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Romeo® posterior osteosynthesis system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as a posterior, non-cervical, non-pedicle screw fixation system, Romeo® posterior osteosynthesis system is intended for the following indications: degenerative disc disease (DDD) (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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Romeo posterior fixation system comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods, and various connectors. The Romeo screws come in various lengths (from 25 to 90 mm) and diameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) to accommodate different patient anatomies. Romeo components are delivered sterile (gamma sterilization) in a dedicated packaging or not sterile upon request. The Romeo posterior fixation system is supplied with a set of surgical instruments.

The provided text is a 510(k) summary for a medical device called the Romeo® posterior osteosynthesis system. It describes the device, its indications for use, and a comparison to predicate devices, including performance testing. However, it does not contain the specific information required to complete all sections of your request regarding clinical study details, such as acceptance criteria based on clinical performance metrics, expert reader studies, or detailed ground truth establishment methods for large datasets.

The document primarily focuses on demonstrating substantial equivalence through non-clinical performance testing, comparing the new components (Setscrew with modified hexalobe imprint, Parallel Rod Connector, and T Rod Connector) to previously cleared predicate devices.

Here's the information that can be extracted and what is missing:

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

Missing: Specific quantitative acceptance criteria (e.g., minimum torque values, maximum displacement, etc.) and quantitative performance data for the device components are not provided in this summary. The summary only states that the results "demonstrate comparable mechanical properties to 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)

• Sample Size for Test Set: Not applicable as this is a non-clinical, mechanical performance study. The "test set" here refers to the actual device components tested. The number of components tested is not specified, but typically these tests involve several samples to ensure reproducibility and statistical power.
• Data Provenance: Not applicable for non-clinical mechanical testing of physical device 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 submission relies on non-clinical, mechanical testing, not clinical data or expert interpretation of medical images.

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

Not applicable. This was non-clinical mechanical testing, not a study requiring adjudication of expert opinions.

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. This document does not mention any multi-reader, multi-case clinical studies, nor does it describe an AI-powered device.

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

No. This document is for a physical orthopedic implant system, not a software algorithm.

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

The "ground truth" for this submission is based on established engineering and biomechanical standards and measurements. The performance of the new components is compared against the known performance of predicate devices through standardized mechanical tests.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

ROMEO® posterior osteosynthesis system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S V vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as a posterior, non-cervical, non-pedicle screw fixation system, ROMEO posterior osteosynthesis system is intended for the following indications: degenerative disc disease (DDD) (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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion

The Romeo® posterior fixation system comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods, and cross connectors. The Romeo® Polyaxial Screws come in various lengths (from 25 to 90 mm) and diameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) to accommodate different patient anatomies. The modification to Romeo® posterior osteosynthesis system consists of the addition of a prebent cross connectors and prebent CoCr rods.

This document is a 510(k) premarket notification for the ROMEO® Posterior Osteosynthesis System, seeking to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain information about the acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical study for an AI/ML device would.

Instead, this document focuses on mechanical and material equivalence for a traditional medical device (spinal system components). Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This document doesn't define pass/fail criteria for a study in terms of accuracy, sensitivity, specificity, etc., as it's not a diagnostic or AI/ML device. The "performance" described relates to the physical characteristics and intended use of the spinal components.
• Sample size and data provenance for a test set: No test set in the context of an AI/ML or diagnostic study is described.
• Number of experts and qualifications for ground truth: Not applicable, as there's no diagnostic ground truth being established.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable, as this is a physical medical device.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

What the document does convey regarding "acceptance criteria" and "study" is related to engineering principles and regulatory compliance for a spinal implant system:

• Acceptance Criteria (Implicitly): The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices. This involves showing that the new components (prebent cross connectors and prebent CoCr rods) have equivalent intended use, material, design, mechanical properties, and function to existing cleared devices. The "special controls established for Pedicle screw spinal system" and the "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" (May 3, 2004) serve as the regulatory framework and implicitly contain design and performance expectations.
• "Study" (Demonstration of Equivalence): The "study" isn't a traditional clinical trial or performance study with human subjects, but rather a technical assessment and comparison. The document states:
  • "No additional testing has been performed for the added prebent cross connectors and prebent CoCr rods." This is a crucial statement and indicates that the manufacturer is relying on the established equivalence of the materials and design to existing cleared components.
  • "Verification Activity and Validation Activity demonstrate that the added prebent cross connectors and prebent CoCr rods are substantially equivalent to previously cleared devices." This suggests that internal engineering verification and validation activities (e.g., material testing, mechanical load testing, fatigue testing, dimensional analysis) were conducted to ensure the new components meet the same functional and safety profiles as the predicate components, even if no new testing was deemed necessary beyond that for existing components.

