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The Spineology Interbody Fusion System (SIFS) is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. SIFS with compatible allograft and autograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

The Spineology Interbody Fusion System (SIFS) is a lumber intervertebral body fusion device comprised of a PET (polyethylene terephthalate) mesh bag designed to contain compatible allograft and autograft as an adjunct to fusion for the treatment of degenerative disc disease. The device is placed into the prepared intervertebral disc space and then is packed with bone graft. The resulting SIFS implant is used with posterior supplemental fixation systems forming the completed SIFS construct.

The provided text describes the acceptance criteria and the study that proves the Spineology Interbody Fusion System (SIFS) meets these criteria. It does not describe an AI/ML device but rather a medical implant. Therefore, the questions related to AI/ML specific aspects (e.g., test set ground truth, MRMC study, standalone algorithm performance, training set) are not applicable to this document. The focus below will be on the information provided regarding the device's clinical and non-clinical performance and acceptance criteria.

Acceptance Criteria and Device Performance for Spineology Interbody Fusion System

This document outlines the evaluation of the Spineology Interbody Fusion System (SIFS), an intervertebral body graft containment device, for De Novo classification. The acceptance criteria are derived from both non-clinical/bench testing and a clinical study designed to demonstrate the device's safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established through a combination of non-clinical performance benchmarks (where applicable) and primary clinical endpoints.

2. Sample Sizes and Data Provenance

• Clinical Study Sample Size:
  • Test Set (Clinical Study Cohort): 102 subjects were enrolled and treated across 10 clinical sites.
  • Follow-up at 24 Months: 96 subjects provided complete data in-window (95.0% follow-up rate). Fusion assessment was conducted on 97 subjects (considering 12- and 24-month assessments).
• Data Provenance: The data is from a 24-month, prospective, single-arm, multi-center clinical study (G140140). The location of the clinical sites is not specified beyond "multi-center," but typically for FDA De Novo, such studies are conducted in the US or with data acceptable to the FDA. The study was based on a previously conducted prospective, randomized, multi-center study (G030106) for the same device. Given the context of a US FDA De Novo submission, it is highly likely that the centers were primarily in the United States, and the data is prospective.

3. Number of Experts and Qualifications for Ground Truth (Clinical Study)

• Ground Truth for Fusion: "Fusion was assessed by independent radiologists at the 12-month time point, and again at 24 months for those subjects who had not fused."
• Number of Experts: Not explicitly stated how many independent radiologists assessed each case, nor is their specific qualification (e.g., years of experience) mentioned. However, "independent radiologists" implies qualified medical professionals specialized in interpreting spinal imaging.

4. Adjudication Method (Clinical Study Test Set)

• The document implies that "independent radiologists" assessed fusion, but it does not specify an adjudication method (e.g., 2+1, 3+1 consensus process) for discrepancies between readers if multiple readers were used per case. It states fusion was "assessed by independent radiologists," which could mean one radiologist per case or multiple without a defined consensus process in the provided text.

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

• No MRMC study was conducted. This was a single-arm study evaluating the device's performance, not a comparative effectiveness study involving human readers with/without AI assistance. The device is an implant, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Not Applicable. This is a medical implant, not an algorithm. Therefore, "standalone (i.e., algorithm only without human-in-the-loop performance)" is not relevant.

7. Type of Ground Truth Used (Clinical Study)

• Combination of Clinical Outcome Measures and Radiographic Assessment:
  • Pain and Function: Ground truth derived from patient-reported outcomes (Visual Analog Scale for pain, Oswestry Disability Index for function).
  • Fusion: Ground truth established through "bridging bone demonstrated on CT Scan," assessed by independent radiologists. This is a radiographic ground truth.
  • Safety: Ground truth based on the occurrence and classification of adverse events, assessed by a Clinical Events Committee (CEC). This involves medical record review and expert medical judgment.

