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When used as a pedicle screw fixation system in skeletally mature patients, the NuVasive Reline System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

The Nu Vasive Reline System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthrosis
7. Tumor resection and/or
8. Failed previous fusion

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System is indicated as an adjunct to fusion to treat:

1. adolescent idiopathic scoliosis.
2. progressive spinal deformities (i.e., scoliosis, or lordosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis,
3. spondylolisthesis,
4. spondylolysis,
5. pseudarthrosis,
6. failed prior fusion and
7. fracture caused by tumor and/or trauma in pediatric patients.

Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

In order to achieve additional levels of fixation, the NuVasive Reline System rods may be connected to the Armada System.

The NuVasive Reline System is a pedicle screw system that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to introduce "Dual-Headed Modular Connectors" which will be included in the NuVasive Reline System. Additionally, this submission is intended to specify pediatric progressive deformities in the indications for use statement for NuVasive Reline System. Lastly, this submission is intended to add minor labeling changes to address compatibility updates to the NuVasive Reline system.

The provided document describes the NuVasive Reline System, a pedicle screw system, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria in the context of diagnostic accuracy or clinical outcomes.

The "Performance Data" section (G) on page 6 refers to nonclinical testing, which are engineering tests to assess the physical properties and mechanical performance of the device. These are distinct from clinical studies designed to evaluate diagnostic accuracy or the effectiveness of AI algorithms.

Therefore, I cannot fulfill the request as the document does not provide the necessary information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study related to meeting such criteria.

The information provided is focused on demonstrating substantial equivalence for a medical device (pedicle screw system), primarily through design comparison, material composition, and mechanical testing according to established ASTM standards.

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When used as a pedicle screw fixation system, the Nu Vasive Reline System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

The Nu Vasive Reline System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthosis
7. Tumor resection and/or
8. Failed previous fusion

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive Reline System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

In order to achieve additional levels of fixation, the NuVasive Reline System rods may be connected to the Armada System.

The NuVasive Reline System is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to introduce design modifications to previously cleared components and add iliac saddle to previously cleared Reline System.

This document describes a 510(k) premarket notification for the NuVasive Reline System, a thoracolumbosacral pedicle screw system.

Here's an analysis based on your request, but please note that this type of FDA 510(k) summary typically does not include detailed clinical study data with acceptance criteria, sample sizes, expert qualifications, or MRMC studies for traditional orthopedic implants like pedicle screw systems. Instead, it relies heavily on substantial equivalence to predicate devices and mechanical performance testing.

Therefore, many of the requested points below will be answered with "Not applicable/provided" or explanations about why such details are not present in this type of submission.

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

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: Not specified in the provided document. The testing seems to be based on mechanical (bench) testing, not patient data.
• Data Provenance: Not applicable, as no human data is described. The engineering rationale and mechanical testing would be conducted in a laboratory setting.
• Retrospective/Prospective: Not applicable, as no human data is described.

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/provided. This device is a mechanical implant, and its performance for 510(k) relies on mechanical testing and substantial equivalence to existing devices, not clinical ground truth established by medical experts in an diagnostic or interpretive sense.

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

• Not applicable/provided. As there's no clinical test set with human assessments or interpretations, adjudication methods are not relevant.

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/provided. This is a spinal implant, not an AI software/diagnostic device. MRMC studies are not relevant to its 510(k) clearance process described here.

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

• Not applicable/provided. This is a physical medical device, not an algorithm or AI system.

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

• Not applicable in the clinical sense. The "ground truth" for this type of device typically refers to engineering specifications, material properties, and the performance standards established by predicate devices and ASTM standards, validated through mechanical testing.

8. The sample size for the training set

• Not applicable/provided. This refers to the training of an algorithm or AI model, which is not relevant to this device's submission.

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

• Not applicable/provided. This refers to the ground truth for an AI model's training, which is not relevant to this device's submission.

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When used as a pedicle screw fixation system, the Nu Vasive Reline System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

When used for posterior non-cervical screw fixation in pediatric patients, Nu Vasive Reline System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive Reline System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The Nu Vasive Reline System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthosis
7. Tumor resection and/or
8. Failed previous fusion

In order to achieve additional levels of fixation, the Reline System rods may be connected to the Armada System.

The NuVasive Reline System is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. This 510(k) is to add new components to the Reline System.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets them because the provided text describes a 510(k) premarket notification for the "NuVasive® Reline™ System" which is a pedicle screw spinal system.

The document is an FDA clearance letter and a 510(k) summary, and it primarily focuses on establishing substantial equivalence to existing predicate devices based on design, intended use, material composition, and function. The "Performance Data" section mentions nonclinical testing (e.g., dynamic compression bending per ASTM F1717) but does not provide quantitative acceptance criteria or detailed results that would allow me to populate a table of acceptance criteria and reported device performance.

Furthermore, this type of device (spinal fixation system) does not typically involve the kinds of studies (e.g., standalone algorithm performance, MRMC studies, expert consensus on image interpretation, training/test set data provenance, ground truth establishment for AI/diagnostics) that would be needed to answer the specific questions posed about device performance for an AI/diagnostic device. The information requested is relevant to AI/machine learning medical devices, which this product is not.

