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The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Arena-L, Dorado TILT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The SpineFrontier Lumbar Interbody Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

The SpineFrontier Lumbar Interbody Fusion Device System is a spinal intervertebral body fusion device system intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The system is comprised of devices made of PEEK Optima® LT1 or titanium coated PEEK Optima® LT1, with varying widths, lengths, and heights to fit the anatomical needs of patients. The devices have raised contours on the superior and inferior surfaces that will resist device movement following implantation.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML algorithm. Instead, it is an FDA 510(k) clearance letter for a SpineFrontier Lumbar Interbody Fusion Device System, which is a physical medical device (an intervertebral body fusion device).

Therefore, I cannot provide the requested information, which pertains to AI/ML device performance studies and associated details like training/test set sizes, ground truth establishment methods, or human reader effectiveness with AI assistance.

The document discusses:

• Device Name: SpineFrontier Lumbar Interbody Fusion Device System
• Regulatory Class: Class II (under 21 CFR 888.3080)
• Indications for Use: Intervertebral body fusion of the spine for skeletally mature patients with degenerative disc disease (DDD) at L2-S1 (one or two contiguous levels), potentially with Grade I spondylolisthesis.
• Device Components: Made of PEEK Optima® LT1, possibly with Tantalum markers and a Titanium Coating.
• Performance Testing: "engineering rationale was performed in lieu of bench testing. No performance data was required because none of the modifications to the subject from its previous clearance under K142504 present a worst case for mechanical testing to the worst case tested for that clearance." This indicates that for this physical device modification, previous mechanical testing from the predicate device (K142504) was considered sufficient.
• Conclusion: The device is substantially equivalent to the predicate (K142504) based on similar intended uses, indications, technological characteristics, and principles of operation, with modifications raising no new safety or effectiveness questions.

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A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.

The A-CIFT™ SoloFuse™ consists of a PEEK or PEEK-OPTIMA HA Enhanced spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. The A-CIFT™ SoloFuse™ PEEK-OPTIMA HA Enhanced implants are provided sterile and irradiated by gamma radiation. The A-CIFT™ SoloFuse™ PEEK implants are provided non-sterile with instructions for sterilization. The lordotic and non-lordotic PEEK or PEEK-OPTIMA HA Enhanced spacers are provided in various sizes. The lag and rigid screws are offered in various diameters and lengths.

This document is a 510(k) premarket notification for a medical device called A-CIFT™ SoloFuse™, an intervertebral body fusion device. The purpose of this submission is to introduce a new material (PEEK-OPTIMA HA Enhanced) for an already cleared device.

Based on the provided text, there is no information about acceptance criteria or a study demonstrating the device meets such criteria in terms of clinical performance or algorithm performance. The document focuses on showing substantial equivalence to a predicate device, primarily through a change in material and a "Failure Effects Analysis" (FEA) instead of mechanical testing.

Here's an analysis of what information is not present related to your request:

1. A table of acceptance criteria and the reported device performance: This is not provided. The submission focuses on substantial equivalence based on design changes (material), not a new performance evaluation against specific criteria.
2. Sample size used for the test set and the data provenance: Not applicable as no new performance testing study is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The document states, "No performance testing is being included as part of this submission."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an implantable medical device, not an AI/algorithm-based diagnostic or therapeutic tool.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The submission for the A-CIFT™ SoloFuse™ is a 510(k) premarket notification to introduce a new material (PEEK-OPTIMA HA Enhanced) for an existing device. It relies on the concept of substantial equivalence to previously cleared predicate devices (K151198 and K142026).

The document explicitly states: "No performance testing is being included as part of this submission. Failure Effects Analysis (FEA) was used in lieu of mechanical testing to show substantial equivalence to the previously cleared design."

Therefore, the submission does not include:

• Acceptance criteria for device performance.
• New studies with test sets, training sets, expert ground truth establishment, or MRMC studies.

Instead, the conclusion is based on "overall technology characteristics and mechanical performance data" (which, for this submission, appears to be primarily the FEA and comparison to the predicate) leading to the conclusion that the device is "safe and effective and substantially equivalent to the previously cleared product."

