Search Results

The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

The DISCOVERY is a cervical interbertebral body fusion device consisting of teeth on the inferior and superior surfaces to prevent back out and migration. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various heights accommodate variability among patients and is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560.

Here's an analysis of the provided 510(k) summary regarding the DISCOVERY cervical intervertebral body fusion device, focusing on its acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical mechanical testing per ASTM F2077 and F2267. These standards typically involve a specific number of test articles for each type of test (e.g., static compression, dynamic compression, torsion, subsidence, expulsion). However, the exact sample sizes (number of devices tested) for these mechanical tests are not explicitly stated in the provided summary.

• Data Provenance: The data is generated from laboratory testing performed by the manufacturer, Intuitive Spine, LLC, to evaluate the physical and mechanical properties of the device. This is a prospective generation of data for the purpose of the 510(k) submission. There is no mention of country of origin for the data other than it being generated by the submitting company.

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

• Not Applicable: For mechanical testing against ASTM standards, the "ground truth" is defined by the performance requirements and test methodologies outlined in those ratified engineering standards. There is no mention or requirement for human experts (e.g., radiologists) to establish ground truth for this type of non-clinical, mechanical performance testing. The "experts" in this context would be the engineers and technicians performing and interpreting the tests according to the ASTM protocols.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods like "2+1" or "3+1" are relevant for tests involving human interpretation or subjective assessments, often in clinical studies or image-reading tasks. For objective mechanical testing against engineering standards, there is no human adjudication process described or typically needed beyond ensuring adherence to test protocols and data analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on mechanical testing and material compatibility, not clinical performance studies involving human readers or cases. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

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

• Not Applicable: This device is a physical medical implant (a cervical interbody fusion device), not a software algorithm or AI-powered diagnostic tool. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

• The ground truth used for the mechanical testing is defined by engineering standards (ASTM F2077, F2267, F2026, F560). These standards specify the test methodologies, acceptance criteria (e.g., load-bearing capacity, fatigue life, material properties), and benchmarks that the device must meet or demonstrate equivalence to.

8. The Sample Size for the Training Set

• Not Applicable: As this is a mechanical medical device, there is no "training set" in the context of machine learning or AI algorithm development. The device itself is manufactured to specifications, and its performance is tested, not "trained."

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

• Not Applicable: Given the absence of a training set, this question is not relevant.

Summary of the Study Proving Acceptance Criteria:

The study that proves the DISCOVERY device meets its acceptance criteria is a series of non-clinical mechanical tests performed in accordance with established ASTM (American Society for Testing and Materials) standards. Specifically, the following tests were conducted:

• ASTM F2077: Standard Test Methods for Intervertebral Body Fusion Devices
• ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

These tests included:

• Static Compression
• Dynamic Compression
• Static Torsion
• Dynamic Torsion
• Subsidence
• Expulsion

Additionally, the material composition (PEEK Optima® LT1 per ASTM F2026) and the tantalum markers (per ASTM F560) were specified and presumably verified to meet those respective standards, forming part of the device's technical specifications and implicitly, its acceptance criteria.

The conclusion drawn from these tests was that "The device functioned as intended and the performance results show that the DISCOVERY is substantially equivalent to the predicate device." This statement indicates that the device met the mechanical and material performance benchmarks required for substantially equivalent claims to the LDR Spine Cervical Interbody Fusion System (K091088).

Ask a specific question about this device