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The PERLA® TL posterior osteosynthesis system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL posterior osteosynthesis system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL posterior osteosynthesis system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PERLA® TL posterior osteosynthesis system consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The Perla®TL system is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® TL posterior osteosynthesis implants are delivered either non sterile or sterile (gamma sterilization) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. The subject product line extension of the PERLA® TL Posterior Osteosynthesis System manufactured by Spineart (K193396) consists of addition of cannulated screws (various models), fenestrated screws (various models), percutaneous rods and associated surgical instruments.

This is a 510(k) premarket notification for a medical device (PERLA® TL posterior osteosynthesis system), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and data provenance related to AI/ML performance is not present in the provided document.

The document discusses the substantial equivalence of the PERLA® TL device to legally marketed predicate devices, focusing on:

• Indications for Use: The system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions in skeletally mature patients and for adolescent idiopathic scoliosis in pediatric patients.
• Device Description: It consists of screws, rods, set screws, hooks, rod connectors, and cross-connectors made from medical-grade titanium alloy and cobalt chromium. The current submission is a product line extension adding cannulated and fenestrated screws, percutaneous rods, and associated instruments.
• Technological Characteristics: The added components share the same indications for use, function, material composition, design, range of sizes, and mechanical performance as predicate devices.
• Non-clinical Performance Testing: Static compression bending, static torsion, and dynamic compression bending tests were conducted according to ASTM F1717 to demonstrate comparable mechanical properties to predicate devices.

Therefore, the information regarding acceptance criteria, study design, and data specifics that would be relevant for an AI/ML-based device (e.g., sample size, expert consensus, ground truth, effect size) is not applicable to this submission.

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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; 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.

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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).

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.

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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).

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.

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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.

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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