8. Sample Size for the Training Set

• Not Applicable. This is a human-implanted medical device, not an AI/ML algorithm. There is no concept of a "training set" in the context of device development as described here. The clinical study served as the primary evidence to demonstrate safety and effectiveness for regulatory approval.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The clinical study's data, as described in point 7, formed the basis of the evidence for the device's performance.

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The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The standard Rampart One devices with 8° and 12° lordotic angles may be used with or without supplemental fixation using a fixation system cleared by FDA for use in the lumbar spine. When used without supplemental fration, the standard Rampart One devices with 8° and 12° lordotic angles must be used with four (4) screws. The standard Rampart One devices with 16° and 20° lordotic angles must be used with four (4) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

The oblique Rampart One devices must be used with two (2) screws and a supplemental fixation system cleared by FDA for use in the lumbar spine.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The provided text is a 510(k) Premarket Notification from the FDA regarding the Spineology Rampart One Lumbar Interbody Fusion System. This documentation is for a medical device (lumbar interbody fusion system), not an AI software/device. Therefore, the content does not discuss acceptance criteria or studies related to AI device performance.

The document details the device's classification, indications for use, comparison to predicate devices, and non-clinical (benchtop mechanical) testing conducted to demonstrate substantial equivalence. It does not contain information about clinical studies with human subjects, ground truth establishment, expert adjudication, or MRMC studies that would be relevant for an AI/software device.

As such, I cannot extract the information required by your prompt, as it is designed for AI/software device evaluation, and the provided document pertains to a physical medical implant.

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The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of carcellous and/or corticocancellous bone graft.

The standard Rampart One device may be used with or without supplemental fixation systems cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One device must be used with four (4) screws.

The oblique Rampart One device must be used with two (2) screws and with supplemental fixation systems cleared by FDA for use in the lumbar spine.

Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

This document, K191091, is a 510(k) premarket notification for the Rampart™ One Lumbar Interbody Fusion System, specifically concerning the addition of a new Implant Inserter and modified Inserter Guides. It asserts substantial equivalence to a predicate device.

Crucially, this submission does not describe an AI/ML-driven device or diagnostic software that would typically have acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC). Instead, it pertains to a physical medical device (intervertebral body fusion system) and its associated surgical instruments. The "acceptance criteria" and "study" described in the document are engineering and non-clinical performance tests for these physical instruments, not clinical performance metrics for an AI algorithm.

Therefore, many of the requested items in the prompt (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device submission.

However, I can extract the relevant "acceptance criteria" and "proof" as described for this mechanical device:

Acceptance Criteria and Study for the Rampart™ One Lumbar Interbody Fusion System (Focus on Inserter and Guides)

Device Under Review: New Implant Inserter and modified Inserter Guides for the Rampart™ One Lumbar Interbody Fusion System.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering Focus):

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

• Not Applicable in the context of clinical AI/ML studies. This submission refers to "design verification testing" and "simulated use" for physical instruments. The sample size would refer to the number of tests/cycles performed on the instruments, which is not detailed in this summary.
• Data Provenance: Not specified as clinical data. It refers to internal engineering tests.

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

• Not Applicable. Ground truth, in the AI/ML sense, is not relevant here. The "ground truth" for a mechanical device is simply its physical performance against engineering specifications, likely established by internal engineers and quality control personnel.

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

• Not Applicable. Adjudication methods are for human interpretation of clinical data, not for engineering tests of physical instruments.

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 is not an AI-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm.

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

• Not Applicable in the AI/ML sense. The "ground truth" is the engineering specifications and functional requirements of the device's mechanical performance.

8. The sample size for the training set:

• Not Applicable. No training set for an AI/ML model is involved.

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

• Not Applicable. No training set for an AI/ML model is involved.

Summary of the Study Proving Acceptance (for this specific device and its modifications):

The "study" cited in this 510(k) summary is comprised of non-clinical engineering design verification tests and a risk assessment.

