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The Elevation Spine Saber-C System is a cervical interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use in one or two adjacent spinal levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.

The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.

The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.
The previously cleared SABER-C interbody devices are offered manufactured from titanium alloy per ASTM F136 or titanium-coated radiolucent polyether ether ketone (PEEK), with titanium alloy or tantalum markers, as specified in ASTM F2026, ASTM F136, ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spikes or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.
The subject submission seeks to expand size offerings and gain clearance for expanded indications and minor design modifications to the previously cleared devices.

The provided text is a 510(k) clearance letter for the SABER-C System, an intervertebral body fusion device. It details the regulatory clearance, indications for use, device description, and a brief summary of performance testing.

However, the document does not contain information related to a study proving the device meets acceptance criteria specific to an AI/ML algorithm, nor does it specify any AI/ML components within the SABER-C System. The performance testing listed is entirely mechanical/physical bench testing for a physical implant (Axial Screw Pullout, Insertion Torque, plate pushoff), which is standard for orthopedic devices.

Therefore, it is not possible to complete the requested table and answer questions about AI/ML acceptance criteria, study design, sample sizes for AI, expert involvement for AI ground truth, MRMC studies, or standalone algorithm performance based on the provided text. The document is for a traditional medical device, not a software as a medical device (SaMD) or an AI-enabled device.

To address the prompt directly based on the provided text, the answer is that the document does not contain the information requested, as the device is a physical implant and not an AI/ML enabled medical device.

Summary of missing information directly related to AI/ML acceptance criteria and study:

• No AI/ML Component: The document describes a physical interbody fusion device and its associated plates and screws. There is no mention of any AI or machine learning functionality.
• Acceptance Criteria for AI/ML: Since there's no AI component, there are no acceptance criteria related to AI performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
• Study Proving AI Compliance: There is no study described that would evaluate AI performance. The performance testing mentioned is purely mechanical (bench testing).
• Sample Size (AI): Not applicable, as there's no AI component.
• Data Provenance (AI): Not applicable.
• Experts for Ground Truth (AI): Not applicable.
• Adjudication Method (AI): Not applicable.
• MRMC Study: Not applicable.
• Standalone Performance (AI): Not applicable.
• Type of Ground Truth (AI): Not applicable.
• Training Set Sample Size (AI): Not applicable.
• Training Set Ground Truth (AI): Not applicable.

If the prompt assumed an AI/ML component was present and requested how one would describe these aspects for a hypothetical AI/ML device in a similar FDA clearance, I would construct a general example. However, as the instruction is to describe "the study that proves the device meets the acceptance criteria" based on the input, and the input clearly does not describe an AI/ML device, the direct answer is that the information is not present.

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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 FIX-C PEEK ACIF SA System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The stand-alone interbody cages must be used with internal screw fixation. The FIX-C PEEK ACIF SA System is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The FIX-C PEEK ACIF SA System consists of a stand-alone interbody fusion device with internal screw fixation. The FIX-C PEEK ACIF SA System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.

The FIX-C PEEK ACIF SA System is comprised of a PEEK interbody cage and screws. The PEEK interbody cage is made from medical-grade polyetheretherketone (PEEK) which is radiolucent and contains radiopaque titanium clips made from medical-grade titanium alloys. The titanium clip assembled in the PEEK cage includes a Zero-Step Mechanism designed to prevent the screw from disengaging or loosening from the cage. The PEEK materials conform to ASTM F2026, and the titanium alloys materials conform to ASTM F1136.

The FIX-C PEEK ACIF SA System is provided non-sterile. The devices must be sterilized prior to use per ISO 17665-1.

This FDA 510(k) clearance letter is for a medical device (an intervertebral body fusion device), not a software or AI-powered device. Therefore, the information provided does not include the details about acceptance criteria, study design (sample sizes, expert adjudication, MRMC studies, ground truth establishment, etc.) that would be relevant for an AI/software-based medical device.

The clearance letter focuses on establishing substantial equivalence to previously cleared predicate devices based on:

• Indications for Use: The FIX-C PEEK ACIF SA System is indicated for anterior cervical interbody fusion procedures, which is compared to the predicate device's indications.
• Technological Characteristics: The device materials (PEEK, titanium), design features (internal screw fixation, Zero-Step Mechanism), and sterilization methods are described and implicitly compared to predicates.
• Non-Clinical Testing (Bench Tests): This is the primary "study" mentioned. The device underwent mechanical bench tests to ensure its structural integrity and performance are comparable to established standards and the predicate device.