In summary, this document is a regulatory filing for a physical medical device (spinal implant components), not for an AI/ML diagnostic or prognostic tool. Therefore, the questions related to clinical performance metrics, ground truth, and reader studies are not applicable to the information provided.

Ask a specific question about this device

ROMEO® posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used as a posterior, non-cervical, non-pedicle screw fixation system, ROMEO® posterior osteosynthesis system is intended for the following indications: degenerative disc disease (DDD) (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.

The Romeo® posterior fixation system comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCrMo rods, and cross connectors. The Romeo® Polyaxial Screws come in various lengths (from 25 to 90 mm) and diameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) to accommodate different patient anatomies. The modification to Romeo® posterior osteosynthesis system consists of the addition of a polyaxial pedicle screw 5 mm in diameter and 25 mm in length.

The provided document is a 510(k) summary for the SPINEART Romeo® posterior osteosynthesis system. This type of regulatory submission in the medical device industry focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proof of meeting acceptance criteria through clinical studies. Therefore, the information requested regarding acceptance criteria and a study proving their fulfillment is largely not present in this document in the way it would be for a software-as-a-medical-device (SaMD) or a novel device requiring extensive performance testing against defined metrics.

However, I can extract the relevant information and explain why certain aspects of your request cannot be fully answered from this specific regulatory submission.

Explanation of Device and Regulatory Context:

The Romeo® posterior osteosynthesis system is a pedicle screw spinal system. The 510(k) submission (K140948) is for a modification to an existing, legally marketed device (Romeo® posterior osteosynthesis system, K101678, and Ellipse posterior osteosynthesis system, K081165). The modification specifically involves the addition of a polyaxial pedicle screw with a 5 mm diameter and 25 mm length.

For this type of modification, the focus of the regulatory review is on demonstrating that the new component (the added screw) does not introduce new questions of safety or effectiveness and remains substantially equivalent to the predicate devices. This is primarily done through material, design, and mechanical property comparisons, often supported by bench testing (mechanical and material characterization). Clinical studies are typically not required unless the modification significantly alters the fundamental scientific technology or poses new clinical risks.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) like one would see for a diagnostic device or an AI algorithm. Instead, the "acceptance criteria" for this type of device modification would relate to its physical and mechanical properties being comparable to, or exceeding, those of the predicate devices and relevant industry standards.

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

• Sample Size for Test Set: Not applicable in the context of this device and submission. There was no "test set" of patient data in the sense of clinical images or outcomes for an AI/diagnostic device. The testing mentioned refers to mechanical and material testing of the physical screw.
• Data Provenance: Not applicable. The "data" pertains to engineering and material specifications, and mechanical test results, not clinical data from patients.

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 & Qualifications: Not applicable. Ground truth, in the context of diagnostic performance (e.g., for AI), is not relevant here. The "ground truth" for a mechanical implant relates to engineering specifications and performance standards. Engineers, material scientists, and biomechanical experts would be involved in designing and testing such a device, but not in establishing "ground truth" in the diagnostic sense.

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

• Adjudication Method: Not applicable. There was no diagnostic "test set" requiring adjudication.

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

• MRMC Study: No. This is a spinal implant, not an AI-assisted diagnostic device. Therefore, no MRMC study was performed, and there is no "effect size of human readers improving with AI."

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

• Standalone Performance: No. This is a physical implant, not a standalone algorithm.

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

• Type of Ground Truth: The "ground truth" for this device's performance is based on established mechanical testing standards (e.g., those referenced in the "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document") and material specifications (e.g., ASTM F136 for Titanium Ta6V Eli grade). The conclusion states that "Verification Activity and Validation Activity" demonstrate performance, indicating these engineering benchmarks were met.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that uses a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI algorithm, no ground truth was established for it.

Summary regarding the Study:

The "study" referenced in the document is the set of Verification Activity and Validation Activity which would typically encompass:

• Material Characterization: Ensuring the Titanium alloy meets ASTM F136.
• Mechanical Bench Testing: Such as static and fatigue testing of the screw, screw-rod assembly, and potentially the construct, compared against the predicate devices and relevant ASTM/ISO standards. This includes evaluating parameters like pull-out strength, bending stiffness, torsional strength, and fatigue life.
• Biocompatibility Assessment: Primarily by demonstrating the material's compliance with established standards for implantable materials.
• Sterilization Validation: If provided sterile, ensuring the gamma sterilization process is effective for the device.

