cross connectors are made of Titanium alloy (Ti6AI4V ELI -ISO 5832-3, ASTM F136) and come in 4 sizes: 35-42, 40-50, 48-66, and 64-98. The M.U.S.T. Extension pedicle screws are made of either Titanium alloy (Ti6Al4V ELI - ISO 5832-3, ASTM F136) or a combination of Titanium alloy (Ti6AI4V ELI - ISO 5832-3, ASTM F136) and CoCrMo (ISO 5832-12, ASTM F 1537). The M.U.S.T. Extension solid polyaxial pedicle screws have diameters of 8, 9, and 10mm and lengths between 20 and 100mm in 5mm increments. The M.U.S.T. Extension solid monoaxial pedicle screws have diameters between 4.5 and 7mm and lengths between 25 and 65mm in 5mm increments in addition to screws with a diameter of 8mm with lengths between 25 and 90mm. The M.U.S.T. Extension cannulated monoaxial pedicle screws have diameters between 5 and 7mm and lengths between 40 and 60mm in 5mm increments. The screw shaft is color anodized to simplify the identification of the screw diameter. The pedicle screw has a dual lead thread to simplify the screw insertion and reduce the number of turns. The threads are designed with a cylindrical diameter. The construct is secured using a set screw made of CoCrMo (ISO 5832-12, ASTM F 1537). The pedicle screws are available both in sterile and unsterile packaging while the cross connectors are available in sterile packaging.

The provided text describes a medical device, the M.U.S.T. Extension, and its substantial equivalence to predicate devices, rather than a study proving performance against acceptance criteria for an AI/ML powered device. The document is a 510(k) summary for a spinal pedicle screw system extension.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set size, and how training ground truth was established) are not applicable to this submission.

However, I can extract the acceptance criteria and a description of the testing performed for this mechanical device.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Description:

The study performed was a design verification study to evaluate the M.U.S.T. Extension's mechanical properties.

• Objective: To demonstrate that the M.U.S.T. Extension is substantially equivalent to its predicate devices in terms of mechanical performance.
• Methodology:
  • A risk analysis was conducted to identify any new risks associated with the changes in the M.U.S.T. Extension.
  • Design verification tests were conducted according to written protocols with predefined acceptance criteria.
  • These protocols and acceptance criteria were based on established standards (specifically ASTM F 1717), FDA guidance, and comparison to existing predicate devices.
  • Testing was performed on the "worst case component size and option/design based on engineering analysis."
  • The M.U.S.T. Extension's performance was compared to the "worst case of the predicate devices."

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

• Sample Size: Not explicitly stated as a number of devices. "Worst case component size and option/design" was tested.
• Data Provenance: Not applicable in the context of clinical data. This is mechanical testing data for new 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 for mechanical testing is based on engineered specifications and established standards, not expert consensus on clinical data.

4. Adjudication method for the test set:

• Not applicable. Mechanical testing results are objectively measured against predefined thresholds.

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

• No, this was not a MRMC comparative effectiveness study. It was mechanical testing of a medical device's components.

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

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

7. The type of ground truth used:

• For mechanical properties, the "ground truth" or reference was based on established industry standards (ASTM F 1717) and the performance of currently marketed, legally predicate devices. The acceptance criteria were derived from these standards and predicate device performance.

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. This is not an AI/ML device.

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