Here's a breakdown of the information that is and is not provided in the context of your request for AI/software device evaluation:

Information Provided in the Document (Relevant to a mechanical device):

1. Acceptance Criteria & Reported Device Performance:

   • Acceptance Criteria: "All test results were higher than the acceptance criteria from the reference literature." (Specific numeric criteria not detailed, but implied to be based on ASTM standards).
   • Reported Device Performance: "All test results were higher than the acceptance criteria... Therefore, substantially equivalent mechanical performance with the predicate device has been demonstrated." (No specific quantitative results are provided in the clearance letter itself, only the conclusion of meeting criteria.)

   Table (As much as can be constructed from the text):

   Acceptance Criteria	Reported Device Performance
   Performance higher than "reference literature" values for ASTM F2077 (Static axial compression, Static compression-shear, Static torsion, Dynamic axial compression, Dynamic compression-shear, Dynamic torsion) and ASTM F2267 (Subsidence)	All test results were reported as "higher than the acceptance criteria."
   Substantial equivalence to predicate device in mechanical performance	Substantial equivalence demonstrated.

2. Sample Sizes and Data Provenance:

   • Not applicable in the AI/software sense. This refers to physical bench testing of device units. The number of units tested is not specified.
   • Data provenance is "bench tests conducted for the subject device" (manufacturer).

3. Experts for Ground Truth, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth:

   • Not applicable: These concepts are entirely relevant to evaluation of diagnostic/AI software performance based on clinical image interpretation or patient data, not for the mechanical performance testing of an interbody fusion device.
   • The "ground truth" for this device's performance would be the physical measurements and results obtained from the bench tests, compared to engineering standards.

4. Training Set Sample Size and Ground Truth Establishment (Training Set):

   • Not applicable: There is no "training set" in the context of a mechanical device. These refer to the data used to train machine learning models.

Summary regarding your specific questions NOT answered by this document (because it's a mechanical device, not AI/software):

• Sample sized used for the test set and the data provenance: Not clinical data, but bench test data. Specific number of samples tested is not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No (not an algorithm).
• The type of ground truth used: Bench test measurements against engineering standards (not expert consensus, pathology, or outcomes data in the clinical sense).
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Conclusion:

This FDA 510(k) clearance letter details the regulatory approval of a physical medical implant based on its compliance with established mechanical safety and performance standards (ASTM F2077, ASTM F2267) and substantial equivalence to existing devices. It does not provide the type of performance metrics, study designs, or data provenance relevant to the validation of an AI/software medical device.

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The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. If the device is being used without the CSTS Integrated Plate, supplemental fixation must be used.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of heights, footprints, and lordotic angles. The CSTS Integrated Plates come in multiple heights and orientations to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the Integrated Plates into adjacent vertebral bodies for bony fixation. The Integrated Plates have a rotating locking tab to prevent back-out of the screws.

This FDA 510(k) clearance letter for the Cervical Spine Truss System (CSTS) is for a physical medical device (an intervertebral body fusion device), not an AI/software device. Therefore, the information typically required to describe the acceptance criteria and study proving an AI/software device's performance (as outlined in the prompt's requested information points) is not present in this document.

The document discusses the mechanical and safety performance of the physical device and its substantial equivalence to a predicate device, but it does not contain details about:

• Acceptance criteria for an algorithm's performance
• Sample sizes for data used in AI model testing
• Expert involvement in ground truth establishment for AI
• Adjudication methods for AI test sets
• MRMC studies for AI assistance
• Standalone AI performance
• Training set details for AI

The 510(k) summary explains that the purpose of this specific submission (K251117) is to "add additional configurations to the integrated plate product offering and to provide the integrated plate as sterile packaged." It then states that "The modifications made to the CSTS Integrated Plate for this submission did not create a new worst-case condition for any mechanical or MR safety tests. The results of the predicate testing are applicable to the subject devices and no further testing was required."

In summary, based solely on the provided FDA 510(k) clearance letter for the Cervical Spine Truss System (CSTS), it is not possible to answer the detailed questions about acceptance criteria and study design for an AI/software device's performance because the device itself is a physical implant, not an AI or software product.

