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The PATHWAY ELIF device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s).

The PATHWAY ELIF device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.

Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY ELIF device(s).

The PATHWAY ELIF device can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF)

Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF)

Used as a PLIF, two devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.

The PATHWAY ELIF implant features three prescribed lordotic angle / height positions and is available in two lengths for posterior lumbar fusion. It allows lordotic adaptability and height restoration to meet patient anatomy. It is comprised of upper and lower expandable surfaces preassembled with a posterior height maintenance component. The device can be expanded to fixed configurations of 0°, 8°, and 16° positions. Each position after 0° provides approximately 2mm of additional mid-body height increase. The superior and inferior surfaces of all components are coated with plasma sprayed titanium to provide a roughened finish.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the PATHWAY ELIF device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with specific numerical targets. Instead, it refers to compliance with established ASTM standards for intervertebral body fusion devices. The reported device performance is that the PATHWAY ELIF System demonstrated "equivalent performance to the predicate" by successfully passing these tests.

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

The document does not specify the exact sample sizes used for each mechanical test (static/dynamic compression, subsidence, expulsion). Instead, it states that "Testing was performed in accordance with the following standard(s):" and lists several ASTM standards. These standards typically define minimum sample sizes for such tests.

The document mentions a "cadaver study" for usability and functionality, but the sample size for this study is not provided.

The provenance of the data is retrospective, as it describes tests conducted to demonstrate the device's characteristics. No information on the country of origin for the data is provided, but given the US FDA submission, it's presumed to be from tests conducted by or on behalf of Custom Spine, Incorporated.

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 to the supplied document. The "ground truth" for this medical device submission is established through objective engineering and material testing standards (ASTM standards), rather than expert consensus on medical images or clinical outcomes. The evaluation is based on whether the device meets pre-defined mechanical and material specifications.

4. Adjudication Method for the Test Set:

This information is not applicable. The assessment is based on quantifiable engineering test results and adherence to material specifications, not on human interpretation that would require an adjudication method.

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. The PATHWAY ELIF is an intervertebral body fusion device (an implant), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This information is not applicable for the same reason as point 5. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for this device is based on:

• Engineering Standards: Compliance with recognized ASTM standards (e.g., F2077, F2267) for mechanical performance (static/dynamic compression, subsidence, expulsion).
• Material Specifications: Adherence to defined material standards for Titanium alloy (ISO 5832-3, ASTM F136) and coating properties (e.g., ASTM F1580, F1854).
• Cadaveric Demonstration: For usability and functionality, a cadaver study provided empirical evidence.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical implant, not an AI model that requires a "training set." The development would involve engineering design, finite element analysis, and physical prototyping, but not a data training set in the AI sense.

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

This information is not applicable, as there is no "training set" in the context of this physical medical device.

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The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-Sl) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment.

The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space.

The Optimus Anterior Lumbar Interbody Fusion (ALIF) system is a zero profile stand-alone interbody that combines the benefits of an anterior fixation plate and fusion device. Optimus is a modular design that consists of a center fixation plate, lordotic end caps and three bone screws for anterior fixation and stability. The bone screws thread into the fixation plate and pass through the superior and inferior openings of the end caps to fixate the implant with the adjacent vertebral bodies. The device is available in two footprints, multiple heights, lordotic angles and screw lengths.

The provided text describes a medical device, the OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System, and its performance testing to demonstrate substantial equivalence to predicate devices. It does not contain information about an AI/ML powered device, nor does it detail a clinical study with human readers or ground truth established by experts in the context of diagnostic accuracy.

Therefore, many of the requested categories are not applicable to the provided document.

Here's an analysis based on the information provided, with "N/A" for sections not covered by the text:

Acceptance Criteria and Device Performance

The device's performance was evaluated through mechanical testing to demonstrate substantial equivalence to previously cleared predicate devices. The acceptance criteria were implicit in establishing mechanical superiority or equivalence to these predicates.

Study Details:

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

   • Sample Size: Not specified. Mechanical testing typically involves a number of samples to ensure statistical validity, but the exact number isn't mentioned in this summary.
   • Data Provenance: The data comes from mechanical testing performed on the physical device components and predicate devices, so it's laboratory-generated data, not patient data from a specific country or retrospective/prospective study.

