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The Sypher Spacer System is a standalone intervertebral body fusion system for use in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone) at one or two contiguous levels of the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Supplemental fixation is required whenever fewer than 3 bone screws are utilized.

The Sypher Spacer System is a standalone intervertebral body fusion system intended for the lumbar spine. The Sypher Spacer System implants include cylinder shaped blocks manufactured from PEEK-OPTIMA™ LT1 conforming to ASTM F2026, tantalum markers conforming to ASTM F560, titanium alloy self-tapping, self-drilling bone screws conforming to ASTM F136, and titanium alloy cage lock assemblies conforming to ASTM F136.

The implants are available in a variety of footprints. heights, and lordotic angles. The device features a hollow center to accommodate autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone). The implants have integrated anterior screw holes to allow for medial placement of screws, and a titanium alloy cage lock assembly for securing the screws in place. The superior and inferior surfaces of the implant have a pattern of teeth to prevent movement.

This document is a 510(k) summary for the Sypher Spacer System, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and mechanical testing. As such, the document does not contain the detailed information typically found in an AI/ML device submission regarding acceptance criteria, performance studies involving human readers, or detailed ground truth establishment.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Study Details for the Sypher Spacer System

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "Substantial Equivalence is supported by the results of mechanical testing and Finite Element Analysis (FEA)." However, it does not provide the specific acceptance criteria thresholds or the quantitative results from these tests. It only lists the types of tests performed.

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

This information is not provided in the document. The document describes mechanical testing of a medical device (intervertebral spacer), not an AI/ML diagnostic or predictive tool that would utilize a "test set" in the context of data. The mechanical tests would typically involve a certain number of manufactured units, but this sample size is not disclosed.

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

This information is not applicable/provided. The device is a physical implant, and its performance is assessed through mechanical testing against standards, not by an expert review of a "test set" of patient data for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling of data, which is not relevant to the mechanical testing of a physical device.

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

This information is not applicable/provided. An MRMC study is relevant for AI-powered diagnostic tools to assess the impact on human reader performance. This document describes a physical medical implant, not an AI system.

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

This information is not applicable/provided. The device is a physical intervertebral spacer. It does not have an "algorithm-only" performance as it is not an AI/ML software.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering standards and specifications for mechanical properties and biocompatibility, as evidenced by the mention of ASTM standards (e.g., ASTM F2077, ASTM F560, ASTM F136). The device's design also ensures it can accommodate autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone) for fusion.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is a physical implant and does not involve a "training set" in the context of AI/ML models.

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

This information is not applicable/provided. As above, there is no "training set" for this type of device. The design and manufacturing process would adhere to established quality systems and design controls rather than data-driven ground truth establishment.

Summary of what the document does provide:

• Device Type: Intervertebral body fusion system (Sypher Spacer System).
• Regulatory Status: 510(k) clearance (K181337) based on substantial equivalence.
• Predicate Devices: Biogennix Sypher Spacer System (K141798) as primary, Zimmer Biomet Solitaire (K081395, K081501) and Zimmer Biomet ROI-A® ALIF Cage System (K153495) as reference predicates.
• Performance Study: Mechanical testing including static compression, static shear compression (both per ASTM F2077), expulsion testing (per ASTM Draft Standard F-04.25.02.02), and Finite Element Analysis (FEA).
• Conclusion: The device demonstrated substantial equivalence based on indications for use, technological characteristics, and comparison with predicate devices supported by mechanical testing and FEA.

The provided document is a 510(k) summary for a traditional medical device (implant), not an AI/ML-powered device. Therefore, many of the requested criteria related to AI/ML device validation are not present or applicable.

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