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INNOVERSE Navigation Instruments are intended to be used during the preparation and placement of INNOVERSE Spinal System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in spinal procedures. These instruments are designed for use with the stereotactic navigation system Medtronic® StealthStation™, 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The INNOVERSE Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation™ Navigation System to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of pedicle screw implants.

The INNOVERSE Navigation Instruments include awls, probes, taps, and drivers and are to be used with the INNOVERSE Spinal System.

All instruments are made from Stainless Steel per ASTM F899. The INNOVERSE Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation™ Navigation System hardware and software.

The provided text is a 510(k) Summary for the "INNOVERSE Navigation Instruments." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and, in this case, a single performance test. It does not contain information about a study designed to prove the device meets specific acceptance criteria in the way one might expect for an AI algorithm or diagnostic tool.

Instead, the performance data section of this document describes non-clinical testing for positional accuracy of the instruments themselves, not a clinical study involving human-in-the-loop performance or AI-driven diagnostic capabilities.

Therefore, many of the requested categories for the description of "the study that proves the device meets the acceptance criteria" are not applicable to the information provided.

Here's an attempt to answer based on the available text, with significant caveats where information is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document only explicitly mentions one performance test and its results.

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

The document describes "non-clinical testing" for positional accuracy (per ASTM F2554-18). This typically involves testing the instruments in a laboratory setting, not on a "test set" of patient data.

• Sample size for the test set: Not applicable in the context of patient data for an algorithm. The "sample" would refer to the number of instruments tested or the number of measurements taken, which is not specified.
• Data provenance: Not applicable. The testing is non-clinical, likely performed in a lab.

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

Not applicable. The ground truth for positional accuracy would be established by precision measurement equipment in a laboratory setting, not by human experts interpreting data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for human interpretation or multi-expert assessment, which is not described here. Positional accuracy is typically measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on the instruments themselves and their positional accuracy, not on human reader performance with or without AI assistance.

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

No, this is not a study of an algorithm's standalone performance. The device is a set of surgical instruments, not an AI or imaging algorithm.

7. The Type of Ground Truth Used

The ground truth for the single mentioned performance test (positional accuracy) would be based on precise physical measurements using calibrated equipment, as per the ASTM F2554-18 standard. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is a set of physical surgical instruments and does not involved a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this type of device.

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The UniSpace® Stand-Alone C Cage is a standalone anterior cervical interbody fusion device indicated for skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The UniSpace® Stand-Alone C Cage implants are to be used with either autogenous bone graff and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. The Cages of the UniSpace® Stand-Alone C Cage must be used with the two internal fixation screws provided. The Cages with ≥ 20° lordosis must be used with an additional supplemental fixation system that has been cleared by the FDA for use in the cervical spine, in addition to the two integrated fixation screws provided.

This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The UniSpace® Stand-Alone C Cage is product for cervical spinal column stability. The implants of the UniSpace® Stand-Alone C Cage consist of the Cages manufactured through additive manufacturing (ASTM F3001) and the machined Variable screws and Locking plates (ASTM F136). The Locking plate consists of a Blocking plate and a Locking screw and is an additional device for the anti-backout of the Variable screw. This optional implant can help users who feel uncomfortable with the primary self-locking mechanism or when rescue screws are utilized. The Cages and Variable screws are provided in a variety of sizes to accommodate each patient's individual clinical case. The Cages are designed to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The Cages of the UniSpace® Stand-Alone C Cage are provided as a sterile pack. The UniSpace® Stand-Alone C Cage is implanted by using the instruments manufactured from stainless steel material that conform to ASTM F899.

The provided text describes the UniSpace® Stand-Alone C Cage, an intervertebral body fusion device. However, it does not contain information about acceptance criteria and device performance in the context of a clinical study or a study involving human readers and AI. The document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence to predicate devices, supported by bench testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
• Standalone (algorithm-only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

The provided text only details the mechanical (bench) testing performed for the device. Here's what can be extracted regarding the bench testing:

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

The document states: "The mechanical performance of UniSpace® Stand-Alone C Cage falls within the acceptance criteria which have been established from the predicate devices." and "The testing meets all acceptance criteria and verifies that performance of the UniSpace® Stand-Alone C Cage is substantially equivalent to the predicate devices and reference devices."

However, the specific numerical acceptance criteria or the reported device performance metrics (e.g., specific load values, displacement, cycles to failure) are not provided in the text. It only lists the types of tests performed.

The remaining points (2-9) are not applicable as the document describes a bench testing study for a physical medical device (intervertebral cage) and not a study involving AI, human readers, or a test/training set of data for diagnostic purposes.