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

   • N/A. The performance data is based on mechanical testing according to established ASTM standards, not on expert-adjudicated ground truth as would be used for AI/ML diagnostic devices. The "ground truth" here is the objective measurement of mechanical properties.

3. Adjudication method for the test set:

   • N/A. Not applicable as this is mechanical testing, not a diagnostic study requiring expert adjudication.

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 not an AI-powered device, nor is it a diagnostic imaging device that would typically involve human readers. Therefore, an MRMC study and effects on human reader performance are not applicable.

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

   • N/A. This is a physical medical implant, not an algorithm. Therefore, standalone algorithm performance is not applicable.

6. The type of ground truth used:

   • Physical Measurement/Standardized Testing Results: The "ground truth" for this device's performance is derived from objective physical measurements obtained through standardized mechanical testing (e.g., force, displacement, torque) performed in accordance with ASTM standards. The comparison is against previously cleared predicate devices' mechanical properties.

7. The sample size for the training set:

   • N/A. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

   • N/A. Not applicable, as there is no training set for this type of device.

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The Kompresa Facet Screw System is indicated for bilateral transfacet fixation and stabilization of the facet joints as an aid to fusion for the treatment of any or all of the following at the T10 to S1 spinal levels: ·

• . Trauma, including spinal fractures and/or dislocation
• . Spondylolisthesis
• Spondylolysis ●
• . Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity
• . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• . Degeneration of the facets with instability

The subject Kompresa Facet Screw System consist of non-sterile, single use cannulated screws of various diameters and lengths to be used in conjunction with different diameter nuts and a universal collet. The screws, nuts and collets are all made from titanium alloy Ti6Al4V. The Instruments and guide wires are made from various grades of stainless steel or aluminum.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KOMPRESA Facet Screw System:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Bench testing was performed to support the equivalence of the proposed facet screw system." This implies that the acceptance criteria for each test was that the performance of the KOMPRESA system should be substantially equivalent to its predicate devices (Trans 1 facet screw (K073515) and Depuy Spine's DISCOVERY facet screw system (K012773)). The document does not provide specific numerical thresholds for acceptance, only that the tests were performed "per" the listed ASTM standards to demonstrate equivalence.

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

• Sample Size: Not explicitly stated in the provided text. For mechanical bench testing, sample sizes are typically determined by the relevant ASTM standard or risk analysis, but this information is absent.
• Data Provenance: The data is from bench testing, which is performed in a laboratory setting. It is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the clinical sense. The firm is located in Parsippany, NJ, USA, so the testing was presumably conducted there or at a testing facility within the U.S.

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

This section is not applicable as the provided document describes bench testing for a medical device (facet screw system), not an AI/PCSA system that requires expert ground truth for image analysis or diagnosis. The "ground truth" here is the physical measurement of mechanical properties according to established engineering standards.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth, not for mechanical bench 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

This section is not applicable. The document describes the mechanical testing of a surgical implant (facet screw system), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This section is not applicable. This device is a physical surgical implant. There is no algorithm to evaluate in a standalone manner.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this device's performance is established by engineering standards and physical measurements. The performance is compared against the known characteristics and performance data of the predicate devices. The material properties and design specifications are the core of the "ground truth" to which the device's physical performance is benchmarked for substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. This is a physical medical device, not an AI model. There is no "training set."

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

This section is not applicable for the same reasons as point 8.

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The PATHWAY AVID intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have Grade I Spondylolisthesis at involved levels. The patients may have had a previous non-fusion spinal surgery at the involved level(s).

The device is intended to be used with supplemental fixation systems that have been cleared for the lumbosacral spine (i.e. posterior pedicle screws and rod systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted from a transforaminal approach (TLIF).

The proposed modification subject device is to be provided to the users in one of two configurations: the predicate device containing PEEK Optima LT1with titanium hinges and linkages (Ti-6Al-4V, ASTM F136) or the proposed PEEK Optima LT1 with MP35N (Co-Cr-Ni-Mo Alloy, ASTM F562).

