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The Reflex™ Anterior Cervical Plate (ACP) System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformities or curvatures (including kyphosis, lordosis or scoliosis), pseudoarthrosis, failed previous fusion and decompression of the spinal cord following total or partial cervical vertebrectomy.

The Reflex " ACP System consists of bone plates and screws. Both components are available in a variety of lengths in order to accommodate patient physiology. The components are fabricated from titanium alloy as described in ASTM F-136, ISO 5832-3 and ASTM F-1813. The implants will be provided non-sterile. The design modification involves changes to the cutting flute, thread design, and color of the 14 mm length screw. In addition, several longer length screws have been added to the system.

Based on the provided text, the document describes a design modification to an existing medical device, the Reflex™ Anterior Cervical Plate System Screws, rather than a study proving the device meets new acceptance criteria. The purpose of this submission (a Special 510(k)) is to demonstrate substantial equivalence to the predicate device, not necessarily to set and meet new performance-based acceptance criteria through a clinical study.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or not provided in this type of regulatory submission because it focuses on demonstrating equivalency through design and material comparisons, often supported by bench testing, rather than a clinical performance study.

Here's a breakdown of the available information:

Description of the Acceptance Criteria and Study:

The document describes a design modification to the Reflex™ Anterior Cervical Plate System Screws. The modifications involve changes to the cutting flute, thread design, and color of the 14mm length screw, and the addition of several longer length screws. The purpose of the submission is to demonstrate "substantial equivalence" to a predicate device.

The "study" conducted for this submission appears to be bench testing rather than a clinical performance study involving patient data or human readers. The statement "Testing has been conducted demonstrating substantial equivalence to the predicate device" refers to such bench testing, which would typically involve mechanical and material property tests to ensure the modified screws perform at least as well as the original design. However, the specific acceptance criteria and detailed results of this testing are not provided in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The document does not explicitly state numerical acceptance criteria for performance outcomes like strength, fatigue life, or screw pull-out force. Instead, it relies on the concept of "substantial equivalence" to an existing predicate device, primarily through material and design comparisons, and general "testing." For a device modification of this nature, acceptance criteria would typically involve demonstrating that the modified components meet or exceed the performance of the original components through mechanical bench testing (e.g., torsion, bending, withdrawal strength, fatigue). However, the details of these tests and their specific acceptance criteria are not included in this 510(k) summary.

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

• Sample Size: Not specified in the provided summary. This type of regulatory submission typically relies on bench testing, where sample sizes are determined by engineering validation protocols (e.g., a certain number of screws per test type for statistical significance). The document does not refer to a "test set" in the context of clinical data.
• Data Provenance: Not applicable in the context of clinical data. Any "testing" would be laboratory/bench testing, not data from a specific country or collected retrospectively/prospectively from patients.

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

• Number of Experts: Not applicable. For a device modification focusing on mechanical properties, ground truth is established through engineering standards, test methods, and potentially comparison to predicate device specifications, rather than expert clinical consensus on patient data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for mechanical device testing for design modifications.

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

• MRMC Study: No. An MRMC study is relevant for evaluating the performance of diagnostic devices often using human readers. This document describes a modification to a spinal implant, which does not involve human readers in the assessment of its primary function.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This concept relates to the performance of AI/algorithms. This document describes a physical medical device (spinal implant), not a software or AI-driven diagnostic.

7. The Type of Ground Truth Used

• Type of Ground Truth: For a physical device design modification, ground truth is typically established through:
  • Engineering Specifications and Standards: Adherence to material standards (ASTM F-136, ISO 5832-3, ASTM F-1813).
  • Mechanical Test Results: Comparison of the modified device's mechanical performance (e.g., strength, fatigue) against the predicate device or established performance requirements.
  • Predicate Device Specifications: The performance and safety profile of the legally marketed predicate device serve as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This concept is for machine learning models.

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

• How Ground Truth Was Established: Not applicable. This concept is for machine learning models.

Summary based on the provided document:

The document is a 510(k) summary for a design modification to a spinal implant. It focuses on demonstrating "substantial equivalence" to a predicate device through material composition and implied mechanical performance testing. The detailed acceptance criteria for this testing, along with specific performance metrics and sample sizes for mechanical tests, are not included in this summary. The concepts of clinical studies, human readers, experts for ground truth, or AI algorithms are not relevant to this particular regulatory submission.

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