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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 Normandy VBR System is indicated for use in the cervical spine (C2-C7), and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Normandy VBR 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy. The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.

The provided text is a 510(k) premarket notification summary for a medical device called the "Normandy VBR System." This document describes the device's indications for use, its mechanical characteristics, and its substantial equivalence to predicate devices based on mechanical performance testing.

It is crucial to understand that this document does not describe a study involving an artificial intelligence (AI) device or a study involving human readers/interpreters of medical images. Therefore, I cannot provide information on acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details as requested in your prompt. These elements are typically associated with studies evaluating diagnostic or prognostic AI algorithms, not with physical implantable medical devices like the Normandy VBR System.

The "Performance Data" section explicitly states: "Mechanical test results demonstrated that the Normandy VBR System is substantially equivalent to the predicate devices. Static and Dynamic Axial Compression, Static and Dynamic Torsion, Subsidence, and Expulsion (per internal protocol) testing was performed in accordance with ASTM F2077 and ASTM F2267."

This refers to physical, biomechanical testing of the device's structural integrity and function, not evaluation of a diagnostic algorithm's accuracy or interpretation by human readers.

Therefore, I must state that the requested information (points 1-9) about acceptance criteria and study proving device performance cannot be extracted from the provided text because the device and the associated testing are not related to an AI/diagnostic imaging context.

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The STERISPINE™ LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with STERISPINET™ PS a supplemental fixation system cleared, by the FDA for use in the lumbar spine

SteriSpine™LC range of products consists of lumbar Interbody fusion devices available in sizes to adapt to anatomical variations. SteriSpine™LC is dedicated to transforaminal approach and is manufactured as single solid-machined piece made of PEEK conforming ASTM F2026. Markers made of tantalum conforming to ASTM F560-08 are used to visualize the position of the implant in the disc space. STERISPINE LC Lumbar Interbody Devices are supplied sterile with a single-use set of surgical instruments.

Here's an analysis of the provided text regarding the STERISPINE LC device's acceptance criteria and study information:

Key Takeaway: The STERISPINE LC device's acceptance criteria and studies are focused on demonstrating mechanical equivalence to predicate devices. There is no clinical data presented in this 510(k) summary, meaning no studies assessing AI performance, human reader improvement, or standalone algorithm performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly met by achieving "comparable mechanical properties to the predicate device." The submission does not specify numerical thresholds for these properties but rather relies on a comparative assessment.

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

• Test Set Sample Size: Not applicable. The provided document details mechanical and cadaveric testing, not clinical studies or AI model evaluations with a "test set" of patient data.
• Data Provenance: Not applicable. The studies are non-clinical mechanical tests and cadaveric studies, not involving patient data from specific countries or types of studies (retrospective/prospective).

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

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus. For cadaver testing, the "ground truth" would be the successful validation of instrument function, likely assessed by surgeons or relevant technical personnel, but no specific number or qualifications are mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept is relevant for clinical or diagnostic studies involving human interpretation or consensus, which are not described here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study Done? No. The submission explicitly states: "No clinical data has been presented." Therefore, no MRMC study assessing human reader improvement with or without AI assistance was performed or presented.

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

• Standalone Study Done? No. This device is an intervertebral body fusion device (an implantable medical device), not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

• Type of Ground Truth:
  • For Mechanical Testing: The ground truth is based on established engineering standards (ASTM F2077-03, ASTM F2267-04) and the mechanical properties of the legally marketed predicate devices (Lumbar I/F cage manufactured by Depuy Acromed and Zavation IBF System manufactured by Zavation LLC).
  • For Cadaver Testing: The ground truth is the successful validation of the instrumentation's function in a simulated surgical environment (cadavers).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI algorithm, so there is no training set mentioned or relevant in this context.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.

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