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The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The KMTI Tesera-k SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of two (2) bone screws and the locking bolt.

When used without the locking bolt and two screws, the KMTI Tesera-k SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.

The Tesera-k SC System (Tesera-k SC) is a spinal fusion system consisting of additively manufactured interbody devices and machined titanium bone screws and cage lock. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tesera-k SC implants are available in a variety of lordosis and footprint options with a superior and inferior porous face and internal lattice structure to offer increased capacity for bone growth.

The Tesera-k SC cages are additively manufactured then machined from Titanium alloy (Ti-6Al-4V) per ASTM F2924 or are additively manufactured from Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, and the bone screws and cage locks are machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The Tesera-k SC System may be implanted as a standalone with two internal fixation screws and the cage lock and without supplemental fixation or may be implanted as a non-standalone system without the internal fixation screws or cage lock but with FDA-cleared supplemental fixation.

The provided FDA 510(k) clearance letter for the Tesera-k SC System focuses on the substantial equivalence of an intervertebral body fusion device. Crucially, as this is a medical device clearance, the performance data provided relates primarily to mechanical testing of the device's structural integrity and does not involve clinical studies with human subjects or AI algorithms to interpret medical images.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone algorithm performance, AI training set details) are not applicable to this type of device clearance and the information provided.

Based on the provided document, here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter mentions the following non-clinical performance tests. It states that the "results of this non-clinical testing show that the strength of the Tesera-k SC System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." However, specific numerical acceptance criteria and precise reported device performance values are not detailed in this public summary document. The document only lists the types of tests performed.

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

• Sample Size for Test Set: Not applicable in this context. The testing involved mechanical evaluation of the device as a physical product, not an AI algorithm on a dataset.
• Data Provenance: Not applicable for AI data. The "performance data" refers to the results of standardized mechanical tests on the device, not clinical data or image data.

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

• This question is not applicable as the clearance is for a physical medical device (intervertebral fusion device), not an AI/software device that requires expert-established ground truth on medical images.

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

• This question is not applicable for the same reasons as #3.

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

• This question is not applicable as the clearance is for a physical medical device, not an AI/software device.

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

• This question is not applicable as the clearance is for a physical medical device, not an AI/software device.

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

• This question is not applicable. For this type of device, "ground truth" relates to the physical and material properties meeting engineering specifications and clinical performance criteria established through mechanical testing and comparison to predicates, rather than a diagnostic 'ground truth' from human interpretation or pathology.

8. The sample size for the training set

• This question is not applicable as the clearance is for a physical medical device, not an AI/software device that requires a training set.

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

• This question is not applicable for the same reasons as #8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Tesera-k SC System meets acceptance criteria consists of a series of non-clinical mechanical tests designed to assess the device's structural integrity, durability, and resistance to various forces it would encounter in its intended use. These tests were conducted according to recognized ASTM standards.

The specific tests performed were:

• Dynamic axial compression per ASTM F2077
• Dynamic compression shear per ASTM F2077
• Dynamic torsion per ASTM F2077
• Tensile Strength per ASTM F1147
• Shear Fatigue per ASTM F1160
• Abrasion per ASTM F1978

Conclusion of the Study:
The document states that "The results of this non-clinical testing show that the strength of the Tesera-k SC System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the device successfully met the performance benchmarks implicitly required for devices of its type and demonstrated equivalent or superior performance to the predicate device, K223105 (Tesera-k SC System by Kyocera Medical Technologies, Inc.). The overall technological characteristics and mechanical performance data led to the conclusion of substantial equivalence.

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The CYLOX® ST implants are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies.

The cervical device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The devices are to be used with autograft bone graft composed of cancellous, cortical, and / or corticocancellous bone and implanted via an anterior approach.

When used as a standalone system, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one level (C3-T1) and must be used with the CYLOX® ST bone screw fixation or connecting plate and must be secured with the corresponding locking screw.

When used with supplemental fixation, such as anterior cervical plates, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-T1).

The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. The system is comprised of interbodies, plates, and screws. The interbody device can be used as a standalone implant with screw holes for integrated fixation, or as a construct fixed with a plate and screws. The interbody implants are additively manufactured from titanium alloy (Ti-6Al-4 V ELI). The plates and screws are traditionally machined from titanium alloy (Ti-6Al-4V).

