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The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) system is an intervertebral body fusion device 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 Hexanium PLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via the posterior approach. Hexanium PLIF system must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the cage as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® PLIF cages are available in heights of 7-16 mm (in 1 mm increments), width of 9 mm, lengths of 22 and 25 mm, and lordosis angles of 0°, 5°, and 8°. Hexanium® PLIF cages are provided sterile and supplied with a set of non-sterile surgical instruments.

The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) system is an intervertebral body fusion device. The provided text lacks the detailed "acceptance criteria" and subsequent "reported device performance" typically found in a clinical study report for AI-powered devices. The document is a 510(k) summary for a medical device (an intervertebral body fusion device, not an AI device) where equivalence to a predicate device is established through mechanical testing, not clinical performance data. Therefore, the questions related to AI device performance metrics, such as sensitivity, specificity, or human-in-the-loop performance, and associated study details are not applicable here.

However, I can extract information related to the device's performance data that was provided to demonstrate substantial equivalence:

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

The document states that the Hexanium® PLIF cages conform to the FDA guidance "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" dated June 12, 2007. The device was evaluated against predetermined functional and performance requirements and external standard requirements.

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

• Sample Size: Not specified in the document for mechanical testing. These tests typically involve a specific number of device samples (e.g., typically N=6 or more) for each test configuration, as defined by the ASTM standards, but the exact number is not provided.
• Data Provenance: The tests are laboratory-based mechanical and biocompatibility tests, not human data. The document does not specify a country of origin for the testing itself, but the submitter is based in France.

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. The device is not an AI device requiring expert-established ground truth for a test set. The performance is assessed against engineering standards and material properties.

4. Adjudication method for the test set:

This question is not applicable. There was no clinical adjudication for an AI device. Mechanical and biocompatibility tests are assessed against predefined pass/fail criteria from international standards.

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. No MRMC study was conducted as this is not an AI device. The document explicitly states: "No clinical data has been presented."

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

This question is not applicable. This is not an AI device.

7. The type of ground truth used:

For mechanical testing, the "ground truth" is defined by the objective pass/fail criteria established within the referenced ASTM international standards for intervertebral body fusion devices (e.g., F2077, F2267, F-04.25.02.02). For biocompatibility, the ground truth is the pyrogen limit specification as per USP.

8. The sample size for the training set:

This question is not applicable. There is no training set as this is not an AI/machine learning device. The device's design and manufacturing process are based on established engineering principles for intervertebral body fusion devices.

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

This question is not applicable. There is no training set for an AI device. The device's performance is demonstrated through in-vitro mechanical and biocompatibility testing against predefined standards.

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The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck 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 weeks of non-operative treatment prior to treatment with Hexanium® ACIF system. This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.

The Hexanium® ACIF is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the device as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® ACIF is available in 2 sagittal profiles (lordotic 6º and convex 6°), heights of 5-12 mm, and 3 footprints (15x12mm, 17x14mm, and 19x15mm). The Hexanium® ACIF screws are self-drilling and available in lengths of 10, 12, 14, and 16mm and diameters of 3.50 and 3.80mm. Hexanium® ACIF is provided sterile. The Hexanium® ACIF system includes a set of reusable surgical instruments. The purpose of this Special 510(k) application is to propose minor modifications to the currently cleared surgical instruments. There are no modifications being proposed for the implantable components of the system

This is not an AI/ML medical device. This is a medical device for intervertebral body fusion. Thus the acceptance criteria for AI devices do not apply here.

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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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When used for anterior screw fixation or as a posterior, non-pedicle system of the U.L.I.S.™ and LUMISTM 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
• · curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• 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 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
• · curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• · 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 design modification and new diameters and lengths of the LUMIS™ Cannulated Polyaxial Pedicle Screws and U.L.I.S.™ Polyaxial Pedicle Screws, creation of LUMIS™ Cannulated Monobloc Pedicle Screws and U.L.I.S.™ Monobloc Pedicle Screws, addition of CoCr Spinal Rods, and new lengths of UNI-Thread® rods.

The provided text describes a medical device submission (K133575) for the SpineVision LUMIS™ Cannulated Pedicle Screw Fixation System and U.L.I.S.™ Pedicle Screw Fixation System. The submission focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, not through clinical or AI-powered studies. Therefore, many of the requested elements (like sample size for test sets, expert qualifications, and AI-specific metrics) are not applicable or cannot be extracted directly from this document.

Here's the information that can be extracted and a clear indication where certain information is not provided:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SpineVision LUMIS™ and U.L.I.S.™ systems are primarily based on demonstrating comparable mechanical properties to legally marketed predicate devices.

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

• Sample Size for Test Set: This information is not provided. The study involved mechanical testing of device components, not a test set of patient data.
• Data Provenance: Not applicable in the context of mechanical testing. The testing was conducted in a laboratory setting as part of the device's engineering analysis and design validation/verification.

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

Not applicable. There was no "ground truth" derived from expert consensus on patient data. The "truth" in this context is established by engineering standards and measurements from mechanical tests.

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

Not applicable. This concept applies to human-reviewed data, not mechanical testing results where outcomes are quantifiable and objectively measured against engineering standards.

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 pedicle screw fixation system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted, and the concept of "human readers improve with AI" is irrelevant to this submission.

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, not an algorithm.

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

The "ground truth" for demonstrating the device's safety and effectiveness relies on engineering standards and direct measurements from mechanical testing. The comparability to predicate devices, as assessed through these tests, serves as the basis for the substantial equivalence determination. There is no clinical ground truth (like pathology or outcomes data) mentioned in this summary for the purpose of demonstrating equivalence.