The conclusion of the 510(k) states that these activities successfully demonstrated that the added polyaxial pedicle screw is "as safe, as effective, and performs at least as safely and effectively as its predicates polyaxial pedicle screws." This means the testing showed equivalence to the previously cleared devices, satisfying the regulatory requirement for this specific type of modification.

Ask a specific question about this device

ROMEO posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as a posterior, non-cervical, non-pedicle screw fixation system, ROMEO posterior osteosynthesis system is intended for the following indications: degenerative disc disease (DDD) (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.

The modifications to ROMEO posterior osteosynthesis system (K081165, K093170, K101678, K111127 and K112108) manufactured by SPINEART consist of:

• Addition of Romeo® 25D & 25T Screws made of Titanium alloy Ti6AI4V ELI . conforming to ISO 5832.3 and ASTM F136
• Addition of Romeo® Straight and Multiaxial Cross Connectors made of Titanium . alloy Ti6AI4V ELI conforming to ISO 5832-3 and ASTM F136
• Additional lengths of Percutaneous Pre-bent and Straight Rods made of Titanium . alloy (Ti6AI4V ELI conforming to ISO 5832-3 and ASTM F136).

These components are supplied either sterile or not sterile.

• Addition of a Cross connector caliper and a 3.5 mm tightener (not sterile). .

The medical device described in K130267 is a spinal osteosynthesis system, not an AI device. Therefore, the acceptance criteria and study information typically sought for AI/ML devices, such as performance metrics like accuracy, sensitivity, specificity, and related study designs (e.g., MRMC, standalone studies, ground truth establishment by experts, sample sizes for training and test sets), are not applicable in this context.

This 510(k) summary focuses on demonstrating substantial equivalence for an extension to an existing mechanical spinal implant system. The "performance data" section explicitly states: "Mechanical testing including static compression bending, static torsion, dynamic axial compression tests have been performed according to ASTM F1717-12. Results demonstrate that additional components perform as safely and effectively as their predicate devices. No clinical data has been presented."

Therefore, I cannot provide a table of acceptance criteria and device performance as requested in the format for an AI device. Instead, I can summarize the mechanical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance (for mechanical testing):

This information is not explicitly detailed in a pass/fail table format within the provided 510(k) summary. However, the summary states:

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

• Test Set Sample Size: Not applicable. For mechanical testing, this typically refers to the number of devices or components tested. The specific number of components and repetitions for each test (static compression bending, static torsion, dynamic axial compression) according to ASTM F1717-12 is not specified in the summary but would have been part of the full testing report.
• Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data originates from laboratory testing conducted by the manufacturer according to specified ASTM standards.

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

• Not applicable. Ground truth as typically understood for AI/ML refers to clinical labels or expert annotations on patient data. For mechanical testing, the "ground truth" is compliance with engineering standards and performance relative to predicate devices, verified by engineering and regulatory experts within the testing facility and the FDA.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are relevant for human expert review of clinical data. For mechanical testing, results are objectively measured and compared against predefined engineering specifications and predicate device performance.

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/ML device that assists human readers.

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

• Not applicable. This is a mechanical device.

7. The type of ground truth used:

• For mechanical testing, the "ground truth" is adherence to validated engineering test standards (ASTM F1717-12) and comparison against the performance of legally marketed predicate devices. The objective is to demonstrate that the new components meet the same safety and effectiveness profiles as the existing, approved devices.

8. The sample size for the training set:

• Not applicable. There is no AI/ML algorithm involved to train.

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

• Not applicable. There is no training set for an AI/ML algorithm.

Ask a specific question about this device

ROMEO posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as a posterior, non-cervical, non-pedicle screw fixation system, ROMEO posterior osteosynthesis system is intended for the following indications for the following indications; degenerative disc disease(DDD) (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.

The modifications to ROMEO posterior osteosynthesis system (K081165, K093170, K101678) manufactured by SPINEART consist of addition of addition of R093170, 11010707 manufacturers - Public Public and pedicle hooks and pedicle hooks (angled, Ma These components are supplied either sterile or not sterile.

The provided text describes a 510(k) summary for a medical device called the "ROMEO posterior osteosynthesis system." It discusses modifications to an existing device, its intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain the level of detail requested regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of device performance metrics like sensitivity, specificity, AUC, or F1 score derived from a clinical or imaging study.

The performance data mentioned is focused on mechanical testing rather than clinical or imaging performance.