The SIGNUS CYLOX® ST Interbody System is placed in the C3 – T1 spinal region via the Cloward or Smith-Robinson approach. The interbody is available in four different footprints, with multiple heights and angulations. The standalone interbody contains a central holes angulated for fixation with screws into the cranial and caudal vertebral body. The construct interbody contains a central hole and indentation features to mate with the anterior plate.

The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The provided text is a 510(k) summary for a medical device (CYLOX® ST) and does not contain information about an AI/ML powered device, nor does it include a study proving a device meets acceptance criteria related to AI/ML performance.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because these elements are specific to the evaluation of AI/ML devices, which is not the subject of this document.

The document describes the non-clinical performance testing conducted for the CYLOX® ST intervertebral body fusion device to demonstrate substantial equivalence to a predicate device. This testing focused on mechanical properties and structural integrity according to ASTM standards.

Here's the relevant information that could be extracted and how it relates to the request (even though it's not AI/ML related):

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

Notes on the above table: The text states, "Substantial equivalence was supported by the results of verification testing to confirm that features, geometry and performance of the subject device performs as well as the predicate system, including: [list of tests]." This implies that the acceptance criteria were the successful completion and meeting of the requirements stipulated by each listed ASTM standard. The reported performance is that the device met these standards, thus demonstrating "substantial equivalence."

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

• Sample Size: Not specified in the provided text. The ASTM standards would define the required sample sizes for each test.
• Data Provenance: Not applicable. These are non-clinical (mechanical) tests, not clinical data or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as this is not an AI/ML study involving expert ground truth.

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

• Not applicable as this is not an AI/ML study involving 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:

• No. This is a non-clinical evaluation of an interbody fusion device, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This device is not an algorithm.

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

• Not applicable. Ground truth for these non-clinical tests would be the physical measurements and observations of the device's behavior under controlled testing conditions, compared against the specified parameters of the ASTM standards.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned as this is not an AI/ML device.

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

• Not applicable.

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When used with the integrated fixation and as a standalone system:

The Genesys Spine AIS-C II Cervical Interbody Fusion System is a standalone 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 AIS-C II Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.

When used without the integrated fixation:

The Genesys Spine AIS-C II Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e., cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.

The Genesys Spine AIS-C II Cervical Interbody Fusion will be offered in various device configurations based on surgical approach and patient anatomy. The AIS-C II System has two interbody options: Regular or Standalone.

The Regular Cervical Interbody System does not require the use of Anchors but is designed for use with supplemental fixation (i.e., cleared cervical plating system).

The Standalone Cervical Interbody System requires the use of Anchors for integrated fixation. This version includes an integrated cam lock mechanism and various sizes of anchors. The cam lock mechanism may be used as a secondary aid in keeping the anchors from backing out of the interbody and vertebral bodies. After anchor deployment, a cam lock key is used to turn the lockwise) to engage the cam lock and secure the anchors. When engaged (closed), the wings of the cam lock cover the anchor channels and provide a backing plate for the anchors.

The subject and predicate devices are based on the same technological characteristics: Integrated fixation anchors provide additional biomechanical support to the interbody. lmplant materials are identical: PEEK, Titanium 6AL-4V ELI alloy, and tantalum. A single inserter can be used to position the interbody and deploy the anchors.

The provided text is a 510(k) summary for the Genesys Spine AIS-C II Cervical Interbody Fusion System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on technological characteristics and mechanical testing. However, the document does not contain information related to software, artificial intelligence (AI), or clinical studies involving human readers or expert ground truth adjudication.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI or software.
• Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for test sets.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Details on standalone algorithm performance.
• Type of ground truth used for AI/software evaluation.
• Sample size for the training set or how ground truth was established for a training set.

The document focuses on the mechanical performance of a physical medical implant (intervertebral body fusion device) and demonstrates substantial equivalence to predicate devices through non-clinical mechanical testing.

Here's the relevant information that is present in the document regarding the device's acceptance criteria and the study proving it:

1. Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The acceptance criteria are implicitly defined by the guidance documents and consensus standards listed, aiming to demonstrate the mechanical performance of the device is equivalent or superior to predicate devices and generally accepted standards for intervertebral body fusion devices.

