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The Republic Spine Dark Deformity Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine 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 (DDD) (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
• Curvature (i.e. scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• . Failed previous fusion

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Dark Star Deformity Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Dark Star Deformity Pedicle Screw System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/ or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Republic Spine Dark Star Deformity Pedicle Screw System (previously cleared as Dark Star Spinal System) is a multi-component posterior spinal fixation system which consists of pedicle screws, set screws, rods, hooks, connectors, and crosslinks. The system contains non-sterile single use components manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and Cobalt Chromium (CoCr per ASTM F1537). Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Deformity Pedicle Screw System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion.

The scope of the Republic Spine Dark Star Deformity Pedicle Screw System is being extended with this submission via a line extension to offer new implant options including connectors, prebent rods, crosslinks, and hooks and to offer implant design modifications to the uniplanar screws, to the connectors, and to the hooks. New instrumentation will also be introduced to aid in the implantation of the new and existing implants. The indications for use are being expanded to include pediatric applications.

This document does not describe an AI/ML medical device, therefore the requested information for AI/ML performance acceptance criteria and study data is not available. This document is a 510(k) premarket notification for a medical device called the "Dark Star Deformity Pedicle Screw System," which is a spinal implant system.

Instead, the document focuses on the mechanical performance (verification testing) of the spinal implant system to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the performance data presented, related to the physical device:

1. Acceptance Criteria and Reported Device Performance (Implied from the study):

The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets. However, the performance data section indicates that the device was subjected to specific ASTM standards, and the conclusion states that the device is "substantially equivalent" to the predicate device based on this data. This implies that the device's performance results met the thresholds or comparable performance to the predicate device as defined by these ASTM standards.

2. Sample Size and Data Provenance for Test Set:

• This is not applicable as the study involves mechanical testing of physical device components, not a "test set" of clinical data for an AI/ML model. The "samples" would be the physical implants tested under laboratory conditions. The document does not specify the number of implants used for each test.
• Data Provenance: The tests are conducted in a laboratory setting, not with human patient data or from a specific country of origin in the context of clinical data.

3. Number of Experts and Qualifications for Ground Truth:

• This is not applicable to a mechanical testing study of a physical device. Ground truth, in the AI/ML context, refers to a verified label or outcome for a data point, typically established by human experts.

4. Adjudication Method:

• Not applicable for mechanical testing.

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

• Not applicable. This is a study on the mechanical properties of a physical medical device, not on the performance of human readers with or without AI assistance.

6. Standalone Performance Study:

• The "performance data" section (ASTM tests) can be considered a standalone performance study for the mechanical properties of the device components. It assesses the device's ability to withstand various forces and stresses independently. However, this is for the physical device, not an algorithm.

7. Type of Ground Truth Used:

• For mechanical testing, the "ground truth" is implicitly the physical properties and behavior of the materials and design under controlled laboratory conditions, as measured against established scientific and engineering standards (ASTM). The "truth" is the physical reality of how the device performs under specific loads, rather than a clinical label or outcome.

8. Sample Size for Training Set:

• Not applicable as this is not an AI/ML device.

9. How Ground Truth for Training Set was Established:

• Not applicable as this is not an AI/ML device.

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Dark Star Navigated Instrument System is intended to be used during the preparation and placement of Dark Star screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Republic Spine, LLC Dark Star Navigation Instrument System consists of reusable surgical instruments intended for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.

The Dark Star Navigation Instrument System includes taps, awls, probes, and drivers. The Dark Star Navigation Instrument System is to be used with the Dark Star Spinal System.

The instruments are made from stainless steel. The Dark Star Navigation Instrument System is not compatible with implants from other manufacturers and is designed for use only with Medtronic StealthStation Navigation System hardware and software.

The provided text describes the "Dark Star Navigation Instrument System," a medical device intended to assist surgeons in spinal surgery by precisely locating anatomical structures. The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Medtronic Navigated Reusable Manual Instruments).

However, the provided document does not contain any information about an AI/Algorithm component or any studies that would involve AI performance metrics, such as accuracy (sensitivity, specificity, AUC), or a multi-reader multi-case (MRMC) study. The performance data section explicitly states that the device was tested per "ASTM F2554-18, 'Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.'" This standard focuses on the positional accuracy of computer-assisted surgical systems, which relates to the hardware and software's ability to accurately track and display instrument positions, not the performance of an AI algorithm in interpreting medical images or providing diagnostic assistance.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI evaluation, ground truth, and expert adjudication cannot be extracted from this document as they are not relevant to the type of device and testing described.

