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TRYPTIK2C-Plate® Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following 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), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions

The TRYPTIK2C-Plate Anterior Cervical Plate System consists of a range of anterior cervical plates and polyaxial (variable angle) bone screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7) and functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.

This is a 510(k) premarket notification for a medical device called the "TRYPTIK2C-Plate Anterior Cervical Plate System". The document describes the device, its intended use, and provides a summary of testing conducted to demonstrate its substantial equivalence to legally marketed predicate devices.

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

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

The document does not explicitly state "acceptance criteria" in the format of pass/fail thresholds against specific performance metrics for the TRYPTIK2C-Plate, but rather implies comparison to predicate devices. The "reported device performance" is described in terms of mechanical testing.

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

The document does not specify the sample size for the mechanical testing (e.g., number of plates or screws tested). It also does not provide information on the data provenance, such as the country of origin or whether the study was retrospective or prospective. The testing described is non-clinical/bench testing, not human or animal studies.

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 applicable. The study is a non-clinical/bench testing study of a medical implant's mechanical properties, not a diagnostic or prediction algorithm requiring expert review for ground truth.

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

This information is not applicable, as it's a non-clinical mechanical testing study.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical implant (anterior cervical plate system), not an AI diagnostic or assistive device.

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

This information is not applicable. The device is a physical implant, not an algorithm.

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

The "ground truth" for this type of study is the established mechanical testing standards (ASTM F1717-15) and the mechanical properties of the legally marketed predicate devices. The performance of the new device is compared against these benchmarks to establish substantial equivalence.

8. The sample size for the training set

This information is not applicable. This is a mechanical testing study for a physical implant, not an AI/machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for a physical implant's mechanical testing.

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The DeGen Medical Hyper-C Anterior Cervical Plate system is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Hyper-C Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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)
• Spinal Stenosis
• Trauma (i.e. fracture or dislocation)
• Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
• Spinal Tumors
• Pseudoarthrosis or failed previous fusion
• Spondylolisthesis
• Decompression of the spine following total or partial cervical vertebrectomy

The DeGen Medical Hyper-C Anterior Cervical Plate Systems consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The HACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options.

The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device called the "Hyper-C Anterior Cervical Plate System." This document is a regulatory approval letter and a summary of the device, not a study report demonstrating the device meets specific acceptance criteria through clinical or AI performance metrics.

Therefore, I cannot extract the information required to answer your questions as they pertain to the evaluation of an AI/ML-driven device or a medical imaging study. The document explicitly states:

• Non-Clinical Performance Testing Conclusion: "Non-clinical testing was performed to demonstrate the DeGen Medical Hyper-C Anterior Cervical Plate System (HACP) is substantially equivalent to other predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. The following tests were performed: Static and dynamic compression testing per ASTM F1717, Static torsion testing per ASTM F1717, Screw strength via ASTM F543, Push-out testing for Locking Screws."

This indicates that the device's performance was evaluated through mechanical and material testing (non-clinical), not studies involving image analysis, AI algorithms, human readers, or clinical outcomes that would generate the kind of data you're asking for.

The questions you've posed (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are highly relevant for the assessment of AI/ML-enabled medical devices, especially those involved in diagnostic imaging or similar analytical tasks. However, the Hyper-C Anterior Cervical Plate System is a physical orthopedic implant, and its approval is based on demonstrating substantial equivalence to existing devices primarily through mechanical integrity and biocompatibility, as outlined in the non-clinical testing section.

In summary, the provided document does not contain the information needed to answer your questions because it describes the regulatory clearance of a physical medical implant, not an AI/ML diagnostic or image analysis system.

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The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation for the following indications: degenerative disc disease, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Comet Anterior Cervical Plate System consists of an anterior cervical plate offered in lengths ranging from 10mm through 22mm. Four (4) barbed plate fixation pins are permanently affixed to the plate. A set of two (2) plate fixation screws are used to secure the plate to the superior and inferior vertebrae. Plate fixation screws are offered in two (2) diameters, each in 14mm, 16mm lengths.

The provided text describes a medical device, the Comet Anterior Cervical Plate System, and its clearance through the 510(k) process. This process is for demonstrating substantial equivalence to a predicate device, not for proving independent efficacy or safety through clinical trials in the way an AI/ML device would. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Comet Anterior Cervical Plate System were based on demonstrating substantial equivalence to a predicate device (Synthes Anterior Cervical Plate System) and meeting pre-determined criteria through bench testing.

The study that "proves" the device meets the acceptance criteria is the Performance Testing described, which consisted of bench tests.

Specific Information Requested - Not Applicable for this Device Type:

The following requested information is not applicable to this 510(k) submission for a physical medical implant device. These questions are typically relevant for AI/Machine Learning (AI/ML) powered devices or diagnostic tools that involve analyzing data sets with ground truth established by experts.

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

Explanation:

The Comet Anterior Cervical Plate System is a physical medical implant. Its clearance relies on demonstrating that its design, materials, and mechanical properties are comparable to an already legally marketed device (predicate device) and that it meets specific engineering performance standards via bench testing (laboratory tests, not clinical studies involving human patients or complex data analysis by AI). There is no "test set" of patient data, "ground truth" derived from expert consensus on images, or AI algorithms to train in this context.