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

• Sample size: Not specified in the provided text. Mechanical testing typically involves a number of devices or components to establish statistical significance for properties like strength, fatigue, and subsidence, but the exact number is not detailed here.
• Data provenance: Not applicable in the context of human data or AI. The "data" refers to the results of in vitro mechanical tests conducted on the device itself.

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; its mechanical performance is measured directly by adherence to engineering standards and comparison to established benchmarks from other devices, not by expert consensus on clinical cases.

4. Adjudication method for the test set:

• Not applicable. Mechanical testing results are objective measurements against defined parameters.

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 explicitly states: "Clinical testing is not required." This device is not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical surgical implant, not a standalone algorithm.

7. The type of ground truth used:

• Not applicable in the AI/software sense. The "ground truth" for this device's performance is established through internationally recognized engineering standards (ASTM, ISO) for static and dynamic mechanical properties, and comparative data from previously cleared devices, as measured in a laboratory setting.

8. The sample size for the training set:

• Not applicable. This device is not an AI/software product, so there is no training set.

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

• Not applicable. This device is not an AI/software product, so there is no training set or ground truth establishment relevant to AI.

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The ProAM ACDF System is a standalone intervertebral body fusion system intended for spinal fusion procedures of the cervical (C2-T1) spine 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 history and imaging studies (radiographs, CT, MRI).

The ProAM ACDF System is intended to be used at multiple contiguous levels of the cervical spine (C2-T1). The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

The ProAM ACDF System is intended for use on patients who have had at least six weeks of nonoperative treatment. It is intended to be used with autogenous and/or allogeneic bone graft comprised of cortical, cancellous, and/or corticocancellous bone graft.

The ProAM™ ACDF System is an intervertebral body fusion system that consists of an intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F3001) and screws manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F136).

The intervertebral body fusion device has a cross-sectional shape that is trapezoidal, and the device is otherwise box-shaped in stature with cavities for containment of bone graft material. The device is available in sizes that vary in footprint size, height, and lordotic angle. It is meant for direct anterior insertion and has 2 holes through which screws are placed to affix to bone. All devices have an open, porous architecture throughout and a pyramidal textured porous surface at the endplate contacting surfaces that helps prevent device migration.

The screws are available in various diameters and lengths. Screws engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone.

The provided text describes a 510(k) premarket notification for a medical device called the ProAM ACDF System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data related to mechanical testing for orthopedic implants.

The document does NOT contain information related to software, human-in-the-loop performance, or AI assistance. Therefore, it is not possible to answer questions 2, 3, 4, 5, 8, and 9 as they pertain to such studies.

Here's an analysis of the available information:

1. Table of acceptance criteria and the reported device performance:

The document broadly states that "The mechanical testing demonstrated that the device performs as well or better than the predicates." However, it does not provide specific numerical acceptance criteria or the reported performance values. The tests performed are listed as:

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

• Sample Size for Test Set: Not specified. The document mentions "mechanical testing" but does not provide details on the number of samples used for each test.
• Data Provenance: The data is generated from in vitro mechanical testing of the device itself. The country of origin for the data is not explicitly stated, but the company is based in Carlsbad, CA, suggesting the testing was likely conducted in the US or by a US-affiliated lab. The testing is for prospective device performance evaluation based on design and manufacturing.

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

Not applicable. This question typically refers to studies involving human interpretation (e.g., image analysis by radiologists). The described study is mechanical testing of a physical implant, where ground truth is established by engineering standards (ASTM F2077, ASTM F2267) and test results.

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

Not applicable. See reasoning for question 3. Adjudication methods are typically used for subjectively assessed data, not objective mechanical 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:

Not applicable. This study is a 510(k) submission for a physical intervertebral body fusion device and does not involve AI assistance or human reader studies.

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

Not applicable. This submission is for a physical medical device, not a software algorithm.

7. The type of ground truth used:

The ground truth for this device's performance is established by engineering standards and specifications (ASTM F2077, ASTM F2267). The device's performance is compared against these established standards and against the performance of predicate devices as a benchmark for substantial equivalence.

8. The sample size for the training set:

Not applicable. Training set refers to data used for machine learning models. This is mechanical testing of a physical device.

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

Not applicable. Refer to reasoning for question 8.

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E3D™ C Interbody System includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical degenerative disc disease (DD), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondy lotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osterior vertebral endplates producing symptomatic nerve root and/or spinal confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

E3D™ C Static Interbodies are intended to be used with supplemental fixation (e.g. cervical posterior fixation).

