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The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Lotus Posterior Cervical/Thoracic Spinal 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 Lotus Posterior Cervical/Thoracic Spinal System may be connected to the Mercury® Spinal System with the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury Spinal System. Refer to the Mercury Spinal System package insert for a list of the Mercury Spinal System indications for use.

The Lotus Posterior Cervical/Thoracic Spinal System consists of a variety of fixation devices manufactured from Ti-6Al-4V that are attached to the spine. Screws may be placed from a posterior approach into the cervical and/or thoracic spine. Hooks may be placed on the posterior elements of the various vertebrae. Rods span the distance between the screws/hooks, and various other connectors may be used between rods or between rods and screws/hooks. The system achieves fixation by the mechanical joining of the rods, screws, hooks and connectors. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.

The provided text is a 510(k) premarket notification for a medical device called the "Lotus® Posterior Cervical/Thoracic Spinal System." This document primarily focuses on demonstrating the substantial equivalence of the device to legally marketed predicate devices, rather than presenting a study that establishes acceptance criteria and then proves the device meets them through clinical or standalone performance studies against a ground truth.

Therefore, many of the requested elements (acceptance criteria, device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth, training set size, and training set ground truth establishment) are not present in the provided text.

The document discusses performance testing but these are typically mechanical tests to ensure structural integrity and safety, not clinical performance against acceptance criteria for diagnostic or therapeutic efficacy as would be seen in AI or drug approval processes.

Here's a breakdown of what can be extracted and what is missing:

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

• Not found. This document doesn't define clinical acceptance criteria (e.g., sensitivity, specificity, accuracy, or a specific clinical outcome measure) for the device. The "performance data" mentioned refers to mechanical testing.

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

• Not found. This section is not applicable as there is no test set for clinical performance, only mechanical testing of components.

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 found. This section is not applicable as there is no test set or ground truth established in the context of clinical performance.

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

• Not found. This is not applicable.

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 found. This device is a surgical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this device.

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

• Not found. This device is a physical surgical implant, not an algorithm.

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

• Not found. Not applicable for this type of device and submission. The "ground truth" for mechanical testing would be the engineering specifications and material properties, against which the physical tests are performed.

8. The sample size for the training set

• Not found. Not applicable, as this device does not involve a training set for an algorithm.

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

• Not found. Not applicable, as this device does not involve a training set for an algorithm.

What is provided regarding "Performance Data":

The document states under "Performance Data":
"Published literature and performance testing support substantial equivalence. Tests included:

• Interconnection testing per ASTM F 1798
• Dynamic Compression Bending per ASTM F 1717
  All data indicates that the device will perform as intended."

Interpretation for your request:

• Acceptance Criteria (Mechanical): The acceptance criteria for these tests would be the specifications outlined in the ASTM F 1798 (Standard Guide for Spinal Implant Material Selection) and ASTM F 1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) standards. These standards define methods for testing the mechanical properties and fatigue life of spinal implant constructs. The device "meets" these acceptance criteria if it passes the specified tests according to the standard's requirements (e.g., withstands certain forces, lasts for a specified number of cycles without failure).
• Reported Device Performance (Mechanical): The document generally states, "All data indicates that the device will perform as intended," implying it met the criteria of the ASTM standards. Specific numerical performance values (e.g., ultimate tensile strength, bending modulus, fatigue life in cycles) are not provided in this summary.
• Study That Proves the Device Meets Acceptance Criteria: The study referred to is the "performance testing" based on the ASTM F 1798 and ASTM F 1717 standards. These are in vitro mechanical engineering studies, not clinical trials.
• Sample Size for Test Set: For mechanical testing, this refers to the number of device constructs tested. This information is not specified in the document (e.g., "n=5 constructs were tested").
• Data Provenance: The tests are in vitro laboratory tests, not human data.
• Ground Truth: For mechanical testing, the "ground truth" would be the engineering specifications and material science principles, and the expectation that the device should not fail under conditions prescribed by the ASTM standards.

In summary, the provided document is a regulatory submission for a physical medical device (spinal system) focusing on substantial equivalence based on prior clearances and mechanical performance testing, not on clinical performance against a diagnostic or therapeutic ground truth as your questions imply for something like an AI device.

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