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The PSG 5.5mm Cannulated Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.

The PSG 5.5mm Cannulated Pedicle Screw System is a non-cervical spinal fixation system. Pedicle screw fixation is limited to skeletally mature patients.

The PSG 5.5mm Cannulated Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.

The provided document is a 510(k) premarket notification for a medical device called the "PSG 5.5mm Cannulated Pedicle Screw System." This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance rather than clinical efficacy studies in the context of AI/software-as-a-medical-device (SaMD). Therefore, many of the requested details about acceptance criteria, clinical study design, and AI performance metrics are not applicable or available in this submission.

However, I can extract the information relevant to the device's mechanical performance and what the submission provides in place of clinical study details.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices such as pedicle screw systems, "acceptance criteria" and "reported device performance" are typically defined by engineering standards to ensure mechanical integrity and safety. In this context, the device's performance is compared against these standards and to predicate devices.

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

The document does not specify the exact sample sizes (number of devices or test repetitions) used for the mechanical tests. It only states that the device "has been tested" according to the ASTM standards.

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

This is not applicable as the device is a mechanical implant, not an AI/SaMD that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM F1717-13).

4. Adjudication method for the test set

Not applicable. Mechanical testing is objective and relies on measurements and adherence to specified test protocols, not human adjudication of results.

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 pedicle screw system, not an AI/SaMD for diagnostic imaging or decision support. No MRMC study was performed.

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

Not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this type of device is defined by engineering standards and established mechanical performance characteristics relevant to spinal implants. Specifically, the ASTM F1717-13 standard dictates the methodologies and expected performance metrics for static and dynamic mechanical integrity. Comparison to legally marketed predicate devices also serves as a benchmark for "ground truth" in terms of acceptable clinical performance and safety.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a mechanical device, not a machine learning algorithm.

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

Not applicable.

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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys® Spinal System is intended to provide immobilization and stabilization of spinal segments 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 neurologic impairment and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys system is indicated for use in patients:

• Who are receiving fusions with autogenous graft only; ●
• Who are having the device fixed or attached to the lumbar or sacral spine; .
• Who are having the device removed after the development of a solid fusion . mass.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer® DTO™ Implant, rodacord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer DTO Implant is a cord-rod combination implant that is assembled intraoperatively by the final tightening of the fastening pin that secures the connection of the cord and the rod. The U & I Corporation OPTIMA ZS Transition Screw is a pedicle screw that is part of the OPTIMA ZS Spinal System. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are implanted on contiguous levels the Zimmer DTO Implant and the OPTIMA ZS Transition Screw are used at the interface of these two systems. The cord portion of the Zimmer DTO Implant interfaces with the Dynesys Spinal System. The rod portion of the Zimmer DTO Implant interfaces with the OPTIMA ZS Transition Screw and with the OPTIMA ZS Spinal System.

The provided text is a 510(k) summary for the Zimmer® DTO™ Implant, a spinal fixation system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices based on design, materials, function, and intended use, rather than presenting a detailed clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided text. The requested information is simply not present in this regulatory submission.

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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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