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The CerviFix® System is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Atlantoaxial fracture with instability
• Occipitocervical dislocation
• Revision of previous cervical spine surgery
• Tumors

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws and Nuts
The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system. and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.

Synthes CerviFix® consists of rods, plate/rods, hooks, clamps, screws, nuts, transconnectors and transverse bars. The implants are composed of Titanium or Stainless Steel.

This document is not about a device that uses AI/ML, nor does it describe any study related to device performance in a way that would require acceptance criteria. The document is a 510(k) summary for the Synthes CerviFix® System, a spinal implant system. It primarily discusses the indications for use and substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The concepts of acceptance criteria, device performance studies, test sets, ground truth, expert adjudication, MRMC studies, or training sets are not present in the provided text.

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When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex, 3.5 mm and 4.0 mm (occept 10), components of the Synthes CerviFix™ System are indicating for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• spondylolisthesis
• spinal stenosis
• fracture/dislocation
• atlantoaxial fracture with instability
• occipitocervical dislocation
• revision of previous cervical spine surgery
• tumors

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system, and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.

Synthes CerviFix System consists of rods, plate/rods, hooks, clamps, screws, nuts and transconnectors. The implants are composed of the titanium alloy Ti6Al7Nb (ASTM F1295) or commercially pure grade 4 Titanium (ASTM F67).

The provided text is a 510(k) Summary for the Synthes CerviFix System, a medical device. This document describes the device, its indications for use, classification, and the basis for its substantial equivalence to previously cleared devices.

Crucially, this document is a 510(k) Summary, which is a premarket notification for devices demonstrating substantial equivalence to a predicate device. It is not a clinical study report or a direct description of acceptance criteria and performance data from a specific study designed to "prove the device meets acceptance criteria" in terms of clinical outcomes or diagnostic accuracy.

Therefore, many of the requested elements for describing a study and acceptance criteria (like sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not typically found in a 510(k) Summary for a spinal fixation system.

The "study" mentioned in the document refers to pre-clinical biomechanical testing, which is used to demonstrate that the device's performance is similar to already cleared predicate devices. It does not involve human subjects or diagnostic performance metrics described in the prompt.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document states, "Pre-clinical testing shows the biomechanical performance of the CerviFix System is similar to the performance of previously cleared spinal systems with similar indications."

Reported Device Performance:
The document implies that the pre-clinical biomechanical testing confirmed this "similarity" to predicate devices. However, no specific quantitative performance metrics, test results (e.g., fatigue strength, pull-out strength values), or detailed acceptance limits are provided in this summary. The acceptance criterion is qualitative: "biomechanical performance... similar to... previously cleared spinal systems."

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

• Sample Size: Not applicable/Not specified. The "test set" here refers to the components of the device undergoing pre-clinical biomechanical testing, not a dataset of patient images or clinical cases. The number of implants or test specimens used in the biomechanical testing is not provided.
• Data Provenance: Not applicable/Not specified. This refers to pre-clinical laboratory testing, not human data.

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

• Not applicable. "Ground truth" in the context of diagnostic accuracy or clinical outcomes is not relevant here. The "ground truth" for biomechanical testing would be established by standardized testing methods and engineering principles, not expert clinicians.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (e.g., 2+1) are used for resolving discrepancies in expert interpretations, which is not relevant to pre-clinical biomechanical testing.

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 spinal fixation system, not an AI-powered diagnostic device. No MRMC study or AI assistance is mentioned or relevant to this type of device.

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

• Not applicable. This device is a manual surgical implant, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: For the pre-clinical testing, the "ground truth" implicitly would be established engineering standards, material properties, and comparative biomechanical data from predicate devices. It is not clinical "expert consensus," "pathology," or "outcomes data."

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI algorithm for this device. If interpreted very broadly as the data informing the design, it would be engineering specifications and prior device performance data, but no explicit "sample size" is mentioned.

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

• Not applicable. As above, there is no "training set" in the AI sense. For the design and comparative testing, the "ground truth" (i.e., expected performance benchmarks) would be established by engineering principles, regulatory standards (e.g., ASTM standards for biomechanical testing of spinal implants), and the known performance characteristics of the predicate devices.

