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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 Reliance Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:

• instability caused by trauma or fracture; .
• instability associated with correction of cervical lordosis and kyphosis deformity; ●
• . instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;
• instability associated with major reconstructive surgery for primary tumors or metastatic . malignant tumors of the cervical spine;
• instability associated with single or multiple level corpectomy in advanced degenerative . · disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.

This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Reliance Anterior Cervical Plate System device is intended to be used as an anterior cervical plate device. The Reliance Anterior Cervical Plate System is comprised of implant and instrument components. The Reliance Anterior Cervical Plate implant device is manufactured from Titanium alloy as specified by ASTM F-136. The Reliance Anterior Cervical Plate is a combination of the plate, cover plate, set screw, and bone screw components. The cover plate is attached to the plate by means of the set screw.

1. Acceptance Criteria and Reported Device Performance:

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

The provided document describes mechanical and other non-clinical performance testing. It does not mention a "test set" in the context of clinical data, human subjects, or data provenance from specific regions. The testing was conducted on samples of the Reliance Anterior Cervical Plate System itself.

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. This was a non-clinical performance study involving mechanical testing and assessments of material properties, not a study requiring expert clinical review to establish ground truth.

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

Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth. This document describes non-clinical performance 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 device is a spinal implant, not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant.

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

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

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

The "ground truth" for this performance study was established through standardized mechanical testing protocols (ASTM F-1717) and assessments of material properties (sterilization, biocompatibility). The comparison was made against the performance of legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. This document describes non-clinical performance testing of a physical device, not a machine learning model that requires a training set.

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

Not applicable, as no training set for a machine learning model was used.

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The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the 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),
• spondylolisthesis,
• trauma (i.e. fractures or dislocations),
• tumors, .
• . deformity,
• pseudarthrosis, .
• . failed previous fusion,
• spinal stenosis. .

The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The ALTUM anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The ALTUM plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the ALTUM Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths. Each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism.

The provided text is a 510(k) Premarket Notification for the ALTUM Anterior Cervical Plate System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify numerical acceptance criteria from ASTM F1717-09, only that the device's performance was compared to predicate systems.

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

• Sample Size: Not explicitly stated for each test, but standard for mechanical testing involves multiple test specimens to ensure statistical validity.
• Data Provenance: The tests are non-clinical (laboratory-based mechanical tests). There is no patient data involved, so country of origin or retrospective/prospective status is not applicable.

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

This question is not applicable. For mechanical tests of spinal implants, the "ground truth" is established by the specifications and performance characteristics defined in the ASTM standard (ASTM F1717-09) and the characteristics of the predicate devices. There are no "experts" in the sense of clinical specialists establishing ground truth for individual test outcomes (e.g., diagnosing a condition). The experts involved would be those who developed the ASTM standard and those who critically evaluate the mechanical test methodologies and results.

4. Adjudication Method for the Test Set

This question is not applicable. Mechanical testing does not involve adjudication as seen in clinical studies or image review. The results are quantitative measurements against predefined standards and comparative data.

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. The document explicitly states: "No clinical studies were performed."

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

This question is not applicable. The device is a physical medical implant (an anterior cervical plate), not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The ground truth used for demonstrating substantial equivalence and meeting acceptance criteria for this medical device is based on:

• Standardized Mechanical Test Protocols: Specifically, ASTM F1717-09 outlines the methods for testing spinal implant constructs.
• Performance of Legally Marketed Predicate Devices: The ALTUM system's performance was compared directly to that of the Envision2 Anterior Cervical Plate System (K020649) and Spider Cervical Plating System (K052292). The "ground truth" for acceptable performance is considered to be the performance demonstrated by these existing, equivalent devices.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of device mechanical testing. The device is evaluated based on its physical properties and mechanical performance.

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

This question is not applicable, as there is no training set for this type of device evaluation.

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