Here's an analysis of the provided text regarding the acceptance criteria and study for the PATHWAY AVID device, conforming to your requested format:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This document is a 510(k) summary for a modification to an existing device. The acceptance criteria and performance data are primarily focused on demonstrating substantial equivalence to the predicate device, rather than proving de novo clinical efficacy or specific accuracy metrics.

Here's a breakdown of the other requested information based on the provided text. Many of these points are not applicable or explicitly stated in a 510(k) summary for a device modification, which focuses on engineering and material equivalence:

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 for Test Set: Not explicitly stated in terms of number of devices tested, but implied to be sufficient for mechanical and corrosion testing. Specific numbers of units are not provided.
• Data Provenance: Not specified. Standard practice for such tests is in a laboratory setting.
• Retrospective or Prospective: Not applicable for engineering bench testing.

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. The "ground truth" for these tests are objective measurements based on engineering standards (tensile strength, corrosion). No human experts are used to interpret the results in the same way as they would for medical images.

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

• Not applicable. This concept pertains to human interpretation/review, not objective engineering tests.

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

• No. This is a medical device (intervertebral body fusion device), not an AI/software device. MRMC studies are not relevant here.

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

• No. This is a physical medical device, not an algorithm.

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

• Ground Truth: For mechanical testing, the ground truth is defined by the objective physical properties and performance under specific force/environmental conditions. For corrosion testing, the ground truth is determined by electrochemical measurements according to ASTM F 2129-08 standards.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device. The "training set" concept is not relevant.

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

• Not applicable. This is not an AI/machine learning device.

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The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

For pedicular use: When used as pedicle screw fixation system of the non cervical posterior r or peareliar assort when matients, these systems are indicated for one or more of the following: decenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudoarthrosis).

In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with m automory wollisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

The ISSYS LP Spinal Fixation System is also intended to provide immobilization and stabilization of the spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion of degenerative disc disease and spondylolisthesis other than severe spondylolisthesis (grade 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurological impairment.

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation System, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:

• Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic . origin with degeneration of the disc confirmed by history and radiographic studies).
• Spondylolisthesis .
• Fracture .
• Spinal deformities such as scoliosis, kyphosis, lordosis .
• . Tumor
• Revision of failed fusion attempts .
• Pseudoarthrosis .
• Spinal Stenosis .

When used in the anterior indication the ISSYS LP Spinal Fixation System is indicated for use in the thoracic and lumbar spine.

The subject ISSYS LP Spinal Fixation System includes will include auxiliary connectors in the form of side to side, axial connectors, and offset connectors with various length arms up to 35mm. Additionally, pre bent 6.0 mm diameter rods, in various lengths, will be provided to be used with the side to side connectors, if required. These connectors are intended to be used with 5.5 mm, 6.0 mm, and 6.35 mm diameter rods. These additional components are to be used in the posterior non-cervical spine (T1-S1). The indications for use are not affected by the addition of these components.

This is a 510(k) premarket notification for a medical device, the ISSYS LP Spinal Fixation System. It is not an AI/ML device, and therefore the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not applicable in the context of an AI/ML device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a modified spinal fixation system. The "performance data" referred to here are mechanical tests, not clinical performance or AI algorithm performance.

Here's the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Performance data per ASTM F1717 and F1798 were submitted to characterize the subject ISSYS LP Spinal Fixation system components in this notification." It further clarifies, "An engineering analysis and testing demonstrate meentined properies, and 'Guidance for Spinal Systems 510(k)' Dated May 3, 2004 was completed for the ISSYS LP Spinal Fixation System, including the subject components."

Without the actual ASTM F1717 and F1798 reports, a specific table of acceptance criteria and reported device performance cannot be generated. However, the general acceptance criterion is that the device components meet the mechanical performance requirements specified in these ASTM standards and the FDA guidance document. The reported device performance is that it does meet these requirements, as indicated by the FDA's 510(k) clearance.

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 specified in terms of clinical patients or data points for an AI model. The "sample size" would refer to the number of physical components tested per ASTM F1717 and F1798. This information is typically detailed in the full test reports, which are not included here.
• Data Provenance: Not applicable in the AI/ML sense. The "data" here refers to mechanical test results. The device firm, Custom Spine, Inc., is based in Parsippany, NJ, USA. The testing likely occurred in a U.S.-based lab or a lab certified to perform these ASTM standards. The tests are prospective in nature regarding the device's design, meaning they are performed on newly manufactured components to ensure they meet specifications.