• Methodology: The submission states "Design verification testing was conducted to support the new Implant Inserter and modified Inserter Guides confirming function and performance in simulated use." This would typically involve mechanical tests, durability tests, dimensional checks, and functional tests to ensure the instruments properly hold, insert, and release the interbody fusion device.
• Proof: The success of these tests, combined with a review of design changes and a risk assessment, led the manufacturer (Spineology) to conclude that the modified components maintained the same intended use, technological characteristics, principle of operation, and risk profile as the predicate device. This forms the basis for their claim of substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission of this type. The FDA's clearance letter indicates their agreement with this conclusion.

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The Palisade Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Palisade Pedicular Fixation System consists of titanium screws and cobalt chrome rods which allow a surgeon to build a spinal implant construct to accommodate the anatomical and physiological needs of the patient. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

This document is a 510(k) premarket notification for a medical device called the "Palisade Pedicular Fixation System." It is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to this type of submission. This document describes a mechanical device used in spinal surgery, not an AI/diagnostic device.

However, I can extract the relevant information from the document regarding the performance testing that was conducted to demonstrate the substantial equivalence of the device.

Here's an interpretation of the provided document in the context of your request, focusing on what is available:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for clinical performance, as it is a mechanical device. Instead, it relies on demonstrating mechanical equivalence to predicate devices through various ASTM standard tests. The "reported device performance" is essentially that the device passed these tests in accordance with applicable standards.

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

• Sample size: Not explicitly stated for each mechanical test. However, typically mechanical testing involves a specific number of samples (e.g., 6 or more) per test configuration as defined by the ASTM standards. This is for product samples, not patient data.
• Data provenance: Not applicable. The data is generated from laboratory mechanical testing of the device components, not from human or animal 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. This is mechanical testing, not a diagnostic or clinical study requiring expert ground truth.

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

Not applicable. This is mechanical testing.

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 is a mechanical spinal fixation system, not an AI or diagnostic device.

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

Not applicable. This is a mechanical device.

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

Not applicable in the sense of clinical ground truth. The "ground truth" for these tests are the established performance requirements and methodologies outlined in the ASTM standards for spinal implant mechanical testing.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

Summary of the Study Discussed in the Document (Performance and Biological Testing):

The document reports on performance tests conducted in accordance with applicable standards and test methods to determine the endurance, strength, and durability of the Palisade Pedicular Fixation System.

• Tests Performed:

  • ASTM F1798
  • ASTM F1717
  • Static Compression Bending
  • Flexural Grip
  • Axial Grip
  • Static Torsion
  • Torsional Grip
  • Dynamic Compression Bending

• Conclusion regarding these tests: Spineology states that the device "passed" these tests and demonstrated substantial equivalence to the predicate devices. The exact quantitative results (e.g., specific load values, cycles to failure) are not provided in this summary document but would have been submitted to the FDA separately.

• Biological Safety Testing: "Not required as there was no change in materials from the predicate device." This implies that the materials used in the Palisade system are identical to those of legally marketed predicate devices, for which biological safety has already been established.

• Packaging and Sterilization Testing: "Not required as there was no change to the sterile barrier system, sterilization method, sterilization parameters, or sterility assurance level (SAL) from the predicate device." This indicates that these aspects of the device delivery are the same as those previously cleared predicate devices.

In essence, this document demonstrates substantial equivalence of a new mechanical spinal fixation device to existing, legally marketed devices by showing it has the same intended use, indications for use, fundamental scientific technology, biological safety, packaging, and sterilization method, supported by mechanical testing that confirms similar performance characteristics as defined by international standards.

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Rampart A is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with 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 patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment.

Rampart A is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Rampart A implants are intervertebral body fusion devices for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are made of PEEK-OPTIMA LT1 with Tantalum markers and are provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The provided text is a 510(k) summary for the Rampart A Lumbar Interbody Fusion Device. This document is a regulatory submission to the FDA for a medical device and does not describe a study involving an AI or an algorithm.