Here's a breakdown based on the information provided and what is missing:

The document states:
"Mechanical testing including static compression bending, static torsion, dynamic Mcchanical testing moraing performed according to ASTM F1717-10. Results compression that additional components perform as safely and effectively as their predicate devices."

And:
"ass, matther, performance testing according to special control demonstrate that Non- ellined. Ponents are as safe, as effective, and performs as safely and effectively as their predicate devices."

This indicates that the acceptance criteria are based on mechanical performance standards and equivalence to predicate devices in those mechanical aspects.

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

• Static compression bending
• Static torsion
• Dynamic mechanical testing | Conforms to ASTM F1717-10 standards.
  "additional components perform as safely and effectively as their predicate devices."
  "as safe, as effective, and performs as safely and effectively as their predicate devices." |
  | Substantial Equivalence:
• Intended use
• Material
• Design
• Mechanical properties
• Function | "ROMEO posterior osteosynthesis system additional Substantial - agently and inter predicate device in terms of interms of intended use, material, design, mechanical properties and function." |
  | Special Controls:
• Conformance to "Spinal System Special - Suidance for Industry and FDA Staff Document" issued on May 3, 2004. | Device "conforms to special control established for Pedicle screw spinal system." |

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

• Not provided. The document describes mechanical testing, not a clinical or imaging study with a "test set" of patient data.

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

• Not applicable. This information is relevant for clinical or imaging studies involving human interpretation or assessment, which is not described here.

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

• Not applicable. This information is relevant for clinical or imaging studies involving human interpretation or assessment, which is not described 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

• Not applicable. This document pertains to a mechanical spinal implant system, not an AI or imaging diagnostic device.

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

• Not applicable. This document pertains to a mechanical spinal implant system, not an AI or imaging diagnostic device.

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

• For mechanical testing, the "ground truth" would be the standards themselves (e.g., ASTM F1717-10 specifications) and the performance of the predicate devices as a benchmark for equivalence. There isn't a "ground truth" in the sense of clinical disease diagnosis or pathology.

8. The sample size for the training set

• Not applicable. This document describes mechanical testing for a spinal implant, not a machine learning model that requires a training set. If "sample size" refers to the number of devices or components tested, that specific number is not provided, only that "Mechanical testing including static compression bending, static torsion, dynamic Mcchanical testing moraing performed..."

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

• Not applicable. As above, this is not a machine learning context.

Ask a specific question about this device

ROMEO posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The modifications to ROMEO posterior osteosynthesis system (K081165, K093170, K101678) manufactured by SPINEART consist of addition of Extension of the length range of pre-bent Rod Ø5.4mm (35, 45 and 55 mm) Extension of the length range of straight Rod Ø5.4mm (55 mm) Extension of the length range of transverse Connectors (20, 30 and 40 mm) Addition of iliac Connectors (Length 15, 20, 30, 40, 50 and 60 mm) Addition of axial Rod Connector, Parallel Rod Connector, Addition of Percutaneous pre-bent and straight titanium Rod Ø5.4 (Length 30 to 200 mm) These components are supplied either sterile or not sterile

The provided document is a 510(k) summary for a medical device called the ROMEO posterior osteosynthesis system. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing of the additional components. It does not describe a study about the performance of an AI/ML powered device, nor does it contain acceptance criteria or reported performance metrics typically associated with such devices.

Therefore, I cannot extract the information required in your request regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI-powered device.

The "Performance data" section refers to:

• Acceptance Criteria/Standards: Conformity to "special control established for Pedicle screw spinal system" and to "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on May 3, 2004.
• Study: Mechanical testing including static axial compression, static torsion, and dynamic axial compression tests have been performed according to ASTM F1717-09.
• Reported Device Performance: "Results demonstrate that additional components perform as safely and effectively as their predicate devices."

This is, however, for the physical components of the spinal system, not for an AI/ML powered device.

Ask a specific question about this device

ROMEO posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The modifications to ROMEO posterior osteosynthesis system (K081165 & K093170) manufactured by SPINEART consist of addition of 4.0 and 8.0 mm in diameter polyaxial screws made of titanium alloy, addition of Cobalt Chrome alloy rods, and extension of length range for other screw diameter and rods.

The provided text is a 510(k) summary for a medical device called the "ROMEO posterior osteosynthesis system." This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, rather than clinical performance based on diagnostic accuracy. Therefore, many of the requested categories related to diagnostic studies and expert-driven ground truth are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This study involves mechanical testing of device components, not a test set of patient data.
• Data Provenance: Not applicable. The data comes from mechanical test reports on the device components, not from patient populations or countries of origin.

