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The Stabilis SA Cervical Stand-Alone System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space.

The Stabilis SA Cervical Stand-Alone System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Stabilis SA Cervical Stand-Alone System cages may be used as a stand-alone device when two (2) vertebral body bone screws are used. Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may be used as a stand-alone device when at least two (2) vertebral body bone screws are utilized with one inferior and one superior screw trajectory on opposite sides of the cage. If the physician chooses to use Stabilis SA Cervical Stand-Alone System cages with fewer than two (2) screws, then an additional supplemental spinal fixation system cleared for use in the cervical spine must be used.

Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may only be used at contiguous levels if at least two (2) vertebral body bone screws are utilized in each cage with one inferior and one superior screw trajectory on opposite sides of the cage, such that no more than two (2) vertebral body bone screws are implanted at the shared vertebral body with one inferior and one superior screw trajectory on opposite sides of the cages. Additionally, a cage with four (4) screw holes and a cage with two (2) screw holes can be implanted contiguously only if the cage with four (4) screw holes uses at least (2) vertebral body bone screws with one inferior screw on the left side of the cage and one superior screw on the right side of the cage.

The Stabilis SA cages are intervertebral body fusion devices intended for cervical interbody fusion using an anterior approach. The devices are intended to improve stability of the spine while supporting fusion. Stabilis SA constructs are intended for use at one or two contiguous levels in the cervical spine (C2-T1). The components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy.

Stabilis SA Cervical Stand-Alone System cages are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. All cages are manufactured using the L-PBF (laser powder bed fusion) additive manufacturing method. L-PBF allows for the formation of solid, non-porous cages with a layered porous lattice structure on the surfaces of the components, including the surfaces of the interior graft window. This intricate structure facilitates bone in-growth by providing a larger surface of implant/bone contact than a buffed surface. The cages are also titanium anodized to allow for identification of various heights by color. The Stabilis SA Cervical Stand-Alone System cages are secured on the vertebral bodies using bone screws. The bone screws are machined from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and passivated according to ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants.

Stabilis Ti SA 2 Interbody, Stabilis Ti SA 2 Interbody, Curved, Stabilis Ti SA 4 Interbody, Stabilis Ti SA 4 Interbody, Curved, Stabilis Ti ZP Interbody, Stabilis Ti ZP Interbody, Curved cages, and bone screws are also available with a hydroxyapatite coating to increase implant anchoring by facilitating osseointegration and enhancing early bone growth. All Stabilis SA Cervical Stand-Alone implants are only available sterile packaged.

Non-sterile, reusable surgical instruments to support implantation of the system are provided for use with Stabilis SA Cervical Stand-Alone devices are provided in steam sterilization trays.

Here's an analysis of the provided FDA 510(k) clearance letter for the Stabilis SA Cervical Stand-Alone System, focusing on the acceptance criteria and study information:

This document describes the mechanical testing performed on an intervertebral body fusion device and does not involve AI. Therefore, many of the typical questions regarding AI device studies are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

Device: Stabilis SA Cervical Stand-Alone System (Intervertebral Body Fusion Device)

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

The document does not specify the exact sample size for the mechanical performance testing (e.g., number of devices tested for each mechanical test). It refers to the tests as being conducted on "the worst-case subject device" and "new implant sizes and configurations."

The data provenance is from non-clinical (mechanical and material) testing performed on the physical device, not patient data. Therefore, concepts like country of origin or retrospective/prospective do not apply in the typical sense for clinical studies.

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

This question is not applicable as this is a non-clinical device clearance for an intervertebral body fusion device, not an AI/software device requiring "ground truth" derived from expert interpretation of clinical data. The "ground truth" here is the adherence to established mechanical and material standards and the performance equivalence to predicate devices.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to how expert disagreements are resolved when establishing ground truth in clinical data interpretation studies. This document describes mechanical and material testing, not clinical data assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or prognostic AI/software devices where human reader performance is being evaluated with and without AI assistance. This document pertains to the mechanical and material safety and effectiveness of a physical implant.

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

Not Applicable. This device is a physical implant, not an algorithm. Standalone performance typically refers to the diagnostic or predictive capability of an AI algorithm without human input or modification of the output.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Adherence to recognized industry standards: ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices), ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices Under Static Axial Compression), ASTM F3001 (Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI), ASTM F136 (Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy), and ASTM F86 (Practice for Surface Preparation and Marking of Metallic Surgical Implants).
• Performance equivalence to previously cleared predicate devices, as demonstrated through mechanical and material testing.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for the device's design is based on engineering principles, material science, and the performance characteristics of previously cleared predicate devices.