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Ask a specific question about this device

Hooks, Plate/Rods, Rods and Screws

When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex, 3.5 mm and 4.0 mm cancellous) components of the Synthes CerviFix™ System are indicating for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as . confirmed by patient history and radiographic studies)
• . spondylolisthesis
• spinal stenosis .
• fracture/dislocation ●
• atlantoaxial fracture with instability
• occipitocervical dislocation ●
• revision of previous cervical spine surgery .
• tumors .

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws and Nuts

The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm and 4.0 mm cancellous, 3.5 mm cortex, 4.0mm and 4.35 expansionhead) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system.

Synthes CerviFix System consists of rods, plate/rods, clamps, screws and nuts. The hooks, clamps, rods and plate/rods are composed of the titanium alloy Ti6Al7Nb (ASTM F1295). The screws are composed of commercially pure grade 4 Titanium (ASTM F67).

This document is a 510(k) summary for the Synthes CerviFix System, a medical device intended to promote fusion of the cervical spine and occipitocervical junction. The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other details typically associated with studies proving device effectiveness as requested.

Instead, it focuses on:

• Device Description: The components and materials of the Synthes CerviFix System.
• Indications for Use: The specific medical conditions for which the device is intended.
• Regulatory Information: A letter from the FDA confirming substantial equivalence to pre-amendment devices and outlining regulatory responsibilities.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and studies, as this information is not present in the provided text.

Ask a specific question about this device

The CerviFix System is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Atlantoaxial fracture with instability
• Occipitocervical dislocation
• Revision of previous cervical spine surgery
• Tumors

The CerviFix Plate/Rods are intended to provide stabilization to promote fusion of the cervical spine and occipitocervical junction (occiput - T3). The screws are limited to occipital fixation only. In addition, the CerviFix Rods are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The CerviFix System can also be linked to the Synthes Universal Spine System using the 3.5/6.0mm parallel connectors from that system.

SYNTHES CerviFix System consists of rods, plate/rods, hooks, bone screws, parallel connectors, trans-connector clamps, parallel connectors and set screws. These components are manufactured from the titanium alloy TiAINb (ASTM F1295). The bone screws are composed of commercially pure grade 4 Titanium (ASTM F67).

The rods are 3.5mm in diameter and are offered in four lengths, 80, 120, 240 and 300mm. The plate/rod is a 3.5 mm or 6.0 mm diameter rod that transitions into a 3.5mm reconstruction plate at the opposite end. Hooks are available in both a left and right configuration to allow bilateral placement of the hook/rod or plate/rod/hook construct. In addition, trans-connector clamps are available in a left and right version. A 3.5mm/3.5mm parallel rod connector is offered with the system. The occipital bone screws are provided in the following configurations: a 3.2mm cortex screw, a 3.5mm cancellous screw, or a 4.0mm cancellous screw.

The device functions as follows: For non occipitocervical fusion, the end of the rod, cut to an appropriate length, is inserted into the rod opening of the hooks and loosely tightened into position with the set screws included in the hooks. The construct is then positioned under the laminae of the spinal segments to be instrumented. Once the construct is compressed together, the set screws are locked down to the rod. For occipitocervical fusion, the plate/rod is bent and cut to an appropriate length. The plate portion of the implant is fixed to the occiput with screws and the rod portion is attached to the cervical spine with hooks. Hooks are available in both right and left opening configurations to allow bilateral placement of the hook/rod construct.

To add a trans-connector construct, a 3.5 mm rod is cut to fit across two longitudinallyplaced 3.5 mm rods. Once the trans-connector clamps are attached to the longitudinal rods and transverse rod, the set screws are locked down to the rods. To use the parallel rod connector, two rods are inserted into the rod openings of the connector and the set screws are locked down to the rods.

The construct can also be linked to the 6.0mm diameter rods of the Universal Spine System (USS) using 3.5mm/6.0mm parallel connectors.

My apologies, but there appears to be a misunderstanding. The provided text is a 510(k) Premarket Notification for a medical device called the "Synthes CerviFix System." This document is a regulatory submission for a device line extension for an orthopedic implant, specifically for spinal fixation.