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The INNOVERSE Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

The INNOVERSE Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of variety pedicle screws, rods, set screws, connectors and cross link. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. Pedicle Screw is provided in Modular type (Tulip is provided in a separated state and assembled after screw insertion.) and pre-assembly type (Tulips are supplied assembled.). All pedicle screws have self-tapping function in INNOVERSE Spinal System. The tulip accommodates a 5.5 and 6.0 mm diameter rod in Ti Alloy and CoCr for increased construct rigidity. The INNOVERSE Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The INNOVERSE Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537).

The provided document is a 510(k) premarket notification summary for the INNOVERSE Spinal System. The device is a posterior, noncervical pedicle fixation system and is categorized as a Class II medical device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing clinical trial data for AI performance. Therefore, many of the requested criteria related to AI device evaluation (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this particular document.

Here's a breakdown of the information that can be extracted from the provided text, and where certain requested information is not available:

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

Note: The document states that the new device's performance is "substantially equivalent" to that of the predicate device for each test. Specific numerical thresholds or detailed results for individual tests are not provided in this summary but would be present in the full 510(k) submission.

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

This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device that would typically use data sets for performance evaluation in the way described. The "tests" here refer to mechanical engineering tests of the device itself.

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 for the same reasons as above. Ground truth, in the context of this device, would relate to the physical properties and performance of the hardware, which are evaluated through standardized mechanical testing methods, not expert consensus on data.

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

This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device. Mechanical tests follow predefined protocols (e.g., ASTM standards) rather than requiring expert adjudication of results in the way clinical data might.

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 submission for a spinal implant system, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

This information is not applicable as this submission is for a mechanical spinal system, not an AI algorithm.

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

For this mechanical device, the "ground truth" or reference for evaluating its performance comes from established ASTM standards (ASTM F1717, ASTM F1798) and comparison to the predicate device's previously cleared performance.

8. The sample size for the training set

This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device that requires a training set.

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

This information is not applicable for the reasons stated above.

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The ANAX™ 5.5 SPINAL SYSTEM is a posterior, non cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• · Spondylolisthesis (Grade 3 and 4)
• · Degenerative spondylolisthesis with objective evidence of neurological impairment
• · Trauma (i.e., fracture or dislocation)
• · Spinal stenosis
• · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• · Pseudoarthrosis
• · Failed previous fusion

The ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors and a transverse (cross) linking mechanism. The ANAX™ 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The ANAX™ 5.5 Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All pedicle screws have self-tapping function in ANAX™ 5.5 Spinal System The double lead thread is applied to the all pedicle screws to shorten the operation time. ANAX™ 5.5 Spinal System with CoCr rods may be used to provide immobilization and stabilization of spinal segment when the rigid system is need. (Recommendation: trauma or deformities) The product life time of ANAX™ 5.5 Spinal System is 2 years based on mechanical test result. The purpose of this submission is to add uniplanar screws and connectors to the ANAX™ 5.5 Spinal System.

The FDA 510(k) summary for the ANAX™ 5.5 Spinal System (K231737) indicates that the device's performance was evaluated through mechanical testing to demonstrate substantial equivalence to its predicate devices. Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the mechanical performance of the ANAX™ 5.5 Spinal System "met the acceptance criteria which have been established from the predicate device." However, the specific quantitative acceptance criteria values (e.g., specific load values, deflection limits, or number of cycles) are not explicitly provided in the excerpt. Similarly, the reported quantitative device performance data is also not presented in the document. The summary only states that the device "met all acceptance criteria."

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

The document does not specify the sample size (number of devices, components) used for each mechanical test. Mechanical tests typically involve multiple samples to ensure repeatability and statistical significance, but the exact numbers are not mentioned in this summary.

Data Provenance: The tests are described as "mechanical strength evaluation" and "performance testing" conducted to compare the proposed device with predicate devices. This is not clinical data, but rather laboratory-based engineering test data. The document does not specify the country of origin for the testing itself, but the manufacturer is based in Korea (Innosys Co., Ltd., Uijeongbu-si, Gyeonggi-do, Korea). These are not retrospective or prospective studies in the clinical sense, but rather benchtop studies.

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" for mechanical performance is established by validated international standards (ASTM F1717, ASTM F1798) and comparison to previously cleared predicate devices, not by human expert consensus on clinical findings. Therefore, no experts were used to establish a "ground truth" in the way clinical diagnostic studies would.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or evaluators in clinical studies. Mechanical testing involves objective measurements against predefined criteria, not subjective interpretation requiring adjudication among experts.

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. The ANAX™ 5.5 Spinal System is a physical medical device (spinal fixation system), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

This question is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical tests, the "ground truth" is defined by the specifications and performance characteristics of the predicate devices and the requirements outlined in the relevant ASTM standards (ASTM F1717 and ASTM F1798). The goal was to demonstrate that the proposed device performs equivalently to the predicate devices and meets established engineering standards for spinal fixation systems.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of mechanical testing for a physical implant. Training sets are typically used for machine learning algorithms.

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

This question is not applicable, as there is no training set for this type of device.

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