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

Not Applicable. As there is no training set in the context of AI/ML, there is no ground truth established for it. The standards and predicate devices guide the design and manufacturing, but this is a different concept than ground truth for machine learning.

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The Tailored-H Cervical Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Tailored-H Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of nonoperative treatment. The Tailored-H Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The Tailored-H Cervical Stand-Alone System is an internal spinal fixation system consisting of additively manufactured interbody devices and machined titanium bone screws. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tailored-H Cervical Stand-Alone System is available in a variety of lordosis and footprint options with a porous architecture to offer increased capacity for bone growth and mechanical properties to suit the individual pathology and anatomical conditions of the patient.

The Tailored-H cages are additively manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F3001. The fixation screws and face plates are machined from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3.

I am unable to find information about acceptance criteria and study detailed in the prompt from the provided document. The document primarily discusses the FDA's 510(k) clearance for the "Tailored-H Cervical Stand-Alone System," focusing on its indications for use, technological characteristics, and a list of mechanical performance tests conducted.

Here's a breakdown of what the document does contain regarding performance testing:

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

The document lists performance tests conducted, but does not provide specific acceptance criteria or quantitative reported device performance values. It only states: "The results of this non-clinical testing show that the strength of the Tailored-H Cervical Stand-Alone System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The tests performed are:

• Static Axial Compression per ASTM F2077
• Static Compression Shear per ASTM F2077
• Static Torsion per ASTM F2077
• Subsidence per ASTM F2267
• Dynamic Axial Compression per ASTM F2077
• Dynamic Compression Shear per ASTM F2077
• Dynamic Torsion per ASTM F2077

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

This information is not provided in the document. The document describes mechanical tests, not clinical studies with human subjects or data sets.

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):

This information is not provided. The testing described is mechanical, not involving human interpretation or ground truth establishment by experts in a clinical context.

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

This information is not applicable as the described tests are mechanical and do not involve human adjudication.

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 provided and is not applicable to an intervertebral body fusion device. The document does not describe any AI component or human reader effectiveness studies.

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

This information is not provided and is not applicable to the device described.

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

This information is not provided and not applicable to the mechanical testing described. The "ground truth" for these tests would be the physical properties and performance measured against established ASTM standards.

8. The sample size for the training set:

This information is not provided. The document describes a medical device undergoing mechanical testing, not an AI or machine learning model that would require a training set.

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

This information is not provided and not applicable.

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The F3D-C2 Cervical Stand-Alone System is a Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels depending on the assembly. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D-C2 Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) depending on the assembly. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone marrow aspirate as an adjunct to fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment.

The F3D-C2 Cervical Stand-Alone System is an interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implants. When used with screws, the F3D-C2 Cervical Stand-Alone System is intended for use at one or two levels of the cervical spine (C2-T1) and requires no additional fixation. When used with one or more anchors, the F3D-C2 Cervical Stand-Alone System is intended for use at one level of the cervical spine (C2-T1) and requires additional supplemental fixation such as posterior cervical screw fixation.

The CoreLink F3D Cervical Stand-Alone Interbody Fusion System is a collection of additively manufactured and machined implants and associated instruments for surgical site preparation and implantation to provide mechanical support to the cervical spine while arthrodesis occurs. The subject cages are additively manufactured from Ti-6Al-4V per ASTM F3001. Integration consists of additive Ti-6Al-4V (ASTM F3001) anchors (also referred to as nails) or machined Ti-6A-4V (ASTM F136 and ISO 5832-3) screws. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a trapezoidal column to provide surgical stabilization of the spine. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft.

The provided text describes a medical device, the F3D-C2 Cervical Stand-Alone System, and its FDA 510(k) clearance. However, it does not include information about acceptance criteria, device performance in terms of metrics like sensitivity, specificity, or accuracy, or any study involving human readers or AI.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because such details are not present in the provided document.

The document discusses the regulatory clearance process for a spinal implant and focuses on:

• Device Description: What the F3D-C2 Cervical Stand-Alone System is made of and its components.
• Indications for Use: The medical conditions and patient population for which the device is intended.
• Technological Characteristics: How it compares to predicate devices.
• Non-Clinical Performance Data: A list of mechanical tests performed to demonstrate its safety and effectiveness compared to predicate devices. These tests are physical and mechanical, not related to AI or diagnostic accuracy.

The performance data mentioned are for mechanical tests such as static axial compression, dynamic axial compression, subsidence, and pullout, all referencing ASTM standards. These are physical properties of the implant, not performance metrics for a diagnostic or AI-driven medical device.