8. The sample size for the training set

Not applicable. This submission concerns a physical medical device and its mechanical properties, not a machine learning model. Therefore, there is no "training set."

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

Not applicable, as there is no training set for a machine learning model.

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When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical 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 pedicie screw systems indicated for skeletally mature patients who:

• · have severe spondvlolisthesis (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.™ Description System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) instrumentations are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods (SpineVision UNI-Thread™ rods or LUMIS™ percutaneous 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 nonsterile. These constructs are assembled using specific instruments. The components of the U.L.I.S.™ and LUMIS™ systems are made of Titanium Ti-6Al-4V ELI complying with ASTM F136 (ISO 5832-3). The components added within this submission include: New reference of LUMIS™ rods (Straight and pre-bent), 12 new instruments for LUMIS™ system, 4 new instruments for U.L.I.S.™ system. The devices provide correction and rigid cannulated. stabilization of the spine during development of solid bone fusion following corrective spine surgery for a number of indications (listed above).

The provided text describes a 510(k) submission for a medical device, the SpineVision U.L.I.S.™ and LUMIS™ Pedicle Screw Fixation Systems. This is a submission for an extension of range of products to a previously cleared device (K112607).

The key takeaway is that no new clinical or additional testing was performed, nor was a new study conducted to prove the device meets acceptance criteria. Instead, SpineVision S.A. claims substantial equivalence to their predicate device based on engineering analysis and design validation/verification.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth cannot be extracted as it is not present in the provided document. The 510(k) summary explicitly states:

• "No additional testing has been performed for the added components."
• "No clinical data has been presented."

The submission relies on the previously established performance of the predicate device (K112607) and asserts that the new components do not alter the fundamental safety and effectiveness.

Given this, I cannot fill out the requested table or paragraphs accurately, as the document explicitly states the absence of such new data.

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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.TM and LUMISTM 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.TM and LUMISTM 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.TM 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.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations are composed of cannulated (LUMISTM) and non-cannulated (U.L.I.S.TM) pedicle screws and fixation rods (Spine Vision Unithread TM rods). Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. These constructs are assembled using specific instruments. The components of the U.L.E.S.TM and LUMISTM systems are made from ASTM F136 titanium alloy (Ti-6Al-4V ELI) complying with ASTM F136 (ISO 5832-3). The SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMISTM System) instrumentations are manufactured in Titanium alloy complying with ASTM 136. The LUMISTM Pedicle screw system is cannulated. The devices provide correction and rigid stabilization of the spine during development of solid bone fusion following corrective spine surgery for a number of indications (listed above).

The manufacturer, Orgenix LLC, submitted a 510(k) Premarket Notification for the SpineVision LUMIS™ Cannulated Polyaxial Pedicle Screw Fixation System and SpineVision U.L.I.S.™ Polyaxial Pedicle Screw Fixation System. The submission refers to non-clinical testing and published retrospective clinical data to support the substantial equivalence claim.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mechanical Testing: The document mentions "worse case" testing and "side-by-side testing with the predicate device." However, specific sample sizes (e.g., number of implants tested) for these mechanical tests are not provided.
• Clinical Data: The clinical data provenance is described as "Published retrospective clinical data for devices similar to the SpineVision Universal Lumbar Intuitive System (U.L.I.S.TM System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) devices."
  • Sample Size: The sample size for this retrospective clinical data is not specified.
  • Country of Origin: The country of origin for the clinical data is not specified.
  • Retrospective or Prospective: Explicitly stated as retrospective.

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

• This information is not provided in the document. The mechanical testing standards inherently define the "ground truth" through specified methodologies and expected outcomes (e.g., specific load failures, fatigue cycles, etc.). For the retrospective clinical data, the "ground truth" would be the observed safety profile and outcomes in prior use, often established by treating physicians, but the review process for that data is not detailed here.

4. Adjudication Method for the Test Set

• This information is not provided. For mechanical testing, adjudication typically refers to the interpretation of test results against established pass/fail criteria. For the retrospective clinical data, the adjudication method of the published studies is not detailed.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or software where human readers interpret cases with and without AI assistance to measure improvement in diagnostic accuracy. The submitted device is a spinal fixation system, not a diagnostic tool.

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

• Not applicable. The device is a mechanical implant (pedicle screw fixation system), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The device's performance is standalone in the sense that it relies on its physical properties when implanted and a surgeon's skill.

7. The Type of Ground Truth Used

• Mechanical Testing: The ground truth is defined by engineering standards and specifications (ASTM F1717, ASTM F543, ASTM F2193, ASTM F1798). These standards establish objective criteria for performance (e.g., force at failure, fatigue life, torsional strength).
• Clinical Data: The ground truth for the clinical data mentioned is based on patient outcomes and safety profiles observed in prior retrospective studies involving similar devices. This would encompass absence of new risks, stability, and effectiveness in achieving fusion, as documented in clinical records.

8. The Sample Size for the Training Set

• Not applicable / Not explicitly provided. This device is a physical implant and not an AI/ML algorithm that requires a "training set" of data in the conventional sense. The design and manufacturing processes are informed by engineering principles, material science, and prior clinical experience, rather than data-driven machine learning training.

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

• Not applicable / Not explicitly provided. As noted above, there is no "training set" for this type of medical device in the context of AI/ML. The "ground truth" for the device's design and engineering is established through fundamental scientific and engineering principles, material properties, and established biomaterial/biomechanical testing methodologies.

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