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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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The Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of the lumbar spine (from L2 to S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis 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. The device system is designed for use with supplemental fixation to facilitate fusion.

The Sypher Spacer System implants are cylinder shaped blocks made of PEEK Optima® LT1 (Polyether ether ketone per ASTM F2026), with tantalum alloy radiological position markers (per ASTM F560), titanium alloy self-drilling and self-tapping bone screws (per ASTM F136), and titanium alloy cage lock assemblies (per ASTM F136).

The implants are available in a variety of footprints, heights and lordotic angles. The shape of the Sypher product allows for a larger implant (height and width) to be used allowing for more surface area contact. The Sypher Spacer System is offered in a closed graft space design. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as a titanium alloy cage lock assembly for securing the screws once in place. Additional or other supplemental fixation may be used, as patient needs dictate. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and to prevent movement of the implants. The Sypher Spacer System is intended to be used with autologous bone graft.

The provided text describes the 510(k) premarket notification for the Sypher Spacer System, an intervertebral body fusion device. While it mentions performance testing, it does not include detailed acceptance criteria or a study that specifically proves the device meets those criteria in the way you've outlined.

Here's what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Static axial compression bending per ASTM F2077-11
• Static compressive shear per ASTM F2077-11
• Static subsidence per ASTM F2267-04 and ASTM F2077-11
• Dynamic axial compression per ASTM F2077-11
• Dynamic compressive shear per ASTM F2077-11
• Expulsion per ASTM Draft Standard F-04.25.02.02 |
  | Comparative Strength | The device's strength is considered "substantially equivalent to legally marketed predicate devices." |

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

• Sample Size for Test Set: Not specified. The document only mentions that the device "has been tested" in various modes. It refers to "non-clinical testing," which typically means bench testing or cadaver studies, not human clinical trials.
• Data Provenance: The testing is "non-clinical," implying it was conducted in a laboratory setting, likely in the US where the company and consultants are located. It is not clinical data (retrospective or prospective from patients).

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

• Not applicable. This document describes non-clinical, mechanical performance testing of an implantable medical device, not a diagnostic device or a study requiring expert interpretation of results to establish ground truth. The "ground truth" for mechanical testing is typically the adherence of the device's physical properties to engineering standards and comparison to predicate devices, measured by instruments.

4. Adjudication Method for the Test Set

• Not applicable. As this is mechanical testing, there is no "adjudication method" in the sense of expert consensus on clinical or imaging readings. The results are quantitative measurements against established engineering standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study (MRMC) is typically done for diagnostic devices where human readers interpret images or other data, and the goal is to assess the impact of an AI tool on reader performance. The Sypher Spacer System is an implantable surgical device, not a diagnostic one, and the reported tests are mechanical performance tests.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Not applicable. The Sypher Spacer System is a physical intervertebral fusion device, not a software algorithm. Its "performance" is its mechanical integrity and ability to facilitate fusion when implanted, which is assessed through bench testing and, eventually, clinical outcomes (though clinical trial data is not presented here, as this is a 510(k) submission based on substantial equivalence to predicates).

7. Type of Ground Truth Used

• For the non-clinical mechanical testing, the "ground truth" is defined by established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices, and comparison to the mechanical properties of legally marketed predicate devices. The goal is to demonstrate that the Sypher Spacer System's mechanical characteristics are equivalent or superior to these benchmarks.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of mechanical performance testing of a physical medical device. Training sets are relevant for machine learning algorithms.

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

• Not applicable. As there is no training set.

In summary: The provided document is a 510(k) clearance letter and summary for a physical medical device. It focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical (bench) testing, adherence to material standards, and similar indications for use. It does not contain information about clinical trials, diagnostic performance, or AI algorithms, which are the contexts in which many of your questions would typically apply.

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