To directly answer your numbered points based only on the provided text, I would have to state that the information is not present for most of them:

1. A table of acceptance criteria and the reported device performance: Not provided. The text lists types of mechanical tests (e.g., Static axial compression per ASTM F2077) but does not provide specific acceptance criteria values or reported performance values for these tests.
2. Sample sized used for the test set and the data provenance: Not provided. The mechanical tests typically involve testing multiple units of the device but the sample size is not stated. Data provenance refers to the origin of clinical data, which is not applicable here as these are non-clinical mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are mechanical tests, not clinical studies involving expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) 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: Not applicable. This document is about a physical medical implant, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context you're asking. For mechanical tests, the "ground truth" would be the engineering specifications and established test methods, but not expert consensus or pathology in a clinical sense.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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The Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The Cervical Stand-Alone System implants are available in various heights and geometric footprints to accommodate individual patient anatomy and graft material size. Cervical Stand-Alone devices are inserted through an anterior cervical approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. The cages are made from medical grade polyetheretherketone (PEEK) per ASTM F2026 with tantalum per ASTM F560 pins, from titanium alloy Ti-6A1-4V ELI per ASTM F136, or from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6A1-4V ELI per ASTM F136. These devices are offered non-sterile.

The provided FDA 510(k) summary is for a medical device called the "Cervical Stand-Alone System," which is an anterior cervical interbody fusion system. This documentation primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and mechanical performance data, rather than presenting a clinical study with detailed acceptance criteria for an AI/software device.

Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance for an algorithm) are not applicable to this type of device and submission. This is a physical implant, not an AI or software-based medical device.

However, I can extract the relevant "acceptance criteria" (which in this context refers to the performance standards the physical device must meet) and the "study" that proves it.

Here's the information based on the provided text, with clarifications where the questions are not relevant to this type of device:

Device Name: Cervical Stand-Alone System

Device Type: Intervertebral Body Fusion Device (physical implant)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary does not explicitly state numerical "acceptance criteria" values prior to presenting the results. Instead, it states that the device was tested per specific ASTM standards. The "reported device performance" is summarized as the device being "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices" based on these tests. The specific numerical results are not provided in this summary document.

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

• Sample Size for Test Set: Not specified in the document. This would refer to the number of physical devices or test specimens used in the mechanical tests. For mechanical testing of implants, sample sizes are typically small, determined by statistical requirements for engineering studies.
• Data Provenance: The data is from non-clinical mechanical testing conducted on the device itself. It is not patient data, nor is there a concept of "country of origin" as it relates to clinical data. The tests were performed to ASTM (American Society for Testing and Materials) standards.

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 physical device subject to mechanical engineering tests, not a diagnostic or AI device requiring expert ground truth for interpretation of clinical conditions. The "ground truth" for these tests would be the physical properties and failure points measured by specialized testing equipment.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in clinical studies or for establishing ground truth in diagnostic AI performance evaluation. This document describes mechanical device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical implant, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

Not applicable. This question pertains to AI algorithms. The Cervical Stand-Alone System is a manufactured physical implant.

7. The type of ground truth used

The "ground truth" for this device's performance is established by engineering measurements against specified ASTM (American Society for Testing and Materials) standards. This involves measuring force, displacement, and cycles to failure under various loading conditions. It is not expert consensus, pathology, or outcomes data related to patient diagnosis or treatment efficacy, but rather the physical and mechanical integrity of the implant.

8. The sample size for the training set

Not applicable. This refers to training data for an algorithm. This device is a physical product, not an algorithm.

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

Not applicable. This refers to establishing ground truth for algorithmic training data.

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The Genesys Spine Cervical Stand-Alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.

The Genesys Spine AIS-C Cervical Stand-Alone System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium alloy bone anchors. The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g. anterior plate, posterior cervical screws) may be needed. The PEEK interbody devices are made of polyether-ether-ketone (Invibio's PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the PEEK implants contain tantalum markers per ASTM F560 to assist the surgeon with proper placement of the device in the disk space. The titanium alloy interbody devices, anchor locking mechanism, and the bone anchor components are manufactured from medical grade Ti6Al-4V ELI titanium alloy per ASTM F136.

The provided text describes the Genesys Spine AIS-C Cervical Stand-Alone System, a medical device, and its equivalency to predicate devices based on non-clinical performance data.