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A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.

The A-CIFT™ SoloFuse™ consists of a PEEK spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. System is provided non-sterile with instructions for sterilization. The lordotic and non-lordotic PEEK spacers are provided in heights of 5mm to 12mm with a width of 17mm and depths of 13.5mm and 14mm. The lag and rigid screws are offered in diameters 4.2mm and 4.5mm and lengths of 12mm to 16mm.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. This document is a 510(k) premarket notification for a medical device (A-CIFT™ SoloFuse™ Intervertebral Body Fusion Device), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance acceptance criteria and a study to meet them.

Specifically, the document states:

• "No performance testing is being included as part of this submission." This explicitly indicates that no performance data or studies are presented.
• The entire submission is for the purpose of including "additional surgical instruments with an optional freehand surgical technique" for an already cleared device, not for proving new performance criteria.

Therefore, I cannot provide the requested information based on the given text.

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The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Arena-L, Dorado TILT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

The SpineFrontier Ti-Coated Lumbar Interbody Fusion Device System is a spinal intervertebral body fusion device system intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The system is comprised of devices made of titanium coated PEEK Optima® LT1, with varying widths, lengths, and heights to fit the anatomical needs of patients. The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant.

The purpose of this submission is the addition of a CP-Ti coating on a previously cleared lumbar intervertebral fusion device.

The provided document describes a 510(k) premarket notification for the SpineFrontier Lumbar Interbody Fusion Device System. This document is a regulatory submission for a medical device and, as such, does not contain information about the performance of an AI/ML powered device, nor does it include a study that proves a device meets acceptance criteria in the context of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics and non-clinical mechanical performance testing. The 'Performance Data' section lists various ASTM standards used for mechanical testing of the device and its coating, but these are related to the physical properties and durability of the implantable device, not the performance of an AI/ML algorithm.

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The SIJFuse™ Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroilitis.

The SIJFuse™ Sacroiliac Joint Fusion Device System implants consist of Solid and Fenestrated Screws. Solid and Fenestrated Screws are available in varying diameters and lengths. Solid and Fenestrated Screws are fabricated from medical grade titanium alloy (Ti-6A1-4V Eli). Solid Screws have a solid outer wall, while Fenestrated Screws have fenestrations on the outer wall. Solid and Fenestrated screws have a cannulated core. Fenestrated screws allow packing of allograft or autograft material.

This document is a 510(k) premarket notification for the "SpineFrontier® SIJFuse™ Sacroiliac Joint Fusion Device System". It describes the device, its intended use, and presents data to demonstrate substantial equivalence to predicate devices. However, this is NOT a study describing acceptance criteria and device performance as typically understood for AI/software devices.

The information provided describes a medical device (implants), specifically screws for sacroiliac joint fusion, and is not an AI/Software as a Medical Device (SaMD). Therefore, the requested information categories (AI-specific acceptance criteria, sample sizes for AI training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, AI ground truth, etc.) are not applicable to this document.

Instead, this document focuses on mechanical performance data to demonstrate the physical characteristics and safety of a hardware implant.

Here's the relevant information provided by the document regarding the device's performance and acceptance:

1. Table of Acceptance Criteria (or rather, performance data compared to predicates):

The document states: "The results of this non-clinical testing show that the strength of the SIJFuse™ Sacroiliac Joint Fusion Device System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The following tests were performed:

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

• Sample Size: Not explicitly stated as a numerical count of devices or tests, but "multiple tests" are implied by the nature of the standards. ASTM F2193 and F543 are standards that specify test methodologies, which would include guidelines on the number of samples required for statistically valid results. This document only states that the tests were performed.
• Data Provenance: The tests were non-clinical, meaning they were performed in a laboratory setting. No country of origin for data is specified beyond the company being US-based (Beverly, MA). It is not retrospective or prospective in the clinical sense, as it refers to engineering tests.

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

• Not Applicable. This is a hardware device. The "ground truth" for mechanical testing is established by adherence to ASTM standards and engineering principles, not by expert medical interpretation.

