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The Space Vision® PLIF (Posterior Lumbar Interbody Fusion® TLIF (Transforaminal Lumbar Interbody Fusion) and Space Vision® OLIF (Oblique Lumbar Interbody Fusion) systems are intervertebral body fusion devices indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with Space Vision® PLIF, SpaceVision® TLIF systems. These devices are to be filled with autogenous bone graft material. These devices can be implanted via posterior or transforaminal approaches. SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF systems must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

The SpaceVision® PLIF system (Posterior Lumbar Interbody Fusion), the SpaceVision® OLIF system (Oblique Lumbar Interbody Fusion) and the SpaceVision® TLIF system (Transforaminal Lumbar Interbody Fusion) are intended as an internal spacer between the vertebral bodies of the lumbar (L2-S1) spine to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain. The design of the cages is adapted to the vertebral anatomy. SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF systems consist of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages. The systems are supplied sterile or non-sterile. The SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF cages are made from PEEK Optima (Invibio, Inc.) ASTM F2026 and ASTM F560 Tantalum wire. X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment. SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF implants are supplied with their specific instrumentation and trial spacers.

The provided document describes the SpaceVision® PLIF, SpaceVision® OLIF, and SpaceVision® TLIF systems, which are intervertebral body fusion devices. This is a 510(k) premarket notification, indicating the device's substantial equivalence to legally marketed predicate devices, not requiring extensive clinical trials to demonstrate effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This is primarily achieved through mechanical testing to show comparable properties.

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

The document does not describe a test set or data provenance in the context of typical clinical studies for performance evaluation. For a 510(k) submission based on substantial equivalence, the "test set" primarily refers to the physical devices undergoing mechanical testing, not a patient cohort.

• Sample Size: Not specified for the mechanical testing. For physical device testing, usually a statistically appropriate number of devices are tested, but the exact count isn't in this summary.
• Data Provenance: Not applicable in the sense of retrospective or prospective patient data from a specific country, as "No clinical data has been presented." The data provenance for the mechanical testing would be the testing facility (ENDOLAB PI-52 protocol is mentioned) and the specific ASTM standards used.

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

This information is not applicable as "No clinical data has been presented." The "ground truth" here is the adherence to mechanical performance standards and comparability to predicate devices, not clinical diagnoses made by experts.

4. Adjudication Method for the Test Set

This information is not applicable as "No clinical data has been presented" and no human expert review or adjudication of a "test set" in the clinical sense was performed.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical data has been presented." Therefore, there is no effect size reported for human readers improving with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical intervertebral body fusion system, not a diagnostic algorithm or AI-powered tool. The concept of "algorithm only" performance is not relevant to this type of medical device submission.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established mechanical performance standards (ASTM standards) and the mechanical properties of the legally marketed predicate devices. The goal is to demonstrate that the SpaceVision® systems meet these standards and are comparable. There is no expert consensus, pathology, or outcomes data used as ground truth for this specific submission, as clinical data was not presented.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical implant, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable. As there is no training set mentioned, the method for establishing its ground truth is irrelevant.

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When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S.™ and LUMIS™ systems are indicated for:
• Degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Fracture
• Spinal stenosis
• Tumors
• Failed previous fusion (pseudoarthrosis)
The U.L.I.S.™ and LUMIS™ systems are pedicle screw systems indicated for skeletally mature patients who:
• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion.
In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems 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 (T10-S1):
• Degenerative spondylolisthesis with objective evidence of neurologic impairment
• Fracture
• Spinal tumor
• Failed previous fusion (pseudoarthrosis)

The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods. Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied non-sterile.
The purpose of this submission is to include new devices: the U.L.I.S.™ Multi-Axial Reduction Screws, additional instruments to the U.L.I.S.™ System; additional lengths for the LUMIS™ Spinal Rods; and the use of LUMIS™ Spinal Rods with U.L.I.S.™ System.

This document is a 510(k) summary for medical devices (pedicle screw fixation systems), which primarily focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about a study proving that the device meets acceptance criteria in the context of an AI/ML powered device.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it describes a traditional medical device submission, not an AI/ML product:

• A table of acceptance criteria and the reported device performance: This document does not present performance metrics or Acceptance Criteria for an AI/ML device. It discusses mechanical performance testing for the pedicle screw system, but that is not relevant to AI/ML acceptance criteria.
• Sample sized used for the test set and the data provenance: No test set for an AI/ML model is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts for ground truth establishment for an AI/ML model are mentioned.
• Adjudication method for the test set: No adjudication method for an AI/ML model's test set is mentioned.
• 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: No MRMC study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is mentioned.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth for an AI/ML model is mentioned.
• The sample size for the training set: No training set for an AI/ML model is mentioned.
• How the ground truth for the training set was established: No ground truth for an AI/ML model's training set is mentioned.

In summary, the provided text is a 510(k) submission for a pedicle screw fixation system, not a submission for an AI/ML powered medical device. Therefore, the requested information regarding AI/ML device acceptance criteria and study details is not present. The document states: "No clinical data is presented." and "No mechanical data is presented: no mechanical test is required for the added components." indicating that the submission relies on engineering analysis and validation/verification to support substantial equivalence to existing predicate devices.

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