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 for a non-AI/ML mechanical device. Ground truth, in this context, would be defined by the physical measurement results compared against the ASTM standard specifications, not by expert consensus on clinical data.

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

Not applicable for a non-AI/ML mechanical device. Mechanical test results are objective measurements that either meet or do not meet a predefined numerical and procedural standard.

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):

The "ground truth" for this device's performance is adherence to established engineering and material science standards, specifically ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) and ASTM F1798 (Standard Guide for Evaluation of Spinal Implants in an Anatomical Model). These standards define the mechanical properties and performance requirements for spinal fixation systems. The device's components must demonstrate mechanical properties (e.g., strength, fatigue life, stiffness) that meet or exceed the performance of the predicate devices and the requirements of these standards.

8. The sample size for the training set:

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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When used as an intervertebral body fusion device, the Custom Spine PATHWAY ACIF is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the Custom Spine ACIF.

When used as a vertebral body replacement, the Custom Spine PATHWAY ACIF is intended for use in the thoracic and/or throcolumbar spine (TI-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The PATHWAY ACIF, when used as a vertebral body replacement, can be packed with autograft.

For all indications, the device is intended to be used with supplemental fixation systems that have been cleared for use in cervical, thoracic, or lumbar spine (posterior pedicle screw systems, anterior plate systems, and anterior screw and rod systems).

The PATHWAY ACIF is a cervical interbody fusion active as identification markers for the (Polyetheretherketone). The device continues of the implant both intra-operatively and postoperatively.

The device is trapezoidal in nature and is provided in various heights ranging from 5 mm to 12 mm and a The device is trapezondan in hatale and is pro naiss a central cavity which is to be packed with width of 15 mm, and 13 mm in length This abouts of Indusis (0 Degree and 7 Degree and 7 Degree). The superior autograft. This device is provided in various degrees of lordos autograft. This device is provided in the resist implant migration/displacement.
and inferior surfaces have serrated teeth to help resist implant migration/displacement.

The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

The product is provided clean and "non-sterile".

The provided text describes the "PATHWAY ACIF" intervertebral body fusion device and its regulatory clearance (510(k) K092904). However, it does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance, nor any AI/ML components for which such a study would be relevant.

The "Performance Data" section explicitly states:

The PATHWAY ACIF device was tested in accordance with ASTM F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices Under Static Axial Websited by Jan ASTM F2077-03 "Test Method For Intervertebral Body Fusion Devices". The data are located in Section 19 of this submission, "Bench Testing". The data demonstrate that the device is capable of performing in accordance with its intended use.

This indicates bench testing (mechanical testing) was performed to demonstrate the device's physical performance, not a clinical study or an AI/ML performance study. Therefore, most of the requested information regarding AI/ML study design (sample sizes, ground truth, experts, MRMC, standalone performance) is not applicable or available in this document.

Here's a breakdown of the information that can be extracted, and where the requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only mentions "mechanical support" and "resistant to migration/displacement" as performance goals, and refers to industry standards for testing. Specific acceptance criteria values (e.g., maximum allowable subsidence, specific load magnitudes) and quantitative performance results are not provided in this summary.

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

• Not applicable for AI/ML performance study. The device underwent mechanical bench testing, not a clinical test set with data provenance in the context of AI/ML.

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 context of clinical images or data interpretation by experts is not relevant to mechanical bench testing of an intervertebral fusion device.

4. Adjudication method for the test set

• Not applicable. This applies to expert review of clinical data, not 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

• No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI/ML diagnostic or assistive tool for human readers.

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

• No, a standalone AI/ML performance study was not done. This describes a physical medical device, not an algorithm.

7. The type of ground truth used

• For mechanical performance: The "ground truth" for the device's performance relies on the established engineering standards and requirements outlined in ASTM F2267-04 and ASTM F2077-03, and the physical measurements obtained during bench testing. There is no biological or expert consensus 'ground truth' in the clinical sense for this type of testing as described.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm, so there is no training set or associated ground truth establishment process.

