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The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (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 Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have three locking tabs to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters of 4.0mm (Variable Angle Implant Screw and Fixed Angle Implant Screw) and 4.4mm (Rescue Screw) and lengths of 12mm, 14mm and 16mm.

This document is a 510(k) premarket notification for the Asfora Anterior Cervical Plate System. It describes a medical device, and the information requested pertains to the performance evaluation and regulatory approval of AI/ML-driven medical devices. Therefore, a direct extraction of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML device performance is not applicable to this document.

However, I can extract the relevant information about the non-AI device's performance testing as described in the document.

Acceptance Criteria and Device Performance for the Asfora Anterior Cervical Plate System (Non-AI device):

The document does not explicitly present acceptance criteria in a table format with corresponding performance results. Instead, it states that "Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff: Spinal System 510(k)s and ASTM F 1717-14 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose."

The types of tests performed indicate the areas where performance had to be satisfactory to meet the specified standards.

Table of Performance Testing (Interpreted from the document):

Regarding the specific questions about AI/ML device studies:

1. 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 document describes mechanical testing of a medical implant, not an AI/ML device analyzing data.
2. 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. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on data interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is objective physical measurement against established engineering standards (ASTM F 1717-14) and FDA guidance for spinal systems.
7. The sample size for the training set: Not applicable. There is no AI/ML model for which to describe a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary for this document:

The document K143688 is a 510(k) premarket notification for a physical medical device (Asfora Anterior Cervical Plate System), not an AI/ML device. Therefore, the specific questions related to AI/ML device performance evaluation (such as test set sample size, data provenance, expert ground truth, MRMC studies, training set details) are not applicable to the information provided in this regulatory submission.

The "study" proving the device meets acceptance criteria is described as "Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff: Spinal System 510(k)s and ASTM F 1717-14". The acceptance criterion is implied that the device "performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose" as defined by those standards. Specific quantitative results are not included in this summary document.

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The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (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 Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have manual locking mechanisms to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters from 4.0mm to 5.0mm (rescue) and lengths from 14mm to 16mm.

The provided document is a 510(k) summary for the Asfora Anterior Cervical Plate System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with acceptance criteria in the manner of AI/software devices. Therefore, much of the requested information regarding AI device evaluation is not explicitly available in this document.

Here's an attempt to extract and interpret the information based on the context of a medical device submission for a spinal implant:

1. Table of Acceptance Criteria and Reported Device Performance

For mechanical implants like the Asfora Anterior Cervical Plate System, "acceptance criteria" and "reported device performance" are typically defined by compliance with recognized ASTM standards for spinal implants. The document states:

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

• Sample Size for Test Set: Not applicable in the context of this type of mechanical device evaluation. The "test set" would refer to the physical samples of the device and its components used for mechanical testing. The document does not specify the number of individual plates, screws, or constructs tested.
• Data Provenance: The mechanical testing data would be generated from laboratory tests conducted on the physical device prototypes. The country of origin for the testing itself is not specified but would typically occur at the manufacturer's facility or a contract testing lab. This is a prospective evaluation in the sense that the device prototypes were specifically manufactured and tested for this submission.

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

• Number of Experts & Qualifications: Not applicable. For mechanical testing of an orthopedic implant, "ground truth" is not established by human experts in the same way as, for example, image interpretation for an AI algorithm. The "ground truth" would be the engineering specifications and performance standards defined by the ASTM F 1717 standard itself. The engineers and technicians conducting the tests are qualified in mechanical testing.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical test results are typically objective measurements (e.g., load at failure, displacement). There is no "adjudication" in the sense of reconciling differing expert opinions. The test results are compared directly against the performance requirements of the relevant ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• MRMC Study: No. This is a mechanical orthopedic implant, not an AI-powered diagnostic or assistive tool. MRMC studies are specific to evaluating AI algorithms that assist human readers (e.g., radiologists, pathologists).

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

• Standalone Performance: No. This is not an AI algorithm.

7. The Type of Ground Truth Used

• Ground Truth: For the mechanical testing, the "ground truth" is the performance specifications and requirements defined by the ASTM F 1717 standard for spinal intervertebral body fixation orthoses. The device is expected to meet or exceed these established engineering benchmarks.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device. The design and manufacturing processes are based on established engineering principles and materials science, not machine learning.

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

• Ground Truth for Training Set: Not applicable. As there's no training set, there's no ground truth needing to be established for it. The design of such a device relies on accepted biomechanical principles, material properties, and clinical experience, rather than data-driven "ground truth" in the AI sense.

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