Therefore, I cannot provide information on acceptance criteria or studies proving device performance related to AI/algorithm performance. The document focuses on demonstrating substantial equivalence to a predicate device for a physical medical implant (an intervertebral body fusion device).

Here's an analysis based on the information available in the provided text, specifically highlighting why the requested AI/algorithm-related information cannot be extracted:

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

• Acceptance Criteria (for the physical device): The document doesn't explicitly list numerical acceptance criteria in a table format for this specific submission beyond demonstrating substantial equivalence. The "performance" assessment is based on comparison to predicate devices, focusing on intended use, technological characteristics, materials, sterilization, packaging, and operating principle.
• Reported Device Performance (for the physical device): The document states "No performance testing was required for this change. An engineering rationale, including a finite element analysis (FEA) to compare the Rampart A to the existing predicate testing (conducted in accordance with ASTM F2077) supported the substantial equivalence of the Rampart A device." This indicates that the performance was demonstrated through an engineering rationale and FEA comparing it to performance data of previously cleared, substantially equivalent predicate devices, rather than new, explicit performance metrics for Rampart A itself.

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

• Not applicable as this is not an AI/algorithm study. The "test set" here refers to the engineering analysis and comparison to predicate device data, not a clinical data set for an algorithm.

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 as this is not an AI/algorithm study. Ground truth in the context of an interbody fusion device would be related to clinical outcomes, which are not detailed in this 510(k) summary as no de novo clinical study was performed. The "ground truth" for the engineering rationale would be established engineering principles and ASTM standards.

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

• Not applicable as this is not an AI/algorithm study.

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 as this is not an AI/algorithm study.

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

• Not applicable as this is not an AI/algorithm study.

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

• For the engineering rationale, the "ground truth" would be established engineering principles and the performance data of the predicate devices as per ASTM F2077. For the device's clinical efficacy, it's based on the established safety and effectiveness of substantially equivalent predicate devices for the specified indications for use (L2 to S1 in patients with degenerative disc disease with up to Grade 1 spondylolisthesis).

8. The sample size for the training set

• Not applicable as this is not an AI/algorithm study.

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

• Not applicable as this is not an AI/algorithm study.

In summary, the provided document is a regulatory submission for a physical medical device. It does not contain information about acceptance criteria or studies related to AI or algorithms.

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The Spineology Fortress™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Spineology Fortress™ Pedicular Fixation System consists of screws (titanium) and rods (cobalt chrome) to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Fortress System screws are available with or without hydroxyapatite coating. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile. The associated instruments are provided non-sterile.

The provided text describes a 510(k) premarket notification for a medical device called the "Fortress™ Pedicular Fixation System." This document is a regulatory approval, and as such, it focuses on demonstrating "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria in the manner one might expect for a new AI/software device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device is not directly applicable or available in the provided text.

Here's why and what information is available:

• Type of Device: The Fortress™ Pedicular Fixation System is a physical medical implant (pedicle screws and rods) used in spinal fusion surgery. It's not an AI or software device that processes data or makes diagnostic/predictive outputs.
• Regulatory Pathway: The 510(k) pathway is for devices that are "substantially equivalent" to legally marketed predicate devices. This means the primary goal is to show that the new device has the same intended use, technological characteristics, and safety and effectiveness as a previously cleared device. It does not typically involve the kind of performance studies with acceptance criteria, test sets, ground truth, and expert adjudication that would be performed for AI/software.
• "Study" in this Context: The "study" mentioned for this device is the "Coating characterization/analyses" and a "risk analysis." These are focused on the physical properties and safety of the hydroxyapatite coating, not on algorithmic performance.

