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The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OPTIMA™ 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system, the OPTIMA™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis such as scoliosis, kyphosis, tumor, pseudoarthrosis, or revision of failed fusion attempts. In case of spinal deformities, OPTIMAT® may be used, with posterior hook.

The OPTIMA™ Spinal System is a top-loading multiple component, anterior / posterior Spinal System which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism.

The OPTIMA™ Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote fusion. The implants are sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) supplied from stock that conforms to AOTM 1-100. Various sizes of these implants are available.
Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system

Here's a breakdown of the acceptance criteria and the study details for the OPTIMA™ Spinal System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary for a spinal system, which is a medical device. For such devices, "acceptance criteria" are typically met by demonstrating substantial equivalence to a predicate device through engineering and mechanical testing, rather than clinical performance metrics often seen with diagnostic software. The "reported device performance" is the successful completion of these standard mechanical tests.

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

• Sample Size: Not applicable. The "test set" in this context refers to the physical samples of the OPTIMA™ Spinal System components used for mechanical testing, not a dataset of patient images or clinical data. The quantity of implants tested is not specified, but it would have been sufficient to meet the requirements of the ASTM standards.
• Data Provenance: Not applicable. The testing described is mechanical, conducted in a lab environment to assess the physical properties and performance of the device.

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

This is not applicable for this type of device and study. "Ground truth" in this context usually refers to a definitive diagnosis or condition established by medical experts for evaluating the accuracy of a diagnostic device. For the OPTIMA™ Spinal System, the "ground truth" for its performance is its physical integrity and mechanical properties as demonstrated by standardized engineering tests.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing according to ASTM standards does not involve adjudication by experts in the way clinical diagnostic studies do. The results are objective measurements against defined criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices to evaluate human reader performance with and without AI assistance. The OPTIMA™ Spinal System is a surgical implant, not a diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. The OPTIMA™ Spinal System is a physical medical implant, not an algorithm or software requiring standalone performance testing.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance (demonstrating substantial equivalence) was compliance with established engineering standards (ASTM F1717-01 & ASTM F1798-97) through mechanical testing. This verifies the physical and mechanical properties of the device are equivalent to, or better than, the predicate device.

8. The Sample Size for the Training Set

Not applicable. The device is a surgical implant, not an AI or machine learning system that requires a "training set."

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

Not applicable, as there is no training set for this device.

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The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OPTIMA™ 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

When used as an anterior screw fixation system, the OPTIMA™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

The OPTIMATM Spinal System is a top-loading multiple component, anterior / posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism.

The OPTIMA™ system will allow surqeons to build a spinal implant construct to stabilize and promote spinal fusion. The OPTIMA™ implant system components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system

The provided text is a 510(k) summary for the OPTIMA™ Spinal System, which is a medical device for spinal fixation. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through materials, design, indications for use, and operational principles, often supported by bench testing. It does not involve the kind of performance criteria and clinical study details related to AI or diagnostic device accuracy that your questions are designed to gather.

Therefore, I cannot provide the requested information in the format you've specified because the submission does not contain:

• Acceptance criteria and reported device performance (beyond general equivalence to predicates).
• Details on sample sizes or data provenance for test sets.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Specific types of ground truth (expert consensus, pathology, outcomes data).
• Training set sample sizes or how their ground truth was established.

The "Performance Data" section explicitly states: "Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices." This refers to mechanical testing, not clinical performance metrics or AI/diagnostic accuracy.

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The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OPTIMA™ 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: degenerative Spondylolisthesis with objective evidence of neurological impairment; fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system, the OPTIMA™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scollosis, kyphosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

The OPTIMA™ Spinal System is a top-loading multiple component, anterior / posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism.

The OPTIMA™ system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The OPTIMA™ implant system components are supplied non-sterile are single use and are fabricated from titanium allov (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system

The provided text describes a 510(k) summary for the OPTIMA™ Spinal System, a medical device. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through comparison of design, materials, and intended use, along with basic bench testing to show functional equivalence.

Therefore, the study described is not a clinical study involving human participants or AI for diagnostic purposes. It is a bench test evaluating the mechanical performance of a spinal implant system. As such, many of the requested categories are not applicable or cannot be answered from the provided text.

Here's the breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified for the bench testing. The ASTM F1717 standard would outline the minimum number of samples required for various tests (e.g., static compression, static torsion, fatigue).
• Data Provenance: Not explicitly stated, but bench testing typically occurs in a controlled laboratory environment. It is not patient data (retrospective or prospective) from a country of origin in the traditional sense.

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

• Not applicable. For mechanical bench testing of an orthopedic implant, "ground truth" is established by adherence to a recognized international standard (ASTM F1717) and engineering principles, rather than expert clinical consensus.

4. Adjudication method for the test set

• Not applicable. Mechanical tests are objective measurements, not subjective evaluations 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

• Not applicable. This device is a physical spinal implant, not an AI-powered diagnostic tool requiring human reader performance evaluation.

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

• Not applicable. This device is a physical spinal implant.

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

• For this type of device, the "ground truth" for demonstrating performance is adherence to validated mechanical testing standards (ASTM F1717) and demonstrating mechanical equivalence to predicate devices. This indicates that the device can withstand the expected physiological loads without premature failure, similar to existing approved devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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The FOREX Corporation, OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OPTIMA™ 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the OPTIMA™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

The OPTIMATM Spinal System is a top-loading multiple component, anterior / posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The OPTIMA™ system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The OPTIMA™ implant system components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system.

The information provided describes the FOREX Corporation OPTIMA™ Spinal System, a medical device. The document primarily focuses on its 510(k) submission for market clearance, establishing substantial equivalence to predicate devices, and thus does not directly address typical acceptance criteria and performance studies commonly seen in AI/ML device submissions.

Instead, the "acceptance criteria" for this device are met through demonstrating substantial equivalence to already legally marketed predicate devices, and the "study" proving this involves bench testing.

Here's how to frame the requested information based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The document states "Bench testing as listed in Section XII". Section XII is not provided, so the specific sample size for the bench tests is not specified in the given text.
   • The data provenance is from bench testing, meaning in-vitro mechanical and material tests, not patient data.

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

   • This question is not applicable in the context of this 510(k) submission. Bench testing for mechanical properties does not typically involve human expert adjudication for ground truth. The "ground truth" for these tests would be the measured physical properties compared against established engineering standards (ASTM F1717) and the properties of predicate devices.

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

   • This is not applicable. Bench testing results are typically objectively measured and do not require adjudication by experts in the same way clinical or imaging studies might.

4. 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 is a spinal implant system, not an AI or imaging device that would involve human readers.

5. 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 device is a physical medical implant, not a software algorithm.

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

   • The "ground truth" for the bench testing was established by standardized mechanical testing protocols (ASTM F1717) and engineering specifications. The performance was compared to that of legally marketed predicate devices.

7. The sample size for the training set:

   • This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

   • This is not applicable as there is no training set for a physical implant device.

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