Here's an analysis of the acceptance criteria and study information, 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

The document does not specify the exact sample sizes (number of devices or specimens) used for each mechanical test (axial compression, compressive-shear, torsion, subsidence, expulsion, cadaver testing, locking mechanism force). It only mentions that "all possible configurations of the AIS-C Cervical Stand-Alone System constructs were analyzed in order to determine the worst case to be used for testing."

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the nature of mechanical testing of devices, it is inherently prospective in the sense that new samples of the device are manufactured and specifically tested for the purpose of the study.

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

This information is not applicable as this study involves non-clinical mechanical testing of a medical device, not a study evaluating human performance or diagnostic accuracy where expert ground truth would be established. The "ground truth" here is adherence to mechanical standards (ASTM F2077-11, ASTM F2267-04) and comparison to predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Mechanical testing results are objective measurements against defined standards and comparisons, not subjective interpretations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the mechanical performance of the device itself, not on the effectiveness of human readers (e.g., radiologists) with or without AI assistance.

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

This question is not applicable because the Genesys Spine AIS-C Cervical Stand-Alone System is a physical medical implant, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by:

• Established ASTM standards: Specifically, ASTM F2077-11 for static and dynamic axial compression, compressive-shear, and torsion; and ASTM F2267-04 for static subsidence.
• Performance of legally marketed predicate devices: The study's acceptance criterion was that the new device's mechanical test results should be "equivalent to (or greater than) previously cleared interbody fusion systems."

8. The Sample Size for the Training Set

This information is not applicable. This is a study of a physical medical device's mechanical properties, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

Cervical Stand Alone system is designed to provide the biomechanical strength to a traditional or minimal invasive ACDF procedure with less disruption of patient anatomy and preserve the anatomical profile. The Cervical Stand Alone system helps to preserve the natural sagittal anatomic profile of the cervical spine while providing anterior column support and stability. Cervical Stand Alone is a hybrid PEEK (ASTM F-2026) and Titanium (Ti-6Al-4V) spacer which incorporates Titanium Bone Screws (Ti-6Al-4V) and a Titanium Cover Plate (Ti-6Al-4V). The Cervical Stand Alone spacers are designed with a zero anterior profile and are implanted using an anterior approach.

The provided document describes a medical device, the "Cervical Stand Alone System," and its premarket notification (510(k)) for FDA clearance. However, this document does not contain information about the acceptance criteria or a study proving the device meets the acceptance criteria in the context of an AI/ML medical device.

The document primarily focuses on:

• Regulatory Clearance: It's an FDA 510(k) clearance letter for a Class II medical device (intervertebral body fusion device).
• Device Description: Details about the Cervical Stand Alone System, its materials (PEEK, Titanium), and its intended use for spinal fusion in the cervical spine for patients with degenerative disc disease.
• Predicate Devices: It compares the device to previously cleared predicate devices (K142152 and K150619) to establish substantial equivalence.
• Performance Data (Non-Clinical): It mentions mechanical testing (Static and Dynamic Axial Compression Test, Static Torsion Test, Static Compression Shear Test, Subsidence Test, and Expulsion Test) conducted according to ASTM standards (F2077-14, F2267-04, and ASTM Draft Standard F-04.25.02.02).

There is no mention of:

• An AI/ML component.
• Acceptance criteria for AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
• A clinical study involving human readers or AI assistance.
• Ground truth establishment in the context of diagnostic performance.
• Training or test set sizes for an AI model.

Therefore, I cannot populate the requested table and answer the specific questions related to AI/ML device performance and testing. The document describes a traditional medical device's mechanical and material performance testing for regulatory clearance, not the performance of an AI-powered diagnostic or assistive tool.

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CONSTRUX Mini PEEK Spacer System

When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with desc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g.: the Ascent™ or Ascent LE™ POCT System.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.

When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.

The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.

CONSTRUX Mini PEEK Ti Spacer System

The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Cervical Stand Alone System

The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

CONSTRUX Mini PEEK Spacer System:

The CONSTRUX Mini PEEK Spacer System is comprised of a variety of implants manufactured from PEEK and with titanium markers. The implants are available in two footprint sizes, a small and a large. The implants are available in various heights, in one-millimeter increments. The superior and inferior surfaces of the implant have a pattern of ridges to provide increased stability and help prevent anterior/posterior movement of the device.

CONSTRUX Mini PEEK Ti Spacer System:

The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The superior and inferior Titanium plate surfaces of the implant provide increased stability for the implants are available in three footprint sizes and various heights. The CONSTRUX Mini PEEK Ti spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

Cervical Stand Alone System

The Cervical Stand Alone Spacer system is designed to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Cervical Stand Alone spacer is manufactured from PEEK and Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior surfaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.