However, I can extract information relevant to the comparison made in the 510(k) process, which functions as the nearest equivalent to "acceptance criteria" and "proof" in this regulatory context:

1. Table of Acceptance Criteria and Reported Device Performance (as interpreted for a 510(k) submission):

Regarding the specific questions about an AI/software device:

2. Sample size for the test set and data provenance: Not applicable. This is not an AI/software device. The "test set" would be the samples of the physical device or its components used for mechanical, material, or biocompatibility testing. The document does not specify sample sizes for these tests. Data provenance would refer to the materials/components themselves.
3. Number of experts used to establish ground truth & qualifications: Not applicable. No "ground truth" (in the AI/clinical data sense) was established by experts for this device. The evaluation is based on engineering specifications, material science, and regulatory comparison.
4. Adjudication method: Not applicable. There is no clinical data or expert interpretation requiring adjudication mentioned.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic or imaging device.
6. Standalone (algorithm-only) performance: Not applicable. This is a physical implant, not an algorithm.
7. Type of ground truth used: Not applicable in the AI sense. Ground truth in this context would implicitly be established engineering standards, material properties, and biocompatibility requirements for spinal implants.
8. Sample size for the training set: Not applicable. This is not a machine learning model.
9. How ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (spinal implant) via the 510(k) pathway, which focuses on demonstrating substantial equivalence to predicate devices, not on the performance criteria and studies typical for AI/software devices.

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Rampart-T implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment.

Rampart-T implants are designed for use with autograft to facilitate fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Spineology Rampart™-T Interbody Fusion implant is a tapered version of the predicate Spineology PEEK Crescent implant. The subject and predicate devices are composed of PEEK -OPTIMA® LT1 (polyetheretherketone). The subject device and the primary predicate are both manufactured as a curved (crescent) shape and contain two areas for the placement of autograft. Additionally, the subject and predicate devices contain tantalum alloy markers to assist in device placement through intraoperative imaging. The devices all have a toothed fish-scale style antibackout design on the surfaces that interface with the vertebral body endplates. The subject device is tapered at its leading end for ease of initial implantation and will maintain the same 6 degree lordotic angle to accommodate a suitable fit in the disc space.

This document is a 510(k) premarket notification decision letter from the FDA regarding the Spineology Rampart™-T Interbody Fusion System. It primarily discusses the device's substantial equivalence to predicate devices and does not contain information about the acceptance criteria or a specific study proving the device meets those criteria in the context of AI/ML performance.

The "Performance Data" section mentions that the device "previously underwent performance testing" in accordance with FDA guidance and ASTM standards (F2077 and F2267). This testing included:

• Static compression shear
• Shear
• Dynamic axial and shear compression
• Subsidence
• Expulsion

However, this refers to mechanical and biocompatibility testing of the interbody fusion device itself, an orthopedic implant, and not performance criteria for an AI/ML device. The document also states this testing was "previously submitted and reviewed by the FDA," implying the detailed results and acceptance criteria for these mechanical tests are not included within this particular submission.

Therefore, none of the requested information regarding acceptance criteria and studies for an AI/ML device's performance can be extracted from this document, as it is related to a traditional medical device (an intervertebral body fusion device).

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The Spineology Threshold™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Spineology Threshold ™ Pedicular Fixation System is an addition to Spineology's Fortress pedicle screw family. The Threshold System consists of cannulated titanium screws and rods to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile. The associated instruments are provided non-sterile.

The provided text is a 510(k) summary for the Spineology Threshold™ Pedicular Fixation System. It describes a medical device, a pedicle screw spinal system, and does not contain information about an AI/ML device or its performance criteria. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets them for an AI/ML system.

The document discusses the substantial equivalence of the Threshold™ Pedicular Fixation System to a predicate device (Spineology Fortress™ Pedicle Screw System) based on intended use, materials, technological features, and comparative performance testing, specifically "Static testing ... performed to verify the design and demonstrate that the Threshold Pedicular Fixation System is substantially equivalent to the Fortress Pedicle Screw System. The performance testing included static compression loading in accordance with ASTM F1717."

This is a physical medical device, not an AI/ML algorithm.