The request asks for information typically associated with studies proving the performance of an AI/software device against acceptance criteria, such as:

• A table of acceptance criteria and reported device performance (in terms of clinical metrics like sensitivity, specificity, AUC)
• Sample sizes for test sets, data provenance
• Number and qualifications of experts for ground truth
• Adjudication methods
• Multi-reader multi-case comparative effectiveness studies
• Standalone performance
• Type of ground truth (e.g., pathology, outcomes data)
• Sample size and ground truth establishment for training sets

The provided 510(k) document for the Synthes CerviFix System does not contain this type of information. It describes a physical medical device (spinal rods, plates, screws, etc.) and focuses on:

• Device Description: What the components are, their materials, and how they function.
• Indications for Use: The medical conditions the device is intended to treat.
• Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is often done by comparing design, materials, manufacturing processes, and performance characteristics (e.g., mechanical testing).
• Mechanical Testing: The document mentions "Mechanical testing was previously performed in accordance with ASTM standard F1717. This testing documented both static and fatigue performance characteristics and demonstrated that the performance characteristics satisfy the requirements of posterior occipitocervical and upper thoracic (Occiput-T3) fixation." This is the only mention of "testing" and it refers to mechanical (physical) testing of the implant's strength and durability, not clinical performance or diagnostic accuracy of an AI/software.

Therefore, I cannot extract the requested information from the provided text because it is not a study about an AI/software device's performance against clinical acceptance criteria. The document pertains to a physical surgical implant and its mechanical properties.

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Hooks, Plate/Rods, Rods and Screws

When intended to promote fusion of the cervical spine and occipitocervical junction (occiput -T3), the plate/rod, rod, hook and screw (3.2mm cortex, 3.5mm and 4.0mm cancellous) components of the Synthes CerviFix System are indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed . by patient history and radiographic studies)
• spondylolisthesis
• spinal stenosis
• fracture/dislocation .
• atlanto axial fracture with instability
• occipitocervical dislocation .
• revision of previous cervical spine surgery
• . tumors

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods. Clamps and Screws

The rods, clamps and screws are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3)

The use of these screws (3.5mm cancellous, 4.0mm cancellous, 4.0mm and 4.35 expansionhead) is limited to placement in T1 -T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The CerviFix System can also be linked to the Synthes Universal Spinal System using the 3.5/6.0mm parallel connectors from that system.

Synthes CerviFix System consists of rods, plate/rods, clamps and bone screws. The hooks, clamps, rods and plate/rods are composed of the titanium alloy Ti6Al7Nb (ASTM F1295). The screws are composed of commercially pure grade 4 Titanium (ASTM F67).

This K990965 document is a 510(k) summary for the Synthes CerviFix System, a medical device for spinal fusion. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a summary for a 510(k) application, not a clinical trial report.

Based on the provided document, the following information is available or can be inferred:

1. A table of acceptance criteria and the reported device performance:
   Not provided in this 510(k) summary. A 510(k) primarily focuses on demonstrating substantial equivalence to a predicate device, often through comparison of indications for use, technological characteristics, and performance data if available (e.g., mechanical testing for spinal implants). Specific clinical acceptance criteria and performance metrics from a study are typically not included in this type of summary unless they were used for a specific performance test demonstrating equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not provided. This document explicitly states, "The Synthes CerviFix System is substantially equivalent to itself." This implies that the basis for equivalence is likely a modification or rebranding of an existing device, or perhaps a component within an existing system, rather than a de novo clinical study with a test set of human patients. For spinal implants, performance data often comes from mechanical testing, not human clinical trials for a 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   Not applicable, as no clinical test set for ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no clinical test set requiring adjudication is described.

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 device is a mechanical spinal implant, not an AI-driven diagnostic or therapeutic tool for which an MRMC study would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a mechanical spinal implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable, as no clinical study requiring a ground truth is described. For spinal implants, "ground truth" might refer to successful fusion rates observed in clinical use of similar devices, or adherence to biomechanical performance standards, but this document does not detail such studies.

8. The sample size for the training set:
   Not applicable. This device is a mechanical spinal implant, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:
   Not applicable.

In summary:

The provided K990965 document is a regulatory submission demonstrating substantial equivalence for a medical device (spinal implant). It is not a report of a study that establishes acceptance criteria through clinical performance or provides data on device performance against specific criteria, especially not in the context of diagnostic accuracy or AI. The focus is on the device's indications for use and its components, and its substantial equivalence to a predicate device (implicitly, itself, suggesting a modification or re-filing).

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