4. Adjudication method for the test set:

• Not Applicable. Mechanical tests are adjudicated by meeting specified physical criteria outlined in the ASTM 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 is a hardware implant, not an AI or imaging device involving human readers.

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

• Not Applicable. This is a hardware implant, not an algorithm.

7. The type of ground truth used:

• Mechanical Engineering Standards: The "ground truth" for this device's performance is compliance with established ASTM (American Society for Testing and Materials) standards for orthopedic implants (F2193 and F543) and demonstrable equivalence in mechanical properties to legally marketed predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a hardware implant, not an AI model requiring a training set.

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

• Not Applicable.

In summary, the provided document relates to a physical medical implant and its mechanical performance testing for FDA 510(k) clearance, not an AI or software device. The acceptance is based on demonstrating substantial equivalence in mechanical properties to already cleared devices, as proven by adherence to specific ASTM testing standards.

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The SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).

In addition, the SpineFrontier® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (L3 to S1).

The SpineFrontier® PedFuse® Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system consists of longitudinal rods, polyaxial screw assemblies, and cross connectors.

This document is a 510(k) summary for a medical device called the "PedFuse® Pedicle Screw System," specifically for the addition of a sliding washer component. It is a regulatory submission for substantial equivalence to previously cleared predicate devices.

It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria in the manner typically associated with studies demonstrating AI or diagnostic device performance metrics (e.g., sensitivity, specificity, accuracy against a ground truth). This document primarily focuses on demonstrating that the new component (sliding washer) does not change the fundamental safety and effectiveness of the existing device and remains substantially equivalent to already cleared devices.

Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of regulatory submission and device.

However, I can extract information related to the device itself and its regulatory context:

• Device Name: PedFuse® Pedicle Screw System
• Manufacturer: SpineFrontier®
• Regulation Number: 21 CFR 888.3070
• Regulation Name: Pedicle screw spinal system
• Regulatory Class: Class II
• Product Code: MNH, MNI
• Indications for Use: The SpineFrontier® PedFuse® Pedicle Screw 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 instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis). It is also indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (L3 to S1).
• Change from Previous System: Addition of a sliding washer.
• Material: Medical grade titanium alloy (ASTM F136).
• Predicate Devices: K133153, K123164, K092420 (SpineFrontier Pedfuse® Pedicle Screw System) and K071420 (Chameleon® FacetFuse® MIS Screw System as a reference).

Regarding your specific questions, based on the provided text, I can state the following:

1. Table of acceptance criteria and the reported device performance: Not applicable. This document is not about performance metrics like sensitivity or accuracy. It's about substantial equivalence for a hardware component.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document does not detail a test set for performance evaluation in the context of diagnostic or AI devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment is not relevant for this type of hardware component submission.
4. Adjudication method: Not applicable.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device component, not a study evaluating performance against specific acceptance criteria for a diagnostic or AI-driven device.

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The SpineFrontier® Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc.

The SpineFrontier® Arena-C® Cervical IBFD is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The purposed of this submission is to add titanium coating to the existing Arena-C® product line. The Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The system is comprised of devices made of Peek Optima® with titanium coating, with various heights to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist the device movement following implantation.

The implants are provided in two configurations: straight and lordotic (6°) implant sizes for both configurations are offered in three footprints (12x14mm, 11x17mm) and heights from 5mm - 12mm. in 1mm increments.

The SpineFrontier Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating implants are supplied sterile, are single use, and are fabricated from PEEK-OPTIMA® LT1® with titanium coating and tantalum markers for radiographic visualization.

This document is a 510(k) premarket notification for a medical device. It does not contain information about the acceptance criteria and study results for an AI/ML powered medical device. Therefore, I cannot fulfill your request based on the provided text.

The document discusses a cervical intervertebral body fusion device and its substantial equivalence to predicate devices based on mechanical performance data. It outlines the device's description, indications for use, and technological characteristics, but it does not mention any AI/ML components or related performance studies.

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The SpineFrontier Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc.

