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The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis at the involved level(s). This device is intended to be used with posterior supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The FBC 921™ is a two-part ALIF device consisting of top and bottom components with an integral anterior plate to allow additional fixation. Both the bottom and the top components come in three footprints. The top component comes in three footprints and one size. It has a starting lordosis of 9 degrees. Lordosis for each assembly is adjustable between 9 and 21 degrees. The bottom component includes the height variation. It comes in the three footprints and four heights (8, 10, 12, and 14mm). The device is anchored to the superior and inferior vertebra using three Ø5.5 variable angle screws. The top and bottom components are made of titanium alloy (Ti-6Al-4V) additively manufactured from biocompatible titanium alloy (Ti-6Al-4V) using powder per ASTM F3001 which are then machined to their final geometry. Screws are made from an implant grade titanium alloy (Ti6Al4V ELI) meeting the requirements of ASTM F136. The FBC 921™ is a single-use device delivered sterile (gamma sterilization) and supplied with surgical instruments (reusable - provided non-sterile).

This is a 510(k) summary for a medical device called FBC 921™ (ALIF), an intervertebral body fusion device. The document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in response to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as pass/fail thresholds for specific quantitative metrics that are then directly compared to "reported device performance" in a separate column. Instead, it describes compliance with recognized standards and a general conclusion of meeting or exceeding predicate device performance.

However, based on the non-clinical performance data section, we can infer the types of tests conducted and the implicit acceptance criteria:

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

The document describes non-clinical (mechanical and material) testing. It does not mention a "test set" in the context of patient data or clinical images. The tests performed are on the device itself (e.g., in a lab setting). Therefore, questions regarding data provenance (country, retrospective/prospective) are not applicable here.

• Sample Size for Test Set: Not specified in terms of patient data. For mechanical testing, industry standards typically dictate the number of samples, but specific counts are not provided in this summary.
• Data Provenance: Not applicable as no clinical data is presented.

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

This question is not applicable to this 510(k) summary. This document details non-clinical, mechanical, and material testing of an implantable device to demonstrate substantial equivalence to predicate devices. It does not involve a "test set" in the context of expert-labeled clinical data for an AI/algorithm (which is what this question implies).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This question is not applicable for the same reasons as point 3. There is no clinical test set requiring expert 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 question is not applicable. This is a 510(k) for an implantable medical device (spinal fusion system), not an AI/CADe/CADx device that would assist human readers in interpreting medical images.

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

This question is not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance data, the "ground truth" is defined by established engineering and material science standards (e.g., ASTM standards) and internal protocols, along with the performance characteristics of the predicate devices. The FBC 921™'s performance is compared against these standards and predicate device performance to show it "meets or exceeds" them.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" mentioned or implied, as this is not an AI/machine learning device.

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

This question is not applicable for the same reasons as point 8.

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