Therefore, I cannot fulfill the request as the provided text relates to a different type of medical device lacking the details you are asking for.

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When used as a pedicle screw fixation system, the Nu Vasive Reline System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).

When used for posterior non-cervical screw fixation in pediatric patients, the NuVasive Reline System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the NuVasive Reline System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatic pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The NuVasive Reline System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline System is also intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudoarthosis, (7) tumor resection, and/or (8) failed previous fusion.

The NuVasive Reline System is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. This 510(k) is to expand the indications for use to include treatment of adolescent idiopathic scoliosis.

This document is a 510(k) premarket notification for the NuVasive Reline System. It is a submission to the FDA for a medical device, which means it addresses substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study. Therefore, most of the information requested in your prompt regarding acceptance criteria and a study to prove performance is not applicable to this type of document.

The document primarily focuses on establishing substantial equivalence based on design, intended use, materials, and technological characteristics compared to existing cleared devices, not on presenting novel performance data from an independent study specifically for this device.

Here's a breakdown based on the provided text, indicating why certain requested information is not available:

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

• Not Applicable. This document does not present acceptance criteria for a new device's performance nor does it report specific performance outcomes from a study on the NuVasive Reline System itself. It asserts substantial equivalence to predicate devices, meaning it is expected to perform comparably to already cleared devices.

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

• Not Applicable. No new performance testing or clinical studies are reported for the NuVasive Reline System in this submission. Therefore, there is no "test set" or associated data described.

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

• Not Applicable. As no new performance testing data is presented, there is no "ground truth" establishment process for a test set described.

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

• Not Applicable. Again, no test set or performance evaluation requiring adjudication is presented in this document.

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 device is a spinal fixation system (pedicle screw system), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant to this submission.

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

• Not Applicable. This is a hardware medical device, not an algorithm or software. "Standalone performance" in the context of an algorithm is not relevant here.

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

• Not Applicable. No new clinical or performance data requiring ground truth is presented for the NuVasive Reline System. The "ground truth" in this context refers to the established safety and effectiveness of the predicate devices to which the NuVasive Reline System is compared.

8. The sample size for the training set

• Not Applicable. As this is a hardware device submission, not an AI/ML algorithm, there is no "training set."

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

• Not Applicable. There is no training set for this device.

Summary from the document relevant to performance/equivalence:

• G. Performance Data: "No new performance testing was performed. Comparison to the predicate devices was provided to support substantial equivalence."
• H. Conclusions: "The subject NuVasive Reline System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use."

The document states that substantial equivalence was demonstrated through comparison in areas including design, labeling/intended use, material composition, and function to its predicate devices (Arsenal Spinal Fixation System K133221 and GSB Global Spinal Balance System K132014), not through new performance studies specific to the NuVasive Reline System.

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The TRUBYTE® SOFT RELINE SYSTEM is for use as a long-term resilient lining material for removable dentures.

The TRUBYTE® SOFT RELINE SYSTEM consists of three components: TRUBYTE® Soft Reline Material, TRUBYTE® Soft Reline Bonder, and TRUBYTE® Adhesive Remover.

TRUBYTE® Soft Reline Material is a silicone putty that is heat polymerizable. It is a one-component material based on an elastomer and benzoyl peroxide.

TRUBYTE® Soft Reline Bonder is a heat polymerizable methacrylate monomer and methacrylate polymer blend liquid.

TRUBYTE® Adhesive Remover is D-Limonene, a liquid food-grade solvent, intended for use in removing impression material tray adhesives.

TRUBYTE™ Soft Reline Material is bonded to the denture with the TRUBYT® Soft Reline Bonder, packed and compressed, and then heat cured. TRUBYTE Adhesive Remover is used to clean an existing denture prior to relining. The Adhesive is completely eliminated prior to using Soft Reline Material and Bonder.

This document describes the TRUBYTE® SOFT RELINE SYSTEM, a dental device. The information provided is primarily focused on safety testing for biocompatibility and does not detail performance acceptance criteria in the typical sense for an AI/CAD-driven medical device. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document confirms these safety aspects but does not provide quantitative metrics or specific thresholds for "acceptance" beyond simply stating "non-cytotoxic," etc. This is characteristic of biocompatibility testing rather than performance metrics for an AI algorithm.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document describes biocompatibility tests performed on the material itself, not on a dataset of patient information for an AI algorithm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. Ground truth, in the context of AI, refers to annotated data for training and evaluating models. This document details material testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used in AI studies to resolve discrepancies in ground truth labels, 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

Not applicable. This is not an AI-driven device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the biocompatibility tests is the scientific methodology and established safety standards (e.g., ISO standards for cytotoxicity, irritation, etc.) for evaluating material safety. The results are based on direct experimental observation (e.g., cell culture reactions for cytotoxicity, animal responses for irritation).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set for an AI algorithm. The components have "prior use in predicate devices," which implies historical clinical experience and material performance data, but this is not a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI training set involved. The "ground truth" for the predicate devices' historical use would have been established through clinical observation, material science testing, and regulatory approval processes over time.

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