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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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