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The PERLA® posterior cervico-thoracic fixation system is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C 1 to C7) and the thoracic spine from TI-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radios, and degenerative disease of the facets with instability.

The PERLA® posterior cervico-thoracic fixation system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the PERLA® posterior cervico-thoracic fixation system may be connected to the ROMEO® Posterior Osteosynthesis System with rod connectors. Transition rods may also be used to connect the PERLA® posterior cervico-thoracic fixation system to the ROMEO® Posterior Osteosynthesis System. Refer to the ROMEO® Posterior Osteosynthesis System package insert for a list of the ROMEO® Posterior Osteosynthesis System indications of use.

The Spineart Perla® system is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and the upper thoracic spine. Perla® system consists of a variety of shapes and sizes of rods, hooks, multi-axial screws, set screws, rod connectors and transverse 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® system can also be linked to the cleared Spineart Romeo®2 spinal system (K151695) using the specific Perla® Axial and Parallel Rod to Rod connectors 3.5/5.4mm or the Perla® Transition Rods 3.5/5.4mm which are part of this submission.

The provided document is a 510(k) summary for the PERLA® Posterior Cervico-Thoracic Fixation System. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about the acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML device.

The information provided describes a traditional medical device (implantable fixation system for spinal segments) and its FDA clearance process. It does not involve AI or algorithms, and therefore, the requested information about AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not applicable or present in this document.

Therefore, the table below will be filled with "Not Applicable" or "Information Not Provided" as the document pertains to a physical medical device and not an AI/ML system.

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: Information Not Provided (Not applicable to a physical spinal fixation system)
• Data Provenance: Information Not Provided (Not applicable to a physical spinal fixation system)

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

• Number of Experts: Information Not Provided (Not applicable to a physical spinal fixation system)
• Qualifications of Experts: Information Not Provided (Not applicable to a physical spinal fixation system)

4. Adjudication method for the test set

• Adjudication Method: Information Not Provided (Not applicable to a physical spinal fixation system)

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 Conducted?: No (Not applicable; this is a physical spinal fixation system, not an AI/ML system for image interpretation or diagnosis by human readers.)
• Effect Size: Not Applicable

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

• Standalone Study Conducted?: No (Not applicable; this is a physical spinal fixation system, not an AI/ML algorithm.)

7. The type of ground truth used

• Type of Ground Truth: Information Not Provided (Not applicable to a physical spinal fixation system. For this device, "ground truth" would refer to manufacturing specifications, material properties, and mechanical testing results, which are detailed in the document but not in the context of diagnostic "ground truth" for AI.)

8. The sample size for the training set

• Training Set Sample Size: Information Not Provided (Not applicable to a physical spinal fixation system)

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

• Ground Truth Establishment: Information Not Provided (Not applicable to a physical spinal fixation system)

Summary of Device Performance (from the document, relevant to a physical device):

The document states that "Published literature and bench testing per ASTM F1717 demonstrate that the PERLA® posterior cervico-thoracic fixation system is substantially equivalent to the predicate devices."

The following non-clinical tests were conducted:

• Static Compression Bending, Static Torsion, and Dynamic Compression Bending according to ASTM F1717.
• Static flexion-extension testing, Static axial gripping, and Static torsion gripping according to ASTM F1798.
• Axial pullout strength and Torque to failure according to ASTM F543.

The conclusion is that "Design comparisons and non-clinical performance testing demonstrate that the PERLA® posterior cervico-thoracic fixation system is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function."

These tests and their results are used to establish substantial equivalence for a traditional spinal implant, not to evaluate the performance of an AI/ML algorithm against predefined acceptance criteria for diagnostic accuracy or similar metrics.

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The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm Systems. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems. When used with the 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems.

When used with the 3.5/6.0 mm and 4.0/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5/5.5 mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be lined to the Matrix System.

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors.