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 this context refers to engineering specifications and performance standards (ASTM F1717-09, FDA guidance), not expert interpretation of diagnostic images or patient outcomes.

4. Adjudication method for the test set

• Not applicable. There was no need for adjudication as the study did not involve interpretation of test results by multiple human readers.

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 not an AI-assisted diagnostic device; it is a spinal implant system.

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

• Not applicable. This is not an algorithmic device. The "standalone" performance refers to the mechanical integrity of the device components themselves.

7. The type of ground truth used

• The ground truth in this submission is the mechanical performance standards defined by ASTM F1717-09 and the FDA's "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document." The device effectively measures up against these established engineering and regulatory benchmarks.

8. The sample size for the training set

• Not applicable. There is no training set of data for this type of device.

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

• Not applicable. There is no training set for this type of device.

Ask a specific question about this device

ROMEO posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

ROMEO posterior osteosynthesis system includes pedicular screws, spondylolisthesis screws longitudinal rods and transverse connector rods, connector and nut. All components of ROMEO posterior osteosynthesis system are made of TA6V4ELI conforming to ISO 5832.3 and ASTM F 136. ROMEO components are supplied either sterile or not sterile and with a complete set of surgical instruments.

This document is a 510(k) summary for the SPINEART ROMEO posterior osteosynthesis system. It details the device's characteristics, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain the specific information required to complete the table and answer all questions related to acceptance criteria and a study proving those criteria.

The 510(k) process for devices like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical performance studies to meet specific acceptance criteria in the same way an AI/ML software device would. The "Performance data" section refers to conformity with "special control established for Pedicle screw spinal system" and "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document," which primarily relate to mechanical properties, material biocompatibility, and sterilization, rather than performance metrics like sensitivity or specificity.

Therefore, many of the requested fields are not applicable or the information is not present in this document.

Here's an attempt to answer based only on the provided text, with clear indications where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

The provided document describes a 510(k) submission, which is a regulatory pathway to demonstrate substantial equivalence to a predicate device, not necessarily a study to prove novel acceptance criteria for device performance in the clinical sense (like AI/ML performance metrics). The "Performance data" section mentions conformity to established special controls and guidance documents for pedicle screw spinal systems. This implies that testing was conducted to meet the mechanical, material, and labeling requirements outlined in those documents, which are the "acceptance criteria" for this type of device within the 510(k) framework. However, the document does not detail specific study methodologies or results beyond the statement of conformity.

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

• Sample size for test set: Not applicable and not provided. The 510(k) does not describe a clinical performance study with a "test set" in the context of diagnostic or AI/ML performance. The "performance data" refers to compliance with regulatory standards, likely involving mechanical testing of device components, not patient data sets.
• Data provenance: Not applicable.

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. Ground truth as typically defined for AI/ML performance evaluation is not relevant to this 510(k) submission for a spinal implant.

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

• Not applicable.

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. This is a spinal implant, not an AI/ML diagnostic or assistive device.

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

• No. This is a spinal implant.

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

• Not applicable. For a spinal implant, "ground truth" would relate to material properties, mechanical strength, biocompatibility, and clinical outcomes, evaluated through engineering tests and clinical follow-up (though no clinical study data is presented in this summary, as per the nature of the 510(k) process for this device type).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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ROMEO posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

ROMEO posterior osteosynthesis system includes pedicular screws, spondylolisthesis screws longitudinal rods and transverse connector rods, connector and nut. All components of ROMEO posterior osteosynthesis system are made of TA6V4ELI conforming to ISO 5832.3 and ASTM F 136. ROMEO components are supplied either sterile or not sterile and with a complete set of surgical instruments

The provided text describes a medical device, the "ROMEO posterior osteosynthesis system," and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria, device performance metrics, or any associated study data (sample sizes, ground truth establishment, expert qualifications, etc.).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study that proves the device meets them based on the provided text. The output will reflect this lack of information for each requested point.

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

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. The document does not describe a clinical or performance study with a test set that would involve sample sizes or data provenance. The clearance is based on substantial equivalence to a predicate device.

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. The document does not describe a study involving ground truth establishment by experts for a test set.

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

Not applicable. The document does not describe a study involving adjudication for a test set.

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. The document is for a physical medical device (osteosynthesis system) and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. The document is for a physical medical device and does not describe an algorithm or software.

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

Not applicable. The document does not describe a study that utilized ground truth.

8. The sample size for the training set

Not applicable. The document does not describe a training set for an algorithm or a study with a training phase.

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

Not applicable. The document does not describe a training set or its ground truth establishment.

Ask a specific question about this device