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The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

• Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
• Spondvlolisthesis .
• Trauma (i.e., fractures or dislocations) .
• Tumors .
• Deformity (defined as kyphosis, lordosis, or scollosis) .
• Pseudoarthrosis .
• Failed previous fusions .

The IST Anterior Cervical Plate is made of titanium alloy. The plate is offered in various lengths to meet individual patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text describes a medical device, the IST Anterior Cervical Plate System, and its 510(k) submission (K072650) to the FDA. The submission focuses on substantial equivalence to predicate devices rather than a standalone clinical study proving specific performance metrics against an acceptance criterion.

Therefore, the information traditionally found in a comprehensive acceptance criteria study (like those for AI/Software as a Medical Device - SaMD) is not present in this document. This submission relies on performance data based on mechanical testing.

Based on the provided text, the direct answers to your questions are as follows:

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

Explanation: In this 510(k) submission, the "acceptance criteria" for the device's performance are implicitly tied to demonstrating substantial equivalence through mechanical testing according to a recognized standard (ASTM F1717). There are no specific numerical clinical performance metrics (e.g., sensitivity, specificity, accuracy) defined in this document that the device had to meet. The performance reported is that it met the ASTM F1717 standard, indicating mechanical equivalence.

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

Not applicable. This submission primarily relies on mechanical testing, not a clinical test set with patient data. Therefore, there is no "test set" in the context of patient data, sample size for such a set, or data provenance. The "testing" refers to mechanical properties in a lab setting.

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 there is no clinical test set with patient data, there was no need for experts to establish ground truth for such a set.

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

Not applicable. Without a clinical test set requiring expert interpretation or labeling, there is no adjudication method.

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

Not applicable. This device is a physical implant (Anterior Cervical Plate System), not an AI/software device designed to assist human readers. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

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

Not applicable. For mechanical testing, the "ground truth" is defined by the physical standards and measurement methodologies outlined in ASTM F1717, which determine material properties and performance under stress. It does not involve clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary of this particular 510(k) submission: This 510(k) for the IST Anterior Cervical Plate System is a traditional submission for a physical medical implant. It primarily relies on mechanical testing (ASTM F1717) to demonstrate substantial equivalence to existing predicate devices. It does not involve clinical trials with patient data, AI algorithms, or human-in-the-loop performance studies. Therefore, many of the questions related to clinical performance, ground truth, and AI-specific evaluations are not applicable to the information provided in this document.

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The Synthes TiLPS is intended for anterior intravertebral body screw fixation/attachment to the LI-S1 spine over one vertebral body extending onto the adjacent intervetebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease. DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies

The system consists of a two hole locking plate, 4.35 mm expansion screws with 1.8 mm locking screws. The two hole plate is available in various lengths and is manufactured from commercially pure titanium.

The provided document is a 510(k) premarket notification for the Synthes Titanium Locking Plate System (TiLPS). This document establishes substantial equivalence to previously marketed devices and outlines the intended use and limitations. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a diagnostic or AI-based device.

The concept of "acceptance criteria" and "device performance" in this context refers to the device being substantially equivalent to existing predicate devices, primarily in terms of materials, design principles, and intended use. The "study" proving this is the 510(k) submission itself, where the manufacturer provides a comparison to legally marketed predicate devices.

Here's an attempt to answer your questions based only on the provided information, interpreting "acceptance criteria" and "device performance" in the context of a 510(k) submission for a spinal implant:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a "test set" in the context of clinical studies for performance metrics. The "test set" here refers metaphorically to the comparison set of predicate devices.

• Sample Size: Three predicate devices (Synthes Anterior Cervical Vertebrae Plate System (K926453 and K945700) and Synthes Anterior Spinal Plate System (K925351)).
• Data Provenance: Not applicable in the typical sense. The information comes from the design specifications, materials, and intended uses of the predicate devices already cleared by the FDA, and a comparison of the new device to these. This is analogous to a retrospective review of existing product data.

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

Not applicable. "Ground truth" in this context refers to the established safety, effectiveness, and regulatory status of the predicate devices. The "experts" are the FDA reviewers who previously cleared the predicate devices and who are reviewing this 510(k) submission. The document doesn't specify the number or qualifications of the FDA reviewers, but they are regulatory experts within the Office of Device Evaluation.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication method" described for a test set. Substantial equivalence is determined by the FDA based on the provided comparison to predicate devices, material specifications, and design.

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

No. This document does not describe an MRMC study. These studies are typically for diagnostic AI devices assessing human reader performance.

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

No. This document describes a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" is the established regulatory clearance and perceived safety/effectiveness of the predicate devices based on their prior 510(k) submissions. The "truth" is that these predicate devices are legally marketed, and the new device is sufficiently similar to them.

8. The Sample Size for the Training Set

No "training set" is mentioned as this is not an AI/machine learning device.

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

Not applicable. There is no training set mentioned.

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