This document is a 510(k) premarket notification for the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System. It primarily addresses expanded indications for use, specifically the inclusion of allograft bone.

Based on the provided text, there is no acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML powered medical device. The document is for a medical implant (intervertebral body fusion device) and discusses its substantial equivalence to predicate devices, focusing on materials, design, and indications for use.

Therefore, most of the requested information regarding AI/ML device performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable to this document.

However, I can extract information related to the clinical data that supported the expanded indication:

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

• Not Applicable. The document does not define specific performance acceptance criteria for an AI/ML device. It discusses the "substantial equivalence" of the implant system to predicate devices based on design, materials, and intended use, and the safety of using allograft bone.

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

• Sample Size: Not explicitly stated. The document refers to "Published retrospective clinical data," not a specific test set with a defined sample size for this submission.
• Data Provenance: The data was "Published retrospective clinical data." The country of origin is not specified but implicitly relates to the use of similar cervical interbody fusion devices.

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. No ground truth establishment by experts for a specific test set is mentioned in the context of this 510(k) submission. The clinical data referred to supports the safety of using allograft bone.

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

• Not Applicable. No adjudication method is mentioned.

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 document is for a physical medical implant, not an AI/ML device, so an MRMC study related to AI assistance is irrelevant here.

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

• Not Applicable. This document is for a physical medical implant, not an AI/ML device.

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

• Not Applicable in the context of an AI/ML ground truth. However, the "Published retrospective clinical data" would have relied on clinical outcomes data related to spinal fusion procedures and the use of allograft. The "outcomes demonstrated that the use of allograft... poses no new risks to patients."

8. The sample size for the training set:

• Not Applicable. No training set is mentioned as this is not an AI/ML device submission.

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

• Not Applicable. No training set or ground truth establishment for a training set is mentioned.

In summary, this 510(k) submission focuses on the substantial equivalence of a spinal implant system with expanded indications for use (specifically regarding bone graft material), rather than the performance of an AI/ML powered device.

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The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD), DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The Cervical Stand Alone System is used with autograft bone material and the two titanium alloy screws which accompany the implant.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

The Cervical Stand Alone device is a stand-alone spacer system designed to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.

The Cervical Stand Alone spacer is manufactured from PEEK and Titanium with Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior suffaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.

Here's an analysis of the provided text regarding the Cervical Stand Alone System, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for Cervical Stand Alone System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document states that these tests were "conducted" in accordance with the specified ASTM standards. It does not provide specific numerical performance results or explicit pre-defined pass/fail criteria beyond the adherence to the standards. The basis of substantial equivalence is that the new device has "the same intended use, similar indications for use, the same technological characteristics and design, same materials and the same principles of operation as the predicate devices." Implied acceptance criteria are that the device's mechanical performance is equivalent to, or better than, the predicate devices when tested to these standards.

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided text. The document mentions "mechanical testing" but does not detail the number of units or repetitions used for each test.
• Data Provenance: Not applicable in the context of clinical data. This study is described as "Non-Clinical Test Conducted." Therefore, there is no country of origin for clinical data, nor is it retrospective or prospective clinical data.

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

• Not applicable. This was a non-clinical, mechanical performance study. There was no "ground truth" derived from expert interpretation of images or patient outcomes. The "ground truth" for these tests would be the established scientific principles of mechanical engineering and the specifications of the ASTM standards themselves.

4. Adjudication Method for the Test Set

• Not applicable. As this was a non-clinical mechanical test, there was no need for expert adjudication. The results were likely compared against predefined limits or against the performance of predicate devices as per the ASTM standards.

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

• No. The document describes non-clinical mechanical testing, not a clinical MRMC study involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

• No. This device is a physical medical implant (intervertebral body fusion device), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

• The "ground truth" for this study was the mechanical performance specifications and methodologies outlined in the ASTM standards (ASTM F2077-11, ASTM F2267-04, and ASTM Draft Standard F-04.25.02.02). The device's performance was evaluated against the requirements, methods, and expected behaviors established by these engineering standards.

8. Sample Size for the Training Set

• Not applicable. Since this is a physical medical device undergoing mechanical testing, there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are informed by engineering principles and standards, but not by a data-driven training set.

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

• Not applicable, as there is no training set. The "ground truth" for the design and manufacturing of such a device is rooted in:
  • Biomechanical principles of the spine.
  • Material science properties of PEEK and Titanium.
  • Clinical experience with similar devices (as inferred by the predicate devices).
  • Engineering design specifications aiming to meet the performance requirements of the relevant ASTM standards.

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