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The REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

• . Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• . Trauma (including fractures)
• . Tumors
• . Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• . Pseudoarthrosis
• . Failed previous fusion
• . Spondylolisthesis
• Spinal Stenosis
  THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS
  WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE

The REGENT Anterior Cervical Plate System is composed of various cervical plates and the screws in made from a Titanium alloy (Ti-6Al-V, ASTM F-136/ISO 5832-3). The REGENT Anterior Cervical System contains multiple level plates (1 Level, 3 Level, and 4 Level) and various diameter screws that are either fixed or variable in nature. The plates and screws are anodized.

The provided text describes a medical device, the REGENT Anterior Cervical Plate System, and its regulatory submission. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a clinical or standalone study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/device performance study is not available in the provided text.

The document explicitly states "Clinical Testing Not Applicable" and "Animal Testing Not Applicable," indicating that the submission primarily relied on bench testing and comparison to predicate devices for substantial equivalence.

Here's what can be extracted from the text in relation to your request, but with the understanding that it doesn't align with a typical AI device performance evaluation:

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

Note: The "acceptance criteria" here are inferred from the mention of ASTM F 1717-04 and the substantial equivalence claim. Actual specified criteria are not provided in detail.

2. Sample sized used for the test set and the data provenance:
Not applicable. No test set for device performance as per an AI study is mentioned. The submission refers to "Bench Testing" data, but details about sample size or data provenance for these bench tests are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set is discussed in the context of an AI/device performance study.

4. Adjudication method for the test set:
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:
No. The document states "Clinical Testing Not Applicable."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
For the bench testing, the "ground truth" would be the engineered specifications and performance standards defined by ASTM F 1717-04.

8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device.

9. How the ground truth for the training set was established:
Not applicable.

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The PATHWAY Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved level(s).

The device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rods systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device.

The PATHWAY AVID Intervertebral body fusion device must be inserted using a transforaminal approach.

The PATHWAY AVID Intervertebral Body Fusion Device is made from PEEK Optima. The device is made from multiple PEEK segments. The segments are serrated on the superior and inferior surfaces. The PEEK segments are attached with titanium pins and have a titanium linkage that attaches the segments. This pins and the linkage provide the means to form into its final articulated shape.

The titanium alloy pins serve as markers providing visual aid in determining the location of the implant both intra and postoperatively.

The articulated device foot print ranges from 8 mm through 14 mm in height, 20mm in width and 35 mm in length.

The implants are non-sterile and instruments are provided clean and non-sterile. These devices are to be sterilized by the user facility.

The provided text describes a medical device, the PATHWAY AVID Intervertebral Body Fusion Device, and its 510(k) summary for FDA clearance. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of AI/ML performance.

The "Performance Data" section states: "Performance data per ASTM 2077 and ASTM 2267 and compared to the predicate devices. In addition, cadaver testing demonstrated the PATHWAY AVID is substantially equivalent to its predicates, as it was shown that the device can be used as intended by the intended user population per its labeling following a standard training program."

This indicates physical performance testing and comparison to predicate devices, and cadaver testing for surgical use, but it does not involve any AI/ML components, acceptance criteria tables, or studies with a test set, ground truth experts, or training sets as requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance from the provided text.

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The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one of two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthcsis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The PATHWAY Interbody Fusion device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems , anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.

Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY Device.

The PATHWAY device can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF)

Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery

Posterior Lumbar Interbody Fusion (PLIF)

Used as a PLIF, multiple devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.

The PATHWAY Interbody Fusion Device is made from Polyetheretherketone (PEEK OPTIMA TM) and contain titanium markers. The titanium markers serve a means for the end user of the device to determine the location of the implant intra-operatively and post- operatively.

The device(s) is rectangular in nature and have various widths, lengths, heights and degrees of lordosis (0 Degree and 6 Degree). The devices contain empty space for the practitioner to insert autogenous bone graft. The devices have serrated teeth on the superior and inferior sides to provide anchorage stability to the vertebrae. They are single use devices.

The 0 Degree PLIF has a width of 10 mm, a length of 23 mm, and ranges in height from 7 to 15 mm.