Based on the provided text, here is what can be inferred:

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

The document states: "The Dark Star Navigation Instrument System has been tested per ASTM F2554-18, 'Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.' The results of this non-clinical testing show that performance of the Dark Star Navigation Instrument System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The specific numeric acceptance criteria for positional accuracy and the reported performance values from the ASTM F2554-18 testing are not detailed in this document. The document only states that the performance was "sufficient for its intended use."

Regarding AI/Algorithm-specific criteria, there are none mentioned.

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

As the performance testing was for the "positional accuracy of computer assisted surgical systems" (hardware/software integration), rather than an image-based AI algorithm, the concept of a "test set" for data provenance (e.g., country of origin, retrospective/prospective) is not applicable in the typical sense for AI studies. The testing would have involved physical measurements and evaluations of the system's accuracy. The sample size for such non-clinical testing (e.g., number of measurements taken, number of test subjects/simulations) is not specified in the document.

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

This information is not applicable as the evaluation is not for an AI algorithm's diagnostic or interpretive performance on medical images. The ground truth for positional accuracy would be established by the physical testing methodology described in ASTM F2554-18.

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

This is not applicable for the type of testing described (positional accuracy).

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

There is no indication that an MRMC study was performed or that an AI component for human reader assistance exists in this device.

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

There is no indication of an AI algorithm in the device that would require standalone performance testing.

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

The ground truth for the device's performance is based on measurements against the "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems" (ASTM F2554-18). It is a technical measurement ground truth, not a clinical or pathological one.

8. The sample size for the training set

There is no mention of a training set, as the document does not describe an AI/machine learning component.

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

There is no mention of a training set or ground truth establishment relevant to AI.

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The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine 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 Disc Disease (DDD) (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;
• Curvature (i.e. scoliosis, kyphosis, and/or lordosis);
• Tumor;
• Pseudoarthrosis; and
• Failed previous fusion.

The Republic Spine Dark Star Spinal System is a multi-component posterior spinal fixation system which consists of pedicle screws, rods, locking spacers, and cross-linking mechanism. The system contains non-sterile single use titanium alloy (Ti-6Al-4V ELI per ASTM F136) and Cobalt Chromium (CoCr per ASTM F1537). Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Spinal System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion.

The scope of the Republic Spine Dark Start Spinal System is being extended via a line extension to include additional rods, connectors, hooks and screws. New instrumentation will also be introduced to aid in the implantation of the new implants.

The safety and effectiveness of the fenestrated screw have not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). The fenestrated screws are intended to be used with saline or radiopaque dye.

This is a medical device submission for the Republic Spine Dark Star Spinal System, which is a multi-component posterior spinal fixation system. As such, the acceptance criteria and performance data are based on non-clinical (mechanical) testing rather than clinical performance (like an AI/CAD system would require).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The subject Republic Dark Star Spinal System implants were subjected to the following verification testing per required standards to establish substantial equivalent performance to the predicate device." It does not provide specific numerical results or pass/fail thresholds for these tests, rather it indicates that the tests were performed and the device demonstrated "substantial equivalent performance."

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

For the non-clinical performance data, the "sample size" refers to the number of devices or components tested for each mechanical test. The document does not explicitly state the exact number of samples tested for each ASTM standard.

• Data Provenance: The tests are described as "verification testing" performed on the "subject Republic Dark Star Spinal System implants." This implies in-house laboratory testing conducted by the manufacturer to demonstrate substantial equivalence to the predicate device. There is no information regarding the country of origin of the data as these are mechanical tests.

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 this type of medical device submission. Ground truth established by experts is typically relevant for diagnostic or clinical evaluation of devices (e.g., AI/CAD systems interpreting images). For mechanical spinal implants, the "ground truth" is defined by the performance requirements of established ASTM standards.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical evaluations or image interpretations where multiple experts assess the same cases. Mechanical testing follows standardized protocols, and results are typically objective measurements.

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

This question is not applicable. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of medical images, often with AI assistance. This submission is for a spinal implant.

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

This question is not applicable. "Standalone performance" refers to the evaluation of an AI algorithm without human involvement. This submission is for a physical medical implant, not an algorithm.

7. The type of ground truth used

For this device, the "ground truth" is based on engineering standards and design specifications. The device's performance is compared against the established mechanical properties and performance characteristics required by the referenced ASTM standards (ASTM F1717 and ASTM F1798) and its predicate device.

8. The sample size for the training set

This question is not applicable. "Training set" is a concept used in machine learning for AI algorithms. For a mechanical implant, there is no "training set" in this context. The manufacturing process and design are based on engineering principles and material science, not statistical training data.

