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The Tempus™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 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 Tempus™ Cervical Plate System consists of screws and plates. Screws are available in a variety of diameter-length combinations. Plates are available in a variety of lengths to accommodate fusion procedures from one to five levels of the cervical spine. Fixation is achieved by inserting bone screws through the openings in the vertebral bodies of the cervical spine. The Tempus™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. The plates and screws are manufactured from titanium alloy meeting requirements of ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

This document details the performance data for the Tempus™ Cervical Plate System.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the sample size (number of devices tested) for the mechanical tests.
• The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, given that it's a 510(k) submission to the FDA, the testing was conducted to meet US regulatory standards.

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

• This is a mechanical performance study of a physical device, not a diagnostic or AI-driven study involving human interpretation. Therefore, there were no experts used to establish ground truth in the context of clinical interpretation. The "ground truth" for these tests is defined by the ASTM F1717-11 standard and the mechanical properties of the predicate device.

4. Adjudication method for the test set:

• Not applicable as this is a mechanical engineering study, not one requiring expert adjudication of clinical findings.

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

• Not applicable. This is not an AI-driven device or a diagnostic device involving human readers.

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

• Not applicable. This is a physical medical device (cervical plate system), not an algorithm or AI system.

7. The type of ground truth used:

• The "ground truth" for the mechanical testing was established by the ASTM F1717-11 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model and the mechanical performance of the predicate device (Tempus™ Cervical Plate System - K120515). The objective was to demonstrate mechanical equivalence to a previously cleared device under standardized test conditions.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable for the same reason as above.

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The Resolute Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

The Resolute Facet Screw System is comprised of various sized single-use, non-sterile facet screws that are designed to provide bilateral transfacet fixation of the lumbar facet joints. The system consists of titanium alloy (6AL-4v-EU per ASTM F136) screws in fully threaded and partially threaded designs, both of which are cannulated.

This document describes the Resolute™ Facet Screw System, a medical device designed for spinal stabilization, and its regulatory submission (510(k)). The provided text does not describe an AI/ML powered medical device, an imaging device, or a study that uses acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).

Instead, this is a 510(k) summary for a traditional medical implant (facet screw system) where "acceptance criteria" and "performance data" refer to mechanical and material testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested fields regarding AI/ML device performance, reader studies, ground truth establishment, and training sets are not applicable.

Here's an analysis of the provided information in the context of the device:

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

The document states: "Cantilever testing and engineering analysis was completed on the Resolute Facet Screw System." and "No new technical characteristics are being introduced with this product."

This implies that the acceptance criteria for the Resolute™ Facet Screw System would be to meet or exceed the mechanical performance (e.g., stiffness, strength) of the predicate devices (Spineology® Capture™ Facet Screw System (K092464) and NuVasive® Triad® Facet Screw System (K020411)) as demonstrated through cantilever testing and engineering analysis. The specific numerical acceptance criteria (e.g., minimum loads, deflections, fatigue cycles) are not provided in this summary but would have been part of the full submission.

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

For a mechanical device like this, the "test set" would refer to the number of screws or test constructs used in the mechanical testing. This information is not provided in the given 510(k) summary. Data provenance is not applicable for this type of mechanical testing, as it's performed in a laboratory 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):

This question is not applicable. The "ground truth" for a mechanical device is established by physical laws and engineering standards, not expert clinical consensus. The testing would be conducted by engineers in a lab.

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

This question is not applicable. Adjudication methods are used for clinical or diagnostic data, not for mechanical testing of an orthopedic implant.

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. This device is a surgical implant, not an imaging or diagnostic AI device. No reader studies would be performed.

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

This question is not applicable as this is a mechanical medical device, not an AI/ML algorithm.

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

The "ground truth" for this device's performance is based on engineering principles, material science, and relevant ASTM standards for mechanical testing of spinal implants. It's not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This question is not applicable. There is no "training set" for a mechanical medical device in the context of the provided information.

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

This question is not applicable for the same reason as above.

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The Tempus™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 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 Tempus™ Cervical Plate System consists of screws and plates. Screws are available in a variety of diameter-length combinations. Plates are available in a variety of lengths to accommodate fusion procedures from one to five levels of the cervical spine. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Tempus™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate.

The provided text describes the 510(k) summary for the Tempus™ Cervical Plate System. This is a medical device, and the evaluation is for substantial equivalence to predicate devices, not for an AI/ML diagnostic or prognostic system. Therefore, many of the requested categories in the prompt are not applicable to this type of medical device submission.

Here's an attempt to address the prompt based only on the provided text, noting where information is not relevant or available:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable as the study described is a non-clinical, mechanical bench testing study (physical testing of the device), not a study involving patient data or a "test set" in the context of an AI/ML model.

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

This is not applicable. Ground truth for mechanical testing is established by physical measurements against engineering standards and specifications, not by expert human interpretation.

4. Adjudication Method for the Test Set

This is not applicable, as the evaluation is based on mechanical performance data against a standard, not on subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical spinal implant, not an AI/ML system that would assist human readers in image interpretation or diagnosis.

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

This is not applicable. The device is a physical product, not an algorithm. The "standalone" performance here refers to the device's mechanical integrity under various loads, which was indeed tested (as described under "PERFORMANCE DATA").

7. The Type of Ground Truth Used

The ground truth for this medical device study is based on:

• Engineering Standards: Adherence to ASTM F1717–11 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
• Mechanical Properties: The device's ability to withstand specified forces and its static and dynamic mechanical performance as measured by standardized tests.
• Predicate Device Performance: Comparison to the known, accepted mechanical performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of mechanical bench testing for a spinal implant. The "training" in this context would refer to the design and refinement process, which isn't detailed here but doesn't involve a data training set.

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

This is not applicable. There is no "training set ground truth" for this type of device. The design specifications and mechanical properties are engineering-driven.

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