The SpineFrontier® Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The system is comprised of devices made of PEEK OPTIMA® HA, with various heights to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist the device movement following implantation.

The implants are provided in two configurations: straight and lordotic (6°) implant sizes for both configurations are offered in three footprints (12x14mm, 11x17mm) and heights from 5mm - 12mm, in 1mm increments.

The SpineFrontier Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device components are supplied non-sterile, are single use, and are fabricated from PEEK-OPTIMA® HA and contain tantalum markers for radiographic visualization.

This document is an FDA 510(k) premarket notification for a medical device called the Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own clinical performance against acceptance criteria in the way an AI/ML device would. Therefore, most of the questions about acceptance criteria, sample sizes, ground truth, and expert adjudication are not applicable (N/A) in this context.

Here's an analysis based on the provided text, addressing the questions where information is available or applicable:

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

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

• Sample size for test set: The document describes non-clinical performance testing (mechanical and material characterization). It does not specify sample sizes for these tests, which are typically determined by engineering standards rather than statistical clinical trial sample size calculations.
• Data provenance: N/A. The data is from laboratory performance testing, not human patient data.
• Retrospective or prospective: N/A. This refers to a study design on human subjects, which is not applicable here.

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)

• N/A. This device is an implant, and its performance is evaluated through mechanical testing and material characterization, not by human experts establishing ground truth for diagnostic imaging or similar.

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

• N/A. No human adjudication is involved in the performance testing of this device type.

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

• N/A. This is not an AI/ML medical device, and therefore, an MRMC study is not relevant.

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

• N/A. This is not an AI/ML medical device.

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

• For mechanical testing, the "ground truth" is defined by the physical properties and performance metrics established by industry standards (e.g., ASTM F2077, F2267).
• For material characterization and biocompatibility, the "ground truth" is established by relevant ISO standards (e.g., ISO 10993) and scientific principles, potentially including animal studies for in-bone assessment.

8. The sample size for the training set

• N/A. This is not an AI/ML device, so there is no "training set."

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

• N/A. This is not an AI/ML device.

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The Arena-C® Cervical Intervertebral Body Fusion System is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc.

The SpineFrontier Arena-C® Cervical Intervertebral Body Fusion System is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment with an intervertebral cage.

This 510(k) Submission is seeking add new sizes to the previously cleared Arena-C device. The SpineFrontier Cervical Interbody Fusion Device System (Arena-C® Cervical Intervertebral) is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The system is comprised of devices made of Peek Optima®, with various heights to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist the device movement following implantation.

This document is a 510(k) summary for the SpineFrontier Arena-C® Cervical Intervertebral Fusion System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically reported for AI/ML devices (e.g., sensitivity, specificity, AUC). This document is for a physical medical device, an intervertebral body fusion system, not a software or AI/ML device.

Therefore, many of the requested fields cannot be answered from the provided text as they pertain to the evaluation of AI/ML software.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be provided. This document does not specify quantitative acceptance criteria for device performance (e.g., success rates, complication rates) that would typically be seen in a clinical study for a physical implant, nor does it present a clinical study with detailed performance results against such criteria. The "performance testing summary" refers to "engineering rationale and finite element analysis" to show that modifications don't create new worst-case scenarios compared to a predicate device, which is a different type of "performance" than what's implied by the request.

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

• Cannot be provided. This document describes a submission for an add-on to an existing cleared device ("seeking add new sizes to the previously cleared Arena-C device"). It references "engineering rationale and finite element analysis" rather than a clinical study with human subjects for the new sizes. There is no mention of a "test set" in the context of clinical data.

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)

• Cannot be provided. No clinical "test set" and corresponding ground truth establishment is described.

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

• Cannot be provided. No clinical "test set" and adjudication method is described.

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

• Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.

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

• Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.

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

• Cannot be provided. No clinical study or ground truth establishment is described. The "ground truth" for this type of device (spinal implant) would typically be successful fusion or long-term patient outcomes, evaluated through clinical trials, which are not detailed here for the size additions.

8. The sample size for the training set

• Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.

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

• Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.