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

This question is not applicable for the reasons mentioned in point 8. The "ground truth" for the design and manufacturing of the device is established by adherence to recognized engineering standards, material specifications, and quality control processes.

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When used as a lumbar intervertebral body fusion device, the Republic Spine Restore Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Republic Spine Restore Intervertebral Body Fixation System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Republic Spine lumbar intervertebral body fusion device, which may be implanted as a single device via an anterior, posterior, transforaminal or lateral approach.

The Republic Spine Restore Intervertebral Body Fusion System implant components are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 or polyether ether ketone (Evonik Vestakeep® i4R) that conforms to ASTM F2026 with tantalum markers (ASTM F560) to assist the surgeon with the proper placement of the device.

The provided document describes a 510(k) premarket notification for the "Republic Spine Restore Intervertebral Body Fusion System," which is a Class II medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to establish safety and efficacy from scratch.

Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial for a novel device. Instead, it focuses on demonstrating that the new device is as safe and effective as existing predicate devices.

Here's how to interpret the available information according to your request categories:

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

The acceptance criteria for a 510(k) submission are generally that the device performs at least as well as (or is substantially equivalent to) the predicate device in relevant performance tests. The "reported device performance" are the results from these comparative tests.

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

• Sample Size for Mechanical Bench Tests: Not explicitly stated as a number of devices (e.g., N=5 per test). It mentions "the subject PEEK device is considered worst case and therefore, was utilized during design verification mechanical bench tests." This implies a representative number of units for each test type was used, as is standard for ASTM testing, but the exact count is not provided.
• Data Provenance: The data is from bench testing conducted by the manufacturer, Republic Spine, LLC, to compare their device to predicate devices. This is not human data (no country of origin or retrospective/prospective designation applies).

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

This information is not applicable as this is a medical device 510(k) submission based on mechanical bench testing and substantial equivalence, not a study involving human subjects or expert image review. There is no concept of "ground truth" derived from expert consensus in this context.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3.

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

This information is not applicable. This is a physical medical device (intervertebral body fusion system), not an AI imaging or diagnostic algorithm. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This information is not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used

For mechanical testing, the "ground truth" is defined by the standards and specifications (e.g., ASTM F2077, ASTM F2267) and the performance characteristics of the predicate devices. The device is considered to meet "ground truth" if its mechanical properties are comparable to or better than the predicate devices and meet the relevant ASTM standards for intervertebral body fusion devices.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning model. The mechanical tests are "verification" tests against standards and predicate performance.

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

This information is not applicable as there is no training set for this type of device submission.

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The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine 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 (T1-S1): · Severe Spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra

• · Degenerative spondylolisthesis with objective evidence of neurologic impairment
• · Trauma (i.e. fracture or dislocation)
• · Spinal stenosis
• · Curvature (i.e. scoliosis, kyphosis, and/or lordosis)
• Tumor
• · Pseudoarthrosis (failed previous fusion)

The Republic Spine Dark Star Spinal System is a multi-component posterior spinal fixation system which consists of pedicle screws, rods, locking spacers, and cross-linking mechanism. The system contains non-sterile single use titanium alloy (Ti-6Al-4V ELI) implantable components that comply with ASTM F136. Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Spinal System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion.

The provided document is a 510(k) premarket notification for a medical device called the "Republic Spine Dark Star Spinal System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel AI/software medical device.

Therefore, the information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment typically requested for an AI/software device is not applicable to this document.

However, I can extract the information that is present concerning the device's performance evaluation, which is focused on mechanical testing for substantial equivalence:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc., as would be expected for an AI/software device. Instead, it states that the device's mechanical strength was evaluated against established standards and found to be "equivalent or better" than the predicate device.

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

This information is not provided in the document. The testing described is mechanical, not involving human data or clinical study subjects.

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. The "ground truth" for mechanical testing is derived from controlled laboratory conditions and adherence to ASTM standards.

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

Not applicable, as this refers to a method for establishing clinical ground truth, which was not part of this submission.

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 spinal implant system, not an AI/software medical device requiring human reader interaction or MRMC studies.

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

Not applicable. This device is a physical medical implant.

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

The "ground truth" for the performance evaluation in this context refers to the specified requirements and methodologies outlined in the referenced ASTM standards (ASTM 1717-13, ASTM F543-07, and ASTM F1798-97). These standards define the acceptable mechanical properties and testing procedures for spinal implants.

8. The sample size for the training set

Not applicable. This device undergoes mechanical testing, not machine learning model training.

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

Not applicable. This device undergoes mechanical testing, not machine learning model training.

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