E3D™ C Integrated Interbodies are intended to be used with screws or anchors. When used with two screws, these devices are stand-alone interbody fusion devices. When anchors, or without screws, these devices are intended to be used with supplemental fixation (e.g. cervical plates or cervical posterior fixation).

The E3D™-C Interbody System provides interbody fusion devices designed to provide structural stability during spinal fusion. The E3D™-C Interbody System consists of Interbodies offered in various sizes to accommodate surgical needs and anatomic requirements. The E3D™-C Interbodies were designed to be placed via an anterior approach. All Interbodies in the system are additively manufactured from titanium alloy powder, per ASTM F3001. The System offers both Static and Integrated Interbodies. The Integrated version is to be used in conjunction with two (2) screws that are subtractively manufactured from titanium alloy, per ASTM F136 or two (2) anchors that are additively manufactured from titanium alloy powder, per ASTM F3001.

Integrated Interbodies were designed to accept two bone screws or anchors which are used to fixate into the adjacent vertebral bodies. When appropriate, the Integrated Interbodies may be used as a standalone system when used with screws. The Titanium Alloy (Ti-6Al-4V ELI) Interbodies are manufactured using an additive Direct Metal Laser Sintering (DMLS) 3D-printing process which enables the creation of the system's double lattice architecture. The double lattice architecture was designed to encourage bone growth on and through the cage. The Integrated Interbody has two screw holes as well as an integral cam locking mechanism to prevent screw back-out.

The E3D™-C Interbody System's implants are available with and without HA"® Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface.

This document is a 510(k) clearance letter and summary for a medical device called the E3D™-C Interbody System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or proving device performance through a clinical study with human readers or AI.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document because it is not a study report relevant to AI/CADe applications.

The "Performance Data" section solely refers to mechanical testing (static compression, static torsion, dynamic compression, dynamic shear, dynamic torsion per ASTM F2077; wear debris analysis per ASTM F1877; expulsion and subsidence per ASTM F2267) to ensure the physical device meets safety and performance standards for an intervertebral body fusion device. This is distinct from the type of performance data typically associated with AI/CADe devices, which would involve diagnostic accuracy metrics on image datasets.

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The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

The Stable-C Interbody System is an anterior cervical interbody device comprised of an interbody cage (lordotic angles of 0,°6°, and 12°) made from titanium alloy (Ti-6Al-4V) per ASTM F3001 and two fixation anchors made from titanium alloy (Ti-6-Al-4V ELI) per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy.

The purpose of this Traditional510(k) submission is to gain clearance for modifications made to the subject device.

This document is a 510(k) premarket notification for a medical device called the "Stable-C Interbody System" by Nexus Spine, LLC. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the study proving the device meets those criteria, such as:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts and their qualifications for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

Instead, the document focuses on:

• Device Description: The Stable-C Interbody System is an anterior cervical interbody device made of titanium alloy, with lordotic angles of 0°, 6°, and 12°. It includes two fixation anchors.
• Indications for Use: Indicated for skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1, defined as discogenic back pain with degeneration confirmed by history and radiographic studies. It is a standalone system to be used with bone anchors and autogenous or allogenic bone graft, after six weeks of non-operative treatment.
• Substantial Equivalence: The primary predicate is Nexus Spine, LLC Stable-C Interbody System (K231763; K232530), with an additional predicate being Nexus Spine, LLC Tranquil-C Interbody System (K240416). The subject device's indications, sizing, geometry, technological characteristics, materials, manufacturing, sterilization, and packaging are stated to be similar or identical to the predicate devices.
• Performance Testing: The submission states that "The subject changes to the Stable-C Interbody System do not introduce a new worst case, as confirmed by bench top usability testing of the device and instrumentation in a simulated implantation. Additional performance testing is not required to establish substantial equivalence." This indicates that no new clinical or significant performance studies were conducted to prove specific acceptance criteria for the current submission beyond bench-top usability testing to confirm the changes did not worsen performance compared to the already cleared predicate device.

In summary, this document is a 510(k) submission and does not describe a study to prove a device meets acceptance criteria in the manner you've requested. It argues for substantial equivalence based on similarities to predicate devices and limited bench testing for modifications.

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