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The Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used for posterior non-cervical screw fixation in pediatric patients, the Rexious System, Statera™ Spinal Fixation System, and Statera-MTM System are indicated as an adjunct to fusion to treat: adolescent idiopathic scoliosis, progressive spinal deformities (i.e., scolosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, spondylolisthesis, spondylolysis, pseudarthrosis, failed prior fusion, and fracture caused by tumor and/or trauma in pediatric patients. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

When used as an anterolateral thoracolumbar system, the Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System are intended for anterolateral screw (with staples) fixation for the following indications: degenerative discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, set screws, connectors, hooks, washers, staples, and transverse (cross) linking mechanisms.

The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.

This document describes the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System, which are spinal fixation systems. However, the provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study for AI/software devices.

Instead, this is a 510(k) summary for a medical device (spinal hardware), which focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than fulfilling specific performance acceptance criteria through clinical trials or software validation studies. The "performance data" referred to is primarily mechanical testing of the physical implants, comparing them to the predicate device.

Therefore, many of the requested sections (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of device and submission.

Here's an analysis based on the provided text, while acknowledging its limitations for the requested AI/software-centric details:

1. Table of Acceptance Criteria and Reported Device Performance

For this spinal fixation system, "acceptance criteria" and "reported device performance" are primarily focused on mechanical integrity and equivalence to the predicate device, not on diagnostic accuracy or AI performance.

• Static compression bending
• Dynamic compression bending
• Static Torsion

These tests "demonstrate that the Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the legally marketed predicate devices." |
| Design and Functionality Equivalence: The device design (components, principle of operation) is substantially equivalent to the predicate device. | The subject device has "the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device." "There are no technological differences between the Subject device and its predicate devices." |

Note: For the Rexious Spinal Fixation System (part of the submission), no performance testing was required because it is identical to a system already cleared under K222415.

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

• Sample Size for Test Set: Not applicable in the context of clinical/AI test sets. For mechanical testing, the "sample size" would refer to the number of physical implants tested. This specific number is not provided in the document, but it would have followed the requirements of ASTM F1717 for mechanical samples.
• Data Provenance: The data is from non-clinical bench testing of physical device components, performed to demonstrate mechanical equivalence. Country of origin is not specified, but it's typically internal lab testing or third-party accredited labs. It is not prospective or retrospective clinical data.

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

• Not applicable. This submission does not involve ground truth established by medical experts for diagnostic or AI performance. The "ground truth" for mechanical testing is adherence to engineering standards and comparison to the predicate device's mechanical properties.

4. Adjudication Method for the Test Set

• Not applicable. There is no adjudication method in the context of expert consensus or diagnostic disagreements, as this is bench testing of physical hardware.

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 hardware medical device, not an AI/software device intended to assist human readers.

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

• Not applicable. This is a physical spinal fixation system, not a standalone algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance Standards and Predicate Device Data: The "ground truth" for this device's performance demonstration is based on established ASTM mechanical testing standards (specifically ASTM F1717) and comparative data from the legally marketed predicate devices. The goal is to show that the subject device performs similarly to or better than the predicate device in these mechanical tests.

8. The Sample Size for the Training Set

• Not applicable. There is no training set as this is not an AI/machine learning device.

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

• Not applicable. There is no training set for this type of device.

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The Rexious Spinal Fixation System 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 disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Rexious Spinal Fixation System is intended for use as a posterior, non-pedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Rexious Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and transverse (cross) linking mechanisms.

The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Rexious implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.

This document is a 510(k) summary for the Rexious Spinal Fixation System. It explicitly states that no performance testing was required for this submission. The basis for clearance is that the device is identical to previously cleared predicate devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be provided from the given text because such studies were not conducted for this specific submission.

The relevant section from the document is:

• Performance Data: "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K100765, K113324, K111362, and K173131. No testing is required."

This means the device's acceptance was based on its substantial equivalence to a previously cleared device, not on new performance data demonstrating it meets specific acceptance criteria through a new study.

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The Rexious Spinal Fixation System is intended to provide immobilization 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

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

The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Rexious implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.

This document describes a spinal fixation system, not an AI device. As such, the typical acceptance criteria and study designs relevant to AI (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable here.

Instead, the document details the Rexious Spinal Fixation System, a medical device subject to FDA 510(k) clearance. The "acceptance criteria" for such a device are primarily demonstrated through substantial equivalence to a predicate device, supported by performance testing and engineering analysis.

Here's an interpretation of the request in the context of this device:

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

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

• Sample Size: The document does not specify a "sample size" in the context of clinical data for a "test set" as one would for an AI algorithm. Instead, it refers to the addition of components and various sizes of these implants. The testing (ASTM F1717) would have been performed on a statistically relevant number of samples of each component or construct configuration to demonstrate mechanical properties. The exact number of samples for each test (e.g., how many rods of each length, how many screws of each size) is not explicitly stated in this summary.
• Data Provenance: Not applicable in the context of clinical data as no clinical study is described for this 510(k) submission. The data provenance refers to material testing and engineering analysis.

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

• Not applicable. This device's clearance is based on mechanical performance testing and substantial equivalence, not on expert-adjudicated clinical "ground truth" data sets like an AI model would require.

4. Adjudication method for the test set:

• Not applicable. There is no human adjudication of a "test set" in the context of this device. Mechanical tests have objective pass/fail criteria based on standards (e.g., ASTM F1717).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with or without AI assistance. This is a spinal fixation system, not a diagnostic imaging or AI device.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• For a spinal fixation system, the "ground truth" for performance is typically established by:
  • Material specifications: Adherence to recognized ASTM standards for implant materials (e.g., ASTM F67, F136, F1295, F1537).
  • Mechanical test standards: Performance meeting the requirements of established international standards for spinal implants (e.g., ASTM F1717 for static and dynamic compression bending). These standards define the expected mechanical behavior and failure modes.
  • Engineering analysis: Demonstrating that design changes (like new rod lengths or materials) do not introduce new "worst-case" scenarios or negatively impact performance compared to the predicate.

8. The sample size for the training set:

• Not applicable. This is a medical device (hardware), not an AI algorithm, so there is no "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

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The Rexious Spinal Fixation System is a posterior 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 Rexious Spinal Fixation System is intended to provide immobilization 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).

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

The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The DIO Spinal System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available.

The provided document does not contain information about acceptance criteria or a study proving the device meets them in the context of AI/ML or diagnostic performance. Instead, it is a 510(k) summary for a spinal fixation system, focusing on substantial equivalence to predicate devices for regulatory approval.

Key points from the document regarding "performance data":

• No new testing: "The addition of components to the system did not introduce a new worst case construct, and therefore no additional testing was performed."
• Substantial Equivalence: The conclusion is based on establishing substantial equivalence to predicate devices (e.g., Fixpine II System (K100765)) in terms of design, materials, indications, intended use, packaging, labeling, and performance.

Therefore, none of the specific questions related to AI/ML device performance (acceptance criteria, sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set details) can be answered from this document. The "Performance Data" section in this submission refers to the mechanical performance and safety of the spinal implant, which is assessed through comparison to an existing device rather than through a clinical study with acceptance criteria as typically defined for diagnostic or AI/ML-driven devices.

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