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The Reflex™ 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, decompression of the spinal cord following total or partial cervical vertebrectomy, spondylolisthesis and spinal stenosis.

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

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. The implants will be provided non-sterile.

The provided text describes a 510(k) premarket notification for the Reflex™ Anterior Cervical Plate System, focusing on adding indications to the device. However, it does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of AI/ML or a clinical study with human readers and ground truth.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Synthes' Cervical Spine Locking Plate (CSLP) System) through mechanical properties.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The study described is a mechanical test comparing the Reflex ACP System to a predicate device. There is no mention of a "test set" in the context of patient data, nor any data provenance (country of origin, retrospective/prospective).

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

This information is not provided. Ground truth in the context of clinical outcomes or expert consensus is not relevant to the type of study (mechanical testing) described.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods are typically used in clinical studies involving interpretation or outcome assessment, which is not the case here.

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 submission focuses solely on demonstrating substantial equivalence through mechanical testing, not on clinical performance or the impact of AI assistance on human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical implant (anterior cervical plate system), not an AI/ML software device.

7. The Type of Ground Truth Used

The "ground truth" used for this device's evaluation was primarily the mechanical performance and material characteristics of the legally marketed predicate device (Synthes' Cervical Spine Locking Plate (CSLP) System). The stated criterion is "comparable mechanical properties" to the predicate.

8. The Sample Size for the Training Set

This information is not provided. The concept of a "training set" is not applicable to the mechanical testing described for this physical medical device.

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

This information is not provided. The concept of "ground truth for a training set" is not applicable. The basis for comparison was the established mechanical properties of the predicate device.

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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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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.

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

The Reflex ACP System consists of a bone plates (an anti-migration mechanism is preassembled to 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 nonsterile.

The provided text (K010115) is a 510(k) Premarket Notification for the Reflex Anterior Cervical Plate System. This document is a regulatory submission for a medical device and describes its intended use, design, and claim of substantial equivalence to already marketed devices.

However, the 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or clinical effectiveness studies as typically found for AI/imaging devices. Instead, it focuses on demonstrating substantial equivalence through similarities in materials, design, and intended use, and indicates "Testing has been conducted demonstrating substantial equivalence to a currently marked device." Such testing for an implantable device like an anterior cervical plate system would typically involve non-clinical performance testing (e.g., mechanical strength, fatigue, biocompatibility) rather than a clinical study with human readers or AI algorithms.

Therefore, most of the requested information regarding clinical studies, ground truth, expert opinions, sample sizes for test/training sets, or MRMC studies is not applicable to this 510(k) document.

Here's a breakdown of the information that can be extracted or inferred, and what is not present in the document based on your questions:

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

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

• Not applicable for a clinical test set. The "testing" mentioned refers to non-clinical performance (bench testing) to demonstrate substantial equivalence, not a clinical study with a patient test set.
• The document does not provide details on the specifics of this non-clinical testing.

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

• Not applicable. This device is an implant, not a diagnostic tool requiring expert interpretation or ground truth establishment in a clinical sense.

4. Adjudication method for the test set

• Not applicable. See point 3.

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. This is not an AI or diagnostic imaging device.

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

• No. This is not an AI or algorithm device.

7. The type of ground truth used

• Not applicable in the context of clinical "ground truth." For substantial equivalence of an implant, the "ground truth" equates to the established performance characteristics of the predicate device, which would be based on its intended use, materials, design, and previously demonstrated safety and effectiveness (likely through non-clinical testing and clinical history).

8. The sample size for the training set

• Not applicable. This device does not involve an AI algorithm or a training set.

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

• Not applicable. See point 8.

Summary of what the 510(k) document states about "proving" the device meets criteria:

The document states:

• "Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed anterior cervical plate systems."
• "Testing has been conducted demonstrating substantial equivalence to a currently marked device."

This means the device's "acceptance criteria" revolve around demonstrating that it is substantially equivalent to a device already on the market (the predicate device) in terms of its intended use, design, materials, and performance (likely mechanical and biocompatibility). The study proving this involves comparing these aspects of the Reflex Anterior Cervical Plate System to a predicate device and conducting relevant non-clinical tests to show similar performance characteristics. The specific details of these non-clinical tests (e.g., fatigue testing, tensile strength, biocompatibility studies) are not disclosed in this 510(k) summary but would be part of the full 510(k) submission.

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