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The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions:

· Degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

• · Trauma (i.e., fracture or dislocation)
• · Spondylolisthesis

• Tumor

The VIATM Spinous Process Fixation System is not intended for stand-alone use.

The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion, and it is not intended for stand-alone use. When the VIA™ Spinous Process Fixation System is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1). The VIA Spinous Process Fixation System consists of a three-piece design. The larger male piece (plate) is comprised of a plate with teeth and a spacer in the middle. The two other additional pieces are plates (with teeth) that contain the female ends of the connection with the male spacer. The two female plates engage with the larger plate independently to accommodate variations in the spinal anatomy. The components are locked together with a set screw after assembly. The spinous process contact areas (with the teeth sections) on both the male and female plates do not vary in size. The central spacer on the male plate varies in height (cephalo-caudad), thus providing the different sizes of the device. All components are composed of titanium alloy (Ti-6A1-4V-ELI ASTM F136). Associated accessories include surgical instruments to facilitate implantation.

This document is a 510(k) premarket notification for the VIA™ Spinous Process Fixation System, a medical device. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device. Instead, it describes a medical device, its intended use, and performance data from engineering verification tests.

Therefore, I cannot provide the requested table and information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are concepts relevant to the evaluation of AI/ML software.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Engineering Verification Tests:
  • Insertion Testing
  • Grip Strength Testing (using a modified ASTM F543-13 setup)
  • Dynamic Compression Bending (per ASTM F1717-13)

The document states that "The results met applicable acceptance criteria and verified the design features," but it does not specify what those acceptance criteria were, nor does it provide detailed study protocols, results, or statistical analyses that would be present in a study report for an AI/ML device.

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The Spineology Fortress™ Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative discase (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; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Spineology Fortress™ Pedicle Screw System consists of screws (titanium) and rods (cobalt chrome) to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile or non-sterile. The associated instruments are provided non-sterile.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what would typically be found in a medical device submission for performance:

The provided text describes a 510(k) submission for the Spineology Fortress™ Pedicle Screw System, a Class III medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device, which often involves mechanical testing rather than studies involving human participants or AI performance.

Therefore, many of the requested categories related to AI performance, human readers, ground truth for training data, and clinical study details are not applicable (N/A) to this specific submission.

Acceptance Criteria and Device Performance

The acceptance criteria for the Spineology Fortress™ Pedicle Screw System are established by demonstrating that its mechanical performance is equivalent or superior to the predicate devices when evaluated against recognized ASTM standards. These standards define the expected performance thresholds for pedicle screw systems.

Study Details (Mechanical Testing)

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

   • Sample Size: Not specified in the provided summary document. For mechanical testing, sample sizes are typically defined by the relevant ASTM standards to ensure statistical validity (e.g., n=6 for certain tests).
   • Data Provenance: The testing was "performed" by the applicant, Spineology Inc., likely in a laboratory setting. This is not clinical data (e.g., country of origin for clinical data, retrospective/prospective). It refers to in-vitro mechanical testing.

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

   • N/A. Mechanical testing against ASTM standards does not involve "ground truth" derived from expert consensus in the same way clinical or AI studies do. The "ground truth" here is the defined performance requirement within the standard.

3. Adjudication method for the test set:

   • N/A. See point 2. The outcome is determined by adherence to the pass/fail criteria of the ASTM standards.

4. 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. This is a 510(k) for a physical implant (pedicle screw system), not an AI/software device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

   • No. This is a physical implant.

6. The type of ground truth used:

   • For this type of mechanical testing, the "ground truth" is adherence to the specified performance characteristics and thresholds defined within the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., acceptable flexural strength, pullout force, fatigue life). The comparison is made against predicate devices, demonstrating the new device performs at least as well.

7. The sample size for the training set:

   • N/A. This is mechanical testing of a medical device, not an AI algorithm. There is no concept of a "training set" in this context.

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

   • N/A. See point 7.

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