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The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P VA should be packed with autogenous bone graft and implanted via an anterior approach.

The Synthes Zero-P VA is a radiolucent and radiopaque intervertebral body fusion device. The Synthes Zero-P VA is composed of a spacer made from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque marker. The marker allows accurate intra-operative radiographic assessment of the position of the implant. The spacer component is preassembled with a mating titanium alloy (Ti-6Al-7Nb: TAN; ASTM F1295) interbody plate. The device is implanted anteriorly by inserting two screws (TAN) through the plate, one screw per vertebral body. The interbody plate incorporates a lock-catch mechanism in each screw hole comprised of a TAV lock-screw and catch, as well as an Elgiloy (ASTM F1058) spring. The screws offered with the Zero-P VA system are 3.7mm in diameter and are currently offered non-sterile. This line extension covers the addition of sterile-packed screws.

The provided document is a 510(k) summary for the Synthes Zero-P VA device, specifically for an extension covering sterile-packed screws. It describes the device, its intended use, and its equivalence to predicate devices. However, this document states that "Non-clinical performance data and conclusions were not needed for this device" and "Clinical data and conclusions were not needed for this device."

Therefore, the information required to answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document. This 510(k) relies on demonstrating substantial equivalence to previously cleared predicate devices without requiring new performance studies for this specific modification (sterile-packed screws).

To fully answer your questions, one would need to refer to the performance data and studies conducted for the original Synthes Zero-P VA device (K112068) and its earlier versions (K093762, K112459), or if such studies were performed for those previous clearances. This document explicitly states that no new performance data was needed for this particular 510(k) submission.

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The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P VA should be packed with autogenous bone graft and implanted via an anterior approach.

The Synthes Zero-P VA is a radiolucent and radiopaque intervertebral body fusion device. The Synthes Zero-P VA is composed of a spacer made from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque marker. The marker allows accurate intra-operative radiographic assessment of the position of the implant. The spacer component is preassembled with a mating titanium alloy (Ti-6Al-7Nb; TAN; ASTM F1295) interbody plate. The device is implanted anteriorly by inserting two screws (TAN) through the plate, one screw per vertebral body. The interbody plate incorporates a lock-catch mechanism in each screw hole comprised of a TAV lock-screw and catch, as well as an Elgiloy (ASTM F1058) spring. The screws offered with the Zero-P VA system are 3.7mm in diameter.

This document describes the Synthes Zero-P VA device, which is an intervertebral body fusion device. The provided text outlines the device description, indications for use, and a comparison to predicate devices, including performance data. However, this document does not contain information about explicit acceptance criteria for a device's performance with numerical targets or a study validating those criteria in the context of device performance in terms of accuracy or efficacy metrics.

The "Performance Date (Nonclinical and/or Clinical)" section primarily discusses bench testing to demonstrate substantial equivalence to predicate devices in mechanical performance, not clinical outcomes or specific performance criteria like accuracy, sensitivity, or specificity that would be typical for an AI/ML-based device.

Therefore, for the information requested in the prompt:

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

Based on the provided text, there are no explicit "acceptance criteria" for accuracy, sensitivity, specificity, or similar performance metrics as would be found for an AI/ML-based device. The performance data presented is for bench testing to demonstrate substantial equivalence in mechanical properties.

• Static Axial Compression
• Dynamic Axial Compression
• Static Compression Shear
• Dynamic Compression Shear
• Static Torsion
• Dynamic Torsion
• Subsidence

(Conclusions: Substantially equivalent in performance to Synthes Zero-P (K072981), Sulzer BAK™/Cervical IBF (P980048), and Medtronic PEEK Prevail (K073285)). |

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

• Test Set Sample Size: Not applicable. The document describes bench testing of the physical medical device, not a test set of data for an AI/ML system.
• Data Provenance: Not applicable in the context of clinical data. The performance data is from laboratory bench tests.

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

• Not applicable. Ground truth for an AI/ML system is not relevant for this device's submission which focuses on mechanical equivalence.

4. Adjudication method for the test set:

• Not applicable.

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:

• Not applicable. This is a physical intervertebral fusion device, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the bench testing, the "ground truth" would be the engineering specifications and established ASTM standards (ASTM F2077-03 and ASTM F2267-04) that dictate acceptable mechanical performance for intervertebral body fusion devices. This is not "ground truth" in the AI/ML sense.

8. The sample size for the training set:

• Not applicable. The device is not an AI/ML algorithm.

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

• Not applicable.

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