Synthes USS

• 6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
• 5.5 mm Rod System: Matrix
• 5.0 mm Rod System: USS Small Stature

CerviFix

• 3.5 mm Rod Systems: CerviFix, Axon, Synapse
• 4.0 mm Rod System: Synapse

The Synthes Matrix System is an addition to Synthes' existing posterior thoracolumbar spine systems. The Matrix System consists of a family of non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2), posterior hook fixation (T1-L5) or anterolateral fixation (T8-L5). The implants include pedicle bone screws, polyaxial pedicle screws, monoaxial pedicle screws, polyaxial heads, reduction screws, reduction heads, locking caps, transconnectors, transverse bars, rods and hooks. The implants are primarily manufactured from titanium (ASTM F67 - 06), titanium alloy (ASTM F1295 - 05), cobalt-chromium-molybdenum alloy (ASTM F1537 - 08) or nitinol (ASTM F2063 - 05), similar to the predicates.

The subject of this submission is the addition of transverse bars and tapered rods.

The document describes the Synthes Matrix System, a spinal fixation device. The study provided focuses on non-clinical performance testing rather than clinical trials with human subjects or AI performance.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Synthes conducted the following non-clinical testing..." but does not detail the number of units tested for each type of test.
• Data Provenance: The testing was non-clinical, conducted by Synthes. It does not involve human subjects, so concepts like country of origin or retrospective/prospective don't apply in the medical imaging sense.

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

• This question is not applicable to the provided document. The study is a non-clinical, mechanical performance test, not a study evaluating human judgment or diagnostic accuracy. The "ground truth" here is compliance with ASTM standards, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

• Not applicable. As noted above, this is a mechanical performance test, not a study involving human readers or adjudicators of medical data.

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 non-clinical performance study of a spinal fixation device, not a study involving AI or human readers of medical images.

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

• No. This is a non-clinical performance study of a spinal fixation device, not an algorithm.

7. The type of ground truth used

• The "ground truth" implicitly used for this non-clinical testing is the mechanical performance requirements specified in ASTM F1717–09 standards for static compression bend, static torsion, and dynamic compression bend testing. The device's performance was compared against these established industry standards and against predicate devices.

8. The sample size for the training set

• Not applicable. This is a non-clinical performance study of a physical device, not an AI algorithm that requires a training set.

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

• Not applicable for the same reason as point 8.

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When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Plate/Rod/Occipital Screws/Hooks
The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.
The use of the occipitocervical plate/rod requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.

Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors
The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

The titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailormade for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion.
The VERTEX® Reconstruction System is fabricated from medical grade titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Never use stainless steel and titanium implant components in the same construct.

The VERTEX® Reconstruction System is a medical device and its "performance" is based on mechanical testing demonstrating substantial equivalence to predicate devices, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This device is not a software or AI-driven system; its "performance" is demonstrated through mechanical testing to show substantial equivalence to already marketed devices. There are no specific acceptance criteria percentages (e.g., sensitivity, specificity) for device performance in this 510(k) summary, as it's a hardware device.

2. Sample Size for Test Set and Data Provenance

Not applicable. This device's clearance is based on mechanical testing (benchtop) rather than a clinical "test set" of patient data. Therefore, there's no data provenance in terms of country of origin or retrospective/prospective nature.

3. Number of Experts for Ground Truth and Qualifications

Not applicable. Ground truth for a hardware device in mechanical testing is typically defined by engineering specifications and objective measurements, not expert consensus.

4. Adjudication Method

Not applicable. There's no adjudication method mentioned as it's not a clinical study involving human assessment of device outcomes or image interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a hardware device submission, not an AI/software device that would involve human readers. Therefore, no MRMC study was performed, and there is no effect size of human readers improving with AI assistance.

6. Standalone Performance Study

In a sense, the mechanical testing is a "standalone" performance evaluation of the device components themselves, independent of human interaction in a diagnostic or interpretive capacity. However, it's not "standalone (i.e. algorithm only without human-in-the loop performance)" as understood in AI contexts. The testing determines if the components meet strength, fatigue, and other biomechanical criteria comparable to predicate devices.

7. Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be engineering specifications, biomechanical standards, and comparative data from predicate devices. This involves objective measurements of strength, durability, and other physical properties.

8. Sample Size for Training Set

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

9. How Ground Truth for Training Set was Established

Not applicable. No training set was used.

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