The 6 Degree PLIF is lordotic in nature and has a width of 8 mm, a length of 23 mm, and ranges in height from 7 to 15 mm

The TLIF is a rectangular in nature and has a width of 10 mm, a length of 28 mm, and ranges in height from 7 to 15 mm.

The implants are provided non-sterile and the instruments are provided cleaned, decontaminated and non-sterile. These devices must be sterilized by the user facility.

Here's a breakdown of the acceptance criteria and study information for the Custom Spine, Inc. PATHWAY Intervertebral Body Fusion Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not explicitly mentioned. The submission relies on demonstrating substantial equivalence through material comparison, design specifications, indications for use, and mechanical testing against predicate devices. There is no mention of a clinical "test set" in the context of a prospective or retrospective patient data study for evaluation of algorithm performance.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a pre-market submission for a physical medical device, not an AI/software device evaluated on patient data. The "data" refers to engineering and material testing data, not patient data.

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

• Not applicable. This submission is for a physical orthopedic implant. "Ground truth" in the context of expert consensus on medical images or diagnoses is not relevant here. The ground truth for device performance is based on established engineering standards and comparison to predicate devices.

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

• Not applicable. No expert adjudication of test set results is mentioned for this type of device submission.

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/software device. No MRMC study was conducted.

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

• Not applicable. This is not an AI/software device.

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

• The "ground truth" for this device's performance is derived from:
  • Established ASTM Standards: ASTM F2026 (for PEEK OPTIMA™), ASTM F-136 (for Titanium), ASTM 2077 (for mechanical performance), and ASTM 2267 (for mechanical performance).
  • Performance of Predicate Devices: The device's performance and characteristics (materials, design, indications for use, mechanical properties) were compared to the cleared predicate devices: Spinal Elements Lucent (K071724) and Depuy Acromed™ Stackable Cage™ System (K990148, K001340, K030833). The equivalence to these legally marketed devices serves as the basis for demonstrating safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/software device that requires a training set of data.

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

• Not applicable. No training set for an algorithm is involved.

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The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:

• Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• Spondylolisthesis
• Fracture
• Spinal deformities such as scoliosis, kyphosis, lordosis
• Tumor
• Revision of failed fusion attempts
• Pseudarthrosis
• Spinal stenosis

When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine.

The subject ISSYS LP Polyaxial Spinal Fixation System includes 5.5 mm diameter rods (preformed rod or straight rod configuration) in addition to the selection of the cleared 6.0 mm and 6.35 mm diameter rods. It is to be used with both the Polyaxial and Monoaxial screws.

This is a 510(k) premarket notification for a spinal fixation system, not an AI/ML medical device. Therefore, much of the requested information regarding AI device performance, such as sample sizes for test and training sets, expert ground truth establishment, adjudication methods, and MRMC studies, is not applicable. The provided document focuses on demonstrating substantial equivalence to predicate devices through material, design, and performance data for a new component (5.5 mm diameter rod) of an existing spinal fixation system.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission is for a physical medical device (spinal fixation system component), not a diagnostic algorithm that uses a "test set" of data in the typical sense. The "testing" refers to mechanical and material characterization.
• Data Provenance: Not applicable in the context of clinical/imaging data. The data provenance refers to materials testing and engineering analysis performed according to recognized standards (ASTM F-136, ASTM F 1717). This would typically be conducted in a laboratory setting by the manufacturer or contracted labs.

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

• Not applicable. This is not an AI/ML device requiring expert-established ground truth from clinical data. The "ground truth" for this device relates to established engineering standards for material properties and mechanical performance.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication method" as would be used for clinical data interpretation. Compliance is assessed 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 is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device submission is based on:

• Established engineering and material standards: Specifically, ASTM F-136 for material composition (implant grade titanium alloy) and ASTM F 1717 for mechanical performance of spinal implant constructs.
• FDA Guidance: The device's design and testing adhered to the "FDA's Guidance For Spinal System 510(k) May 3, 2004."
• Predicate Device Characteristics: The core of a 510(k) is demonstrating substantial equivalence to legally marketed predicate devices in terms of material, design, and indications for use. The characteristics of these predicate devices serve as a benchmark.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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