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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 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 should be packed with autogenous bone graft and implanted via an anterior approach.

The purpose of this submission is to introduce an additional, larger footprint Zero-P spacer, as well as minor modifications to approved labeling.

The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P spacer is composed of PEEK Optima (ASTM F2026-02) with a radiopaque marker (ASTM F136-2a), and a titanium alloy anterior plate and screws (ASTM F F1295-01). The screws are inserted through the plate into the adjacent vertebral bodies and lock securely to the plate using a tapered-thread locking mechanism.

The Synthes Zero-P is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.

The provided text describes a 510(k) summary for the Synthes Zero-P "Large Footprint" intervertebral fusion device.
This document focuses on establishing substantial equivalence to predicate devices based on design and mechanical performance, rather than clinical efficacy studies with specific acceptance criteria as you might see for novel medical diagnostics or AI/ML-driven devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to a 510(k) submission for an intervertebral fusion device like the Synthes Zero-P. These types of studies are typically conducted for different types of devices, such as diagnostic imaging software or AI algorithms, where performance is measured against a ground truth and often involves human readers.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable: This device is an implantable medical device, not a diagnostic or AI/ML device that would typically have a "test set" in the sense of clinical data points for performance evaluation against a ground truth. Performance is demonstrated primarily through non-clinical (benchtop) mechanical testing and comparison to predicate devices.

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

• Not Applicable: See point 2. Ground truth in this context would relate to the established mechanical standards (ASTM F2077) and engineering principles for implant design. The "experts" would be the engineers and biomechanical testing professionals performing and interpreting the tests.

4. Adjudication Method for the Test Set

• Not Applicable: See point 2.

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 an implantable device, not an AI-driven diagnostic tool. An MRMC study is not relevant to its clearance.

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

• Not Applicable: This is an implantable device; there is no algorithm or standalone performance study in this context.

7. The Type of Ground Truth Used

• For the non-clinical performance data, the "ground truth" is based on established engineering standards (ASTM F2077) for static and dynamic mechanical testing of intervertebral body fusion devices, and the mechanical performance characteristics of legally marketed predicate devices.
• For material composition, the ground truth is established by ASTM standards for medical-grade PEEK Optima and titanium alloy (ASTM F2026-02, ASTM F136-2a, ASTM F1295-01).

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" for this device. The design, materials, and mechanical properties are based on well-established engineering principles and existing predicate devices, not machine learning or AI models trained on data.

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

• Not Applicable: See point 8.

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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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The Synthes Zero-P 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-TI. 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 should be packed with autogenous bone graft and implanted via an anterior approach.

The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P is composed of a PEEK (ASTM F2026) spacer with a radiopaque marker (ASTM F136-2a), a titanium alloy anterior plate and screws (ASTM F F1295). The screws are inserted through the plate into the adjacent vertebral bodies and lock securely to the plate using a tapered-thread locking mechanism. The Synthes Zero-P is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions. This line extension covers the addition of sterile screws.

The provided text is a 510(k) summary for the Synthes Zero-P, an intervertebral fusion device. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets them. Instead, it explicitly states:

"Mechanical and clinical data and conclusions were not needed for this device. The enclosed information demonstrates the subject device is as safe, effective and performs as well as the predicate."

Therefore, based on the provided document, I cannot fulfill the request as it asks for information that is not present. The document indicates that a study for acceptance criteria was not required for this specific filing.

Ask a specific question about this device

The Synthes Zero-P 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 should be packed with autogenous bone graft and implanted via an anterior approach.

The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P is composed of a PEEK spacer with a radiopaque marker, a titanium alloy anterior plate and screws. The screws are inserted through the plate into the adjacent vertebral bodies. The screws lock securely to the plate using a tapered-thread locking mechanism. The Synthes Zero-P is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.

This device, the Synthes Zero-P, is an intervertebral fusion device. The provided text indicates that no clinical data was needed for this device. Therefore, a study demonstrating the device meets acceptance criteria via clinical performance data does not exist in this submission as it was not required.

Instead, the performance data cited is non-clinical, specifically "Bench testing results demonstrate that the Synthes Zero-P is substantially equivalent to the predicate devices." This implies that the acceptance criteria for this device were met through demonstrating equivalence in design, function, and materials to already approved predicate devices via non-clinical, benchtop testing, rather than through a clinical study with human subjects.

Given that no clinical study was performed, the following information cannot be provided from this submission:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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