Summary of available information from the document:

The document focuses on demonstrating substantial equivalence to predicate devices for a physical implant rather than proving performance against specific acceptance criteria through a clinical study for the new sizes. The core of the submission for the new sizes relies on:

• Identical Indications for Use.
• Identical Materials of manufacture (Peek Optima®).
• Identical Structural support mechanism.
• "Engineering rationale and finite element analysis were used to demonstrate that the modifications to the Arena-C Cervical Intervertebral Fusion Device do not generate new worst case compared to the predicate device."

Essentially, the "study" demonstrating that the device meets criteria is primarily a biomechanical and materials equivalence assessment, not a clinical study with patient outcomes or expert reads, as would be expected for AI/ML performance evaluation.

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The SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).

In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

The SpineFrontier® PedFuse® Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system consists of longitudinal rods, polyaxial screws, and cross connector. Hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods are added to the System in this submission.

The provided text describes a 510(k) premarket notification for a medical device, the SpineFrontier® PedFuse® Pedicle Screw System. This specific submission focuses on modifications to an already cleared device, adding hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods.

Therefore, the performance data presented is for the mechanical substantial equivalence of these new materials and components to previously cleared versions and predicate devices, rather than a usability or clinical effectiveness study of the entire system as an AI device or a novel medical device establishing its own set of acceptance criteria.

The document does not describe the use of AI in this device, nor does it detail a study involving human readers, test sets, ground truth establishment, or training sets in the context of AI performance. The study mentioned is purely mechanical testing of the physical components.

However, I can extract information related to the mechanical performance testing conducted to demonstrate substantial equivalence, framed in the context of acceptance criteria if we interpret "acceptance criteria" as meeting the performance standards of the predicate devices.

Description of Acceptance Criteria and Study for SpineFrontier® PedFuse® Pedicle Screw System (Mechanical Performance)

This 510(k) submission (K133153) describes an update to the SpineFrontier® PedFuse® Pedicle Screw System, specifically adding Hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods. The study presented is a mechanical performance testing summary to demonstrate that these modifications maintain adequate and substantially equivalent mechanical strength compared to previously cleared versions and predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like pedicle screw systems, "acceptance criteria" for mechanical testing typically involve meeting or exceeding the performance established by recognized ASTM standards or demonstrating equivalence to predicate devices under those standards. The document states the purpose of the testing is to "demonstrate that the modifications... provide adequate and substantially equivalent mechanical strength for their intended use." While explicit numerical acceptance criteria are not provided in this summary, the implicit acceptance criterion is that the modified device's performance is comparable to or better than previously cleared devices and predicate devices when tested under specified ASTM standards.

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

• Sample Size: The document does not specify the exact sample size (number of devices or test repetitions) used for each mechanical test. Mechanical testing, especially for medical devices, typically involves multiple samples to ensure statistical validity, but the specific number is not disclosed in this summary.
• Data Provenance: The testing was conducted by SpineFrontier, Inc. in support of their 510(k) submission. This is internal testing performed by the manufacturer, likely in the USA where the company is based. It is a prospective generation of data specifically for this submission.

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 the described study is mechanical performance testing of physical components, not a study involving human interpretation of data where "ground truth" would be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is mechanical performance testing and does not involve human readers or adjudication processes.

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 submission concerns mechanical properties of spinal implants, not an AI device or a study involving human readers.

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

This information is not applicable. This submission concerns mechanical properties of spinal implants, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established mechanical performance benchmarks set by:

• ASTM standards (specifically ASTM F1717-13).
• The known performance of the previously cleared SpineFrontier® PedFuse® Pedicle Screw System (K123164, K092420).
• The known performance of predicate devices (Medtronic TSRH® Spinal System K091797, Pioneer Quantum Spinal System K101790, Globus Transition™ Stabilization System K073439).

The aim of the study was to demonstrate that the modified device's mechanical properties met or were equivalent to these established benchmarks.

8. The Sample Size for the Training Set

This information is not applicable as the described study is mechanical performance testing and does not involve a training set for an algorithm.

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

This information is not applicable as the described study is mechanical performance testing and does not involve a training set for an algorithm.

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