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It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial pedicle screws and offset connectors are limited to the thoracic spine (T1-T3) in treating thoracic conditions only. These screws and offset connectors are not intended to be placed in the cervical spine. The components in the SOLANAS Posterior stabilization system can be linked to the components in the Zodiac Polyaxial spinal fixation system offered by Alphatec Spine using the axial rod connectors, parallel rod connectors or transitional rods

1. Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
2. Spondylolisthesis
3. Spinal stenosis
4. Fracture/Dislocation
5. Atlanto/Axial fracture with instability
6. Revision of previous cervical spine surgery
7. Tumors

The Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graff healing and/or fusion mass development. Device implants include a range of sizes of bone screws, hooks, rods and bridge assemblies to provide the versatility required for the specific conditions listed in the indications. The implants are manufactured from surgical grade titanium alloy (Ti-6AI-4V, ASTM F 136) with an electrolytic conversion coating. All hook components are intended for fixation/attachment to the cervical spine only (CI-C7). It is intended that the implants be removed after successful fusion.

The Solanas Posterior Stabilization System is a rod system designed to improve the stability of the cervical, cervico-thoracic and upper thoracic spine from C1-T3. This titanium alloy (Ti6Al-4V ELI, ASTM F136) system is simple in design and in its application of posterior rod fixation. It contains integrated functioning screws, rods, hooks, and connectors. The laminar hooks are an integral part of this system providing stabilization to the cervical (C1-C7) portion of the spine. These hooks attach to the lamina via the blade portion of the hook on one end and to a rod via a set screw and collar connection on the other end.

The provided text is related to a 510(k) premarket notification for a medical device called the "Solanas Posterior Stabilization System." This document is a regulatory filing for a spinal implant system and does not describe a study involving device performance metrics, human readers, or AI.

Therefore, I cannot extract information related to:

• A table of acceptance criteria and reported device performance (in terms of clinical or algorithmic metrics)
• Sample sizes for test sets or data provenance in the context of device performance
• Number and qualifications of experts for ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies
• Type of ground truth used (expert consensus, pathology, outcomes data)
• Sample size for the training set
• How ground truth for the training set was established

However, I can provide information about the non-clinical testing performed to establish substantial equivalence for this spinal implant system.

Based on the provided text, here is the relevant information:

Acceptance Criteria and Study for the Solanas Posterior Stabilization System (Mechanical Testing)

The Solanas Posterior Stabilization System is a spinal implant. The "acceptance criteria" and "study" mentioned in the document refer to mechanical testing performed to demonstrate that the modified device (with larger hook blades of 7mm and 8mm) is substantially equivalent to a previously cleared predicate device.

Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: The document does not specify the exact number of units or subassemblies tested. It refers to "a subassembly" and "the subject and predicate devices."
• Data provenance: Not applicable in the context of mechanical testing of physical devices. The testing was performed by Alphatec Spine, Inc.

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. This was mechanical testing of a medical device, not a study involving ground truth established by medical experts. The "ground truth" here is the adherence to mechanical testing standards.

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

• Not applicable. This refers to consensus among human readers, which is not relevant for mechanical testing.

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 510(k) for a physical spinal implant, not an AI or imaging device.

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

• Not applicable. This is for a physical spinal implant, not an algorithm.

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

• For this mechanical test, the "ground truth" or reference standard would be the established mechanical testing standards and parameters defined in ASTM F1798 and FDA guidance documents. The performance of the modified device was compared against these standards and the predicate device's performance.

8. The sample size for the training set:

• Not applicable. This refers to mechanical testing, not a dataset used for training an algorithm.

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

• Not applicable.

In summary: The provided document describes a regulatory submission for a physical medical device. The "study" mentioned is a mechanical performance comparison to demonstrate substantial equivalence, rather than a clinical trial or an AI/imaging device performance study with expert-adjudicated ground truth.

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It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine. The components in the Solanas Posterior Stabilization System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods

• l Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• 트 Spondylolisthesis
• . Spinal Stenosis
• 트 Fracture/Dislocation
• Atlanto/Axial fracture with instability
• 트 Revision of previous cervical spine surgery
• 트 Tumors

The SOLANAS III™ Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).

Acceptance Criteria and Device Performance for SOLANAS™ Posterior Stabilization System

Based on the provided 510(k) summary for the SOLANAS™ Posterior Stabilization System, the device's acceptance criteria and the study proving its performance are primarily based on substantial equivalence through mechanical and dynamic testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a sample size for the "mechanical and dynamic testing." The data provenance is also not explicitly stated beyond the fact that testing was performed. However, for mechanical and dynamic testing of medical devices in a regulatory submission, these tests are typically conducted in a laboratory setting, not with human or animal subjects, and thus "country of origin of the data" or "retrospective/prospective" wouldn't apply in the same way as clinical data.

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

This type of information is not applicable to the provided performance data. Mechanical and dynamic testing of spinal implants typically involves engineering and material science experts, not medical experts establishing ground truth in the diagnostic sense. The "ground truth" for these tests would be established by validated test methods and established engineering specifications.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable to mechanical and dynamic testing of devices. Adjudication methods are used in clinical trials or studies where human interpretation or consensus is required to establish an outcome or ground truth.

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, an MRMC comparative effectiveness study was not done. The device described is a spinal fixation system (hardware); it is not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical and dynamic testing would have been established by recognized engineering standards and validated test methodologies used to assess the strength, durability, and functional performance of spinal fixation systems. The comparison is made against the performance of legally marketed predicate devices, implying that the predicate devices also met these types of engineering "ground truths."

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this type of device. Training sets are used in machine learning or AI algorithm development. This device's performance is established through physical testing, not algorithmic learning.

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

As noted above, the concept of a "training set" and its associated "ground truth" is not applicable to this medical device.

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Indications for Use: It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine.

1. Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
2. Spondylolisthesis
3. Spinal stenosis
4. Fracture/Dislocation
5. Atlanto/Axial fracture with instability
6. Revision of previous cervical spine surgery
7. Tumors

The SOLANAS™ Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and upper thoracic spine, C1-T3. There are a variety of implants that can be used for this procedure including cervical hooks, polyaxial pedicle screws and rods. All components are made from titanium alloy (ASTM F136).

The provided text describes a medical device submission (K052201) for the SOLANAS™ Posterior Stabilization System, focusing on its substantial equivalence to a predicate device and its indications for use. It outlines the product description, classification, and regulatory disposition. However, it does not contain information related to specific acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or any study results validating such performance in the context of an AI/ML device.

The document primarily focuses on:

• Product Description: SOLANAS™ Posterior Stabilization System, made from titanium alloy, intended for cervical and upper thoracic spine stabilization.
• Indications for Use: Degenerative disk disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, revision of previous cervical spine surgery, and tumors.
• Substantial Equivalence: To the Summit™ system (K002733).
• Performance Data: Mentions "Mechanical testing... was performed and submitted," but provides no details on the tests, criteria, or results. This is typical for mechanical devices where structural integrity and biocompatibility are key, not diagnostic accuracy.
• Regulatory Approval: A 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested table or detailed information about acceptance criteria and study designs (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) because this document pertains to a mechanical spinal fixation system, not a device with performance metrics related to diagnostic accuracy, which is usually the context for the questions you've asked (e.g., sensitivity, specificity, comparison to human readers, ground truth establishment).

In summary, none of the requested information regarding acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) and detailed study methodologies for validating such performance are present in the provided text. The "Performance Data" mentioned refers to mechanical testing, not a clinical study assessing diagnostic or prognostic accuracy.

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